As enacted

Contents

National Medicines Regulatory Authority Act 2015 · As enacted · Part IV · General

47. Authority to give general guidelines for the evaluation

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

(1)

The Authority shall issue general guidelines to the MEC for the evaluation of medicines and other related items, submitted to the MEC.

(2)

(a)

The general guide lines referred to in subsection (1) shall be based on the Good Manufacturing Practices

(GMP) and other recommendations issued by the World

Health Organization and other regulatory bodies recognized by the Authority.

(b)

The Authority may revise the general guidelines from time to time in order to maintain parallels with internationally recognized standards and practices.

(3)

The MEC shall take into consideration the efficacy, safety, quality, need and cost of each medicine, in the process of evaluation and may consider pharmacoeconomic analysis where necessary.

(4)

The Minister may make regulations -

(a)

setting out the procedures to be followed, including the specified time limits, for the conduct of respective evaluations;

(b)

to give effect to the Good Manufacturing

Practices (GMP) guidelines, Good Review

Practices (GRP) and any other applicable guidelines as may be recommended by the

Authority; and

(c)

in respect of bioequivalence and biowaiver data relating to generic medicines submitted for evaluation.

Read on from s 48