Pharmacovigilance, Incl. Qualified Person for Pharmacovigilance and Post-Marketing Authorisation Procedures

The qualified person responsible for pharmacovigilance must reside and carry out his/her tasks in a Member State of the EU. As of the end of the transition period, QPPVs currently residing/carrying out their tasks in the United Kingdom have to have been transferred to the EU.

As of the end of the transition period, PSMFs currently located in the United Kingdom have to have been moved to the EU. Changes to the location of the PSMF (street, city, postcode, country) may be updated through the Article 57 database only.

It is no longer mandatory to submit to EudraVigilance reports of suspected nonserious adverse reactions that have occurred in the United Kingdom as of the end of the transition period. As of the end of the transition period, UK authorities will no longer have access to EudraVigilance.

Marketing authorisation holders are reminded that they will need to submit into EudraVigilance information that they might receive from UK authorities regarding cases occurring in the United Kingdom. As of the end of the transition period, UK authorities will no longer have access to EudraVigilance.

Relevant safety data obtained from UK the sources after the transition period are to be included in PSURs. For the calculation of exposure from marketing experience by region, patients exposed in the United Kingdom before the end of the transition period are to be included in the EU estimate. UK patient exposure is to be considered as part of the non-EU regions.

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-stakeholders-withdrawal-united-kingdom-eu-rules-medicinal-products-human-use-veterinary_en

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