Meeting to disseminate guidelines for submission of periodic safety update report and any other reports that may be relevant to determine the safety efficacy and quality of a drug
Reference is made to the National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014. Market Authorization Holders (MAH) are required to have an appropriate system for pharmacovigilance and risk management in place in order to assure responsibility and liability with regards to the safety, efficacy and quality of their products on the Ugandan market. NDA has…
