Medicinal product marketing authorisations in the UK: post‑Brexit framework, NI/Windsor arrangements, IRP recognition, accelerated routes, rolling review, variations and penalties

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note outlines the law on marketing authorisations (MAs) for medicinal products intended for the UK market following the close of the Brexit transition period (11 pm (GMT) on 31 December 2020, termed in UK law ‘IP completion day’). It covers:

exemptions from the need to hold an MA (eg ‘specials’, investigational medicinal products (IMPs), and the Early Access to Medicines Scheme (EAMS))
the various categories of MA
the licensing pathways to secure an MA in the UK, Great Britain (GB), or Northern Ireland (NI) (eg Northern Ireland Medicines and Healthcare products Regulatory Agency (MHRA) Authorised Route (NIMAR), Innovative Licensing and Access Pathway (ILAP), unfettered access, the 150‑day accelerated national procedure, rolling review, the reliance routes on EU authorisations now integrated into the International Recognition Procedure (IRP), Project Orbis and Access Consortium)
information on applying the Ireland/Northern Ireland Protocol as amended under the Windsor Framework
the offences and penalties arising from breaches of these provisions

Governing law

The UK was a Member State of the EU from 1 January 1973 until 31 January 2020. During that period, the law...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Web page updated on 21/05/2026

Popular documents

Using the Judicial College Guidelines to assess general damages in personal injury claims

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

Tomlin orders in England and Wales: CPR guidance on drafting, confidentiality, approval, variation, enforcement, limitation, CCA issues, court-specific requirements, sample wording and precedents

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

Precedent: Deed of Surrender of Lease with Optional Premium, Settlement and Release, Landlord, Mortgagee and Guarantor Consents, Reimbursement and HM Land Registry Provisions (England and Wales)

Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

Precedent Statutory Declaration: Standard Wording under the Statutory Declarations Act 1835

I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...