- Operation of a pharmacovigilance system
- Appoint a QPPV that resides and operates in the UK
- Maintain a PSMF (located in the UK)
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: