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(1) A person shall not manufacture a drug, herbal medicinal product, cosmetic, medical device or household chemical substance for sale unless

(a) the manufacturing operation is carried on, or is supervised by a pharmacist or a qualified person approved by the Authority as having specialist knowledge in the article to be manufactured, and

(b) the conditions under which the manufacture is to be carried on are as specified in the Guidelines of the Authority to ensure that the article will be of good quality and safe to use.

(2) An application for approval under subsection (1) shall be made to the Authority and may be granted by the Authority subject to the conditions determined by the Authority.