With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations.
The UK House of Commons last week voted to reject the UK leaving the EU without a deal. However, that vote is not legally binding and does not automatically change the underlying position in UK and EU law, which remains that the UK will leave the EU with "no deal" in place at 11pm on 29 March unless (i) the UK agrees a deal with the EU and the EU grants a short extension to ratify the deal, (ii) the EU agrees to extend the Article 50 period to give the UK more time to agree a deal, or (iii) the UK revokes Article 50.
Given the remaining possibility of a "no deal", pharmaceutical, biotech and medical device companies are continuing to take steps to secure their supply chains in the event that the UK does leave the EU without any transitional arrangements in place either on 29 March or possibly at the end of any extension period.
The MHRA has over recent weeks issued a number (16 in the last three days alone) of new and updated guidance documents on how medicines and medical devices will be regulated in the UK if the UK leaves the EU with "no deal" to assist companies with their continued contingency plan.
The new documents include guidance on:
Marketing authorisations, variations and licensing guidance
- Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), 'grandfathering' and managing lifecycle changes
- Handling of applications for Centrally Authorised Products (CAPs) pending on exit day
- Handling of Decentralised and Mutual Recognition Procedures
- Guidance on Reference Medicinal Products (RMPs)
- New UK assessment routes
- How renewals of Marketing Authorisations will be handled
- Variations to Marketing Authorisations (MAs)
- Updates to packaging components and instructions on submissions for those marketing authorisations (MA) issued following conversion of EU MA
- Licensing of biological products: biosimilars, ATMPs and PMFs
- How UK orphan medicinal products will be managed
- Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs)
- Handling of Active Substance Master Files and Certificates of Suitability
- Registration of clinical trials for investigational medicinal products and publication of summary results
- Completed Paediatric Studies - submission, processing and assessment
- Procedures for UK-PIPs
- New provisions for traditional herbal medicinal products and homoeopathic medicinal products
Importing and exporting
- Importing medicines from an EEA State which is on an approved country for import list
- Importation of investigational medicinal products from approved countries
- Exporting active substance manufacturer in the UK
- Guidance on air freight of medicines
Regulatory submissions and vigilance activities
- Making submissions to the MHRA
- Qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
- Pharmacovigilance procedures
- Regulating medical devices (covering manufacturers, authorised representatives, importers and distributors, MHRA registration, clinical investigations, notified bodies, labelling and post-market surveillance requirements)
The guidance documents contain new detailed information in a number of key areas including the actions that holders of "grandfathered" UK MAs granted on the basis of an EU MA and that UK wholesale dealer licence holders importing products from the EEA would need to take, as well as on the new role of a "UK Responsible Person" for medical device manufacturers.
Companies need to check that their contingency plans are aligned with the MHRA's stated position and already cover or allow for all of the elements addressed in the guidance.
All of the new (and previous) guidance is available here.