Archive

01 Feb 2-Weekly Abridged Public Health Emergency Interim Progress Report Form for Clinical Trials

Posted at 14:37h in

Due to the rapidly changing dynamics of the condition/disease, it has become necessary for the South African Health Products Regulatory Authority (SAHPRA) to introduce a two-weekly public health emergency (PHE) Abridged Interim Safety and Futility Monitoring Report Form for clinical trials. ...

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01 Feb Clinical Trial Application Form – Guidance in conditions of a Public Health Emergency

Posted at 14:35h in

Application to conduct a clinical trial with limited information....

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01 Feb Clinical Trial Application Form

Posted at 14:32h in

This document is intended to be used for new clinical trials applications...

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01 Feb Notification Studies: Phase IV

Posted at 14:30h in

This is the primary application form for applicants to use in case of an application for Phase IV applications....

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01 Feb Application for a Permit to Export Narcotic and/or Psychotropic Substances in terms of the Medicines and Related Substances Act, 1965 (Act 101 Of 1965), The Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances, 1971: Regulation 20(4) and 20(7)(A)

Posted at 12:46h in

This document has been archived....

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01 Feb Application for a Permit to Import Drugs and/or Psycotropic Substances in terms of the Medicines and Related Substances Act, 1965 (Act 101 Of 1965), the Single Convention on Narcotic Drugs, 1961, and the Convention on Psycotropic Substances, 1971; Regulation 20(4) And 20(7)(S)

Posted at 12:44h in

This document has been archived....

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01 Feb Application for possession/research or analytical purpose

Posted at 12:41h in

This document has been archived....

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01 Feb Form for Licence Application for a Wholesaler to Export Medicines

Posted at 11:44h in

An application form for the purpose of obtaining a licence by a licensed wholesaler to export medicinal products (i.e. medicines and scheduled substances) in terms of the provisions of the Medicines and Related Substances Act, 101 of 1965, Section 22C and 22D read together with...

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01 Feb Licence Application to act as a Wholesaler of Medicines and Scheduled Substances

Posted at 11:43h in

An application form for the purpose of obtaining a licence or renewing/amending a licence in terms of the provisions of the Medicines and Related Substance Act, 1965 Section 22C and 22D read together with Regulation 23 and 24 of the General Regulations to the Medicines...

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01 Feb Form for Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories

Posted at 11:41h in

An application form for the purpose of obtaining a licence or renewing/amending a licence in terms of the provisions of Section 22C(1)(b) and Section 22D of the Medicines and Related Substance Act 101 of 1965 as amended, read together with Regulations 23 and 24 of...

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