Explanatory note

In accordance with Decision No 1/2023 of the Joint Committee established by the Agreement of the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 24 March 2023 laying down arrangements relating to the Windsor Framework, the United Kingdom (“UK”) and the European Union (“EU”) agreed to the Windsor Framework in March 2023. The Northern Ireland Protocol as amended is referred to as the Windsor Framework.

The Windsor Framework includes new arrangements in relation to the grant of marketing authorisations for medicinal products for human use in Great Britain and Northern Ireland (“NI”) to come into effect on 1st January 2025.

These Regulations amend Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (“the SPC Regulation”) to reflect those new arrangements.

These Regulations also amend the SPC Regulation to reflect new arrangements under the Windsor Framework for the grant of marketing authorisations for medicinal products for veterinary use under Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (“the EU Veterinary Medicines Regulation”).

Regulation 3 amends Article 1 to insert a new definition of “transitioned-UK authorisation” to reflect a GB authorisation in force immediately before 1st January 2025 that becomes a UK authorisation from that date. Regulation 3 also inserts a new definition of “former NI authorisation” to reflect a NI authorisation for a medicinal product for human use which is prohibited by Regulation (EU) 2023/1182 from being placed on the market in NI.

Regulation 4 amends Article 5(1b) to insert a reference to a UK authorisation such that for an application previously filed on the basis of a NI authorisation, a later UK authorisation (whether a transitioned-UK authorisation or a new UK-wide authorisation) may trigger the extension of the territorial scope of the SPC to cover the remainder of the UK (subject to notification under Article 13A).

Regulation 4 also inserts a new paragraph (1c) into Article 5, and along with Regulation 8, addresses the territorial scope of the certificate or its paediatric extension, respectively, extending to the whole of the UK where, in respect of an application involving a GB authorisation, that authorisation becomes a transitioned-UK authorisation.

Regulation 10 inserts a new Annex III which sets out transitional provisions applying to applications and certificates relating to medicinal products for human use.

Regulation 3 amends the definitions of “EEA” and “NI authorisation” in Article 1(h) and (jb), respectively, to insert a reference to the EU Veterinary Medicines Regulation and also inserts a reference to the Windsor Framework in Article 1(jb).

Regulation 5 inserts a new paragraph (2a) in Article 7 to recognise that, for the purpose of assessing applications after 1st January 2025, applications submitted before 1st January 2025 based on authorisations granted under the EU Veterinary Medicines Regulation have a valid legal basis.

Regulation 6 amends Article 8 to insert a reference to the EU Veterinary Medicines Regulation in relation to the content of an application for a certificate based on an authorisation for veterinary medicines under that legislation.

An impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public and voluntary sectors is forseen.

Details of the Windsor Framework are available at www.gov.uk/government/publications/the-windsor-framework or from the Cabinet Office, 100 Parliament Street, London, SW1A 2BQ

A copy of this instrument and the Explanatory Memorandum are available from the Intellectual Property Office at Concept House, Cardiff Road, Newport, South Wales, NP10 8QQ. The Explanatory Memorandum is also available alongside this instrument on the Legislation UK website at www.legislation.gov.uk.