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Focus on Regulation

Updated EMA guidance on centrally authorised medicines raises new considerations for Brexit preparations

On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making Brexit related changes to the authorisations for those products.

The updated version (“Rev 03”) of the EMA Q&A document includes new paragraphs relating to the validity of inspections carried out by UK inspectors, multi-country packaging, back-up arrangements for pharmacovigilance, batch release certificates for human immunological and human blood and plasma medicinal products, and the procedure for assessment of ancillary medicinal substances.

In particular, the new information confirms:

  • the outcome of inspections carried out by the UK competent authority (the MHRA) before 30 March 2019 relating to good manufacturing practice, good clinical practice and pharmacovigilance obligations will continued to be recognised following Brexit;
  • it will only be possible to include UK labelling information on packaging for medicinal products intended for multiple EU markets if the UK information is fully compatible the summary of product characteristics as authorised in the EU;
  • back-up arrangements for situations in which the Qualified Person for Pharmacovigilance is absent will need to be transferred to another EU Member State if they are currently based in the UK;
  • human immunological medicinal products and medicinal products derived from human blood or plasma that have been tested and certified for batch release by an Official Medicines Control Laboratory (OMCL) or by a designated laboratory located in the UK will no longer be permitted to be placed on the EU market following Brexit. Marketing authorisation holders (MAHs) will need to appoint an OMCL located in the EEA or batch release will need to be carried out by a country with which the EU has a mutual recognition agreement; and
  • manufacturers of medical devices which incorporate ancillary medicinal substances will no longer be able to appoint a UK notified body for the purposes of obtaining a scientific opinion from the EMA or a competent national authority concerning the quality and safety of the ancillary medicine.

The updates to the procedural document include new guidance on:

  • changing a UK based applicant for an on-going marketing authorisation application to an applicant established in another EU Member State;
  • how the assignment of existing rapporteurs and co-rapporteurs from the UK to another EU member state will work in practice. This procedural guidance follows the redistribution of the UK’s portfolio of centrally authorised medicinal products and the reallocation of UK rapporteurs and co-rapporteurs, which has been agreed by the EMA and the national competent authorities in April 2018 (link);
  • timings for submitting Brexit-related type IA variations;
  • combining multiple transfers of orphan designations from the UK to another EU Member State; and
  • considerations when changing the pharmacovigilance system master file (PSMF) location from the UK to a remaining EU Member State.

The Q&A and procedural guidance supplement the EMA’s Notice to holders of centrally authorised marketing authorisations, last updated in January 2018. The Notice emphasises the need for MAHs to ensure the continuity of supply of medicines in the EU following Brexit and proactively review the marketing authorisations they hold to assess the need for any changes.

Both documents are based on the UK leaving the EU on 29 March 2019 without any transitional arrangements in place.