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Acts and Regulations

Consultations/reviews (e.g Draft Guidelines)

Exemptions (Section 36 of Act 101)

Fees

Category List(s)

Acts and Regulations

Amendment of Schedules: Scheduling of Ephedrine,Pseudoephedrine,D-Nor-Pseudoepherine and 1-Benzylpiperazine (BZP) - Medicines and related substances act , 1965 (Act 101 of 1965) - Schedules(zipped PDF 2842kb)

Intergrated Act 101 - Medicines and Related Substances Act (zipped MS - word 46Kb)

Regulations to Act 101 (Zipped MS-Word 84Kb)

Scheduling of Pseudo Ephedrine, BZP April 08 (PDF 70kb)

Consultations/reviews (e.g Draft Guidelines)

2.08 - Post-Registration Amendments (zipped Ms-Word 119kb)

2.17 - Implementation of safety-related package insert notifications (SR-PINs)(PDF 180kb)

2.18 - Proprietary names for Medicinal products - for comment by 28 February 2009 (Ms-Word 132kb)

5.10 - Recall/Withdrawal of Medicines - for comment by 28 February 2009 (Ms-Word 175kb)

9.29 - Applications for Registration of Pandemic Influenza Vaccines (Ms-Word 76kb)

Exemptions (Section 36 of Act 101)

Exemptions in terms of section 36 of act 101 - August 2005 (Ms-Word - 91kb)

Fees

Fees payable to the Registrar (zipped Ms-Word 31kb)

Guideline for the direct transmission of fees payable to the Registrar of medicines ( Ms-Word 54kb)