Archive
27 Jan Communication to Stakeholders: Licensing of Complementary Medicines Manufacturers, Wholesalers, Distributors, Importers and Exporters
Posted at 22:42h
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2020 Feb...
27 Jan REQUESTS: Existing Category D (Complementary Medicines) Registration Applications – COMPLEMENTARY MEDICINES APPLICATIONS SUBMITTED FOR REGISTRATION
Posted at 22:41h
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Category D Medicines (Complementary Medicines) has been established in the General Regulations made in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Medicines compliant with the prescribed definition for this category are included in Guidance on progression to regulatory compliance...
27 Jan Review of detained product at a port of entry as a Category D medicine
Posted at 22:39h
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Customs and Port Health Service (PHS) in SA, is the first line of defence to protect the citizens of the Republic of South Africa against the health risks associated with cross-border movement of people, conveyances, baggage, cargo and imported consignments. Among the imported consignments are...
27 Jan Application for a certificate of free sale for Category D medicines (Complementary Medicines)
Posted at 22:37h
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Medicines Act” means the Medicines and Related Substances Act, 1965 (Act 101 of 1965), as amended. ...
27 Jan updated – Roadmap and transitional process for the Regulation of complementary medicines
Posted at 09:45h
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The amended Guideline 7.02 (Roadmap and Transitional Process for the regulation of Complementary medicines) with transitional arrangements was developed and published on the SAHPRA website by early August 2019. The guideline established the roadmap and general overview for the regulatory pathway of complementary medicines including...
27 Jan Communication to industry on Clones and Replicas
Posted at 08:18h
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A clone is defined as an application submitted by the Innovator as a copy of its own product under a different proprietary name at any stage during the product life cycle. A replica is defined as a copy of an already registered generic product,...
27 Jan Communication to industry on metformin-containing medicines
Posted at 08:17h
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The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing the final pharmaceutical products for immediate and extended release dosage forms containing metformin hydrochloride as an active substance. This review was triggered because of the detection of an impurity,...