Extension of Notification Deadline – Oral Phenylephrine Pathway Selection

Extension of Notification Deadline – Oral Phenylephrine Pathway Selection

In the communication dated 30 July 2026 (COMM Issue No. CLINPR_06_2026_27_Final.pdf), SAHPRA notified all Holders of Certificates of Registration (HCRs) of the final regulatory position regarding orally administered phenylephrine-containing medicines. HCRs were required to notify SAHPRA in writing of their chosen pathway (effectiveness study or reformulation) for each product by 31 August 2026.

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Document Number: CEM-POST07-2026/27
Version: 1
Date Updated: 28/08/2026
File Type: www
Category: Communication to industry
Unit: CEM Post-Reg, Clinical Evaluations Management, General ECTD & human medicines