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https://mhrainspectorate.blog.gov.uk/2021/02/12/guidance-on-pharmacovigilance-requirements-for-uk-authorised-products-from-1-january-2021/

Guidance on pharmacovigilance requirements for UK authorised products from 1 January 2021

Posted by: , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice

Since before the end of the transition period on 31 December 2020, we have been working hard to provide the guidance you need to become familiar with the pharmacovigilance requirements for UK marketing authorisation holders (MAH) which are set out in a revised legal framework. In this blog post, we’ve pulled together all the sources of guidance that we’ve published so far, as well as information on where to go if you still have questions.

Statutory pharmacovigilance guidance

The EU guidance on good pharmacovigilance practices (GVP) continues to apply in the UK. The full guidance is available here.

The MHRA guidance note on the exceptions and modifications to the EU guidance on good pharmacovigilance practices (GVP) that apply to UK MAHs and the MHRA is available here.

Pharmacovigilance systems

Guidance on the UK qualified person for pharmacovigilance (QPPV) and the pharmacovigilance system master file (PSMF), as well as submission of the summary of pharmacovigilance system details to the MHRA, is available here.

Pharmacovigilance procedures

Guidance on pharmacovigilance procedures, including the submission of reports of adverse drug reactions and periodic safety update reports, is available here.

Webinars

Recordings of pharmacovigilance webinars that took place on 22 October 2020 and 13 January 2021 are available.

Frequently asked questions

Frequently asked questions (FAQ) in relation to pharmacovigilance have been compiled and shared with pharmaceutical trade associations. If you have a query that you cannot find an answer to from the published guidance, please contact your trade association by emailing:

Contact

If you need to contact the MHRA with a question, please use one of the following contacts:

Updates

We continue to review our guidance and FAQs. You can register to receive updates to our website guidance pages here.

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