Government Gazette

Vol. , No. , 6 September 2002

GENERAL NOTICE

Notice 1139 of 2002

DEPARTMENT OF HEALTH

EXCLUSION OF CERTAIN MEDICINES FROM THE OPERATION OF CERTAIN PROVISIONS OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 1965 (ACT NO. 101 OF 1965)

I, Malebona Precious Matsoso, Registrar of Medicines, acting by virtue of a delegation in terms of section 34A of the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965), hereby exclude in terms of section 36 of Act 101 of 1965, on the unanimous recommendation of the Medicine Control Council, the medicines listed in the schedule hereto from the operation of the therein listed provisions of the regulations promulgated by Government Notice No. R. 352 of 21 February 1975, as amended, subject to the conditions likewise listed in the Schedule.

MEBONA PRECIOUS MATSOSO, 
REGISTRAR OF MEDICINES

REGISTRATION  NO. NAME OF MEDICINE FORM OF PREPARATION PROVISIONS FROM WHICH EXCLUDED CONDITIONS OF EXCLUSION APPLICANT
27/13.4.2/0355 Alphosyl 2 in 1 Shampoo
  1. Regulation 9(1): Bilingualism of the immediate container label
  2. Regulation 9(1b):Registration number on the immediate container label
  3. Regulation 9(1q): Storage conditions on the immediate container label.
  4. Regulation 9(1e): Percentage of bacteriostatic agent on immediate container label
 The package insert  Genop Healthcare Pty (Ltd)

B 513

 

 Largactil 100mg Tablets
  1. Section 15
    (4): Conditions of registration with respect to Manufacturer.

 
  1. Each batch is accompanied by valid certificate of analysis, and the Council is supplied with details on the batch number, quantity and expiry date.
  2. Comparative dissolution test to be conducted.
  3. All product release criteria to be conducted on each imported batch
  4. Once off exemption

 

 Aventis Pharma
(Pty) Ltd