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

Regulations

General Regulations

Registration of Medicines

17. Particulars to be published in respect of applications received for registration in terms of section 14(3)

 

The following particulars with regard to applications for registration referred to in section 15(10) of the Act shall be published in the Gazette:

(a) The proprietary name of the medicine;
(b) the approved name and quantity of each active ingredient of the medicine contained in a dosage unit or per suitable mass or volume or unit;
(c) the dosage form of the medicine;
(d) the name of the applicant who lodged the application for registration;
(e) the number allocated to it in terms of section 15 of the Act;
(f) the name and address of the manufacturer;
(g) the name of the person responsible for the final product release control; and
(h) name of the person responsible for final product release responsibility.

 

 


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