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

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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.