| (a) |
manufacturer, importer, exporter or wholesaler licensed in terms of section 22C(1)(b) of the Act selling specified Schedule 5 medicines or substances or Schedule 6 medicines or scheduled substances; |
| (b) |
person selling specified Schedule 5 medicines or substances, other than a community or institutional pharmacy, or a person licensed in terms of section 22C(1)(a); or |
| (c) |
person selling Schedule 6 medicines or substances, |
shall keep a register of such medicines or substances.
| (2) |
The register referred to in subregulation (1) shall— |
| (a) |
indicate the quantity of every such medicine or substance remaining in stock on the last day of March, June, September and December of each year; and |
| (b) |
contain the following information: |
| (i) |
the date on which the medicine or substance was received or supplied; |
| (ii) |
the name, business address of the person from whom the medicine or substance was received or sent and in the case of imported medicine or substance, the import permit number; |
| (iii) |
the name and address of the person who purchased the medicine or substance; |
| (iv) |
the quantity, in words and figures, of such medicine or substance indicated per dosage unit, mass or volume; |
| (v) |
in the case of the supply of the medicine or substance on prescription, the name and address of the authorised prescriber unless such prescription was issued at a hospital in which case the name of the authorised prescriber must be recorded; |
| (vi) |
in the case of the manufacturer, the quantity of the medicine or substance manufactured or used during the manufacturing process; and |
| (vii) |
any other information as may be required by the Authority. |
| (3) |
The register referred to in subregulation (1) shall be kept for a period of five years after the date of the last entry made therein. |
| (4) |
In a case where the register is kept electronically, a printout shall be made monthly, dated, signed and filed. |
| (5) |
Records must be stored in an orderly manner so that they can be accessed easily. |
Statistics Act, 1999
