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Contents

Part IV · General

118. Pricing of medicines &c

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

(1)

(a)

The Authority shall appoint a Committee to be known as the Pricing Committee.

(b)

The composition, powers and functions of the Pricing

Committee shall be as prescribed.

(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.

Part V

General

Part VI

Rules and Regulations

Part VII

Repeals and Transitional Provisions

Part VIII

Interpretation