ACT, No. 5 OF 2015

5of2015.pdf
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PARLIAMENT OF THE DEMOCRATIC
SOCIALIST REPUBLIC OF
SRI LANKA
NATIONAL MEDICINES REGULATORY
AUTHORITY ACT, No. 5 OF 2015
[Certified on 19th March, 2015]
Printed on the Order of Government
Published as a Supplement to Part II of the Gazette of the Democratic
Socialist Republic of Sri Lanka of March 20, 2015
PRINTEDATTHE DEPARTMENTOFGOVERNMENTPRINTING,SRILANKA
TO BEPURCHASED AT THE GOVERNMENT PUBLICATIONS BUREAU, COLOMBO 5
Price : Rs. 100.00 Postage : Rs. 70.00

National Medicines Regulatory Authority 1
Act, No. 5 of 2015
[Certified on 19th March, 2015]
L.D.—O. 21/2012
AN ACT TO PROVIDE FOR THE ESTABLISHMENT OF A REGULATORY
AUTHORITY TO BE KNOWN AS THE NATIONAL MEDICINES
REGULATORY AUTHORITY WHICH SHALL BE RESPONSIBLE
FOR THE REGULATION AND CONTROL OF, REGISTRATION,
LICENSING, MANUFACTURE, IMPORTATION AND ALL OTHER
ASPECTS PERTAINING TO MEDICINES, MEDICAL DEVICES,
BOARDERLINE PRODUCTS AND FOR THE CONDUCTING OF CLINICAL
TRIALS IN A MANNER COMPATIBLE WITH THE NATIONAL MEDICINES
POLICY; TO PROVIDE FOR THE ESTABLISHMENT OF DIVISIONS OF
THE NATIONAL MEDICINES REGULATORY AUTHORITY
INCLUDING THE MEDICINES REGULATORY DIVISION, MEDICAL
DEVICES REGULATORY DIVISION, BORDERLINE PRODUCTS
REGULATORY DIVISION AND CLINICAL TRIALS REGULATORY
DIVISION; TO ESTABLISH A NATIONAL ADVISORY BODY; TO REPEAL
THE COSMETICS, DEVICES AND DRUGS ACT, NO. 27 OF 1980;
AND FOR MATTERS CONNECTED THEREWITH OR INCIDENTAL
THERETO.
BE it enacted by the Parliament of the Democratic
Socialist Republic of Sri Lanka as follows :-
1. This Act may be cited as the National Short title and
date of
Medicines Regulatory Authority Act, No. 5 of operation.
2015 and shall come into operation on such date as
the Minister may appoint by Order published in
the Gazette (hereinafter referred to as “the appointed
date”).
2—PL 008818—2,950 (02/2015)
2 National Medicines Regulatory Authority
Act, No. 5 of 2015
CHAPTER I
NATIONAL MEDICINES REGULATORY
AUTHORITY
PART I
ESTABLISHMENT OF THE AUTHORITY
Establishment of 2. (1) There shall be established an authority called the
the National National Medicines Regulatory Authority (hereinafter
Medicines
Regulatory referred to as the ‘Authority’).
Authority.
(2) The Authority shall, by the name assigned to it by this
section be a body corporate and shall have perpetual
succession and a common seal and may sue and be sued in
such name.
Objects of the 3. The objects of the Authority shall be to –
Authority.
(a) ensure the availability of efficacious, safe and
good quality medicines, efficacious, safe and
good quality medical devices and efficacious,
safe and good quality borderline products to the
general public at affordable prices;
(b) function as the central regulator for all matters
connected with the registration, licensing,
cancellation of registration or licensing, pricing,
manufacture, importation, storage, transport,
distribution, sale, advertising and disposal of
medicines, medical devices and borderline
products;
(c) ensure that all activities related to registration,
licensing and importation of medicines, medical
devices, borderline products and investigational
medicinal products are carried out in a
transparent, sustainable and equitable manner;
National Medicines Regulatory Authority 3
Act, No. 5 of 2015
(d) encourage the manufacturing of good quality
medicines in Sri Lanka with a view to assuring
the availability of essential medicines at
affordable prices;
(e) promote the safe and rational use of medicines,
medical devices and borderline products by
health care professionals and consumers;
(f) recommend appropriate amendments to relevant
laws pertaining to medicines, medical devices
and borderline products;
(g) educate the general public, health care
professionals and all stakeholders on medicines,
medical devices and borderline products;
(h) regulate the promotion and marketing of
medicines, medical devices and borderline
products;
(i) regulate the availability of the medicines,
medical devices and borderline products;
(j) conduct post marketing surveillance on quality,
safety and adverse reaction of the medicines,
medical devices and borderline products; and
(k) regulate all matters pertaining to the conduct of
clinical trials in Sri Lanka.
4. The Authority shall consist of the following :- Constitution of
the Authority.
(a) ex-officio members –
(i) the Director-General of Health Services;
(ii) the Secretary to the Treasury or his
nominee; and
(iii) the Chief Executive Officer of the
Authority appointed under section 15
who shall function as the Secretary to the
Authority;
4 National Medicines Regulatory Authority
Act, No. 5 of 2015
(b) following persons who shall be appointed by
the Minister, (hereinafter referred to as
“appointed members”) –
(i) four specialist clinicians attached to the
Ministry of Health, representing the
following clinical disciplines, nominated
by their respective professional bodies:-
(A) General Medicine;
(B) General Surgery;
(C) Pediatrics; and
(D) Gynaecology and Obstetrics;
(ii) a Professor in Pharmacology of any
University in Sri Lanka established under
the Universities Act, No.16 of 1978,
appointed in rotation for every three years,
in consultation with the respective Deans
of Faculties of Medicine;
(iii) a Professor or Senior Lecturer in Pharmacy
of any University in Sri Lanka established
under the Universities Act, No.16 of 1978,
appointed in rotation for every three years,
in consultation with the respective Deans
of relevant Faculties;
(iv) four professionals, who have gained
eminence in the fields of management, law,
accountancy or health respectively.
Chairman of the 5. (1) The Minister shall, in consultation with the
Authority.
Authority appoint one of the appointed members to be the
Chairman of the Authority.
National Medicines Regulatory Authority 5
Act, No. 5 of 2015
(2) The Chairman may resign from the office of Chairman
by letter addressed to the Minister and such resignation shall
be effective from the date on which it is accepted by the
Minister.
(3) The Minister may for reasons assigned remove the
Chairman from the office of Chairman.
(4) Subject to the provisions of subsections (2) and (3),
the term of office of the Chairman shall be the period of his
membership of the Authority.
(5) Where the Chairman is temporarily unable to perform
the duties of his office due to ill health, other infirmity,
absence from Sri Lanka or any other cause, the Minister may
appoint any other appointed member to act as Chairman in
addition to his normal duties as an appointed member.
6. (1) The Minister shall, prior to appointing a person Conflict of
as a member of the Authority, satisfy himself that such person interests of the
has no financial or other conflict of interest in the affairs of members.
the Authority, as is likely to affect adversely, the discharging
of his functions as a member of the Authority.
(2) The Minister shall also satisfy himself, from time to
time, that no member of the Authority has since being
appointed acquired any such interest.
(3) The person to be appointed as a member of the
Authority shall be a person who has not been engaged in
any employment or assignment in the pharmaceutical
industry within the period of three years immediately prior
to such appointment.
(4) No person shall engage in any employment or
assisgnment in the pharmaceutical industry within the period
of three years immediately after such person ceased to be a
member of the Authority.
(5) (a) A member of the Authority who is in any way,
directly or indirectly interested in any contract made or
6 National Medicines Regulatory Authority
Act, No. 5 of 2015
proposed to be made by the Authority shall disclose the
nature of his interest at a meeting of the Authority; and
(b) Such disclosure shall be recorded in the minutes of
the Authority and the member shall not participate in any
deliberation or decision of the Authority with regard to that
contract.
(6) Minister may make regulations to further specify and
give effect to the provisions of this section.
(7) For the purposes of this section-
“a member of the Authority” includes the Chairman,
an appointed member and an ex-officio member;
and
“conflict of interest” includes any dealing with any
company or undertaking which engages in
manufacturing, importation, distribution or sale
of medicines, medical devices, borderline products
or investigational medicinal products.
Disqualifications 7. A person shall be disqualified from being appointed
to be a member. or continuing as a member of the Authority, if he –
(a) is or becomes a Member of Parliament, any
Provincial Council or of any Local Authority;
(b) is not, or ceases to be, a citizen of Sri Lanka;
(c) directly or indirectly holds or enjoys any right or
benefit under any contract made by or on behalf of
the Authority;
(d) has any financial or other interest as is likely to
affect prejudicially the discharge by him of his
functions as a member of the Authority;
National Medicines Regulatory Authority 7
Act, No. 5 of 2015
(e) is absent himself from three consecutive meetings
of the Authority;
(f) is under any law in force in Sri Lanka or any other
country, found or declared to be of unsound mind;
(g) is a person who having been declared as insolvent
or bankrupt under any law in force in Sri Lanka or
in any other country, is an undischarged insolvent
or bankrupt; or
(h) is serving or has served a sentence of imprisonment
imposed by any court in Sri Lanka or any other
country.
8. Every ex-officio member of the Authority shall hold Ex-officio
office so long as such officer holds office by virtue of which members.
such officer has been appointed to the Authority.
9. (1) Every appointed member of the Authority shall, Provisions
unless such officer vacates office earlier by death, resignation relating to
appointed
or removal, hold office for a period of three years, and shall members.
be eligible for re-appointment, unless removed on
disciplinary grounds.
(2) The Minister may for reasons assigned remove any
appointed member from office.
(3) Any appointed member may resign from office at any
time by letter addressed in that behalf to the Minister and
such resignation shall take effect upon it being accepted by
the Minister.
(4) (a) In the event of the death, resignation or removal
from office of any appointed member, the Minister may
having regard to the provisions of this Act in relation to the
appointment of that particular appointed member, appoint
another person to act in his place.
8 National Medicines Regulatory Authority
Act, No. 5 of 2015
(b) The Minister shall appoint the member for the
purposes of paragraph (a) within one month of the occurrence
of such vacancy.
(c) The member appointed under paragraph (a) shall hold
office for the unexpired period of the term of office of the
member whom he succeeds.
(5) Where any appointed member is temporarily unable
to perform the duties of his office due to ill health or absence
from Sri Lanka or for any other reason, the Minister may
having regard to the provisions of section 4(b) appoint
another person to act in his place.
(6) Subject to the preceding provisions, an appointed
member may continue to hold office, after lapse of the period
of three years referred to in subsection (1), until
he is reappointed or a new member is appointed by the
Minister.
Meetings of the 10. (1) The Chairman shall preside at every meeting of
Authority.
the Authority. Where the Chairman is absent, the members
present shall elect a Chairman for that meeting from among
themselves.
(2) (a) All matters for decision by the Authority shall be
dealt with at a meeting, of the Authority and shall be
determined by the majority of the members present and
voting.
(b) In the event of an equality of votes on any question
considered at a meeting the Chairman of that meeting shall
have a casting vote in addition to his original vote.
(c) All decisions of the Authority supported by reasons,
shall be in writing and the seal of the Authority affixed
thereto.
National Medicines Regulatory Authority 9
Act, No. 5 of 2015
(3) (a) Any member of the Authority may by written
notice, request the Chairman to call a meeting and the
Chairman shall not otherwise than for justifiable reasons
refuse to do so.
(b) The Chief Executive Officer appointed under section
15 shall summon all meetings of the Authority.
(4) No act, decision or proceeding of the Authority, shall
be deemed to be invalidated by reason only of the existence
of any vacancy of the Authority or any defect in the
appointment of any member thereof.
(5) The quorum for any meeting of the Authority shall be
seven.
(6) Subject to the preceding provisions of this section,
the Authority may regulate the procedure with regard to the
meetings of the Authority and the transaction of business at
such meeting.
11. (1) The seal of the Authority shall be as determined The Seal.
by the Authority.
(2) The seal of the Authority –
(a) may be altered in such manner as may be
determined by the Authority;
(b) shall be in the custody of such person or persons
as the Authority may, determine;
(c) shall not be affixed to any instrument or
document without the sanction of the Authority
and except in the presence of two members of
the Authority, both of whom shall sign the
instrument or document in token of their
presence.
10 National Medicines Regulatory Authority
Act, No. 5 of 2015
(3) The Authority shall maintain a register of documents
to which the seal of the Authority has been affixed.
Authority to 12. (a) The Authority may invite experts on a relevant
invite experts to
subject matter to meetings of the Authority for the purpose
meetings.
of obtaining their views for the effective discharge of the
functions of the Authority.
(b) The Authority shall have the discretion of accepting
or rejecting the views of the experts.
(c) The experts shall have no voting rights.
Remuneration 13. The members of the Authority and the experts may
for attending
be paid such remuneration for attendance at meetings of the
meetings of the
Authority. Authority, as may be determined by the Minister with the
concurrence of the Minister assigned the subject of Finance.
Powers and 14. The powers and functions of the Authority shall be
functions of to :-
theAuthority.
(a) decide on classifying a product as a medicine,
medical device, borderline product or any other
product;
(b) authorize registration and licensing of medicines,
medical devices, borderline products and
investigational medicinal products or cancel or
suspend any such registration or licence in terms of
this Act;
(c) regulate the registration, licensing, manufacture,
importation, storage, re-packing, transportation,
distribution, sale, advertising, promotion, recall and
disposal of medicines, medical devices, borderline
products or investigational medicinal products;
National Medicines Regulatory Authority 11
Act, No. 5 of 2015
(d) authorize registration and regulation of Pharmacies
and medicines stores;
(e) issue licences for manufacture, import, storage,
distribution, transport and sale of medicines,
medical devices, borderline products or
investigational medicinal products and to cancel
such licences in terms of this Act;
(f) appoint sub-committees as may be necessary for
the effective discharge of the functions of the
Authority;
(g) grant approval for the custom clearance of
consignments of medicines, medical devices,
borderline products, raw materials, packing
materials, machinery or laboratory material needed
for local manufacture of medicines, medical
devices, borderline products or investigational
medicinal products subject to the provisions of this
Act and any other written law;
(h) conduct awareness programmes in relation to
medicines, medical devices and borderline products
and post market surveillance on the quality and
safety of medicines, medical devices, borderline
products and investigational medicinal products
which are registered and licensed under this Act;
(i) monitor the registration and licensing process and
the usage of medicines, medical devices, borderline
products or investigational medicinal products
which are registered and licensed under this Act for
adverse reactions through use thereof, and to take
immediate and necessary action in such an instance;
(j) collect data on quantities of medicines, medical
devices, borderline products or investigational
medicinal products imported under licences;
12 National Medicines Regulatory Authority
Act, No. 5 of 2015
(k) collect data on utilization of medicines, medical
devices, borderline products and investigational
medicinal products in Sri Lanka, including data on
expenditure of industry and trade, relating to
promotional activities;
(l) advise the Minister on matters which are required
to be prescribed;
(m) acquire, hold, take or give on lease or hire,
mortgage, pledge, sell or otherwise dispose of, any
movable or immovable property;
(n) charge fees where necessary and appropriate in the
discharge of its functions;
(o) recognize and appoint other local or overseas
laboratories for testing of any medicine, medical
device or borderline product as may be deemed
necessary;
(p) follow Good Regulatory Practices (GRP) as
prescribed in regulations;
(q) determine the initial price of medicines, medical
devices and borderline products and advise the
Minister on subsequent price revisions;
(r) provide information pertaining to the functions of
the Authority to the stakeholders and general
public; and
(s) issue, review and update guidelines,
recommendations, directives and rules as applicable
to medicines, medical devices and borderline
products.
National Medicines Regulatory Authority 13
Act, No. 5 of 2015
PART II
APPOINTMENT OF CHIEF EXECUTIVE OFFICER AND STAFF OF THE
AUTHORITY
15. (1) The Authority shall in consultation with the Appointment of
Minister, appoint to the Staff of the Authority a Chief the Chief
Executive
Executive Officer (hereinafter referred to as the “CEO”) from Officer of the
among persons who hold a postgraduate degree from a Authority.
recognized University in Medicine, Pharmacology,
Pharmacy or any other related discipline with at least five
years management experience at senior executive level.
(2) The CEO shall subject to the general directions and
supervision of the Authority –
(a) be charged with the administration of the affairs of
the Authority including the administration and
control of the staff;
(b) be responsible for the execution of all decisions of
the Authority;
(c) carry out all such functions as may be assigned to
him by the Authority; and
(d) function as the Secretary to the Authority.
(3) The Authority may in consultation with the Minister
remove the CEO from office –
(a) if he becomes permanently incapable of performing
his duties;
(b) if he has done any act which, is of a fraudulent or
illegal character or is prejudicial to the interests of
the Authority; or
14 National Medicines Regulatory Authority
Act, No. 5 of 2015
(c) has failed to comply with any directions issued by
the Authority.
(4) The term of office of the CEO shall be for a period of
three years from the date of appointment and shall be eligible
for re-appointment.
(5) The office of the CEO shall become vacant upon the
death, removal from office under subsection (3) or resignation
by letter in that behalf addressed to the Minister by the holder
of that office.
(6) If any vacancy occurs in the office of the CEO, the
Authority may appoint any other suitable officer of the
Authority to perform the duties of the CEO until an
appointment is made under subsection (1).
Staff of the 16. (1) The Authority may appoint such technical and
Authority. other officers and employees as may be necessary for the
efficient discharge of its functions.
(2) The Authority may, in respect of the officers and
employees appointed to the Authority under subsection (1)-
(a) exercise disciplinary control over or dismiss such
officers and employees;
(b) fix the rates at which such officers and employees
shall be remunerated in keeping with related
guidelines of the Government;
(c) determine the terms and conditions of employment
of such officers and employees; and
(d) establish a staff welfare and social security schemes
for the benefit of such officers and employees and
make contributions to any such schemes.
National Medicines Regulatory Authority 15
Act, No. 5 of 2015
(3) The Authority may make rules in respect of all or any
of the matters referred to in subsections (1) and (2).
(4) The Authority shall not however appoint as an officer
or an employee of the Authority, any person who has been
dismissed from any previous position held by such person
in the public or private sector as an officer or an employee.
17. (1) At the request of the Authority any officer in the Public officers
public service may, with the consent of that officer and the to be appointed
to the Staff of
Secretary to the Ministry under which that officer is
the Authority.
employed, and the Secretary to the Ministry of the Minister
assigned the subject of Public Administration, be
temporarily appointed to the staff of the Authority for such
period as may be determined by the Authority or with like
consent, be permanently appointed to such staff.
(2) Where any officer in the public service is temporarily
appointed to the staff of the Authority, the provisions of
section 14(2) of the National Transport Commission Act,
No.37 of 1991 shall, mutatis mutandis, apply to and in
relation to such officer.
(3) Where any officer in the public service is permanently
appointed to the staff of the Authority, the provisions of
section 14(3) of the National Transport Commission Act,
No.37 of 1991 shall, mutatis mutandis, apply to and in
relation to such officer.
(4) Where any officer or employee of the Department of
Health is appointed to the staff of the Authority, the
provisions of sections 16, 17, 18 and 19 of the National
Aquaculture Development Authority of Sri Lanka Act, No.
53 of 1998 shall mutatis mutandis apply to and in relation
to such officer or employee.
(5) Where the Authority employs any person who has
entered into a contract with the Government by which he
16 National Medicines Regulatory Authority
Act, No. 5 of 2015
has agreed to serve the Government for a specified period,
any period of service with the Authority by that person shall
be regarded as service to the Government for the purpose of
discharging the obligations of such contract.
PART III
FINANCE
Fund of the 18. (1) The Authority shall have its own Fund.
Authority.
(2) There shall be paid into the Fund –
(a) all such sums of money as may be voted upon
from time to time by Parliament for the use of
the Authority;
(b) all such sums of money as may be received by
the Authority by way of charges and levied for
services provided by the Authority under this
Act;
(c) all such sums of money as may be received by
the Authority in the exercise, performance and
discharge of its powers and functions under
this Act;
(d) all such sums of money as may be received by
the Authority by way of loans, donations, gifts
and grants ;
(e) all such sums of money accruing to the credit of
the Authority; and
(f) all such sums of money received by alienating,
leasing or renting of property owned by the
Authority.
National Medicines Regulatory Authority 17
Act, No. 5 of 2015
(3) There shall be paid out of the Fund all such sums of
money required to defray the expenditure incurred by the
Authority in the exercise and performance of its powers and
functions under this Act.
19. The Authority may open and maintain any account Authority to
with any bank as it may think appropriate, and such account maintain
accounts.
shall be operated in accordance with prevailing financial
regulations of the Government pertaining to financial
transactions of public corporations.
20. (1) The financial year of the Authority shall be the Financial year
calendar year. and audit of
accounts.
(2) The Authority shall cause proper books of accounts
to be kept of the income and expenditure, assets and liabilities
and all other financial transactions of the Authority.
(3) For the purpose of presenting a true and fair view of
the financial performance and financial condition of the
Authority, the Authority shall prepare the accounts in
accordance with the Sri Lanka Accounting Standards
adopted by the Institute of Chartered Accountants of Sri
Lanka under the Sri Lanka Accounting and Auditing
Standards Act, No. 15 of 1995.
(4) The provisions of Article 154 of the Constitution
relating to the audit of accounts of public corporations shall
apply to the audit of the accounts of the Authority.
21. Moneys belonging to the Authority may, with the Investment of
approval of the Minister and with the concurrence of the funds.
Minister assigned the subject of Finance, be invested in
Government approved securities.
22. (1) The Authority may, with the written consent of Borrowing
the Minister and the Minister assigned the subject of Finance powers of the
Authority.
and in accordance with the terms of any general authority
given, borrow or obtain on credit terms such sums as the
Authority may require to meet the obligations of the
Authority.
18 National Medicines Regulatory Authority
Act, No. 5 of 2015
(2) The aggregate of the amount outstanding in respect
of any loans raised by the Authority under this section shall
not at any time exceed such amount as may be determined
by the Minister.
PART IV
GENERAL
Annual Report. 23. (1) The Authority shall within six months of the
end of each financial year, submit to the Minister an annual
report of the activities carried on by the Authority during
that financial year, and cause a copy each of the following
documents to be attached to the report –
(a) the audited accounts of the Authority for the year
along with the Auditor-General’s report; and
(b) a report of proposed activities for the year
immediately following, the year to which such
report and accounts relates.
(2) The Minister shall lay copies of the report and
documents submitted under subsection (1) before Parliament
within six months from the date of receipt of such report.
Declaration of 24. Every member of the Authority and all officers and
secrecy. employees of the Authority shall, before entering upon
duties, sign a declaration pledging to observe strict secrecy
in respect of all matters connected with the affairs of the
Authority, which has come to his knowledge in the
performance or exercise of his powers and functions under
this Act and shall by such declaration pledge himself not to
disclose any such matter, except –
(a) when required to do so by a court of law; or
(b) for the purpose of exercising or performing the
powers and functions under this Act or any other
written law.
National Medicines Regulatory Authority 19
Act, No. 5 of 2015
25. (1) The Authority may in writing and subject to Delegation of
such conditions as may be specified therein, delegate to the powers of the
Authority.
CEO and any Head of the relevant division of the Authority
any of its powers or functions and any such person or any
Head of the relevant division shall exercise or perform such
powers or functions in the name and on behalf, of the
Authority.
(2) The Authority may, notwithstanding any delegation
made under subsection (1), by itself exercise or perform any
power or function so delegated and may at any time revoke
any such delegation.
26. (1) The Minister may from time to time, issue to the Directions by
Authority such general or special directions in writing as to the Minister.
the exercise and performance of its powers and functions so
as to ensure the giving proper effect to Government Policy
and it shall be the duty of the Authority to give effect to
such directions.
(2) The Minister may direct the Authority to furnish to
him in such form as he may require, returns, accounts and
any other information relating to the work of the Authority,
and it shall be the duty of the Authority to give effect to
such directions.
27. The CEO and the officers and employees of the Officers and
Authority shall be deemed to be public officers within the employees of
the Authority
meaning of and for the purposes of the Penal Code . deemed to be
public officers.
28. The Authority shall be deemed to be a Scheduled Authority
Institution within the meaning and for the purposes of the deemed to be a
Scheduled
Bribery Act and the provisions of that Act shall be construed
institution.
accordingly.
29. (1) Any expenses incurred by the Authority in any Expenses in suit
suit or prosecution brought by or against it before any Court, or prosecution
to be paid out of
shall be paid out of the Fund of the Authority and any costs
the Fund.
paid to or recovered by the Authority in any such suit or
prosecution shall be credited to the Fund of the Authority.
20 National Medicines Regulatory Authority
Act, No. 5 of 2015
(2) Expenses incurred by any member, the CEO or any
officer or employee of the Authority in any suit or
prosecution brought against him before any Court or
Tribunal in respect of any act which is done or purported to
be done by him under the provisions of this Act or any other
written law or if the court holds that such act was done in
good faith, be paid out of the Fund of the Authority, unless
such expenses are recoverable by him in such suit or
prosecution.
CHAPTER II
NATIONAL ADVISORY COMMITTEE AND
DIVISIONS OF THE AUTHORITY
PART I
ESTABLISHMENT OF NATIONAL ADVISORY
COMMITTEE AND DIVISIONS
Establishment of 30. (1) There shall be established a National Advisory
National Committee, the main function of which shall be to advise
Advisory
Committee and the Minister and the Authority on matters pertaining to
divisions. proper implementation of the National Medicines Policy of
Sri Lanka.
(2) There shall be established divisions of the Authority
including the following divisions-
(i) National Medicine Quality Assurance Laboratory
(NMQAL) which shall be responsible for the
analysing of the quality of any medicine, medical
device or borderline product forwarded by the
Authority.
(ii) Medicines Regulatory Division, which shall be
responsible for regulation and control of all aspects
pertaining to medicines as may be authorized and
directed by the Authority;
National Medicines Regulatory Authority 21
Act, No. 5 of 2015
(iii) Medical Devices Regulatory Division which shall
be responsible for regulation and control of all
aspects pertaining to medical devices as may be
authorized and directed by the Authority;
(iv) Borderline Products Regulatory Division which
shall be responsible for regulation and control of
all aspects pertaining to borderline products as may
be authorized and directed by the Authority;
(v) Clinical Trials Regulatory Division which shall be
responsible for regulation and control of all aspects
pertaining to clinical trials carried out in Sri Lanka
as may be authorized and directed by the Authority;
(vi) Information, Education, Communication and
Research Division which shall be responsible for
educating the people as well as stake holders and
healthcare professionals on rational use of
medicines, medical devices and borderline products
and promoting research into medicines, medical
devices and borderline products as may be
authorized and directed by the Authority;
(vii) Inspectorate and Enforcement Division which shall
be responsible for inspecting and investigating
issues pertaining to proper implementation of the
provisions of this Act as may be authorized and
directed by the Authority;
(viii) Pharmacovigilance Division which shall be
responsible for monitoring and dealing with adverse
drug reaction, quality failure and counterteit
medicines as may be authorized and directed by
the Authority;
(ix) Pharmacies Regulatory Division which shall be
responsible for the regulation and control of
pharmacies in Sri Lanka as may be authorized and
directed by the Authority;
22 National Medicines Regulatory Authority
Act, No. 5 of 2015
(x) Manufacturing Regulatory Division which shall be
responsible for the regulation and promotion of
manufacturing of good quality medicines, medical
devices and borderline products in Sri Lanka; and
(xi) Organization Development Division which shall
be responsible for the Human Resources, Finance,
Administration and Audit of the Authority as may
be authorized and directed by the Authority.
(3) The Authority shall appoint a head to each division
who shall communicate with the Authority on behalf of such
division.
(4) The Authority may where necessary-
(a) establish any other division or sub division;
(b) merge any two or more divisions or discontinue
any division or subdivision.
(5) The Authority shall appoint such number of officers,
employees and advisors as may be necessary for the proper
discharge of the functions of a division or a sub division.
(6) All rules and regulations applicable for the Staff of
the Authority referred to in sections 16 and 17 of this Act
shall be applicable to the officers, advisors and employees
of any division or sub division.
PART II
NATIONAL ADVISORY COMMITTEE
Constitution of 31. (1) The National Advisory Committee shall consist
the National of the following members appointed by the Minister –
Advisory
Committee.
(a) the Director General of Health Services;
National Medicines Regulatory Authority 23
Act, No. 5 of 2015
(b) the Deputy Director General of Health Services
(Laboratory Services);
(c) the Chairman of the Authority;
(d) a nominee from the Secretary to the Treasury;
(e) the Chairman of the State Pharmaceuticals
Corporation of Sri Lanka established under State
Industrial Corporation Act, No. 49 of 1957;
(f) a Professor in Pharmacology in any University in
Sri Lanka established under the Universities Act,
No. 16 of 1978, appointed in consultation with the
respective Deans of the relevant Medical Faculties;
(g) a Pharmacologist from the Ministry of Health
nominated by the Director General of Health
Services;
(h) the President of the Sri Lanka Medical Association
or his nominee;
(i) the President of the Pharmaceutical Society of Sri
Lanka or his nominee;
(j) the Commissioner of Ayurveda or his nominee;
(k) Director General of Customs or his nominee;
(l) a legal officer from the Ministry of Health
nominated by the Secretary;
(m) a representative of the Ceylon College of
Physicians nominated by that College;
(n) a representative of the College of Surgeons of Sri
Lanka nominated by that College;
24 National Medicines Regulatory Authority
Act, No. 5 of 2015
(o) a representative of the College of General
Practitioners of Sri Lanka nominated by that
College;
(p) a representative of the College of Community
Physicians of Sri Lanka nominated by that College;
(q) a representative from the Attorney General’s
Department nominated by the Attorney General;
(r) a representative from the Consumer Affairs
Authority nominated by the Chairman of that
Authority;
(s) a representative of the Sri Lanka Standards
Institution established under the Sri Lanka
Standards Institution Act, No. 6 of 1984, nominated
by the Director General of such Institution;
(t) a representative from a patient interest group
nominated by the Minister of Health;
(u) a representative from the Sri Lanka Pharmaceutical
Manufacturers Association nominated by that
Association;
(v) a representative from the Sri Lanka Chamber of the
Pharmaceutical Industry nominated by such
Chamber;
(w) a representative of the public nominated by the
Minister; and
(x) a representative of the Senaka Bibile
Commemoration Committee.
(2) (a) Every member of the National Advisory Committee
nominated under paragraphs (m), (n), (o), (p), (q), (r), (s),
(t),(u),(v), (w) and (x) of subsection (1) shall, unless earlier
vacates office by resignation, death or removal, hold office
National Medicines Regulatory Authority 25
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for a period of three years from the date of appointment and
shall be eligible for re-appointment.
(b) Every other member of the National Advisory
Committee shall hold office so long as such member holds
office by virtue of which such member has been appointed
to the National Advisory Committee.
32. (1) The Minister shall appoint any member of the Chairman &c.,
of the National
National Advisory Committee as the Chairman of the
Advisory
National Advisory Committee. Committee.
(2) The National Advisory Committee may discharge its
functions notwithstanding any vacancy among its
membership.
(3) The quorum for any meeting of the National Advisory
Committee shall be eleven members.
(4) Subject to the provisions of this Act, the National
Advisory Committee may regulate its own procedure in
regard to its meetings and transactions of business at such
meetings.
33. The members of the National Advisory Committee, Remuneration of
the members of
shall not receive any remuneration for being in the National
the National
Advisory Committee, except an honorarium which may be Advisory
given for attending at the meetings of the National Advisory Committee.
Committee.
34. (a) The Authority shall appoint such number of Appointment of
officers,
officers employees and advisors as may be necessary for the employees &c.
proper discharge of the functions of the National Advisory
Committee.
26 National Medicines Regulatory Authority
Act, No. 5 of 2015
(b) All rules and regulations applicable for the staff of the
Authority referred to in sections 16 and 17 of this Act shall
be applicable to the officers, employees and advisers referred
to paragraph (a).
Functions of the 35. The functions of the National Advisory Committee
National
shall be –
Advisory
Committee.
(a) the overall supervision of the proper
implementation of the provisions of this Act;
(b) the overall supervision of the proper
implementation of the national medicines policy;
and
(c) to advise the Minister and the Authority on issues
pertaining to the matters specified in paragraphs
(a) and (b) and any other related matters.
Regulations. 36. The Minister may make regulations to give effect
to the provisions of this Part of this Act.
Application of 37. The provisions of sections 5, 6, 7, 8, 9, 10, 11, 12
certain
and 13 of this Act shall mutatis mutandis apply to and in
provisions of
this Act in relation to the Chairman, members and the conducting of
relation to the affairs of the National Advisory Committee.
National
Advisory
Committee. PART III
NATIONAL MEDICINES QUALITY ASSURANCE LABORATORY
Establishment of 38. (1) For the purpose of this Act there shall be a
the National
Medicines Division to be known as the National Medicines Quality
Quality Assurance Laboratory (hereinafter referred to as the
Assurance
“NMQAL”).
Laboratory.
National Medicines Regulatory Authority 27
Act, No. 5 of 2015
(2) (a) The National Drug Quality Assurance Laboratory
functioning under the Ministry of the Minister on the day
immediately preceding the appointed date shall, with effect
from the appointed date, be vested with the Authority and
shall be deemed to be the NMQAL for the purposes of this
Act.
(b) All testing assignments and other work assigned to
the National Drug Quality Assurance Laboratory and
pending on the appointed date, shall, with effect from the
appointed date, be carried out and completed by the NMQAL.
(c) Any officer or employee of the National Drug Quality
Assurance Laboratory may, with effect from the appointed
date, be employed in the NMQAL and the provisions of
sections 16, 17, 18 and 19 of the National Aquaculture
Development Authority of Sri Lanka Act, No. 53 of 1998
shall mutatis mutandis apply to and in relation to such officer
or employee.
39. (1) The functions of the NMQAL shall be – Functions of
NMQAL.
(a) the testing of the quality of medicines,
medical devices or borderline products
submitted by the Authority including the
articles –
(i) submitted with the application for
registration;
(ii) collected at the entry to the country;
(iii) submitted as a complaint by users;
(iv) collected during the post marketing
surveillance by the Authority;
28 National Medicines Regulatory Authority
Act, No. 5 of 2015
(v) submitted by the Authority for any
reason other than the reasons specified
above;
(b) to function, as an additional approved
Analyst, when the circumstances so
require;
(c) to coordinate with laboratories local or
overseas when their services are deemed
necessary as decided by the Authority;
(d) to carry out research projects pertaining to
quality assurance of medicines, medical
devices or borderline products.
(2) The NMQAL shall carry out any other functions as
may be requested by the Authority and the Department of
Health through the Authority.
(3) The NMQAL shall carry out any testing or
analysis of an article submitted to the NMQAL strictly
according to the quality and standards guidelines as
may be introduced by the Authority, from time to time.
(4) The NMQAL shall submit the analysis report on
the quality and standards of the article submitted within
the time period stipulated by the Authority.
(5) For the purposes of this part of this Act “article”
includes any article of medicine, medical device,
borderline product or investigational medicinal
product.
Regulations. 40. The Minister may make regulations to give effect
to the provisions of this Part of this Act.
National Medicines Regulatory Authority 29
Act, No. 5 of 2015
CHAPTER III
REGULATION AND CONTROL OF ALL ASPECTS
PERTAINING TO MEDICINES
PART I
MEDICINES REGULATORY DIVISION
41. (1) The Medicines Regulatory Division established Medicines
under section 30(2) shall hereinafter in this Act be referred Regulatory
Division.
to as the MR Division.
(2) The Authority shall appoint the head of the MR
Division from among persons holding a recognized degree
in Medicine, Pharmacology, Pharmacy or any other related
discipline.
42. (a) The principal function of the MR Division shall Functions of the
be to co-ordinate and assist the Authority to regulate and MR Division.
control all aspects pertaining to medicines.
(b) The other functions of the MR Division shall be
the –
(i) co-ordination of applications submitted
for registration of medicines and renewal
of such registration;
(ii) co-ordination of matters pertaining to
cancellation or suspension of registration
of medicines;
(iii) co-ordination of matters pertaining to
registration of importers and distributers
of medicines;
(iv) co-ordination of the issuance of licences
under this section; and

30 National Medicines Regulatory Authority
Act, No. 5 of 2015
(v) provisions of administrative assistance to
the Medicines Evaluation Committee
appointed under section 43 of this Act.
PART II
MEDICINES EVALUATION
Medicines 43. (1) There shall be appointed for the purposes of
Evaluation this Act, a Committee which shall be known as the
Committee.
Medicines Evaluation Committee (hereinafter referred to as
“the MEC”).
(2) (a)The principal function of the MEC shall be to carry
out the technical evaluation of the medicines forwarded for
registration and submit a report in respect thereof to the
Authority.
(b) The report shall specify the benefits and risks attached
to such medicines and the quality, efficacy, safety, need
and cost of such medicines with pharmacoeconomic analysis
where necessary in keeping with the National Medicines
Policy.
Constitution of 44. (1) The MEC shall consist of the following persons
the MEC. who shall be appointed by the Authority –
(a) ex officio members –
(i) the head of the MR Division who shall
function as the Chairman of the Committee;
(ii) the head of the National Medicines Quality
Assurance Laboratory (NMQAL);
(b) nominated members –
(i) four specialist clinicians attached to the
Ministry of Health representing the
following fields, nominated by their
respective professional bodies-
(A) General Medicine;
National Medicines Regulatory Authority 31
Act, No. 5 of 2015
(B) General Surgery;
(C) Pediatrics; and
(D) Gynaecology and Obstetrics;
(ii) a Professor in Pharmacology in University
of Colombo established under the
Universities Act, No. 16 of 1978, nominated
by the Dean of the Faculty of Medicine;
(iii) a Professor or Senior Lecturer in Pharmacy
of any University established under the
Universities Act, No.16 of 1978, nominated
by the Deans of relevant Faculties; and
(iv) a Pharmacist functioning under the
Authority.
(2) The quorum for meetings shall be five members
excluding the members of the Panel of Experts.
(3) The term of office of a nominated member shall be
three years.
45. (1) The Authority shall appoint a Panel of Experts, Panel of
comprising of eminent professionals of medicine and other Experts.
relevant fields.
(2) The Authority may where necessary appoint additional
members to the MEC from the Panel of Experts, depending
on the subject matter dealt with by the MEC.
(3) The members appointed under subsection (2) shall be
present at the meetings for which their presence is required
and express their opinion but they shall have no voting
rights at such meetings.
32 National Medicines Regulatory Authority
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Declaration of 46. Every member of the MR Division and the MEC
secrecy.
and all officers and employees of the MR Division and the
MEC shall, before entering upon duties, sign a declaration
pledging to observe strict secrecy in respect of all matters
connected with the affairs of the MR Division and the MEC,
which has come to his knowledge in the performance or
exercise of his powers and functions under this Act and shall
by such declaration pledge himself not to disclose any such
matter, except –
(a) when required to do so by a court of law; or
(b) for the purpose of exercising or performing the
powers and functions under this Act or any other
written law.
Authority to 47. (1) The Authority shall issue general guidelines to
give general
guidelines for the MEC for the evaluation of medicines and other related
the evaluation. items, submitted to the MEC.
(2) (a) The general guide lines referred to in subsection
(1) shall be based on the Good Manufacturing Practices
(GMP) and other recommendations issued by the World
Health Organization and other regulatory bodies recognized
by the Authority.
(b) The Authority may revise the general guidelines from
time to time in order to maintain parallels with internationally
recognized standards and practices.
(3) The MEC shall take into consideration the efficacy,
safety, quality, need and cost of each medicine, in the process
of evaluation and may consider pharmacoeconomic analysis
where necessary.
National Medicines Regulatory Authority 33
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(4) The Minister may make regulations –
(a) setting out the procedures to be followed,
including the specified time limits, for the
conduct of respective evaluations;
(b) to give effect to the Good Manufacturing
Practices (GMP) guidelines, Good Review
Practices (GRP) and any other applicable
guidelines as may be recommended by the
Authority; and
(c) in respect of bioequivalence and biowaiver
data relating to generic medicines submitted
for evaluation.
48. The provisions of sections 5, 6, 7, 8, 9, 10, 11, 12 Application of
certain
and 13 of this Act shall mutatis mutandis apply to and in
provisions of
respect of the Chairman, members and the conducting of the this Act in
affairs of the MEC. relation to
MEC.
PART III
OFFENCES PERTAINING TO MEDICINE
49. (1) No person shall import, distribute, exhibit or Regulation of
sell any medicine that- manufacture,
importation, sale
and distribution
(a) is manufactured, prepared, preserved, packaged or of medicine.
stored under insanitary conditions;
(b) consists in whole or in part any contaminant or
decomposed substance or any foreign matter;
(c) has in or upon it any deleterious substance that
may cause injury to the health of the user; or
(d) is adulterated.
34 National Medicines Regulatory Authority
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(2) No person shall manufacture, prepare, store, preserve,
package or re-pack any medicine without adhering to Good
Manufacturing Practices (GMP) and any other prescribed
guidelines or conditions.
(3) No person shall import or distribute any medicine
without adhering to Good Distribution Practices (GDP) and
any other prescribed guidelines and conditions.
Labelling, 50. (1) Where the standard is prescribed for any
&c.,to be in medicine, no person shall label, package, sell, exhibit,
conformity with distribute or advertise any medicine which does not conform
the prescribed
to such standard or in such manner as is likely to be mistaken
standards.
for the medicine for which the standard has been prescribed.
(2) Where the standard has not been prescribed for
any medicine, but a standard for that medicine is contained
in any prescribed publication, no person shall label, package,
sell, exhibit, distribute or advertise any medicine which does
not conform to the standard contained in that publication
in such a manner as is likely to be mistaken for the medicine
which the standard is contained in that publication.
(3) Where a standard has not been prescribed for any
medicine, or a standard for that medicine is not contained in
any prescribed publication, no person shall sell, exhibit or
distribute such medicine –
(a) unless it is in conformity with the standard set out
in the label accompanying the medicine; or
(b) in such a manner as is likely to be mistaken for a
medicine for which a standard has been prescribed
or for which a standard is contained in any
prescribed publication.
(4) No person shall label, package, re-pack, treat, process,
sell, distribute, exhibit or advertise any medicine in a manner
that is false, misleading, deceptive or likely to create an
erroneous impression regarding efficacy, quality,
composition or safety.
National Medicines Regulatory Authority 35
Act, No. 5 of 2015
(5) A medicine that is not labeled or packaged in a manner
as may be prescribed shall be deemed to be labeled or
packaged contrary to subsection (1).
51. No person shall sell, exhibit or distribute any Sale of
medicine as may be prescribed unless the premises in prescribed
medicine is
which the medicine was manufactured and the process prohibited
and conditions of manufacture of that medicine have unless premises
been approved in the prescribed form and manner as being and process of
manufacture
suitable to ensure that the medicine will be safe for use.
have been
approved.
52. No person shall sell, exhibit or distribute any Sale of
medicine as may be prescribed unless the batch from which prescribed
medicine
that medicine was taken has been approved in the prescribed prohibited
form and manner as reliable for use. unless the batch
from which such
medicine is
taken approved
as reliable.
53. No person shall manufacture, import, store, sell, Sale &c., of
re-pack, distribute, transport, exhibit or have in his prohibited
medicine.
possession any medicine which is prescribed as not safe
for use.
Possession of
54. No person other than the persons as may be prohibited
permitted by regulations shall obtain or have in his medicine.
possession any medicine restricted or prohibited by
regulations.
55. (1) No person shall advertise or promote Advertising,
any medicine without prior written approval of the Authority. importation,
sale and
distribution
(2) No person shall advertise or promote any medicine of medicine
as treatment
to the general public as a treatment, prevention or cure for
for
any of the prescribed diseases, disorders or abnormal prescribed
physical states. diseases
prohibited.
36 National Medicines Regulatory Authority
Act, No. 5 of 2015
(3) No person shall, without prior written approval of
the Authority, import, sell or distribute any medicine to
the general public as a treatment, prevention or cure for
any of the prescribed diseases, disorders or abnormal
physical states.
Generic name of 56. (1) Every Medical Practitioner, Dentist or Veterinary
a medicine to be Surgeon shall write the generic name of the medicine in
written in the
prescription. every prescription issued by him.
(2) Where the Medical Practitioner, Dentist or Veterinary
Surgeon so requires, he may in addition to the generic name
write a particular brand name of the medicine in the
prescription.
(3) A Medical Practitioner, Dentist or Veterinary
Surgeon may write only the brand name of a medicine in
the prescription where the medicine prescribed is a
combined medicine for which the generic name is not
available.
(4) Where the brand name of the medicines, which is in
the prescription is not available or affordable to the customer,
the Pharmacist may dispense any other generic medicine
with the consent of the customer.
(5) The Pharmacist shall inform the customer the range of
generic medicines with or without brand names available in
the Pharmacy and their prices enabling the customer to buy
the medicine according to his choice.
(6) A Pharmacist who fails to disclose the generic
medicines with or without brand names available in the
Pharmacy and their prices to the customer at the time of sale,
commits an offence.
Contravention 57. Any person who contravenes any of the provisions
of the provisions specified in this Part of this Act commits an offence.
of this Part to be
an offence.
National Medicines Regulatory Authority 37
Act, No. 5 of 2015
PART IV
REGISTRATION AND LICENSING OF MEDICINES
58. (1) No person shall manufacture or import any Requirement to
medicine without registering such medicine with the register &c., of
Authority and obtaining a licence from the Authority medicines.
therefor.
(2) No person shall store, assemble, re-pack, distribute,
transport or sell any medicine without obtaining a licence
for that purpose from the Authority.
(3) Any person who contravenes any of the provisions
specified in subsection (1) or (2) commits an offence.
59. (1) Any person who intends to manufacture or import Application for
any medicine shall make an application for the registration Registration of a
medicine.
of that medicine in the prescribed form to the Authority.
(2) The application shall be accompanied by the
prescribed particulars, the samples of the medicine and the
prescribed fee.
(3) (a) The Authority shall maintain a register in which
every application received for the registration of a medicine
shall be recorded.
(b) The particulars to be entered in such register shall be
as prescribed.
(4) The Authority shall upon receipt of an application
submit that application together with the sample of the
medicine and all particulars, available –
(a) to the MEC, for the evaluation of the application
and the medicine considering the need to ensure
the availability of efficacious, safe and good quality
medicine relevant to the healthcare needs of the
public at an affordable price; and
38 National Medicines Regulatory Authority
Act, No. 5 of 2015
(b) to the NMQAL, for testing of the quality of the
medicine.
(5) The Authority shall inform the applicant in writing
that the application has been received and submitted for
evaluation and testing.
(6) The Minister may make regulations –
(a) setting out the procedures to be followed, by
the MEC and the NMQAL in their respective
evaluation and testing processes;
(b) specifying –
(i) the time-limits in conducting such
testing or evaluation;
(ii) the manner in which the MEC to
conduct its meetings and the procedure
to be followed at such meetings; and
(iii) the matters which should be included
in the reports to be submitted.
(7) (a) The Authority may require the MEC and the
NMQAL to finalize the evaluation or testing of a medicine
within a specified time period considering the urgency of
such medicine for the national health.
(b) The MEC and the NMQAL shall within the time
limits specified submit their reports to the Authority unless
there are compelling reasons for any delay.
Registration of 60. (1) (a) The Authority may where necessary, call for
medicines. clarifications from the MEC, NMQAL or any other expert,
with regard to the reports submitted by the MEC and the
NMQAL.
National Medicines Regulatory Authority 39
Act, No. 5 of 2015
(b) The Authority may upon taking into consideration
the reports submitted by the MEC, NMQAL and all other
relevant factors, register such medicine, or refuse the
registration, within the stipulated time period.
(2) Where the Authority registers the medicine, such
registration shall be informed to the applicant in writing
and may inform the public of such registration by order
published in the Gazette.
61. Where the Authority refuses the registration of the Refusal of
medicine, such refusal shall be communicated to the Registration.
applicant with reasons therefor within the stipulated time
period and shall inform the public of such refusal by order
published in the Gazette.
62. (1) (a) The Authority shall on registration of any Issuing of
medicine, issue a Certificate of Registration to the applicant certificate of
registration.
who shall, hereinafter in this part of this Act, be referred to
as “the holder of certificate”.
(b) The Authority may grant full or provisional registration
in respect of the medicine and the conditions for each type
of registration shall be prescribed.
(c) The period of registration granted shall be decided by
the Authority as appropriate.
(2) The Certificate of Registration shall include the
purpose for which the registration is granted, its period of
validity and the terms and conditions applicable thereto.
(3) Upon obtaining the Certificate of Registration, the
holder of certificate shall enter into an agreement with the
Authority to inform the Authority of any new developments
of the medicine including the changes to indications, side
effects, cautions, contra-indications, new recommendations
by regulatory bodies in other countries, strictures,
cancellations within a stipulated time period upon such facts
and information being revealed.
40 National Medicines Regulatory Authority
Act, No. 5 of 2015
Issuing of 63. (1) The Authority may upon issuing the Certificate
licence. of Registration, and on the written request by the holder of
certificate, issue him a licence to import the medicine and
market the medicine in Sri Lanka.
(2) It shall be the responsibility of the importer to ensure
quality, safety and efficacy of every medicine imported by
him.
Renewal. 64. (1) The holder of certificate may make an
application to the Authority, for renewal of such registration
or the licence six months prior to the date of expiry of such
registration or the licence.
(2) The application for renewal of registration or the
licence shall be in the prescribed form and shall be
accompanied by the prescribed fee.
(3) The Authority shall, upon receiving an application,
submit the application to the MEC for its opinion.
(4) The MEC may, through the Authority, request for
samples, documents or any other evidence, which it deems
necessary, from the applicant or any other person or
institution for the evaluation of the medicine.
(5) The MEC may, where the MEC deems necessary,
request the NMQAL to submit an evaluation report on the
medicine and the NMQAL shall submit the evaluation report
as required by the MEC.
(6) The Authority may upon taking into consideration
all relevant factors, renew the registration or the licence for
a further period of not less than one year and not exceeding
five years.
Cancellation or 65. (1) Where the Authority is of the opinion that –
suspension of
registration and
(a) the holder of certificate has failed to comply with
licence.
any condition subject to which any medicine has
been registered;
National Medicines Regulatory Authority 41
Act, No. 5 of 2015
(b) the medicine does not comply with any prescribed
requirement;
(c) it is not in the public interest that the medicine
shall be available;
(d) the medicine has not been imported to Sri Lanka
within two years from the date of registration;
(e) the holder of certificate has failed to comply with
any direction of the Authority; or
(f) the holder of certificate has violated any provision
of this Act or any regulation made thereunder,
the Authority shall cause notice of cancellation or
suspension to be issued to the holder of certificate in respect
of such medicine.
(2) Any such notice shall specify the grounds on which
the Authority’s opinion is based, and shall indicate that the
holder of certificate may within one month after receipt
thereof submit to the Authority in writing any comments he
may wish to submit.
(3) Where the holder of certificate fails to submit
his comments within the time stipulated therefor or
after consideration of any comments submitted, the
Authority may suspend or cancel the Certificate of
Registration and any related license and inform in
writing the suspension or cancellation to the holder of
certificate immediately.
(4) Where the holder of certificate, does not apply for a
renewal of such Certificate six months before its expiry date,
the registration or licence of the medicine for which such
Certificate relates, shall be deemed to have automatically
been cancelled.
42 National Medicines Regulatory Authority
Act, No. 5 of 2015
CHAPTER IV
REGULATION AND CONTROL OF ALL ASPECTS
PERTAINING TO MEDICAL DEVICES
PART I
MEDICAL DEVICES REGULATORY DIVISION
Medical Devices 66. (1) The Medical Devices Regulatory Division
Regulatory
established under section 30(2) shall hereinafter in this Act
Division.
be referred to as the MDR Division.
(2) The Authority shall appoint the head of the MDR
Division from among persons holding a recognized degree
in Medicine, Pharmacology, Pharmacy or any other related
discipline.
Functions of the 67. (a) The principal function of the MDR Division
MDR Division. shall be to co-ordinate and assist the Authority to regulate
and control all aspects pertaining to medical devices.
(b) The other functions of the MDR Division shall be
the –
(i) co-ordination of applications submitted for
registration of medical devices and renewal of such
registration;
(ii) co-ordination of matters pertaining to cancellation
or suspension of registration of medical devices;
(iii) co-ordination of matters pertaining to registration
of importers and distributers of medical devices;
(iv) co-ordination of the issuance of licences under this
section; and
(v) provisions of administrative assistance to the
Medical Devices Evaluation Committee appointed
under section 68 of this Act.
National Medicines Regulatory Authority 43
Act, No. 5 of 2015
PART II
MEDICAL DEVICES EVALUATION
68. (1) There shall be appointed for the purposes of this Medical Devices
Act a Committee which shall be known as the Medical Evaluation
Committee.
Devices Evaluation Committee (hereinafter referred to as
“the MDEC”).
(2) (a) The principal function of the MDEC shall be to
carry out the technical evaluation of the medical devices
forwarded for registration and to submit a report in respect
thereof to the Authority.
(b) The report shall specify the benefits, risks attached to
such medical devices, and the efficacy, quality, safety, need
and cost of such medical devices with pharmacoeconomic
analysis where necessary in keeping with the National
Medicines Policy.
69. (1) The MDEC shall consist of the following persons Constitution of
who shall be appointed by the Authority- the MDEC.
(a) ex-officio members-
(i) the head of the MDR Division who shall
function as the Chairman of the Committee;
(ii) the Deputy Director General of Laboratory
Services of the Ministry;
(iii) the Deputy Director – General of Dental
Services of the Ministry;
(iv) the Deputy Director – General (Biomedical
Engineering) of the Ministry;
(v) the Head of the National Medicines Quality
Assurance Laboratory (NMQAL);
44 National Medicines Regulatory Authority
Act, No. 5 of 2015
(b) nominated members-
(i) a Professor or a Senior Lecturer in
Pharmacology of any University established
under the Universities Act, No. 16 of 1978,
nominated by the Deans of Medical Faculties
of such Universities;
(ii) a Professor or Senior Lecturer in Pharmacy of
any University in Sri Lanka established under
the Universities Act, No.16 of 1978,
nominated by the Deans of relevant Faculties;
(iii) a Professor or a Senior Lecturer in
Biomedical Engineering from any University
in Sri Lanka established under the Universities
Act, No. 16 of 1978, nominated by the
University Grants Commission;
(iv) the Director of the Sri Lanka Standards
Institute established under the Sri Lanka
Standards Institute Act, No.6 of 1984, or his
nominee;
(v) the Director – General of the Sri Lanka
Atomic Energy Board and the Director-
General of the Sri Lanka Atomic Energy
Regulatory Council appointed under the Sri
Lanka Atomic Energy Act, No. 40 of 2014, or
their nominees;
(vi) a Consultant in Transfusion Medicine,
nominated by the Sri Lanka College of
Transfusion Physicians;
(vii) a Consultant General Surgeon, nominated by
the College of Surgeons of Sri Lanka;
(viii) a Consultant Microbiologist nominated by
the Sri Lanka College of Microbiologists;
(ix) a Consultant Biochemist, nominated by the
Association of Biochemists;
National Medicines Regulatory Authority 45
Act, No. 5 of 2015
(x) a Consultant Anesthesiologist, nominated by
the Sri Lanka College of Anesthesiologists;
(xi) an Oral Maxillo Facial Surgeon, nominated
by the College of Dental Surgeons of Sri
Lanka;
(xii) a Consultant Physician nominated by the
Ceylon College of Physicians;
(xiii) a Consultant Radiologist nominated by the
Sri Lanka College of Radiology; and
(xiv) a Pharmacist in charge of the subject of
medical devices in the Authority nominated
by the Authority.
(2) The quorum for meetings shall be seven members
excluding the members of the Panel of Experts.
(3) The term of office of a nominated member shall be
three years.
70. (1) The Authority shall appoint a Panel of Experts, Panel of
comprising of eminent professionals specialized in medical Experts.
devices.
(2) The Authority may where necessary appoint additional
members to the MDEC from the panel of experts, depending
on the subject matter dealt with by the MDEC.
(3) The members appointed under subsection (2) shall be
present at the meetings for which their presence is required
and express their opinion but they shall have no voting
rights at such meetings.
71. Every member of the MDR Division and the MDEC Declaration of
secrecy.
and all officers and employees of the MDR Division and the
MDEC shall, before entering upon duties, sign a declaration
pledging to observe strict secrecy in respect of all matters
connected with the affairs of the MDR division and the
46 National Medicines Regulatory Authority
Act, No. 5 of 2015
MDEC, which has come to his knowledge in the performance
or exercise of his powers and functions under this Act and
shall by such declaration pledge himself not to disclose any
such matter, except –
(a) when required to do so by a court of law; or
(b) for the purpose of exercising or performing the
powers and functions under this Act or any other
written law.
Authority to 72. (1) The Authority shall issue general guidelines to
give general the MDEC for the evaluation of medical devices and other
guidelines for
the evaluation. related items, submitted to the MDEC.
(2) (a) The general guidelines referred to in subsection
(1) shall be based on the Good Manufacturing Practices
(GMP) guidelines and other recommendations and
guidelines issued or recommended by the Authority.
(b) The Authority may revise the general guidelines from
time to time in order to maintain parallels with internationally
recognized standards and practices.
(3) The MDEC shall take into consideration the efficacy,
safety, quality, need and cost of each medical device or
related item in the process of evaluation and may consider
pharmacoeconomic evaluation where necessary.
(4) The Minister may make regulations –
(a) setting out the procedures to be followed, including
the specified time limits, for the conduct of
respective evaluations;
(b) to give effect to the Good Manufacturing Practices
(GMP) guidelines and any other applicable guide
lines as may be recommended by the Authority;
National Medicines Regulatory Authority 47
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73. The provisions of sections 5, 6, 7, 8, 9, 10, 11, 12 Application of
certain
and 13 of this Act shall mutatis mutandis apply to and in
provisions of
relation to the Chairman, members and the conducting of this Act in
the affairs of the MDEC. relation to
MDEC.
PART III
OFFENCES PERTAINING TO THE MEDICAL DEVICES
74. (1) The Authority shall list from time to time the Prohibition of
medical devices registered under this Act. importation &c.,
of medical
devices other
(2) No person shall import, sell, transport, distribute or than the listed.
advertise any medical device, other than a medical device
listed under subsection (1).
75. (1) No person shall manufacture, prepare, store, Regulation of
preserve, package or re-pack any medical device without manufacture,
importation, sale
adhering to Good Manufacturing Practices (GMP) and any and distribution
other prescribed guidelines or conditions. of medical
devices.
(2) No person shall import or distribute any medical
device without adhering to Good Distribution Practices
(GDP) and any other prescribed guidelines or conditions.
(3) No person shall sell any medical device without
adhering to Good Pharmacy Practices and any other
prescribed guideline or condition.
76. No person shall manufacture, import, assemble, Prohibition of
transport, sell or distribute any medical device that may manufacturing,
importation,
cause any injury to the health of the user when that medical
assembling, sale
device is used— and distribution
&c., of medical
(a) under conditions that are customary or usual in the devices.
use of the medical device; or
(b) according to the directions on the label
accompanying that medical device.
48 National Medicines Regulatory Authority
Act, No. 5 of 2015
Labeling, 77. No person shall label, package, treat, process, sell,
packaging and
assemble, distribute or advertise any medical device in a
advertising of
medical device. manner that is false, misleading, deceptive or likely to create
an erroneous impression regarding its safety and efficacy.
Prescribed 78. Where a standard is prescribed for any medical device,
standards of a no person shall label, package, sell, distribute or advertise
medical device
any medical device which does not conform to that standard
to be
maintained. or in such a manner as is likely to be mistaken for the medical
device for which the standard has been prescribed.
Advertising, 79. (1) No person shall advertise or promote any medical
importation, sale device without prior written approval of the Authority.
and distribution
of medical
(2) No person shall advertise or promote any medical
devices as a
treatment for device to the general public as a treatment, prevention or
prescribed cure for any of the prescribed diseases, disorders or abnormal
diseases physical states.
prohibited.
(3) No person shall without prior written approval of the
Authority import, sell or distribute any medical device to the
general public as a treatment, prevention or cure for any of the
prescribed diseases, disorders or abnormal physical states.
Possession of 80. No person other than the persons as may be permitted
prohibited
by regulations shall obtain or have in his possession any medical
medical devices.
device as may be restricted or prohibited by regulations.
Contravention of 81. Any person who contravenes any of the provisions
the provisions of specified in this Part of this Act commits an offence.
this Part to be an
offence.
PART IV
REGISTRATION AND LICENSING OF MEDICAL DEVICES
Requirement to 82. (1) No person shall manufacture or import any
register &c., of medical device without registering such medical device with
medical devices.
the Authority and obtaining a licence from the Authority
therefor.
(2) No person shall store, assemble, re-pack, distribute,
transport or sell any medical device without obtaining a
licence for that purpose from the Authority.
National Medicines Regulatory Authority 49
Act, No. 5 of 2015
(3) Any person who contravenes any of the provisions
specified in subsection (1) or (2) commits an offence.
83. (1) Any person who intends to manufacture or import Application for
any medical device shall make an application for the Registration of a
Medical device.
registration of that medical device in the prescribed form to
the Authority.
(2) The application shall be accompanied by the
prescribed particulars, the samples of the medical device
and the prescribed fee.
(3) (a) The Authority shall maintain a register in which
every application received for the registration and licensing
of a medical device shall be recorded.
(b) The particulars to be entered in such register shall be
as prescribed.
(4) The Authority shall upon receipt of an application
submit a copy of that application together with the sample
of the medical device and all particulars, available –
(a) to the MDEC, for the evaluation of the application
and the medical device considering the need to
ensure the availability of efficacious, safe and good
quality medical device relevant to the healthcare
needs of the public at an affordable price; and
(b) to the NMQAL, for testing of the quality of the
medical device.
(5) The Authority shall inform the applicant in writing of
the receipt of the application.
(6) The Minister may make regulations –
(a) setting out the procedures to be followed, by the
MDEC and the NMQAL in their respective testing
or evaluation processes;
50 National Medicines Regulatory Authority
Act, No. 5 of 2015
(b) specifying—
(i) the time-limits in conducting such testing or
evaluation;
(ii) the manner in which the MDEC to conduct
its meetings and the procedure to be followed
at such meetings; and
(iii) the matters which should be included in the
reports to be submitted.
(7) (a) The Authority may require the MDEC and the
NMQAL to finalize the evaluation or testing within a
specified time period considering the urgency of the medical
device.
(b) The MDEC and the NMQAL shall within the time
limits specified submit their reports to the Authority unless
there are compelling reasons for any delay.
Registration of 84. (1) (a) The Authority may where necessary, call for
medical devices. clarifications from the MDEC, NMQAL or any other expert,
with regard to the reports submitted by the MDEC and the
NMQAL.
(b) The Authority may upon taking into consideration
the reports submitted by the MDEC, NMQAL and all other
relevant factors register such medical device, or refuse the
registration, within the stipulated time period.
(2) Where the Authority registers the medical device, such
registration shall be informed to the applicant in writing
and may inform the public of such registration by order
published in the Gazette.
Refusal of 85. Where the Authority refuses the registration of the
Registration. medical device, such refusal shall be informed to the
applicant with reasons therefor within the stipulated time
period and shall inform the public of such refusal by Order
published in the Gazette.
National Medicines Regulatory Authority 51
Act, No. 5 of 2015
86. The provisions of sections 62, 63, 64 and 65 of this Application of
Act shall mutatis mutandis apply to and in relation to— the provisions of
sections 62, 63,
64 and 65.
(a) the issuing of certificate of registration;
(b) issuing of licence;
(c) renewal of registration or licence;
(d) cancellation or suspension of registration or licence,
under this part of this Act.
CHAPTER V
REGULATION AND CONTROL OF ALL ASPECTS
PERTAINING TO BORDERLINE PRODUCTS
PART I
BORDERLINE PRODUCTS REGULATORY DIVISION
87. (1) The Borderline Products Regulatory Division Borderline
established under section 30(2) shall hereinafter in this Act Products
Regulatory
be referred to as the BPR Division.
Division.
(2) The Authority shall appoint the head of the BPR
division from among persons holding a recognized degree
in Medicine, Pharmacology, Pharmacy or any other related
discipline.
88. (a) The principal function of the BPR division shall Functions of the
be to co-ordinate and assist the Authority to regulate and BPR Division.
control all aspects pertaining to borderline products.
(b) The other functions of the BPR division shall be the—
(i) co-ordination of applications submitted for
registration of borderline products and
renewal of such registration;
52 National Medicines Regulatory Authority
Act, No. 5 of 2015
(ii) co-ordination of matters pertaining to
cancellation or suspension of registration of
borderline products;
(iii) co-ordination of matters pertaining to
registration of importers and distributers of
borderline products;
(iv) co-ordination of the issuance of licences
under this section;
(v) provisions of administrative assistance to the
Borderline Products Evaluation Committee
appointed under section 89 of this Act.
PART II
BORDERLINE PRODUCTS EVALUATION
Borderline 89. (1) There shall be appointed for the purposes of this
Products
Act a Committee which shall be known as the Borderline
Evaluation
Committee. Products Evaluation Committee (hereinafter referred to as
“the BPEC”).
(2) (a) The principal function of the BPEC shall be to
carry out the technical evaluation of the borderline products
forwarded for registration and submit a report in respect
thereof to the Authority.
(b) The report shall specify the benefits, risks attached to
such borderline products, and the efficacy, quality, safety,
need and cost of such borderline products with
pharmacoeconomic analysis where necessary in keeping with
the National Medicines Policy.
Constitution of 90. (1) The BPEC shall consist of the following persons
the BPEC. who shall be appointed by the Authority—
(a) ex-officio members—
(i) the head of the BPR Division who shall
function as the Chairman of the Committee;
National Medicines Regulatory Authority 53
Act, No. 5 of 2015
(ii) the head of the National Medicines Quality
Assurance Laboratory (NMQAL);
(iii) the Government Analyst or his nominee;
(b) nominated members-
(i) a Professor or a Senior Lecturer in
Pharmacology of any University established
under the Universities Act, No. 16 of 1978,
nominated by the Deans of Medical
Faculties;
(ii) a Professor or a Senior Lecturer in Pharmacy
of any University in Sri Lanka established
under the Universities Act, No.16 of 1978,
nominated by the Deans of relevant Faculties
of such Universities;
(iii) a Pharmacist of the Authority;
(iv) a Nutritionist from the Ministry of Health to
be nominated by the Director General of
Health Services;
(v) the Director of the Sri Lanka Standards
Institute established under the Sri Lanka
Standards Institute Act, No. 6 of 1984 or his
nominee;
(vi) the Director of the Industrial Technology
Institute or his nominee;
(vii) a representative from the Consumer Affairs
Authority established under the Consumer
Affairs Authority Act, No. 9 of 2003
nominated by the Chairman; and
(viii) a representative of Ayurveda Department
nominated by the Commissioner of
Ayurveda.
(2) The quorum for meetings shall be five members
excluding the members of the Panel of Experts.
54 National Medicines Regulatory Authority
Act, No. 5 of 2015
(3) The term of office of a nominated member shall be
three years.
Panel of 91. (1) The Authority shall appoint a Panel of Experts,
Experts. comprising of eminent professionals specialized in
borderline products.
(2) The Authority may where necessary appoint additional
members to the BPEC from the panel of experts, depending
on the subject matter dealt with by the BPEC.
(3) The members appointed under subsection (2) shall be
present at the meetings for which their presence is required
and express their opinion but they shall have no voting
rights at such meetings.
Declaration of 92. Every member of the BPR division and the BPEC
secrecy.
and all officers and employees of the BPR division and the
BPEC shall, before entering upon duties, sign a declaration
pledging to observe strict secrecy in respect of all matters
connected with the affairs of the BPR division and the BPEC,
which has come to his knowledge in the performance or
exercise of his powers and functions under this Act and shall
by such declaration pledge himself not to disclose any such
matter, except—
(a) when required to do so by a court of law; or
(b) for the purpose of exercising or performing the
powers and functions under this Act or any other
written law.
Authority to 93. (1) The Authority shall issue general guidelines to
give general the BPEC for the evaluation of borderline products and other
guidelines for related items, submitted to the BPEC.
the evaluation.
(2) (a) The general guidelines referred to in subsection
(1), shall be based on the Good Manufacturing Practices
(GMP) guidelines and other recommendations issued by the
World Health Organization and other regulatory bodies
recognized by the Authority.
National Medicines Regulatory Authority 55
Act, No. 5 of 2015
(b) The Authority may revise the general guidelines from
time to time in order to maintain parallels with internationally
recognized standards and practices.
(3) The BPEC shall take into consideration the efficacy,
safety, quality, need and cost of each borderline product, in
the process of evaluation.
(4) The Minister may make regulations—
(a) setting out the procedures to be followed, including
the specified time limits for the conduct of
respective evaluations;
(b) to give effect to the Good Manufacturing Practices
(GMP) guidelines and any other applicable guide
lines as may be recommended by the Authority.
94. The provisions of sections 5, 6, 7, 8, 9, 10, 11, 12 Application of
and 13 of this Act shall mutatis mutandis apply to and in certain
provisions of
relation to the Chairman, members and the conducting of this Act in
the affairs of the BPEC. relation to
BPEC.
PART III
OFFENCES PERTAINING TO BORDERLINE PRODUCTS
95. (1) The Authority shall list from time to time the Prohibition of
borderline products registered under this Act. importation &c.,
of borderline
products other
(2) No person shall import, sell, transport, distribute or than listed.
advertise any borderline product, other than a borderline
product listed under subsection (1).
96. (1) No person shall import, distribute, re-pack or Regulation of
sell any borderline product which— manufacture,
importation, sale
and distribution
(a) is not manufactured, prepared, preserved, packaged of borderline
or stored under good manufacturing practices and products.
good storage practices;
56 National Medicines Regulatory Authority
Act, No. 5 of 2015
(b) consists in whole or in part of any contaminant
material, foreign body or decomposed substance
or any foreign matter; or
(c) has in or upon it any substance that may cause
injury to the health of the user when the borderline
product is used—
(i) according to the directions on the label
accompanying the borderline product; or
(ii) for such purposes and by such methods of
use as are customary or usual in the use of
that borderline product.
(2) No person shall label, package, treat, process,
transport, distribute, sell, exhibit or advertise any borderline
product in a manner that is false, misleading, deceptive or
likely to create an erroneous impression regarding its
efficacy, safety, quality or composition.
(3) No person shall manufacture any borderline product
unless Good Manufacturing Practices (GMP) and Good
Storage Practices (GSP) are complied with.
Where standard 97. Where a standard is prescribed for borderline
is prescribed for
product, no person shall label, package, distribute or sell
borderline
products. any such product which does not conform to that standard
or in such a manner as is likely to be mistaken for the
borderline product for which the standard has been
prescribed.
Advertising, 98. (1) No person shall advertise or promote or
importation, sale
distribute any borderline product without prior written
and distribution
of borderline approval of the Authority.
products for
prescribed (2) No person shall advertise or promote any borderline
diseases product to the public as a treatment, prevention or cure for
prohibited.
any of the prescribed diseases, disorders or abnormal physical
states.
National Medicines Regulatory Authority 57
Act, No. 5 of 2015
(3) No person shall without prior written approval of the
Authority import, sell or distribute any borderline product
to the general public as a treatment, prevention or cure for
any of the prescribed diseases, disorder or abnormal physical
states.
99. No person other than the persons as may be Possession of
prescribed by regulations shall obtain or have in his prohibited
borderline
possession any prohibited borderline product which is not
product.
safe for general use.
100. Any person who contravenes any of the provisions Contravention
of the
specified in this Part of this Act commits an offence. provisions of
this Part to be
an offence.
PART IV
REGISTRATION AND LICENSING OF BORDERLINE PRODUCTS
101. (1) No person shall manufacture or import any Requirement to
register &c., of
borderline product without registering such borderline
borderline
product with the Authority and obtaining a licence from the products.
Authority therefor.
(2) No person shall store, assemble, re-pack, distribute,
transport or sell any borderline product without obtaining a
licence for that purpose from the Authority.
(3) Any person who contravenes any provision specified
in subsection (1) or (2) of this section commits an offence.
102. (1) Any person who wishes to import, sell, Application for
manufacture, prepare or distribute any borderline product Registration of a
borderline
shall make an application for the registration of that
product.
borderline product in the prescribed form to the Authority.
(2) The application shall be accompanied by the
prescribed particulars, the samples of the borderline products
and the prescribed fee.
58 National Medicines Regulatory Authority
Act, No. 5 of 2015
(3) (a) The Authority shall maintain a register in which
every application received for the registration and licensing
of a borderline product shall be recorded.
(b) The particulars to be entered in such register shall be
as prescribed.
(4) The Authority shall upon receipt of an application
submit the application together with the sample of the
borderline products and all particulars, available –
(a) to the BPEC, for the evaluation of the application
and the borderline products considering the need
to ensure the availability of efficacious, safe and
good quality borderline products relevant to the
healthcare needs of the public at an affordable price;
and
(b) to the NMQAL or where necessary any other
laboratory for testing of the quality of the borderline
product.
(5) The Authority shall inform the applicant in writing of
the receipt of the application.
(6) The Minister may make regulations –
(a) setting out the procedures to be followed, by the
BPEC and the NMQAL in their respective
evaluation and testing processes;
(b) specifying –
(i) the time-limits in conducting such testing or
evaluation;
(ii) the manner in which the BPEC to conduct its
meetings and the procedure to be followed at
such meetings; and
National Medicines Regulatory Authority 59
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(iii) the matters which should be included in the
reports to be submitted.
(7) (a) The Authority may require the BPEC and the
NMQAL to finalize the testing or evaluation within a
specified time period considering the urgency of the
borderline product for the national health.
(b) The BPEC and the NMQAL shall within the time limits
specified submit their reports to the Authority unless there
are compelling reasons for any delay.
103. (1) (a) The Authority may where necessary, call Registration of
for clarifications from the BPEC, NMQAL or any other borderline
products.
expert, with regard to the reports submitted by the BPEC
and the NMQAL.
(b) The Authority may upon taking into consideration
the reports submitted by the BPEC, NMQAL and all other
relevant factors register such borderline product or refuse
the registration, within the stipulated time period.
(2) Where the Authority registers the borderline product,
such registration shall be informed to the applicant in writing
and may inform the public of such registration by Order
published in the Gazette.
104. Where the Authority refuses the registration of the Refusal of
borderline product, such refusal shall be informed to the Registration.
applicant with reasons therefor within the stipulated time
period and shall inform the public of such refusal by Order
published in the Gazette.
105. The provisions of sections 62, 63, 64 and 65 of Application of
this Act shall mutatis mutandis apply to and in relation to the provisions of
sections 62, 63,
the — 64 and 65.
(i) issuing of certificate of registration;
(ii) issuing of licence;
60 National Medicines Regulatory Authority
Act, No. 5 of 2015
(iii) renewal of registration and licence; and
(iv) cancellation or suspension of registration or licence,
under this part of this Act.
CHAPTER VI
COLLECTIVE PROVISIONS PERTAINING TO
MEDICINES, MEDICAL DEVICES AND
BORDERLINE PRODUCTS
PART I
COMMON PROVISIONS
Prohibition of 106. (1) No person shall store, re-pack, assemble,
dishonest transport, distribute or sell any illegal, counterfeit or
dealings.
smuggled, medicine, medical device or borderline product.
(2) (a) No person shall import, distribute, re-pack, display
or sell any medicine, medical device or borderline product
after the expiry date of such medicine, medical device or
borderline product.
(b) No person shall store any medicine, medical device or
borderline product after the expiry date of such medicine,
medical device or borderline product except under
conditions stipulated by the Authority.
(3) No person shall without lawful authority import, store,
assemble, transport, distribute, re-pack, display or sell any
medicine, medical device or borderline product containing
the State logo or any other mark indicating that such
products are a State property.
Authority to 107. (1) The Authority shall, decide the residual shelf-
decide residual life of every medicine, medical device or borderline product
shelf-life of
medicines &c. imported into Sri Lanka at the port of entry.
National Medicines Regulatory Authority 61
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(2) It shall be the responsibility of the importer to ensure
quality, safety and efficacy of every medicine, medical device
or borderline product imported by him.
108. (1) The Authority shall, where the Authority finds Ban or
that any medicine, medical device or borderline product withdrawal
&c.,from, use of
does not meet the required standard or that the medicine,
medicine &c.
medical device or the borderline product as manufactured
would cause serious health problems to the person using,
issue an order requiring the importer, manufacturer, trader or
distributor of that medicine, medical device or borderline
product to –
(a) cease the distribution immediately;
(b) withdraw from sale or use;
(c) notify immediately the health professionals and
users to cease using of;
(d) dispose according to prescribed methods,
such medicine, medical device or borderline product.
(2) The Authority shall cause notice of the ban or
withdrawal from use of medicine, medical device or
borderline product in terms of this section, to be published
in a daily newspaper in Sinhala, Tamil and English or website
of the Ministry or broadcast over any electronic media.
(3) Any person who contravenes the provisions of
subsection (1) commits an offence and shall on conviction
by a Magistrate’s Court after summary trial, be liable to a
fine not exceeding one million rupees or to an imprisonment
of either description for a period not exceeding three years
or to both such fine and imprisonment.
109. (1) The Authority may grant permission in special Emergency and
other special
circumstances such as to save a life, to control an outbreak
circumstances.
of an infection or an epidemic or any other national
62 National Medicines Regulatory Authority
Act, No. 5 of 2015
emergency or for national security to import and supply a
particular medicine, medical device or borderline product
in specified quantities.
(2) Such permission may be granted:—
(a) on a request made by the Ministry of Health; or
(b) on a request made by an individual or an
organization recommended by the Ministry of
Health.
(3) The importer shall be responsible for the
accountability and management of the medicine, medical
device or borderline product imported under this section.
(4) The importer shall submit routine reports in the
prescribed manner to the Authority, on the medicine, medical
device or borderline product imported under this section.
Sale or 110. (1) (a) No person shall distribute any medicine,
distribution of medical device or borderline product marked as Physician’s
samples of
sample to the general public.
medicine &c., to
be prohibited.
(b) The provisions of paragraph (a) shall not apply to the
distribution of any medicine, medical device or borderline
product marked as physician, sample by a Medical
Practitioner, Dentist or Veterinary Surgeon to a patient of
such Medical Practitioner, Dentist or Veterinary Surgeon.
(2) (a) No person shall transport, exhibit or store any
medicine, medical device or borderline product marked as a
Physician’s sample.
(b) The provisions of paragraph (a) shall not apply to any
representative of a company duly authorized by the
Authority.
(3) No person shall sell any medicine, medical device or
borderline product marked as a physician’s sample.
National Medicines Regulatory Authority 63
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111. (1) Subject to the provisions of subsection (3) no Permission to
person shall import or accept as a donation any medicine, import and to
accept as a
medical device or borderline product for free distribution or
donation of any
to promote within Sri Lanka, without the approval of the medicine &c.
authority.
(2) The provisions of subsection (1) shall apply to the
importation or receiving of medicine, medical device or
borderline product as a donation during an emergency or
disaster situation.
(3) Minister may, prescribe the guidelines, for accepting
donations of medicines, medical devices or borderline
products at any disaster or emergency situation, taking into
consideration the guidelines of the World Health
Organization issued in relation to accepting or receiving
medicines, medical devices or borderline products during
similar situations.
112. (1) The provisions of sections 58, 82 and 101 shall Importation &c.,
not apply to any patient who needs for his personal of medicines
&c., for
medication a medicine, medical device or borderline product
personal use.
which is not registered and licensed under this Act.
(2) Such person may import the required quantity of such
medicine, medical device or borderline product on a
prescription issued by the medical practitioner treating him,
with the prior approval of the Authority.
(3) It shall be an offence to sell any medicine, medical
device or borderline product manufactured or imported under
this section.
113. (1) No person shall manufacture, prepare, store or Licensing of
sell any medicine, medical device or borderline product in premises for
manufacturing
any premises unless such premises has been licensed in that &c., of medicine
regard by the Authority. &c.
(2) (a) No person shall store or sell any medicine, medical
device or borderline product, in any premises unless such
premises has been licensed by the Authority.
64 National Medicines Regulatory Authority
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(b) The provisions of paragraph (a) shall not apply to—
(i) any patient who keeps any medicine,
medical device or borderline product
registered under this Act, for his personal use;
(ii) any medicine, medical device or borderline
product prescribed by regulations as safe for
general use.
(3) The Authority shall maintain a register of registered
manufacturers and importers and the criteria for registering
shall be as prescribed.
Conditions &c., 114. (1) Every licence granted under this Act shall—
pertaining to
licence. (a) be in such form as may be prescribed;
(b) be subject to such conditions as may be prescribed;
(c) unless cancelled earlier, be in force for such period
as may be specified in such licence.
(2) A licence granted under this Act may be suspended or
revoked by the Authority in case of non-compliance with
the prescribed conditions.
(3) An applicant may at any time withdraw an application
for a licence by notifying the Authority in writing, without
prejudice to his right to re-apply for a licence.
PART II
REGULATION OF MANUFACTURING OF MEDICINES, MEDICAL DEVICES
AND BORDERLINE PRODUCTS
Establishment of 115. (1) The Authority shall establish for the purpose
the of this Act a Division to be known as Manufacturing
Manufacturing
Regulatory Division.
Regulatory
Division.
(2) The Authority shall appoint the head of that Division
from among persons holding a recognized degree in
Pharmacology, Pharmacy or any other related subject.
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116. (1) The principal function of the Manufacturing Functions of the
Manufacturing
Regulatory Division shall be the regulation of manufacturing
Regulatory
of medicines, medical devices and borderline products in Division.
Sri Lanka.
(2) The other functions of the Manufacturing Regulatory
Division shall be to—
(a) formulate schemes to provide all necessary
assistance including technical knowhow to the
prospective manufacturers;
(b) provide necessary assistance to the manufacturers
to market their products locally;
(c) provide necessary assistance to manufacturers to
export their products;
(d) advise the Authority to restrict the importation of
certain products where locally manufactured
products are sufficiently available in Sri Lanka.
(3) For the purpose of this section “product” means a
medicine, medical device or borderline product.
117. Minister may make regulations to give effect to Regulations.
all or any of the provisions of this Part of this Act.
PART III
PRICING OF MEDICINES, MEDICAL DEVICES AND BORDERLINE
PRODUCTS
118. (1) (a) The Authority shall appoint a Committee Pricing of
to be known as the Pricing Committee. medicines &c.
(b) The composition, powers and functions of the Pricing
Committee shall be as prescribed.
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(2) (a) The Authority shall in consultation with the Pricing
Committee, determine the introductory price of medicines,
medical devices and borderline products at the time of
registration, based on the criteria as may be prescribed.
(b) For the purpose of paragraph (a), the Authority shall
consider the prevailing market prices of similar products
within the same therapeutic class, International Reference
Prices and other factors as may be prescribed.
(3) For the purpose of determining the prices of New
Chemical Entities, the Authority shall consider the prices in
the region, the benefit of the new product and the cost
effectiveness.
(4) The Minister shall in consultation with the Pricing
Committee, the Consumer Affairs Authority and all
stakeholders and taking into consideration all other relevant
factors including the provisions of the Consumer Affairs
Authority Act, No. 9 of 2003, prescribe a pricing mechanism
for medicines, medical devices and borderline products.
CHAPTER VII
MISCELLANEOUS
PART I
REGULATION OF PHARMACIES
Every person to 119. (1) No person shall carry on a Pharmacy without
carry on a obtaining a licence from the Authority.
Pharmacy to
obtain a licence.
(2) Any person who intends to carry on a Pharmacy shall
make an application for that purpose in the prescribed form
to the Authority.
(3) The application shall contain all such information
and be forwarded with all such documents as may be set out
in such form and be accompanied by the prescribed fee.
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(4) The Authority may on receipt of an application refer
the application to the Pharmacies Regulatory Division for
their observations which shall be submitted within a specified
time period.
(5) The Authority may upon consideration of all records
and information pertaining to the application,
(a) grant the applicant the licence; or
(b) refuse the application and inform the reason for such
refusal to the applicant in writing forthwith.
(6) The holder of a licence shall before the commencement
of the business of a Pharmacy shall register the premises
where the Pharmacy is to be carried on.
(7) The Minister shall by regulations prescribe the terms
and conditions of a licence and the conditions to be satisfied
to register a Pharmacy.
(8) For the purpose of this part of this Act, “holder of
licence” means the person granted a licence to carry on a
Pharmacy under this section.
120. (1) Every person who carries on a Pharmacy shall Requirement to
comply with Good Pharmacy Practices and other guidelines comply with
Good Pharmacy
and conditions prescribed by the Authority.
Practices.
(2) The holder of licence shall employ at least one
Pharmacist in the pharmacy to be responsible for all
operations of the Pharmacy relating to medicines, medical
devices or borderline products.
(3) The dispensing of medicines, medical devices or
borderline products shall be carried out by the Pharmacist or
a registered apprentice Pharmacist under the direct
supervision of the Pharmacist.
(4) The Pharmacist shall before the sale of every medicine,
medical device or borderline product, inform the buyer the
cost of such medicines, medical device or borderline products.
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(5) The Pharmacist shall when dispensing the medicine,
medical device or borderline product provide the customer
with a description of such medicine, medical device or
borderline product, in the language requested for by such
customer.
Regulations. 121. Minister may make regulations to give effect to
all or any of the provisions of this Part of this Act.
PART II
APPEALS
Appeals. 122. (1) (a) Any person aggrieved by any decision of
the Authority made under this Act may appeal in writing to
the Authority to reconsider such decision within one month
of the receipt of such decision.
(b) The Authority shall as soon as practicable inform its
decision on such appeal to the appellant.
(2) Where the appellant is dissatisfied with the decision
of the Authority, the appellant may appeal against such
decision to the Appeals Committee appointed under section
123.
The Appeals 123. (1) The Minister shall appoint an Appeals
Committee.
Committee to hear and determine appeals made in terms of
this Act.
(2) The Appeals Committee shall consist of the
following–
(a) a member appointed from among retired judges of
the Supreme Court or the Court of Appeal of Sri
Lanka who shall be the Chairman of the Appeals
Committee;
(b) the Secretary of Health; and
(c) a member appointed from among retired Medical
Consultants who has distinguished himself in the
field of medicine.

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(3) The members of the Appeals Committee shall hold
office for a term of three years from the date of appointment,
and shall be eligible for reappointment.
(4) The Minister may make regulations specifying the
manner in which the meetings and business of the Appeals
Committee shall be carried out.
(5) The Appeals Committee may, after studying the
appeal, call for further information regarding the medicine,
medical device or borderline product in question from the
appellant and respective Divisions established under this
Act and may call for expert opinion on such medicine,
medical device or borderline product.
(6) The Appeals Committee shall on consideration of all
relevant factors inform its decision to the Authority.
(7) Upon receiving the decision of the Appeals
Committee, the Authority shall inform the appellant the
decision of the Appeals Committee forthwith and act in
accordance with the decision of the Appeals Committee.
(8) The members of the Appeal Committee may be paid
such remuneration out of the Fund of the Authority with the
concurrence of the Minister assigned of the subject of
Finance.
PART III
POWERS AND FUNCTIONS OF THE AUTHORIZED OFFICERS
124. (1) The Minister may appoint any Provincial Authorized
Director of Health Services, any Regional Director of Health Officers.
Services, any Medical Officer of Health, any Divisional
Pharmacist, any Food and Drugs Inspector, Drugs Inspector
or any Pharmacist attached to the Authority to be an
“Authorized Officer” for the purposes of this Act.
(2) Every Authorized Officer shall exercise the powers of
a peace officer in terms of the Code of Criminal Procedure
Act, No. 15 of 1979, for the purpose of discharging his
functions under this Act.
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(3) Any Authorized officer who-
(a) acts in contravention of the provisions of this Act
or any regulation or rule made thereunder or the
provisions of any other written law; or
(b) exercises the powers assigned to him under this
Act in a manner or for an intention contrary to the
objects of this Act, shall after a due inquiry held by
a disciplinary committee appointed by the Minister,
be removed from such office.
(4) The Minister shall by regulations, prescribe the
constitution of the disciplinary committee and manner of
conducting an inquiry.
Powers of 125. (1) An Authorized Officer, for the performance of
Authorized his duties and the exercise of his powers under the Act may-
Officers.
(a) enter at any reasonable hour to any place where he
believes any article is manufactured, prepared,
packaged, re-packed, preserved, sold or stored and
examine any such article and take samples thereof,
and examine anything that he believes is used for
the manufacture, preparation, packaging,
preservation or storing of such article;
(b) open and examine any receptacle or package that
he believes to contain any article;
(c) for the purposes of examining or search, stop or
detain any vehicle in which he believes that any
article is being conveyed, search that vehicle and
examine such article and take samples of the said
article;
(d) examine any book, document or other records
including electronic data found in any place
referred to in paragraph (a) and make copies thereof
or take extracts therefrom; and
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(e) seize and detain for such time as may be necessary,
any article or vehicle by means of or in relation to
which he believes any provisions of this Act or
regulations made thereunder have been
contravened.
(2) An Authorized Officer acting under this section shall
if so required, produce his authority.
(3) The owner or person in charge of a place entered by an
Authorized Officer in pursuance of subsection (1) and every
person found therein shall give the Authorized Officer all
reasonable assistance in his power and furnish him with such
information and such samples as he may require.
(4) No person shall obstruct any Authorized Officer acting
in the exercise of his powers under this Act or any regulation
made thereunder.
(5) Where any Authorized Officer applies to obtain
samples of any article exposed for sale, and the person
exposing the article refuses to sell to the Authorized Officer
such quantity thereof as he may require or refuses to allow
that officer to take the quantity which he is empowered to
take as samples, the person so refusing shall be deemed for
the purposes of subsection (4) to have obstructed an
Authorized Officer.
(6) No person shall knowingly make a false or misleading
statement either orally or in writing to any Authorized Officer
engaged in the exercise of his powers under this Act or any
regulation made thereunder.
(7) No person shall remove or alter, tamper or otherwise
interfere in any manner with any article seized under this
Act by an Authorized Officer, without the authority of the
Authorized Officer.
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(8) Any article seized under this Act may, at the option of
the Authorized Officer, be kept or stored in the building or
place where it was seized or may at his discretion be removed
to any Government Institution functioning under the
Ministry of Health or the Provincial Health Services.
(9) An Authorized Officer shall inform the Authority of
any seizure made under this Act as soon as practicable.
Procedure in 126. (1) Upon the receipt of any information under
respect of section 125 (9) where the Authority is satisfied that there
articles and
vehicles seized. has not been a contravention of any of the provisions of this
Act or any of the regulations made thereunder-
(a) the Authority shall direct the Authorized Officer to
release such article and vehicle;
(b) where the owner of such article or the person in
possession of such article at the time of seizure-
(i) consents in writing for the destruction of
such article, the Authority shall direct
destruction or disposal of such article and
release of the vehicle;
(ii) does not consent in writing to the destruction
of such article, the Authority shall direct the
Authorized Officer, with notice to such person
in possession of the article and the owner of
such vehicle, to make a complaint to the
Magistrate’s court having jurisdiction over
the area in which the offence was committed
of the seizures of the article or the vehicle in
respect of which the offence was committed.
(2) On complaint being made to the court under
subsection (1) (b), such court shall, after trial, if found the
owner or person in possession of the article-
(a) guilty of contravening any of the provisions of this
Act or regulations made thereunder, order that such
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article be forfeited to the Authority to be disposed
of, as the court may direct:
Provided however, that where the offender is
not known or cannot be found, such article shall be
forfeited to the Authority without the institution
of proceedings in respect of such contravention; or
(b) not guilty of contravening any of the provisions of
this Act or regulations made thereunder, order that
such article be released to such owner or person in
possession thereof.
127. (1) Where a sample obtained by an Authorized Authorized
Officer is required to be divided by him into parts, one of Officer to
produce before
which shall be retained by him and the part retained by him
court the part of
shall be produced in court at the commencement of the trial the sample
of the prosecution in relation to such sample. retained by him.
(2) The Magistrate may on his own motion and shall, at
the request of any party to the prosecution, forward for
analysis or examination such part of the sample produced in
court under subsection (1), to the Approved Analyst.
(3) The Approved Analyst to whom such part of the sample
is forwarded under subsection (2) shall send his report or
certificate to the court within twenty eight days of the receipt
by him of such part of the sample.
(4) The expenses of the analysis or examination shall be
paid by such party as the court may direct.
128. A copy made or extract taken from any book, Copy or extract
document or record by an Authorized Officer under section of document
taken by an
125(1) (d) shall, if certified to be a true copy or extract by the Authorized
Authorized Officer, be admissible in evidence against the Officer.
person keeping or maintaining that book, document or record
or causing that book, document or record to be kept or
maintained and shall be prima facie evidence of the contents
of that book, document or record.
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Analysis. 129. (1) An Authorized Officer shall submit any article
seized by him or any portion thereof or any sample taken by
him to the Authority and, unless destroyed under section
126 (1), to the Approved Analyst for analysis or examination,
as decided by the Authority.
(2) Where the Approved Analyst has made an analysis or
examination of the article submitted to him under subsection
(1), he shall issue a certificate or report to the Authority and
to the relevant authorized officer setting out in that certificate
or report the results of his analysis or examination.
(3) For the purposes of this part of this Act-
“Approved Analyst” includes an Additional Approved
Analyst; and
“article” means medicine, medical device or
borderline product.
PART IV
GENERAL OFFENCES
General 130. Every person who—
offences.
(a) being a person acting under the authority of this
Act, discloses any information obtained by him in
or in connection with the exercise of his powers or
the discharging of his functions under this Act, to
any person for any purpose other than a purpose for
which he is authorized to disclose such information;
(b) obstructs, without any justifiable or lawful basis,
any person acting in the exercise of his powers under
this Act or any regulation made thereunder;
(c) being a person acting under the authority of this
Act, behaves or conducts himself in a vexatious or
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provocative manner, while exercising or
discharging any power or function under this Act;
or
(d) fails to furnish any return or information in
compliance with any requirement imposed on him
under this Act or knowingly makes any false
statement in any return or information furnished by
him,
shall be guilty of an offence under this Act.
131. (1) Every person who contravenes any of the Punishment for
provisions of this Act or any regulation made thereunder the
contravention of
shall be guilty of an offence and shall on conviction be the provisions of
liable— this Act.
(a) where the nature of the offence involves injury to
the health of the public, to a fine not exceeding
two hundred thousand rupees or to imprisonment
for a term not exceeding three years or to both
such fine and imprisonment;
(b) for unauthorized use of State logo or any other mark
which indicates that a medicine, medical device or
borderline product to be state property, to a fine
not exceeding one hundred thousand rupees or to
imprisonment for a term not exceeding three years
or to both such fine and imprisonment;
(c) for carrying on a Pharmacy without obtaining a
licence from the Authority, to a fine not exceeding
one hundred thousand rupees or to imprisonment
for a term not exceeding three years or to both
such fine and imprisonment;
(d) for any other offence –
(i) for the first offence, to a fine not exceeding
one hundred thousand rupees or to
76 National Medicines Regulatory Authority
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imprisonment for a term not exceeding three
months or to both such fine and
imprisonment;
(ii) for a second or subsequent offence, to a fine
not exceeding two hundred thousand rupees
or to imprisonment for a term not exceeding
six months or to both such fine and
imprisonment;
(e) to publish an apology in addition to the punishment
mentioned in paragraphs (a), (b), (c) and (d) to the
general public in one Sinhala, Tamil and English
newspaper each, circulating in Sri Lanka
substantially in the size of 10"x 10" in front page
to the effect that he shall not repeat the offence.
(2) Where a person convicted of an offence under this
Act or any regulation made thereunder is convicted of a
second or subsequent, offence of a like or similar nature
under this Act or regulations made thereunder, the court
convicting him for the second or subsequent offence may –
(a) cause the name and address of the person convicted
and the offence and the punishment imposed for
such offence to be published in such newspaper or
in such other manner as the court may direct and
recover the cost of publication from the person
convicted as if it were a fine imposed on him;
(b) cancel any licence or registration issued to the
person convicted for the manufacture, importation,
sale and distribution of any medicine, medical
device or borderline product under this Act or any
other law and inform the relevant licensing
Authority accordingly.
(3) Where a person is convicted of an offence under this
Act or the regulations made thereunder relating to the storage,
sale, distribution and transportation of any illegal,
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unregistered, counterfeit and smuggled medicine, medical
device or borderline product which is marked state logo
or any other marking indicating that such medicine, medical
device or borderline product is state property, the
Magistrate may, in addition to the punishment provided
under this Act, upon application made by an Authorized
Officer for closure of such premises, order the closure of
such premises or discontinuance of trade or business carried
on therein.
(4) Where such person fails to comply with the order
issued under this section, the Magistrate shall forthwith issue
an order to the Fiscal of such Court requiring and authorizing
such Fiscal to close such premises and discontinue the trade
or business carried on therein before a date specified in the
order, not being a date earlier than three days and not later
than seven days from the date of issue of such order.
132. Every person who commits an offence under this Person
Act or any regulation made thereunder may be arrested committing
offence to be
without a warrant and every offence under this Act or arrested without
regulations made thereunder shall be triable by a magistrate a warrant and to
Court. be tried by a
Magistrate’s
Court.
133. (1) Where a person (hereinafter referred to as “the Where the
accused”) is charged with an offence under this Act, he shall, accused proves
that some other
upon complaint duly made by him in accordance with the
person is guilty
provisions of section 136 of the Code of Criminal Procedure of the offence.
Act, No. 15 of 1979, and on giving to the prosecution not
less than three days’ notice of his intention, be entitled to
have any other person whom he charges as the actual offender
brought before the court, and if, after the commission of the
offence has been proved, the accused proves to the
satisfaction of the court that the commission of the offence
was due to the act or default of such other person, such other
person may be convicted of the offence, and, if the accused
further proves that he has used all due diligence to enforce
the provisions of this Act, he shall be acquitted of the offence.
78 National Medicines Regulatory Authority
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(2) Where an accused seeks to avail himself of the
provisions of subsection (1)—
(a) the prosecution, as well as the person whom the
accused charges with being the actual offender, shall
have the right to cross-examine him, if he gives
evidence and any witness called by him in support
of his pleas, and to call evidence in rebuttal; and
(b) the court may make such order as it thinks fit for the
payment of costs by any party to the proceedings
to any other party thereto.
Defence. 134. (1) In a prosecution for the offence of sale of any
medicine, medical device or borderline product contrary to
the provisions of this Act or any regulation made thereunder,
subject to subsection (2) it shall be a defence for the accused—
(a) that he purchased the medicine, medical device or
borderline product in a package and sold it in the
same package and in the same condition that it was
at the time he purchased it; and
(b) that he could not have with reasonable diligence,
ascertained that the sale of the medicine, medical
device or borderline product would be in
contravention of the Act or any regulation made
thereunder.
(2) The defence specified in subsection (1) shall not be
available to an accused unless he has within thirty days of
the detection of the offence informed in writing to the
Authorized Officer detecting the offence—
(a) of his intention to avail himself of such defence;
and
(b) the name and address of the person from whom he
purchased the medicine, medical device or
borderline product and the date of purchase.
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135. (1) For the purposes of this Act and of any Presumptions.
regulations made thereunder—
(a) any medicine, medical device or borderline product
found, kept or exhibited in any shop or other place
commonly used for the sale of articles shall be
presumed until the contrary is proved to be intended
for sale; and
(b) any substance capable of being used in the
composition or preparation of any medicine,
medical device or borderline product which is found
in the premises and used in a preparation shall be
presumed until the contrary is proved, to be intended
for use in the composition or preparation of that
medicine, medical device or borderline product.
(2) Where in a prosecution for the offence of
manufacturing a medicine which is adulterated, it is
established –
(a) that such medicine was adulterated with the
addition of any other substance; and
(b) that the accused had in his possession or premises
such other substance,
it shall be presumed until the contrary is proved that such
medicine was adulterated by the addition of that other
substance.
(3) Where a package containing any medicine, medical
device or borderline product has on or upon it the name and
address purporting to be the name or address of the person
who manufactured or packaged it, it shall be presumed until
the contrary is proved that the medicine, medical device or
borderline product was manufactured or packaged, as the
case may be, by the person whose name or address appears
on the package.
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Offence 136. Where an offence under this Act or any regulation
committed by made thereunder is committed by a body of persons and-
body of persons.
(a) if that body of persons is a body corporate, every
person who at the time of commission of the offence
was a Director, General Manager, Secretary or other
similar officer of that body; or
(b) if that body is not a body corporate, every person
who at the time of commission of the offence was a
member of that body,
shall be deemed to be guilty of that offence, unless he proves
that such offence was committed without his consent or
concurrence and that he exercised all due diligence to
prevent the commission of such offence as he ought to have
exercised in the circumstances having regard to the nature
of his functions.
PART V
GENERAL
Approved 137. (1) For the purposes of this Act and the regulations
Analyst. made thereunder the Government Analyst shall be the
Approved Analyst.
(2) The NMQAL and the Medical Research Institute shall
be the Additional Approved Analysts.
(3) Notwithstanding the provisions of subsections (1) and
(2), the Minister may approve any other laboratory or
institution recommended by the Authority to be an
Additional Approved Analyst and notification of the
approval shall be published in the Gazette.
(4) No person, laboratory or institution shall be approved
as an Additional Approved Analyst-
(a) if that person, the laboratory or institution does
not possess the prescribed qualifications or facilities
as the case may be; or
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(b) if that person is engaged directly or indirectly in
any trade or business connected with the
manufacture, importation, sale or distribution of
medicine, medical device or borderline product.
138. (1) In the absence of evidence to the contrary, a Report or
document purporting to be a report or a certificate signed by certificate of the
Approved
the Approved Analyst or an Additional Approved Analyst Analyst or an
upon any matter submitted to him for analysis or examination Additional
shall be sufficient evidence of the facts stated therein. Approved
Analyst.
(2) When a party against whom a report or a certificate
referred to in subsection (1) is produced, requests the
Approved Analyst or an Additional Approved Analyst, to
be summoned as a witness, the court shall summon him,
upon that party depositing in court the expenses of
summoning him including such fees as may be prescribed,
payable to him and shall examine him as witness.
(3) The report or the certificate referred to in subsection (1)
shall not be received in evidence unless the party intending
to produce it has given the party against whom it was intended
to be produced a copy of the report or the certificate and
reasonable notice of his intention to produce it.
139. Every Court shall give priority to the trial of any Priority for trial
person charged with, or indicted for, any offence under this and appeal
under this Act.
Act and to the hearing of any appeal from the conviction of
any such offence and sentence imposed on such conviction.
140. (1) The provisions of this Act and any regulation Application of
made thereunder relating to medicine which are excisable other written
laws.
articles within the meaning of the Excise Ordinance
(Chapter 52) shall be in addition to and not in substitution
for the provisions of that Ordinance.
(2) The provisions of the Customs Ordinance (Chapter
235) shall apply for the purpose of the enforcement, and the
prevention and punishment of contraventions or attempted
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contraventions of the provisions of this Act and any
regulation made thereunder relating to the importation of
any medicine, medical device or borderline product.
(3) For the purposes of the application of the Customs
Ordinance to any medicine, medical device or borderline
product the importation of which is prohibited under this
Act, medicine, medical device or borderline product shall
be deemed to be goods the importation of which is prohibited
under that Ordinance.
PART VI
RULES AND REGULATIONS
Rules. 141. (1) Subject to the provisions of this Act the
Authority may make rules in respect of all matters for which
rules are authorized or required to be made under this Act.
(2) Every rule made by the Authority shall be approved
by the Minister and be published in the Gazette and shall
come into operation on the date of its publication or on such
later date as may be specified therein.
Regulations. 142. (1) The Minister may make regulations in respect
of any matter required by this Act to be prescribed or in
respect of which regulations are authorized by this Act to be
made.
(2) In particular and without prejudice to the generality
of the powers conferred by subsection (1), the Minister may
make regulations in respect of all or any of the following
matters:-
(a) declaring that any medicine, medical device or
borderline product or class of medicine, medical
device or borderline product is adulterated if any
prescribed substance or class of substance is present
or has been added to or extracted from or omitted
in, that medicine, medical device or borderline
product;
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(b) declaring that any medicine, medical device or
borderline product is safe for general use or not safe
for general use;
(c) pricing of medicines, medical devices and
borderline products;
(d) the labeling and packaging and the offering,
exposing and advertising for sale of medicine,
medical device or borderline product;
(e) prescribing the size, dimensions, fill and other
specifications of packages of, medicine, medical
device or borderline product;
(f) the use of any substance as an ingredient in
medicine, medical device or borderline product to
prevent the user or purchaser from being deceived
or misled as to its quality, character, value,
composition or to prevent injury to the health of
the user or purchaser;
(g) the standards of composition, strength, potency,
purity, quality or other property of medicine,
medical device or borderline product;
(h) the method of preparation, the manufacture,
preservation, packaging, storing and testing of any
medicine in the interest of, or for the prevention of
injury to, the health of the user or purchaser;
(i) (i) the persons to whom, the circumstances in
which, and the terms and conditions subject
to which, licences and registrations under this
Act may be granted or refused; and
(ii) the manner and mode in which applications
for licences and registrations under this Act
may be made and dealt with;
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(j) requiring persons who manufacture or sell any
medicine, medical device or borderline product to
furnish information and maintain books and
records;
(k) the registration and regulation of Pharmacies and
drug stores;
(l) the terms and conditions for storage and transport
of medicine, medical device, borderline product or
investigational medicinal product;
(m) the disposal of medicine, medical device,
borderline product or investigational medicinal
product;
(n) the specification of recalling procedure of
medicines, medical devices and borderline products
and composition of committees;
(o) the conditions relating to importers and market
authorization holders;
(p) the procedure for parallel imports and licensing
for non-commercial use by the Government;
(q) Forms to be used for the registration, renewal and
licensing under this Act and the regulations made
thereunder;
(r) prohibition and restrictions relating to the sale and
transport for sale of any adulterated medicine or
borderline product;
(s) prescribing the medicines, medical devices or
borderline products prohibited under the Act;
(t) the distribution and the conditions of distribution
of sample of any medicine, medical device,
borderline product or investigational medicinal
product;
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(u) the mode and manner in which any medicine,
medical device or borderline product shall be
registered, the terms and conditions applicable to
such registration and licensing, the fees to be levied
for such registration or licensing;
(v) the manner in which the Appeal Committee shall
function and procedure of hearing Appeals;
(w) the standards of shelf-life for manufacture of
medicines, medical devices or borderline products;
(x) procedure to be followed by the MEC, MDEC and
BPEC in the conduct of its functions and the
transaction of its business;
(y) the procedure of inquiries;
(z) the procedure to be followed by MEC, MDEC and
BPEC for the respective evaluations and matters
which should be included in reports;
(aa) the review and revision of all guidelines formulated
under this Act;
(bb) the procedure for issuing of lot release certificate
by Medical Research Institute in relation to vaccines
and sera;
(cc) evaluation of advertisements and other promotional
material of manufacturers, importers, distributors
and retailers of medicines, medical devices and
borderline products;
(dd) regulation of promotional activities pertaining to
medicines, medical devices, borderline products and
investigational medicinal products;
(ee) any other matters as may be necessary for the
purposes of achieving the objects and discharging
the functions of the Authority.
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(3) Every regulation made by the Minister shall be
published in the Gazette and shall come into operation on
the date of such publication or on such later date as may be
specified in such regulation.
(4) Every regulation made by the Minster, shall not later
than three months after its publication in the Gazette, be
brought before Parliament for approval. Any regulation
which is not so approved shall be deemed to be rescinded as
from the date of such disapproval, but without prejudice to
anything previously done thereunder.
(5) A notification of the date of such disapproval shall be
published in the Gazette.
Institution of 143. (1) A prosecution for an offence under this Act or
proceedings. any regulation made thereunder shall not be instituted-
(a) except by an Authorized Officer; and
(b) after the expiration of a period of three months from
the date of detection of that offence or where sample
is analysed, after the expiration of a period of one
month from the date of the receipt of Analyst’s report
on such sample.
(2) No civil or criminal proceedings shall be instituted
against person for any act which in good faith is done or
purported to be done by him under this Act or any regulation
make thereunder.
PART VII
REPEALS AND TRANSITIONAL PROVISIONS
Repeal of Act, 144. Cosmetics, Devices and Drugs Act, No. 27 of 1980
No. 27 of 1980.
is hereby repealed.
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145. Notwithstanding the repeal of Cosmetics, Devices Transitional
and Drugs Act, No. 27 of 1980 (hereinafter referred to as provisions.
“the repealed Act”), –
(a) all contracts and agreements entered into under the
repealed Act and subsisting on the day immediately
preceding the appointed date shall, with effect from
the appointed date, be contracts and agreements
entered into under this Act with or on behalf of the
Authority and may be enforced accordingly;
(b) all suits, prosecutions, appeals or other legal
proceedings which have been instituted in any court
or tribunal by or against the Cosmetics, Devices
and Drugs Authority and pending before such court
or tribunal on the day immediately preceding the
appointed date shall with effect from the appointed
date be deemed to have been instituted by or against
the Authority and may be continued accordingly;
(c) all decrees, orders and judgments entered or made
by a competent court or tribunal in favor of or
against the Cosmetics, Devices and Drugs Authority
and remaining unsatisfied on the day preceding
the appointed date shall with effect from the
appointed date be deemed to have been made in
favor of or against the Authority, and may be
enforced accordingly;
(d) every regulation or rule made under the repealed
Act , and in force on the day immediately preceding
the appointed date and not inconsistent with the
provisions of this Act, shall with effect from the
appointed date be deemed to have been made under
this Act and may accordingly be amended or
rescinded by regulations or rules made under this
Act;
(e) every licence or registration issued by the
Cosmetics, Devices and Drugs Authority and in
force immediately prior to the date of operation of

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this Act shall with effect from the appointed date
be deemed to be a licence or registration granted
by the Authority under the provisions of this Act;
(f) every application for a licence or registration of a
medicine, medical device or borderline product
made to the Cosmetics, Devices and Drugs
Authority under the provisions of the repealed Act
shall with effect from the appointed date be deemed
to be an application made to the Authority
established under this Act and shall be dealt with
accordingly;
(g) all movable and immovable property vested in the
Cosmetics, Devices and Drugs Authority on the day
immediately preceding the appointed date, shall,
with effect from the appointed date, be vested with
the Authority;
(h) all sums of money lying to the credit of the fund of
the Cosmetics, Devices and Drugs Authority on the
day immediately preceding the appointed date,
shall stand transferred, with effect from the
appointed date, to the Fund established under
section 18 of this Act;
(i) all declarations, notifications, licences and orders
made or issued under the repealed Act and subsisting
on the day immediately preceding the appointed
date, shall in so far as they are not inconsistent
with the provisions of this Act, be deemed with
effect from the appointed date, to be declarations,
notifications, licences and orders made or issued
under the provisions of this Act and shall be
construed accordingly;
(j) every reference to the Cosmetics, Devices and Drugs
Authority in any written law, notice, notification,
instrument, contract, communication or other
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document shall with effect from the appointed date
be read and construed as a reference to the Authority
established under this Act; and
(k) every reference to the National Druge Quality
Assurance Laboratory of the Cosmetics, Devices
Drugs Authority in any written law, notice,
notification, contract, communication or other
document shall with effect from the appointed
date be read and construed as a reference to
the NMQAL of the Authority established under
this Act.
PART VIII
INTERPRETATION
146. In this Act, unless the context otherwise requires:— Interpretation.
“adulterated” means the addition of any substance
to or subtraction of any constituent from a
medicine, medical device or borderline
product so as to affect its quality, composition
or potency;
“advertisement” includes any representation by any
means whatsoever, for the purpose of
promoting directly or indirectly the
manufacture, sale or disposal of any medicine
medical device or borderline product;
“article” means —
(a) any medicine, medical device or
borderline product;
(b) anything used or capable of being used
for the manufacture, preparation,
preservation, packaging or storing of any
medicine, medical device or borderline
product ; and
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(c) any labeling or advertising material;
“bioequivalence” means two pharmaceutically
equivalent or pharmaceutical alternative
products having their bio availabilities after
administration in the same molar dose are
similar to such a degree that their effects, with
respect to both efficacy and safety, will be
essentially the same. This is considered
demonstrated if the 90% confidence
intervals (90% CI) of the ratios for AUC0-t and
Cmax between the two preparations lie in the
range 80.00 – 125.00%;
“biowaiver” means a regulatory approval process
when the application (dossier) is approved on
the basis of evidence of equivalence other than
an in vivo bioequivalence test. For solid oral
dosage forms, the evidence of equivalence is
determined on the basis of an in vitro
dissolution profile comparison between the
multisource and the comparator product;
“borderline products” means the products having
combined characteristics of medicines and
foods, medicines and medical devices or
medicines and cosmetics and in deciding
whether a product is a borderline product the
following shall be taken into consideration:-
(a) the intended use of the product (or its
primary function) and its mode of action;
(b) the therapeutic claims that the
manufacturer makes about the product
(claims to treat or prevent disease or to
interfere with the normal operation of a
physiological function of the human
body);
(c) the pharmacological active substance(s),
if any, used in the product;
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(d) the concentration of the active
substances;
(e) the level of efficacy of the active
substance of the product; and
(f) the ingredients used and the
concentrations at which they are used;
“Cosmetics” means any substance or mixture of
substances manufactured, sold or represented
for use in cleaning, improving or altering the
complexion, skin, hair or teeth and includes
deodorants, perfumes and cosmeceuticals;
“Cosmetics, Devices and Drugs Authority” means
Cosmetics, Devices and Drugs Authority
established under the Cosmetics, Devices and
Drugs Act, No. 27 of 1980;
“counterfeit medical device” means a device which
is labeled or packaged fraudulently with regard
to identification;
“counterfeit medicine” means a medicine which
is labeled or packaged fraudulently with regard
to identification and includes any product
with proper ingredients with inferior quality
or containing different or inactive
ingredients;
“dentist” means a person for the time being
registered as a dentist under the Medical
Ordinance (Chapter 105);
“Drug Inspector” mean any person with prescribed
qualifications appointed as a drug inspector
by the Authority;
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“exhibit” refers to a public display of medicines,
medical devices or borderline products at a
conference, exhibition or trade fair;
“Generic medicine” means a medicine that-
(a) has the same quantitative composition of
therapeutically active substances, being
substances of similar quality to those used
in the registered medicine;
(b) has the same pharmaceutical form;
(c) is bioequivalent; and
(d) has the same safety and efficacy
properties;
“Good Distribution Practice” means good
distribution practice guidelines issued by the
Authority;
“Good Manufacturing Practice Guidelines” means
good manufacturing guidelines issued by
World Health Organization;
“Good Pharmacy Practice” means good Pharmacy
practice guidelines issued by the Authority;
“Good Storage Practice” means good storage
practice guidelines issued by the Authority;
“Government Analyst” means the person for the
time being holding the office of the
Government Analyst, any Additional
Government Analyst, Deputy Government
Analyst, Senior Assistant Government Analyst
or Assistant Government Analyst;
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“insanitary conditions” means such conditions or
circumstances as are likely to contaminate
medicine, medical device or borderline product
with dirt or filth or render same injurious to
health;
“investigational medicinal product” means a
product which is under investigation by a
clinical trial or equivalent studies which may
include a medicine, medical device or a
borderline product;
“label” includes any tag, brand, mark, pictorial or
other descriptive matter, written, printed,
stenciled marked, embossed or impressed on,
or attached to a container of medicine, medical
device or borderline product;
“labeling” includes the label and any written
printed or graphic matter relating to and
accompanying the medicine, medical device
or borderline product;
“licence” means a licence issued under this Act;
“Medical Council” means the Medical Council
established under the section 12 of the Medical
Ordinance (Chapter 105);
“medical device” means any instrument, apparatus,
appliance, software, material or any other
article, whether used single or in combination,
including the software necessary for its
proper application intended by the
manufacturer used in or on human beings for
the purpose of:-
(a) diagnosis, prevention, monitoring,
treatment or alleviation of disease;
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(b) diagnosis, monitoring, treatment,
alleviation of or compensation for an injury
or handicap;
(c) investigation, replacement or
modification of the anatomy or of a
physiological process;
(d) control of conception,
and which does not achieve its intended action
in or on the human body by pharmacological,
immunological or metabolic means but which
may be assisted in its function by such means;
a medical device does not include an Ayurveda
device or a Homeopathy device;
“medical practitioner” means a person registered
as a medical practitioner under section 29 or
section 41 of the Medical Ordinance (Chapter
105);
“medicine” means—
(a) any substance or mixture of substances
manufactured, sold, offered for sale or
represented for use in—
(i) the diagnosis, treatment, mitigation
or prevention of disease, abnormal
physical states or the symptoms
thereof in man or animal; and
(ii) restoring, correcting or modifying
functions of organs in man or
animal;
(b) a medicine or combination of medicine
ready for use and placed on the market
under a special name or in a characteristic
form, both patent and non-proprietary
preparations;
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(c) a product made out of medicinal herbal
extract;
(d) nutraceutical with therapeutic claims;
and
(e) vaccines and sera,
but does not include an Ayurvedic medicine
or Homoeopathic medicine;
“Minister” means the Minister to whom the subject
of Health is assigned and the term Ministry
shall be construed accordingly;
“need” refers to circumstances in which a product
is necessary because it is essential or very
important rather than just desirable;
“nutraceutical” means a product isolated or purified
from food which is generally sold in medicinal
form not usually associated with food and
provide physiological benefit or protection
against chronic disease;
“package” includes anything in which any
medicine, medical device or borderline
product is wholly or partly contained, placed
or packed;
“person” includes a company;
“Pharmacist” means a Pharmacist registered under
the Medical Ordinance (Chapter105);
“prescribed” means prescribed by rules or
regulations made under this Act;
“prescription” means an authorization in writing
to a Pharmacist from a person authorized by
law to prescribe medicines or medical devices
to dispense a specified medicine or medical
device for use by a designated individual or
for animal use;
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“prohibited medicine, medical device or borderline
product” means which are prohibited by
regulations made under the Act;
“secretary” means the Secretary to the Minister to
whom the subject of Health is assigned;
“sell” means offer, keep or expose for sale, transmit,
convey or deliver for sale, for cash or credit or
by way of exchange and whether by wholesale
or retail and the term “sale” shall be construed
accordingly;
“smuggled medicine, medical device or borderline
product” means a medicine, medical device or
borderline product imported or brought in to
the country in contravention of the provisions
of this Act and without obtaining an import
license from the Authority; and
“veterinary surgeon” means a person registered as
Veterinary Surgeon or a Veterinary Practitioner
under the Veterinary Surgeons’ and
Practitioner Act, No. 46 of 1956.
In case of an 147. In the event of an inconsistency between the
inconsistency Sinhala and Tamil texts of this Act, the Sinhala text shall
the Sinhala text
shall prevail. prevail.

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Annual subscription of English Bills and Acts of the Parliament Rs. 885 (Local), Rs. 1,180
(Foreign), Payable to the SUPERINTENDENT, GOVERNMENT PUBLICATIONS BUREAU, DEPARTMENT OF
GOVERNMENT INFORMATION, NO. 163, KIRULAPONA MAWATHA, POLHENGODA, COLOMBO 05 before 15th
December each year in respect of the year following.
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