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

Regulations

General Regulations

Permits, Licensing and Authorisation

36. Register for specified Schedule 5 or Schedule 6 medicines or substances

Purchase cart Previous page Return to chapter overview Next page

 

(1)Any—
(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.