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Notice to all Market Authorization Holders & Local Technical Representatives

Thursday, 22nd March 2018

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 developed afore-mentioned guideline as part of the implementation road map for this regulatory requirement. This is therefore to invite all Market Authorisation Holders and Local Technical Representatives to a dissemination meeting on Wednesday 28th March 2018, starting at 8:00am. Meeting venue will be communicated later.

The objective of the meeting will be to ensure that the relevant stakeholders clearly understand NDA`s requirements and expectations with regards to this regulatory provision.


Sincerely,

Helen Byomire Ndagije

DIRECTOR PRODUCT SAFETY