Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsPermits, Licensing and Authorisation28. 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. |