The size of the South Africa’s pharmaceutical market has a value of more than $4 billion (2021 data). A substantial grow of the market is also expected for the upcoming years driven by the growing population and life expectancy, prevalence of chronic diseases and introduction of the universal health insurance. Imported products play a significant role in the pharmaceutical market of the country accounting for more than two-third of pharmaceutical sales.
On 22nd June 2022, the South African Health Products Regulatory Authority (SAHPRA) issued the Renewal of Registration of Human & Veterinary Medicinal Products marketing authorization renewal guideline. This is the first ever renewal guideline released by SAPHRA since the renewal of a marketing authorization was not foreseen according to the previous existing guidelines. SAHPRA will also be introducing a change to the current registration certificate to allow for an expiry date to be added.
Based on the guideline, a renewal application must be submitted to SAHPRA six (6) months prior to the expiry of the health product registration.First submissions are expected on or before the 15th of March 2023.
For pharmaceutical products registered before 2017, a full eCTD baseline submission in line with the General Guidelines for registration will be required.
SAHPRA will charging a fee for applications to be renewed that will be derived from a cost to serve analysis.
Failure to submit a complete and compliant renewal application may lead to the expiry of the registration and the product registration no longer being valid. If the product registration would expire, the applicant must submit a new product registration application.
The renewal evaluation process will mainly consist of a benefit/risk balance re-evaluation. The product will not be renewed if serious public health issues remain at the end of the renewal procedure or if an existing suspension on the product registration or marketing authorisation cannot be lifted.
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