SMedicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsSchedulesAnnexure 3 : Certificate of registration for medicines |
Annexure 3
Certificate of registration for medicines
MEDICINES AND RELATED SUBSTANCES ACT 1965, (ACT NO. 101 OF 1965): MEDICINE REGISTRATION CERTIFICATE
It is hereby certified that registration of the medicine described below has been approved by the Authority in terms of section 15(3)(a) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), subject to the conditions indicated.
1. Proprietary name ..........................................................................................................
2. Registration number .....................................................................................................
| 3. | Approved name of every active pharmaceutical ingredient and quantities thereof per dosage unit or per suitable mass or volume or unit of the medicine |
.....................................................................................................................................
4. Dosage form .................................................................................................................
5. Conditions under which the medicine is registered .......................................................
6. Name of holder of certificate of registration .................................................................
7. Name and address of the manufacturer and the manufacturing facility .........................
.....................................................................................................................................
8. Name of the final product release control ....................................................................
9. Name of the final product release responsibility ..........................................................
10. Date of registration ......................................................................................................
11. Category of medicine ...................................................................................................
12. Class of the medicine ...................................................................................................
13. Discipline of medicine, if falling under Category D .......................................................
Chief Executive Officer
Issued at ......................................................... on ................................................ 20 .............