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

In respect of all applications for amendments in terms of Section 15A, the name of the medicine approved by the Authority under Section 15(5), which shall be the proprietary name, 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, the conditions of registration, the name of the applicant, the name and address of the manufacturer, packer, final product release control, final product release responsibility: R770 per application.