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Blog - MHRA Inspectorate
MHRA GPvP Inspectorate Guide to Marketing Authorisation Holder Considerations for Agreements with Pharmacovigilance System Service Providers
22-01-2018
The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much as any other. This blog expands upon the areas identified as problematic for MAHs and service providers and provides points to consider when producing contracts and agreements text.

PV Inspection Metrics Multiple Agencies around the world have published information resulting from their Pharmacovigilance Inspection activities including the MHRA, the US FDA, and the Australian TGA.

New SAHPRA PV guidance The South African Health Products Regulatory Authority (SAHPRA) has issued a revised version of the guideline covering Post-Marketing Pharmacovigilance, which brings changes to Periodic Reporting requirements.

Hot topics are taken from Safety Observer Lite 167, May 2020

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