The Human Medicines Regulations 2012 (Regulations) came into force on 14 August 2012. These Regulations consolidate the law concerning medicinal products for human use in the UK, currently contained in the Medicines Act 1968 and approximately 200 statutory instruments.
Of particular note is that the Regulations implement the new pharmacovigilance requirements required under the European Directive 2010/84/EU. The amendments, contained primarily in Part 11 of the Regulations, are intended to create stronger systems and clearer responsibilities, improve efficiencies and foster greater openness and transparency. Changes include:
- The definition of adverse drug reporting (ADR) has been expanded such that reports of ADRs should be provided for ADRs resulting from error, misuse, abuse and use off-label. The reporting of suspected ADRs is to be centralised and rationalised, and will include direct patient reporting of suspected ADRs;
- The introduction of a Pharmacovigilance System Summary (PSS) in the marketing authorisation, removing the requirement for new applications to contain a Detailed Description of the Pharmacovigilance System, DDPS;
- Full descriptive information about a company's pharmacovigilance system to be contained in a pharmacovigilance system master file, which should be made available to the National Competent Authorities upon request;
- Risk Management Plans are required to be submitted for all new medicines as part of the authorisation application process;
- The introduction of an EU single assessment of periodic safety update reports (PSURs) where a substance is authorised in more than one Member State and establishes the list of European Union Reference Dates (EURD). Routine PSURs are no longer required for certain types of medicines (e.g. well established use or homeopathic medicines);
- A new Pharmacovigilance Risk Assessment Committee (PRAC) will be formed to replaces the Pharmacovigilance Working Party in the current EU regulatory network
The new pharmacovigilance requirements are underpinned by EC implementing measures and a series of good pharmacovigilance modules (GVPs), the first seven of which have been released and the full set of 16 of which is expected to be available by early 2013.
The MHRA has published a series of questions and answers on its website that will be of interest to those wanting further information on the new requirements. More comprehensive guidance is to be developed by the MHRA and will be available in due course.
The ABPI Code has been reviewed in light of the Regulations and the revised version is now available from the PMCPA's website. The Blue Guide has also been revised to coincide with the Regulations 2012, and has been amended to explain the provisions and requirements in the legislation on advertising medicines and provide additional clarification on the interpretation of the law.