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.
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.
Guidance on pharmacovigilance procedures, including the submission of reports of adverse drug reactions and periodic safety update reports, is available here.
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:
- Association of the British Pharmaceutical Industry (ABPI): email@example.com
- British Generic Manufacturers Association (BGMA): firstname.lastname@example.org
- BioIndustry Association (BIA): email@example.com
- Clinical & Contract Research Association (CCRA): firstname.lastname@example.org
- Ethical Medicines Industry Group (EMIG): email@example.com
- Health Food Manufacturers’ Association (HFMA): firstname.lastname@example.org
- The National Pharmacy Association (NPA): email@example.com
- Proprietary Association of Great Britain (PAGB): firstname.lastname@example.org
If you need to contact the MHRA with a question, please use one of the following contacts:
- General queries relating to the QPPV, PSMF and establishment of pharmacovigilance systems for UK authorised products should be sent to email@example.com
- Queries relating to the UK PSMF number should be sent to UKPSMFadmin@mhra.gov.uk
- Queries relating to submission of Type IA variations relating to the summary of pharmacovigilance system should be sent to firstname.lastname@example.org
- For further information, please email our Customer Services Centre at mailto:email@example.com or call 020 3080 6000. You can also email firstname.lastname@example.org with urgent questions.
We continue to review our guidance and FAQs. You can register to receive updates to our website guidance pages here.
Don’t miss the next post, sign up to be notified by email when a new post comes out