UK Government has issued a series of new Brexit guidance documents for the life sciences sector. With the transition period coming to an end on 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on its role as the UK’s standalone medicines and medical devices regulator in under four months.
In this article, we take a look at the guidance on licensing of medicines and related products, particularly marketing authorisations. This addresses the following topics:
- Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021
- Registering new packaging information for medicines from 1 January 2021
- Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021
- How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021
- Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021
- Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021
- Reference Medicinal Products (RMPs) from 1 January 2021
- Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes
- Renewing Marketing Authorisations for medicines from 1 January 2021
- Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
- Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021
- Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021
The guidance is detailed and extensive – about time some might say – and it will be worth spending some time on the material that affects your business. We highlight some important points below.
There are occasional references to new UK routes to market. Guidance on this topic was issued under the ‘no-deal Brexit’ scenario in March 2019, but was later withdrawn. We expect to see further information in this area to flesh out the details.
It is worth noting that Northern Ireland will remain under the EU system, at least for now. The changes apply to the rest of the UK (England, Scotland and Wales). This is a source of some confusion in the guidance, and care is needed to understand this difference.
Converting Centrally Authorised Products to UK Marketing Authorisations – the grandfathering process
The grandfathering process deals with products that currently benefit from an EU-wide marketing authorisation issued by the European Medicines Agency. This has been flagged before, and the new guidance includes greater detail as to how it will work.
Existing EU central marketing authorisations will convert to UK MAs free of charge. Marketing authorisation holders (MAHs) can opt out of the process up to 21 January 2021. Assuming they do not take this option, a new marketing authorisation applicable to the UK market only will be issued. This will be valid from 1 January 2021.
MAHs must submit essential baseline data in electronic Common Technical Document format during the following year (ie in 2021). Annual fees will be payable from 1 April 2021.
Transfer to a UK-based MAH will be required by 1 January 2023. This can be done at the outset or within 21 months of the changeover.
Pending applications for EMA central authorisation
Where applications are pending in the central process, two options will be available. These are:
- an ‘in-flight’ assessment in parallel with the EU application process
- applying once a positive Commission for Medicinal Products for Human Use opinion is obtained.
The new material is certainly a helpful addition to the information available to producers and importers. However, it remains incomplete and includes references to future legislation – not easy for businesses to navigate.
This article was written by Medilink EM Patron, Mills and Reeve LLP.