Acts Online
GT Shield

Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Regulations

General Regulations

Permits, Licensing and Authorisation

28. Information to be furnished annually to Chief Executive Officer

 

(1) The holder of a permit referred to in regulation 27 shall furnish, annually, to the Chief Executive Officer, the following information:
(a) The quantity of the substance, as a raw material or as contained in a preparation, which was held in stock on 1 January of the preceding calendar year;
(b) the quantity of such substance acquired during the preceding calendar year by—
(i) importation of the substance, as a raw material or as contained in a preparation;
(ii) local production of the raw material; and
(iii) local purchasing of the raw material, in which case the name of the supplier must also be furnished;
(c) the quantity of such substance, as a raw material or as contained in a preparation, which was disposed of during the preceding year through exportation or other means;
(d) the quantity of such substance used during the preceding calendar year in the production of any other Schedule 6 or Schedule 7 substance or a specified substance referred to in section 22A(12)(a)(ii) and (iii) of the Act; and
(e) the quantity of such substances and preparations containing such substances remaining in stock on 31 December of the preceding year.

 

(2) The information referred to in subregulation (1) shall comply with the following requirements:
(a) Quantities shall be expressed in metric units or as a percentage of the relevant substance;
(b) in the case of opium and any preparations containing opium, quantities must be expressed in terms of opium containing 10 per cent of anhydrous morphine;
(c) preparations not obtained directly from opium but from a mixture of opium alkaloids must be expressed in terms of morphine;
(d) quantities of coca- leaves must be expressed in terms of coca-leaves containing 0,5 percent of cocaine; and
(e) where stocks are held or manufacture has been undertaken on behalf of another person, this fact must be indicated.