There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. Each of them would reflect in obtaining a specific MA number:
- UK PL (New National Applications)
- GB PL (National procedures, Reliance Procedure)
- NI PL (NI national MA, CAP and DCP/MRP as CMS)
The options available will be determined by the intended market and the type of application. You need to follow a specific application procedure depending on the licence (marketing authorisation) you need. To obtain a medical product authorization, you need to use one of the following procedures:
- National Routes
- International routes (collaborative procedures)
Below you could find a list of available application types and references to the MHRA guidelines.
- Innovative Licensing and Access Procedure (ILAP) – only for the innovative medicines, including new chemical entities, and biological medicines, new indications and repurposed medicines.
- National Procedure (a 150-day procedure) only for high-quality applications to market a medicine in the United Kingdom, Great Britain or Northern Ireland
- Rolling review – modules submission authorisation in the UK, GB and NI
- EC Decision Reliance Procedure (a 67-day procedure) – for EU CAP authorized products parallel application in GB (CAP would include NI).
- MR/DC Reliance Procedure (a 67-day procedure) – for EU DCP and MRPs approved products for GB.
- Unfettered Access from Northern Ireland (a 67-day procedure) - recognition in GB of a marketing authorisation approved in NI under certain qualifying conditions.
International routes (collaborative procedures)
- Access consortium - if you want to market a medicine in the UK, Australia, Canada, Singapore and/or Switzerland.
- Project Orbis – Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA), involving the regulatory authorities of Australia (TGA), Canada (Health Canada), the United Kingdom (MHRA), Singapore (HSA) and Brazil (ANVISA) to review and approve promising cancer treatments.
- Northern Ireland may be included in decentralised or mutual recognition procedure as a Concerned Member State (CMS)
- Also, Marketing authorisations approved in the European Union centralised procedure will automatically affect Northern Ireland.
Applications can be fast-tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine that has been verified by the Department of Health and Social Care (DHSC).
Types of application (legal basis)
You must include the appropriate legal basis for your application when you apply to the MHRA for a marketing authorisation:
- Full application (previously Article 8(3) of Directive 2001/83/EC)-> Regulation 50
- Generic application (previously Article 10.1) -> Regulation 51
- Hybrid application (previously Article 10.3) -> Regulation 52
- Similar biological application (previously Article 10.4) -> Regulation 53
- Well-established use application (previously Article 10a) -> Regulation 54
- Fixed-combination application (previously Article 10b) – Regulation 55
- Informed consent application - Regulation 56 (previously Article 10c)
- Traditional herbal registrations – Regulation 125 & 126 (previously Article 16a)
- Certificate of homoeopathic medicinal products - Regulation 102 (previously Article 14(1))
- National homeopathic products - Regulation 50(6)(g) and Schedule 10 (previously Article 16(2))
Application process highlights
- A dossier should be submitted in eCTD or NeeS format
- ASMF must be submitted either before you submit your application or at the same time
- Procedures concerning the use of Certificates of Suitability (CEPs) will remain the same
- Get a PL number (for a UK, Great Britain or Northern Ireland licence) from the MHRA Portal or by emailing PLNumberAllocation@mhra.gov.uk before you submit your application.
- All applications should be submitted through the MHRA Submissions Portal.
- The SmPC should be submitted in the correct SmPC template
Important notice: Products in the UK are expected to meet the standards published by the BP. BP continues to reproduce European Pharmacopoeia text.
More detailed info: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk or on our website https://brexit.freyrsolutions.com/