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MHRA Explains No-Deal Brexit Pharmacovigilance Requirements

Posted 12 March 2019 | By Michael Mezher 

MHRA Explains No-Deal Brexit Pharmacovigilance Requirements

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued guidance for drugmakers on how to comply with pharmacovigilance requirements in the event the UK leaves the EU without a deal later this month.
The guidance comes the same day as the UK Parliament voted down a revised version of the Brexit deal the UK and EU negotiated last November.
After the vote, UK Prime Minister Theresa May reiterated her commitment to leaving the EU with a deal in place and said that the Parliament must now decide whether to go ahead with a no-deal Brexit or to ask the EU for an extension on the Brexit date.
No-Deal Pharmacovigilance Requirements
In the event of a no-deal Brexit, MHRA says that drugmakers must ensure their pharmacovigilance practices are in compliance with the UK’s EU Exit Regulations.
This includes operating a pharmacovigilance system for all UK authorized products, employing a UK-based qualified person for pharmacovigilance (UK QPPV) and maintaining a pharmacovigilance system master file (PSMF).
According to MHRA, “the role and responsibilities of the UK QPPV are equivalent to that of the EU/EEA [European Economic Area] QPPV,” but require that the QPPV be based in the UK.
The UK QPPV will be responsible for establishing and maintaining a drugmaker’s pharmacovigilance for all UK authorized products. MHRA also notes that it will allow drugmakers an exemption to the requirement that the QPPV be based in the UK until the end of 2020 if their current EU/EEA QPPV is based in the EEA immediately before Brexit.
For PSMFs, MHRA says that the file must be located at the same site within the UK where reports of suspected adverse reactions are accessible. “This differs from the EU concept where the EU PSMF shall be located either at the site where the main pharmacovigilance activities are performed or at the site where the EU/EEA QPPV operates,” MHRA says.
MHRA says the format and content requirements for the UK PSMF are “equivalent to that of the EU PSMF.”
While drugmakers can operate multiple pharmacovigilance systems or share a single pharmacovigilance system with other drugmakers, MHRA says that each UK PSMF must have a unique identification number, which will be available for request from the MHRA website on 30 March 2019.
However, MHRA says that drugmakers should not request a UK PSMF number until they are ready to submit a variation application updating the summary of pharmacovigilance system in their product license.


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