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

Regulations

General Regulations

Registration of Medicines

18. Information that must appear in register for medicines

 

The medicines register shall, in respect of any registered medicine, contain the following information:

(a) The proprietary name of the medicine;
(b) the registration number allocated to the medicine;
(c) the approved name of each active ingredient of the medicine and the quantity thereof contained in a dosage unit or per suitable mass or volume or unit of the medicine;
(d) the dosage form of the medicine;
(e) the name of the holder of the certificate of registration;
(f) the name and address of the manufacturer(s) and the manufacturing facilities;
(g) the name of the final product release control;
(h) the name of the final product release responsibility;
(i) the date of registration of the medicine;
(j) the conditions of registration of the medicine, as may have been determined in terms of section 15(6) of the Act;
(k) category of the medicine;
(I) class of the medicine; and
(m) if falling under Category D a statement identifying the—
(i) sub-category of the medicine; and
(ii) the associated discipline where applicable.