FOI release

Freedom of Information request on reporting regulations for Adverse Drug Reactions (ADRs) from 2007 to date (FOI 21/983)

Published 25 February 2022

8th September 2021

FOI 21/983

Dear

Thank you for your email dated 20th August 2021 where you requested guidance on retrieving the reporting regulations for Adverse Drug Reactions (ADRs) from 2007 to date.

As you know, the reporting requirements on pharmaceutical companies have changed over time and the details of where this information is available is provided below.

From 2001 to 2012

The relevant UK legislation at this time is provided in the Medicines Act 1968 and the applicable Statutory Instruments, including The Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994, SI 3144, which is the most relevant information with regards to Adverse Drug Reaction (ADR) recording and reporting.

This required Marketing Authorisation holders to comply with the obligations, including those related to pharmacovigilance and the recording and reporting of suspected adverse drug reactions, which were provided for in the relevant European Community legislation.

The EC regulations were provided in Directive 2001/83/EC and Regulation (EC) N0 726/2004. This included provisions in Article 106 of Directive 2001/83/EC for the production of accompanying guidance that included requirements for the collection, verification and presentation of adverse reactions reports in order to facilitate exchange of pharmacovigilance information within the community – known as Volume 9A.

At that time, EU legislation required that Marketing Authorisation holders kept records of any suspected adverse reactions to their medicinal products that were received and occurred within the EU or in a third country and that the record must comply with the guidance outlined in Article 106 of the 2001 Directive (Volume 9A guidance), which included that for serious adverse reactions that record was made within 15 days of them first being made aware of the reaction.

With regards to serious adverse reactions, there was also a requirement to report these to the relevant competent authority within 15 days of first being aware of the adverse reactions. For serious reports that occurred in the UK, they were required to be reported to the UK licensing authority (the MHRA and its predecessor the Medicines Control Agency). For products authorised through one of the European licensing procedures we also required that reports of serious adverse reactions that occurred in the EU and also reports occurring in third countries were also reported to the UK for products where we were the lead Member State (Rapporteur for centralised products or Reference Member State for MR/DCP products).

The European Commision website provides further links to the relevant Directive and if you click on the ‘Show all versions’ tab on the left hand side this also provides the updates on the directive since it came in force in 2001.

From 2012 to date

The UK Regulations were revoked and consolidated by the Human Medicine Regulations 2012 which came into force on 14 August 2012, available at https://www.legislation.gov.uk/uksi/2012/1916/contents/made

Specifically, part 11 provides the reporting requirements for both the licensing authority, ie the MHRA, as well as the marketing authorisation holders, ie the pharmaceutical companies. Post 31st December 2020 this legislation should be viewed in association with the Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team, Vigilance and Risk Management of Medicines Division