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News and Updates

Media

Stay up to date with our latest news, media coverages, interviews and announcements on SAHPRA TV.

Databases and Registers

OTC Medicine Information

The SAHPRA Medicines’ Online Directory provides healthcare professionals and the consumer with a guide to all SAHPRA registered over-the counter (OTC) medicines that are available in South Africa without a doctor’s prescription.

Safety alerts

SAHPRA Whistleblower

The SAHPRA hotline has been established with the aim of enhancing an honest work ethic and simultaneously providing the public with a mechanism to bring any unethical business practices to the attention of management.

Product Recalls

Champix 0,5 mg and 1,0 mg (varenicline) film coated Tablets – combo

Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable Daily Intake (ADI) threshold of 733 ng/day calculated by Pfizer, based on ICH M7 guidance, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Champix, batch 18069 and notified SAHPRA Regulatory Compliance Units. Recall process: Recall letter distributed to all healthcare professionals via medpages.

ZAARIO 50 and ZAARIO 100 film coated Tablets (lorsatan potassium)

The products are being recalled due to quality defect: the presence of a mutagenic impurity above the threshold limit observed during analysis, as requested by the European Directorate for the Quality of Medicines and Healthcare (EDQM) on new Azido impurities [the presence of Azido (5-AMBBT) mutagesic impurity beyond total threshold limit was observed during analysis].

Clonam 0.5 mg and Clonam 2 mg film coated Tablets (clonazepam)`

The products are being recalled due to quality defect: the tablet description should be cross-scored, but instead the tablet has only a single score.

Events & Webinars

Stay up to date with SAHPRA’s upcoming, and past recorded events.

Social Media Feeds

3 weeks ago

Workshop postponement: Please be advised that the Regional Workshop on Good Regulatory Practices and its Implementation in the Medical Device Sector in Africa, has been postponed to a future date ... See more

3 weeks ago

Don't know what the South African Health Products Regulatory Authority does and who we are...Register for this webinar and be in the know!

National Department of Health (South Africa) South African ... See more