Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsPermits, Licensing and Authorisation37. Returns to be furnished in respect of specified Schedule 5 and Schedule 6, 7 or 8 |
| (1) | No person may import, export, sell by wholesale, produce, manufacture or use, in the manufacture of any medicine or substance, any substance referred to in section 22A(12) of the Act unless the Authority is supplied with a return on or before 28 February of each year, reflecting the following information: |
| (a) | The quantity of such 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, as a raw material or contained in a preparation; |
| (ii) | production of the raw material in the Republic; and |
| (iii) | purchasing of the raw material in the Republic and the name of the supplier must be stated; |
| (c) | the quantity of such substance, as a raw material or as contained in a preparation, which was disposed of during the preceding calendar year through— |
| (i) | exportation; or |
| (ii) | destruction thereof; |
| (d) | the quantity of such substance used during the preceding calendar year in— |
| (i) | the production of any other Schedule 6 or Schedule 7 substance or a specified substance referred to in section 22A(12) of the Act; and |
| (ii) | the production of any other chemical substance not included in Schedule 6 or Schedule 7 or specified in section 22A(12)(a) of the Act; and |
| (e) | the quantity of such substance and preparations containing such substance remaining in stock on 31 December of the preceding year. |
| (2) | Notwithstanding subregulation (1), the Authority may exempt an importer or exporter from furnishing a return, if the particular return is not necessary in determining the consumption of any of the substances included therein. |
| (3) | The return referred to in subregulation (1) shall comply with the following requirements: |
| (a) | All quantities shall be expressed in metric units as a percentage base of the relevant substance; |
| (b) | in the case of opium and any preparations containing opium, quantities shall be expressed in terms of opium containing 10% of anhydrous morphine; |
| (c) | preparations obtained not directly from opium itself but by mixing opium alkaloids shall be expressed in terms of morphine; |
| (d) | in the case of any preparations of coca -leaves, quantities of coca -leaves shall be expressed in terms of coca -leaves containing 0,5% of cocaine; and |
| (e) | where stocks are held or manufacture has been undertaken on behalf of another applicant, this fact shall be indicated. |