News
The Veterinary Medicines Directorate (VMD) has published guidance for pharmacovigilance for veterina
The VMD is responsible for the pharmacovigilance of all UK-held veterinary medicine Marketing Authorisations (UK-wide, GB-only and NI-only)
The Veterinary Medicines Regulations 2013 sets out the legal framework for pharmacovigilance of veterinary medicines in Great Britain (England, Scotland and Wales)
For products authorised in Northern Ireland the guidance set out in Eudralex Volume 9B should also be followed
Post-transition period information published on the MHRA website updated 04Jan2021
The MHRA continues to provide updates on Brexit post-transition arrangements this includes:
· Exceptions and modifications to EU GVP for UK MAHs and the MHRA
· Pharmacovigilance guidance and UK PSMF, UK QPPV and National Contact Person for Pharmacovigilance requirements
· Procedures for marketing authorisations including the Unfettered Access Procedure (UAP) and European Commission Decision Reliance Procedure (ECDRP)
Great Britain (England, Scotland and Wales) fall under UK legislation. Northern Ireland falls under both EU and UK legislation
MAHs can have a QPPV based in the UK or EU. MAHs with a QPPV in the EU must have a national contact person for PV based in the UK that reports to the QPPV
The PSMF must be electronically accessible at the location in the UK where suspected adverse reactions are accessible and must be immediately available for inspection at that location
Post-transition period information published on the MHRA website 04/Sep/2020
On 04Sep2020 the MHRA posted guidance on the UK QPPV and PSMF requirements from 01Jan2021
MAHs can have a QPPV based in the UK or EU. MAHs with a QPPV in the EU must have a national contact person for PV based in the UK that reports to the QPPV
The PSMF must be electronically accessible at the location in the UK where suspected adverse reactions are accessible and must be immediately available for inspection at that location
Post-transition period information published on MHRA 01/Sep/2020
Covers:
· Clinical trials
· Devices
· Licensing
· Importing and exporting
· IT systems
· Pharmacovigilance
· Paediatrics
Centrally Authorised Product licences will be converted to UK Marketing Authorisations covering Great Britain only (Northern Ireland will remain part of the EU Centrally Approved licence)
MAHs must register for the MHRA Submissions portal and either the MHRA Gateway (database to database) or ICSR Submissions (MHRA equivalent of EVWeb)
GVP will remain in force, but Great Britain and Northern Ireland will be treated differently. Medicines sold or supplied in Northern Ireland will require submissions to follow EU requirements. If a Marketing Authorisation covers the UK (Great Britain and Northern Ireland) information will need to be submitted according to both UK and EU requirements
MHRA inspection update 23Jul2020
Having made a change to their GxP inspections programme during the peak of the COVID-19 pandemic, the MHRA is planning to return to onsite GxP inspections from September
The MHRA will provide a further update later in the summer
EMA guidance COVID-19 04May2020
The EMA has also published guidance which includes:· Advice for sponsors of clinical trials for COVID-19 Advice for sponsors of clinical trials affected by the pandemic Guidance on regulatory expectations and flexibility
The EMA update includes: Q&A on regulatory expectations
https://ec.europa.eu/health/sites/health/files/human-use/docs/guidance_regulatory_covid19_en.pdf
Detailed guidance on ICSRs in the context of COVID-19
MHRA updated COVID-19 guidance for medicines safety - 27Apr2020
In their April 2020 Drug Safety Update, the MHRA has posted their latest COVID-19 guidance for medicines safety. https://www.gov.uk/drug-safety-update/coronavirus-covid-19-latest-guidance-for-medicines-safety
Their guidance includes: Requests for healthcare professionals (HCPs), patients and caregivers to submit suspected side effect reports electronically via the Yellow Card website · Asking HCPs to discuss side effects with and encourage self-reporting by patients and caregivers· Advice on medicines safety concerns linked to COVID-19
MHRA Guidance on Coronavirus - 19Mar2020
The MHRA has set up a page where they are posting regular guidance covering the following areas:
Clinical Trials
Inspections
Medical devices
Medicines regulation
https://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19
Clinical Trials:
Guidance includes paperwork to submit if a trial is halted due to COVID-19
Providing IMP to trial participants
Remote monitoring for trials
Reporting adverse events and annual safety reports
Protocol deviations and serious breaches
Inspections:
The MHRA will only be carrying out essential on-site GxP inspections until further notice. They will use alternative approaches for routine regulatory oversight (which includes office-based assessment and information sharing with the international regulatory network)
MHRA - 10Mar2020
The MHRA has published an inspectorate blog today with the dos and don’ts for GCP inspections.
It is an interesting and helpful piece and, as usual, includes a bit of inspector humour.
Publications
29Nov2019
Sarah’s speaker abstract ‘Medical Information and Pharmacovigilance working together’ from the 3rd European Pharmacovigilance Congress is published in Therapeutic Advances in Drug Safety Volume 10
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6886266/
09Oct2018
Sarah’s article ‘How is Brexit expected to impact UK Pharmacovigilance?’ is published in Health Europa Quarterly Issue 7
FAQ
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