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Detailed guide: From 1 January 2021 Pharmacovigilance System and Qualified Person for Pharmacovigilance explainer

Veterinary Medicines Directorate

October 7
11:11 2020

Qualified Person for Pharmacovigilance location

Centrally authorised Marketing Authorisations

Centrally authorised Marketing Authorisations (MAs) are issued by the European Medicines Agency which must comply with EU Regulations and as such the Qualified Person for Pharmacovigilance (QPPV) must be located in the EU for these products to be on the NI market.

For existing Centralised MAs, you will be offered a GB MA for these products from 1 January, see below and Application and Authorisation process. For GB MAs, the QPPV can be located anywhere.

Mutual Recognition and Decentralised MAs

MAs issued following Mutual Recognition/decentralised procedures will continue to be issued by the VMD in respect of NI. Due to interpretation of the requirements of the Northern Ireland Protocol (reference: Section 20 of Annex 2) for authorisations issued by the UK in respect of NI, the QPPV can be located in the EU, NI or GB.

UK national MAs (existing), GB MAs and NI MAs

Due to interpretation of the requirements of the Northern Ireland Protocol (reference: Section 20 of Annex 2) for authorisations issued by the UK in respect of NI, such as existing UK wide and NI MAs, the QPPV can be located in the EU, NI or GB.

The QPPV for GB MAs can be located anywhere.

Pharmacovigilance inspections

From the 1 January 2021, the VMD will carry out inspections of all Marketing Authorisation Holders (MAHs) for products authorised in the UK. This includes those MAHs located outside of the UK.

We will use a risk-based approach to scheduling inspections and will conduct these remotely where appropriate. Risk basis considerations will include last EU inspection date, previous inspection findings and surveillance intelligence.

Detailed Description of Pharmacovigilance System

The UK requirement for the Detailed Description of Pharmacovigilance System is under review. We will update this section with more information as it becomes available.

Published 7 October 2020

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