FOI release

Freedom of Information request (FOI 22/842)

Published 17 January 2024

FOI 22/842

2nd September 2022

Dear

Statutory Requirement for Biennial Audit of MHRA’s Pharmacovigilance System

Thank you for your email dated 25 July 2022 containing the Freedom of Information (FOI) request below:

The Human Medicines Regulations require biennial audit of MHRA’s pharmacovigilance system.

I request a copy of:

a) the two most recent audit reports; and

b) the MHRA’s submission to the Department of Health and Social Care proposing deviation from the statutory requirement for biennial audit of MHRA’s pharmacovigilance system

You are requesting the audits referred to in Human Medicines Regulation 2012 (HMR), Regulation 180. These internally completed audits are not reported to the Department of Health and Social Care, but to the European Commission and therefore an MHRA’s submission to the Department of Health and Social Care proposing deviation does not exist. Furthermore, the audit previously provided in FOI 22/562 was an externally completed audit and therefore does not need to be reported to the European Commission. To assist your understanding, we have explained the legal framework below, including changes resulting from the UK’s exit from the European Union and have provided the two most recent reports as requested. We cannot provide documents shared with Department of Health and Social Care (DHSC) because these do not exist.

The position prior to departing the European Union (EU) was that National competent authorities (in the United Kingdom (UK), the Medicines and Healthcare products Regulatory Agency (MHRA)) were required under Directive 2001/83/EC to perform a regular audit of their pharmacovigilance system and report the results to the European Commission no later than the 21st September (this requirement commenced in 2013 and requires a report every two years), the European Medicines Agency required regular audits of its pharmacovigilance tasks and reported the results to its Management Board on a 2-yearly basis (Regulation (EC) No. 726.2004 Art 28f).

The UK then left the EU on 31st January 2020 and entered into a transition period immediately thereafter, which ended on 31st December 2020. Under the terms of the EU Withdrawal Agreement, the provisions of European Union law concerning medicines regulation continued to apply in the UK during the transition period. Preparations for the UK exit from the EU required new legislation, new regulatory processes, the development of Information Technology systems and

publishing detailed guidance on the regulatory framework for the conduct of pharmacovigilance by the licensing authority and UK marketing authorisation holders following the transition period.

The current situation (post departure) from the EU is that the MHRA retains responsibility for pharmacovigilance across the UK from 1st January 2021. There are however differences in the requirements for medicinal products placed on the market in the UK with respect to Great Britain (GB) and Northern Ireland (NI). From 1st January 2021 under the terms of the Protocol on Ireland/Northern Ireland, medicinal products licensed for sale or supply in Northern Ireland must continue to conform to applicable European Union law.

The HMR 2012 amended requires that the licensing authority (MHRA) must perform a regular audit of its pharmacovigilance system relating to medicinal products for sale or supply in Great Britain and in Northern Ireland. The results of the pharmacovigilance audits for medicinal products for sale or supply in Northern Ireland must be reported to the European Commission no later than 21st September 2021 and every two years thereafter.

The EU guidelines on good pharmacovigilance practices (GVP) modules remain in force however a statutory guidance note on the ‘exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority’ has been published.

Please find attached the two most recent audit reports to the European Commission on

Pharmacovigilance audits carried out in The Medicines and Healthcare products Regulatory

Agency of the United Kingdom: September 2017 to September 2019 and September 2019 to September 2021.

The latest MHRA report covers the period September 2019 to September 2021 and includes information on both external audits and the internal audit programmes. The Operating Divisions of the Agency, formerly Inspection, Enforcement and Standards, Safety and Surveillance, Licensing, Medical Devices as well as the National Institute for Biological Standards and Control and the Clinical Practice Research Datalink, post restructure now Health, Quality and Access, Science, Research and Innovation and Safety and Surveillance are certified to the ISO 9001:2015 standard, the internal audit programme also covers the requirements for Pharmacovigilance audits. The British Standards Institution audits the Agency annually as part of a three-year audit cycle, years one and two are surveillance audits, year three is a recertification audit, the most recent was in January 2022 and the Agency retained certification, certificate number FS 27268.

I hope this information is of use to you.

For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre