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srilawsby aturio
As enacted
Contents

Part IV · General

89. Borderline Products 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 Borderline

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.

Read on from s 90

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