Statistics Act, 1999
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsRegistration of Medicines15. Batch release for biological medicines |
| (1) | The Authority may, with regard to the registration of biological medicines in terms of section 15(6) of the Act, require that the number of samples of every batch, together with one copy of the protocol of testing of the bulk batch and filling batch and one copy of the certificate of release issued by the competent Authority in the country in which the product was manufactured, be submitted to the Authority as a batch release condition and the holder of the certificate of registration must pay the prescribed batch release fee. |
| (2) | The Authority may, with regard to the registration of biological medicines in terms of section 15(6) of the Act, require that at least the number of samples of every batch, together with one copy of the protocol of testing of the bulk batch and filling batch of the biological medicine manufactured in the Republic be submitted to the National Control Laboratory of the Authority as a batch release condition and the holder of the certificate of registration must pay the prescribed batch release fee. |
| (3) | The Authority may, with regard to the sale of unregistered biological medicines as per the provisions of section 21 of the Act, request a batch release of the medicine as per the requirements of subregulation 1 and 2. |
