01 Feb Communication to industry on ranitidine-containing medicines
Posted at 09:31h
in
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Archive
01 Feb Communication to industry on Post Marketing Reporting of ADRs guideline
Posted at 09:17h
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The South African Health Products Regulatory Authority (SAHPRA), have reviewed the Post Marketing Reporting of ADR guideline following concerns raised by the industry on version 7 of the guideline published September 2020. In addition to the review, SAHPRA conducted a webinar with holders of...
28 Jan SAHPRA survey to determine company turnover
Posted at 14:29h
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SAHPRA will be embarking on a survey to determine the latest annual company turnover of licence holders to understand the impact of inspection fees on the licence holders within local industry....
28 Jan GMP CERTIFICATES FOR CANNABIS CULTIVATED BY CULTIVATORS HOLDING A SECTION 22C(1)(b) LICENCE (LICENCE TO CULTIVATE CANNABIS FOR THE PURPOSES OF PRODUCING SCHEDULED SUBSTANCES)
Posted at 14:27h
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Applicants who are in possession of a Licence to Cultivate Cannabis for Purposes of Producing Scheduled Substances in terms of section 22C(1)(b) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) may apply for a GMP certificate for their facility. ...
28 Jan Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators
Posted at 13:52h
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2021 Jun...
28 Jan Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs)
Posted at 13:49h
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2021 Mar...
28 Jan Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19
Posted at 13:46h
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2020 Sep...
28 Jan Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits
Posted at 13:45h
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2020 Sep...