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(This note is not part of the Regulations)
The United Kingdom (“UK”) and the European Union (“EU”) agreed to the Windsor Framework in March 2023, including new arrangements relating to the supply of medicines from Great Britain (“GB”) to Northern Ireland (“NI”) (“the Agreement”) to come into effect in January 2025.
Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC implements the Agreement in EU law. These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”) to implement the Agreement in domestic law and to make consequential changes.
Under the Agreement, medicinal products that would previously have fallen within the scope of the centralised procedure (products required under EU law to be authorised across the EU and NI on a centralised basis by the European Commission (on the recommendation of the European Medicines Agency)) must now be authorised by the UK regulator in accordance with the law of the UK. The Medicines and Healthcare products Regulatory Agency has existing powers to authorise products falling outside the scope of the centralised procedure across the UK. These arrangements will therefore enable all types of medicines to be supplied with a single licence in a single pack for the whole of the UK.
These regulations amend the 2012 Regulations to apply these new arrangements, by providing for two categories of UK-wide marketing authorisation (Categories 1 and 2). Whether a medicinal product is authorised under Category 1 or 2 will depend on whether the product in question would have fallen within the centralised procedure or not. This means that, where there previously would have needed to be an EU authorised pack for NI, and a UK authorised pack for GB, there need now only be one pack. The 2012 Regulations continue to provide for marketing authorisations with a territorial limit of Northern Ireland, and for marketing authorisations with a territorial limit of Great Britain, although it will no longer be possible to apply for that latter type of authorisation.
The Agreement also removes the requirement under EU law that medicines packaging include a bar code encoding data that is uploaded into an EU-wide database.
Regulation 7 of these Regulations amends regulation 8 of the 2012 Regulations to provide that a “UK marketing authorisation” comprises the following different types of authorisation: UKMA(UK)(Category 1), UKMA(Category 2), UKMA(GB) and UKMA(NI).
Regulation 25 of these Regulations amends regulation 49 of the 2012 Regulations to define the different types of authorisation: UKMA(UK)(Category 1) and UKMA(UK)(Category 2), which permit marketing of a medicinal product in all the territories of the UK; UKMA(GB) which does not permit marketing of a medicinal product in Northern Ireland; and UKMA(NI) which does not permit marketing of a medicinal product in Great Britain.
The remainder of the amendments fall into the following categories:
amendments to references in the 2012 Regulations to different types of authorisation to ensure that the correct type of authorisation is referred to, so as to implement the Agreement,
amendments to ensure that provisions relating to guidance are consistent throughout the 2012 Regulations,
provision relating to data and marketing exclusivity periods for medicinal products marketed in the different territories of the UK,
provision to disapply the product identification and anti-tampering device rules contained in Commission Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use and to provide for a new “UK only” labelling requirement for products that are placed on the market in Northern Ireland.
Specific provision is made in relation to advanced therapy medicinal products and medicinal products for paediatric use to reflect the Agreement relating to these.
Regulations 133 and 146 make transitional provision in relation to existing authorisations and applications.
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.
An impact assessment relating to this instrument has been published and copies can be obtained from the Department of Health and Social Care, 39 Victoria Street, London SW1H 0EU, and is available on the www.legislation.gov.uk website. An explanatory memorandum has been published alongside this instrument at www.legislation.gov.uk.
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