The Human Medicines Regulations 2012 (the “Regulations”), which came into force today, consolidate the Medicines Act 1968 and over 200 of the statutory instruments thereto. The aim of the Regulations is to (i) simplify the existing legislative framework relating to medicines in the UK and (ii) introduce policy changes, of which the most significant - from the perspective of marketing authorisation holders (“MAHs”) and applicants - relate to a new pharmacovigilance (“PV”) regime introduced by European Directive 2010/84/EU. Examples of the changes to the existing PV framework that will arise as a result of the Regulations include the following:

  • The requirement for MAHs to submit ADR reports into EudraVigilance (the database and data-processing network set up and maintained by the European Medicines Agency) only; the submission of reports to the MHRA will no longer be required.
  • In place of the Detailed Description of the Pharmacovigilance System (DDPS), MAHs will be required to maintain a Pharmacovigilance System Master File (PSMF) for submission or inspection by the MHRA.
  • The requirement for Periodic Safety Update Reports (“PSURs”) to be submitted by MAHs in electronic format to the European Medicines Agency only.
  • The submission of routine PSURs by MAHs for low risk, old or established products will no longer be required unless specific concerns arise.