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Public notice on re-registration of pharmaceutical products

Thursday, 5th July 2018

National Drug Authority updated its Guidelines for Registration of Human Pharmaceutical Products to Common Technical Document (CTD) format in a bid to meet internationally acceptable practices and standards.


In order to improve safety, efficacy and quality of pharmaceutical products on the Ugandan market, all marketing authorization holders for human pharmaceutical products registered before January 2015 are requested to submit applications in CTD format as per requirement of the current registration guidelines.  Please include scanned photos of product samples for each pack size in your applications.


All the Marketing Authorization Holders and Local Technical Representatives should note that the deadline for the submission of the application for re-registration is 31st July, 2020.


Guidelines for Registration of Veterinary Pharmaceutical Products in CTD format are under development, and the implementation process will be communicated in due course.