GovWire

1. Overview

The following legal obligations apply to holders of UK marketing authorisations (MA). These include products authorised as both Category 1 and Category 2 and those authorised as a PLNI or a PLGB licence.

To operate a pharmacovigilance system for UK authorised products To have an appropriately qualified person responsible for pharmacovigilance (QPPV) that resides and operates anywhere in the UK or in the EU/EEA and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products To maintain and make available upon request a pharmacovigilance system master file (PSMF) that describes the pharmacovigilance system for UK authorised products. The PSMF must be accessible electronically from the UK at the same site at which reports of suspected adverse reactions may be accessed

2. Guidance on the QPPV for UK authorised products

For all UK MAs, the marketing authorisation holder (MAH) must have permanently and continuously at its disposal a QPPV who resides and operates anywhere in the UK or in the EU/EEA, and is responsible for the establishment and maintenance of the pharmacovigilance system (the UK QPPV). Where the QPPV is not in the UK, there will be a need for a national contact person for pharmacovigilance as set out below.

This is provided for by regulation 182 of the Human Medicines Regulations 2012 (HMR).

For Category 2 MAs, the legal requirements concerning the qualifications and responsibilities of the QPPV that are outlined in Article 10 of the Commission Implementing Regulation (EU) No 520/2012 (IR) will remain unchanged.

For Category 1 MAs or any PLGBs granted by the MHRA, legal requirements concerning the qualifications and responsibilities of the QPPV are outlined in paragraph 10 of HMR Schedule 12A (inserted by the EU Exit Regulations 2019), which mirrors Article 10 of CIR.

Statutory guidance concerning the QPPV for UK authorised products is described in the Good Pharmacovigilance Practices (GVP) Module I. This guidance is supplemented by the Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders.

There is no temporary exemption as to the requirement to have a QPPV who resides and operates in the UK or the EU/EEA and is responsible for the pharmacovigilance system for UK authorised products.

2.1 National contact person for pharmacovigilance

If you choose to establish a QPPV who resides and operates in the EU/EEA, you must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV. This individual should have access to the reports of suspected adverse reactions referred to in regulation 187 of the HMRs and the PSMF for UK authorised products. The individual should be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.

Once the national contact person for pharmacovigilance has been appointed, their details should be notified to the MHRA via the MHRA Submissions Portal. You should follow the instructions for submitting these details. You should receive a confirmation by email immediately upon completion of the form.

There is no requirement to appoint a deputy for the UK national contact person for pharmacovigilance, but for periods of extended absence greater than one month (such as maternity leave, long-term sick leave, etc.), it is expected that another individual is assigned as the national contact person for pharmacovigilance and their details should be notified to the MHRA within two weeks of the change. In practice, this means editing the existing details of the national contact person for pharmacovigilance that are saved in the MHRA Submissions portal.

3. Guidance on the PSMF for UK authorised products

For all UK MAs, the MAH must maintain, and make available upon request of the MHRA, a PSMF that describes the pharmacovigilance system for UK authorised products (the UK PSMF).

3.1 PSMF accessibility in the UK

All UK PSMFs must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the HMRs are accessible.

The PSMF needs to be permanently and immediately available for inspection at the stated location in the UK. The content within the PSMF must be up to date as of the point it is requested by the MHRA.

3.2 PSMF format, content and representation of pharmacovigilance systems

For Category 2 MAs or PLNIs, the legal requirements concerning the format and content of the PSMF that are outlined in Chapter I of IR will remain unchanged.

For Category 1 MAs or those which the MHRA grant as PLGBs , legal requirements concerning the format and content of the PSMF are outlined in Part 1 of Schedule 12A of HMR, which mirrors Chapter I of IR.

As the legal requirements concerning PSMF format and content are identical for all UK MAs a single UK PSMF can be used for all UK authorised products. This is assuming that the pharmacovigilance system applied to all products is the same.

Statutory guidance concerning the PSMF for UK authorised products is described in GVP Module II. This guidance is supplemented by the Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders.

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