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Update: Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant

Home >  Update: Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant

28 Jan

Posted at 20:41h in

This document is intended to communicate with the Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines.   Following the communication issued to stakeholders on 30 July 2024 regarding the ineffectiveness of oral phenylephrine preparations as nasal decongestants, HCRs for orally administered phenylephrine-containing medicines were...

22 Jan

Posted at 11:40h in

This communication is intended to provide an update to applicants on the process for the cancellation of registered health products in Specification 3.1 and as of 01 November 2024. Reference is made to ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information, July 2024,...

13 Dec

Posted at 11:04h in

This document is intended to assist the holder of a medical device establishment licence (referred to as the “licensee)” and the holder of a certificate of Registration (HCR) in the reporting of an adverse event associated with the use of a medical device (including an...

22 Nov

Posted at 15:25h in

Attn: Board/Committee Members/Evaluators:  Please take note of the dates for submission of claims for the remainder of the 2024/25 financial year....

20 Nov

Posted at 09:03h in

This guideline intends to narrate the critical framework of sealing and unsealing hazardous substances. It stipulates all enforcement actions necessary, according to the Hazardous Substance Act, 15 of 1973 with respect to Grouped Hazardous Substances, related regulations and prescribed licence conditions, that may be imposed...