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Contents

Part IV · General

43. Medicines Evaluation Committee

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

(1)

There shall be appointed for the purposes of this Act, a Committee which shall be known as the

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.

Part V

General

Part VI

Rules and Regulations

Part VII

Repeals and Transitional Provisions

Part VIII

Interpretation