On 1 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) issued extensive guidance (accessible here) addressing how medicines and medical devices will be regulated in the UK, once the Brexit transition period comes to an end on 31 December 2020.
From the end of the transition period, the MHRA will be the UK’s standalone medicines and medical devices regulator. In light of this, the guidance aims to inform businesses about what they will need to do in the context of their regulatory obligations from 1 January 2021.
The MHRA’s guidance provides detailed information, applicable from 1 January 2021, in the following areas:
- Registration of clinical trials for investigational medicinal products and publication of summary results
- Guidance on substantial amendments to a clinical trial
- Regulating medical devices
- Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
- Registering new packaging information for medicines
- 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
- Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs)
- Handling of Active Substance Master Files and Certificates of Suitability
- Reference Medicinal Products (RMPs)
- Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), 'grandfathering' and managing lifecycle changes.
- Renewing Marketing Authorisations for medicines.
- Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products
- Guidance on licensing biosimilars, ATMPs and PMFs
- Comparator products in Bioequivalence/Therapeutic Equivalence studies
Importing and exporting
- Importing medicines on an approved country for import list
- Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland
- Importing investigational medicinal products into Great Britain from approved countries
- List of approved countries for authorised human medicines
- Acting as a Responsible Person (import)
- Registering to make submissions to the MHRA
- Webinars: preparing to make submissions to the MHRA
- Guidance on pharmacovigilance procedures
- Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
- Procedures for UK Paediatric Investigation Plan (PIPs)
- Completed Paediatric Studies - submission, processing and assessment
- Format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check
Following the withdrawal of the government’s earlier no-deal guidance in March 2020, this new guidance will provide welcome detail to businesses operating in the life sciences sector. However, with fewer than three months until the end of the transition period, businesses will need to work swiftly to ensure they are ready for the start of the new regime in 2021.