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As enacted
Contents

Part IV · General

30. Establishment of National Advisory Committee and divisions

Official English translation. Where it differs from the Sinhala or Tamil text, the Act itself says which text prevails.

(1)

There shall be established a National Advisory

Committee, the main function of which shall be to advise the Minister and the Authority on matters pertaining to 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;

(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;

(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.

NATIONAL ADVISORY COMMITTEE

Read on from s 31

Part V

General

Read on from Part V

Part VI

Rules and Regulations

Read on from Part VI

Part VII

Repeals and Transitional Provisions

Read on from Part VII

Part VIII

Interpretation

Read on from Part VIII