Pharmacovigilance and Regulatory services in the UK

PV and Reg Services

Pharmacovigilance and Regulatory services in the UK

As of 1 February 2020, the United Kingdom (UK) is no longer an EU Member State and acts as a third country. This means that the UK no longer participates in EU institutions and their decision-making. However, EU law still applies to the UK during the transition period, which is due to end on 31 December 2020. The transition period can be extended once by up to one to two years. Such a decision must be taken jointly by the EU and UK before 1 July 2020.

Marketing authorisation holders/applicants can still be established in the UK and Qualified Persons for Pharmacovigilance (QPPVs) and pharmacovigilance system master files (PSMFs) can still be based in the UK until the end of 2020.

EMA has recently remarked on a press release that companies have until 31 December 2020 to make the necessary changes to ensure that their authorised medicines comply with EU law and can remain on the EU market.

In this regard, ASPHALION can support you by providing Pharmacovigilance and Regulatory services in the UK. If you want to learn more about us, don’t forget to visit our post about ASPHALION’s new PV contact in the UK.

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