Title: National Medicines Regulatory Authority Act

Type: Act/Ordinance

Issuing Agency: National Medicines Regulatory Authority

Responsible Agency: National Medicines Regulatory Authority

Issuing Date: 20-03-2015

 

NATIONAL MEDICINES REGULATORY AUTHORITY ACT, No. 5 OF 2015

[Certified on 19th March, 2015]

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, REGISTRA TION, LICENSING, MANUFACTURE, IMPORTATION AND ALL OTHER ASPECTS PERTAINING TO MEDICINES, MEDICAL DEVICES, BORDERLINE 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 REGULA TORY DIVISION, BORDERLINE PRODUCTS REGULA TORY DIVISION AND CLINICAL TRIALS REGULA TORY 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 Medicines Regulatory Authority Act, No. 5 of 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)

Short title and date of operation.

Establishment of the National Medicines Regulatory Authority.

Objects of the Authority.

National Medicines Regulatory Authority Act, No. 5 of 2015

CHAPTER I

NATIONAL MEDICINES REGULATORY AUTHORITY

PART I ESTABLISHMENT OF THE AUTHORITY

(1) There shall be established an authority called the National Medicines Regulatory Authority (hereinafter referred to as the ‘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.

3. The objects of the Authority shall be to –

(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

4. (d)  encourage the manufacturing of good quality medicines in Sri Lanka with a view to assuring the availability of essential medicines at affordable prices;

5. (e)  promote the safe and rational use of medicines, medical devices and borderline products by health care professionals and consumers;

6. (f)  recommend appropriate amendments to relevant laws pertaining to medicines, medical devices and borderline products;

7. (g)  educate the general public, health care professionals and all stakeholders on medicines, medical devices and borderline products;

8. (h)  regulate the promotion and marketing of medicines, medical devices and borderline products;

9. (i)  regulate the availability of the medicines, medical devices and borderline products;

10. (j)  conduct post-marketing surveillance on quality, safety and adverse reaction of the medicines, medical devices and borderline products; and

11. (k)  regulate all matters pertaining to the conduct of clinical trials in Sri Lanka.

4. The
(a) ex-officio members –

Authority shall consist of the following :-

Constitution of the Authority.

1. (i)  theDirector-GeneralofHealthServices;

2. (ii)  the Secretary to the Treasury or his nominee; and

3. (iii)  the Chief Executive Officer of the Authority appointed under section 15 who shall function as the Secretary to the Authority;

Chairman of the Authority.

(1) The Minister shall, in consultation with the Authority appoint one of the appointed members to be the Chairman of 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”) –

1. (i)  four specialist clinicians attached to the Ministry of Health, representing the following clinical disciplines, nominated by their respective professional bodies:-

   1. (A)  General Medicine;

   2. (B)  General Surgery;

   3. (C)  Pediatrics; and

   4. (D)  Gynaecology and Obstetrics;

2. (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;

3. (iii)  aProfessororSeniorLecturerinPharmacy 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;

4. (iv)  four professionals, who have gained eminence in the fields of management, law, accountancy or health respectively.

5. 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 as a member of the Authority, satisfy himself that such person has no financial or other conflict of interest in the affairs of 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

Conflict of interests of the members.

Disqualifications to be a member.

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) Ministermaymakeregulationstofurtherspecifyand 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.

7. A person shall be disqualified from being appointed or continuing as a member of the Authority, if he –

1. (a)  is or becomes a Member of Parliament, any Provincial Council or of any Local Authority;

2. (b)  is not, or ceases to be, a citizen of Sri Lanka;

3. (c)  directly or indirectly holds or enjoys any right or benefit under any contract made by or on behalf of the Authority;

4. (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

5. (e)  is absent himself from three consecutive meetings of the Authority;

6. (f)  is under any law in force in Sri Lanka or any other country, found or declared to be of unsound mind;

7. (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

8. (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 office so long as such officer holds office by virtue of which such officer has been appointed to the Authority.

9. (1) Every appointed member of the Authority shall, unless such officer vacates office earlier by death, resignation or removal, hold office for a period of three years, and shall 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.

10. (1) The Chairman shall preside at every meeting of 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 by the Authority.

(2) The seal of the Authority -

1. (a)  may be altered in such manner as may be determined by the Authority;

2. (b)  shall be in the custody of such person or persons as the Authority may, determine;

3. (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.

The Seal.

Authority to invite experts to meetings.

Remuneration for attending meetings of the Authority.

Powers and functions of the Authority.

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.

12. (a) The Authority may invite experts on a relevant subject matter to meetings of the Authority for the purpose 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.

13. The members of the Authority and the experts may be paid such remuneration for attendance at meetings of the Authority, as may be determined by the Minister with the concurrence of the Minister assigned the subject of Finance.

14. The powers and functions of the Authority shall be to :-

(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

4. (d)  authorize registration and regulation of Pharmacies and medicines stores;

5. (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;

6. (f)  appoint sub-committees as may be necessary for the effective discharge of the functions of the Authority;

7. (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;

8. (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;

9. (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;

10. (j)  collect data on quantities of medicines, medical devices, borderline products or investigational medicinal products imported under licences;

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