As enacted

Contents

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

108. Ban or withdrawal &c.,from, use of medicine &c

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

(1)

The Authority shall, where the Authority finds that any medicine, medical device or borderline product does not meet the required standard or that the medicine, medical device or the borderline product as manufactured would cause serious health problems to the person using, issue an order requiring the importer, manufacturer, trader or distributor of that medicine, medical device or borderline product to –

(a)

cease the distribution immediately;

(b)

withdraw from sale or use;

(c)

notify immediately the health professionals and users to cease using of;

(d)

dispose according to prescribed methods, such medicine, medical device or borderline product.

(2)

The Authority shall cause notice of the ban or withdrawal from use of medicine, medical device or borderline product in terms of this section, to be published in a daily newspaper in Sinhala, Tamil and English or website of the Ministry or broadcast over any electronic media.

(3)

Any person who contravenes the provisions of subsection (1) commits an offence and shall on conviction by a Magistrate’s Court after summary trial, be liable to a fine not exceeding one million rupees or to an imprisonment of either description for a period not exceeding three years or to both such fine and imprisonment.

Read on from s 109

Part V