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. |