The UK PSMF – What Will It Look Like?
How will the Pharmacovigilance System Master File (PSMF) be impacted by the UK’s departure from the EU? What actions will companies with a UK Marketing Authorisation Holder (MAH) need to take in the event of a no-deal Brexit? We consider the questions and give advice on what you need to consider and what you need to do if you are impacted.
It is apparent that the MHRA will follow a similar approach to the EMA with respect to the management of PV activities, meaning that the following legal obligations will apply to a UK based MAH in a no-deal scenario:
- Operation of a pharmacovigilance system
- Appoint a QPPV that resides and operates in the UK
- Maintain a PSMF (located in the UK)
What will the “UK PSMF” Look Like?
Firstly, the format and content of the UK PSMF are equivalent to that of the EU PSMF, so that’s helpful! Most MAHs are already familiar with the requirements of the EU PSMF and they follow the guidance outlined in GVP Module II. However, one should also be aware of the minimum requirements for the content and maintenance of the “UK PSMF” as laid out in HMR Schedule 12A.
Question: Do you have more than one PV system?
If so, the UK PSMF must describe the global PV operations and reflect the global availability of safety information for UK authorized products however, the annex content should be specific to UK authorized products.
Furthermore, all UK PSMFs must be registered with the MHRA and a unique PSMF number requested for each pharmacovigilance system for UK authorized products. Where the pharmacovigilance system is shared by several MAHs, a single request for a UK PSMF number should be submitted to the MHRA.
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