A high volume of guidance documents has been issued by the MHRA on a possible no deal scenario in the last week. Further to the previous no-deal guidance and draft legislation already published (and covered in this blog), the MHRA has in recent days published a huge raft of further guidance covering a much more detailed range of regulatory rules for medicines and medical devices, and how they would be handled should the UK exit the European Union next Friday without a withdrawal deal in place.

Both pharmaceuticals and medical devices companies need to stay alert to keep up with the developments as MHRA will add further links as new guidance and information is published.

Links to the most recent guidance, covering the regulation of medicines and medical devices if the UK leaves the EU with no deal, include:

 

  1.  Guidance on registration of clinical trials for investigational medicinal products and publication of summary results (March 2019)
  2.  Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on exit day (March 2019)
  3.  Guidance on Marketing Authorisation Applications submitted to the UK that have been referred under Article 29 in a no deal scenario (March 2019)
  4.  Guidance on Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no deal scenario (March 2019)
  5.  Handling of Active Substance Master Files and Certificates of Suitability in the event of no deal (March 2019)
  6.  Guidance on handling of Decentralised and Mutual Recognition Procedures in a no deal scenario (March 2019)
  7.  Guidance note on new assessment routes in a no deal scenario (March 2019)
  8.  Guidance on Reference Medicinal Products (RMPs) if the UK leaves the EU without a deal (March 2019)
  9.  Guidance on how variations to Marketing Authorisations (MAs) will be handled after exit day if there is no deal (March 2019)
  10.  Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no deal scenario, ‘grandfathering’ and managing lifecycle changes (March 2019)
  11.  How renewals of Marketing Authorisations will be handled in a no deal scenario  (March 2019)
  12.  How UK orphan medicinal products will be managed in a no deal scenario (March 2019)
  13.  Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products in a no deal scenario (March 2019)
  14.  Licensing of biological products: biosimilars, ATMPs and PMFs in a no deal scenario (March 2019)

 

  1.  Importing medicines from an EEA State which is on an approved country for import list  (March 2019)
  2.  List of approved countries for authorised human medicines in a no deal scenario (March 2019)
  3.  Guidance on importation of investigational medicinal products from approved countries (March 2019)
  4.  Exporting active substance manufacturer in the UK if we leave the EU without a deal (March 2019)
  5.  Guidance on air freight of medicines in a no deal scenario (March 2019)

 

  1.  Procedures for UK-PIPs in the event the UK leaves the EU without a deal  (March 2019)
  2.  Completed Paediatric Studies – submission, processing and assessment in the event of a no deal scenario (March 2019)

 

  1.  Regulating medical devices in the event of a no deal scenario (March 2019)

 

  1.  Making submissions to the MHRA in a no deal scenario (March 2019)
  2.  Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal (March 2019)
  3.  Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal (March 2019)
  4.  Guidance on pharmacovigilance procedures in the event the UK leaves the EU without a deal (March 2019)
Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Author

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

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