G/TBT/N/GBR/86  
26 April 2024  
(24-3424) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED KINGDOM  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Department for Health and Social Care  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from abo ve:  
UK TBT Enquiry Point  
Trade Policy, Implementation and Negotiations  
Department for Business and Trade  
Old Admiralty Building  
London  
SW1A 2DY  
tbtenquiriesuk@businessandtrade.gov.uk  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Human 
Medicinal Products  
5. Title, number of pages and language(s) of the notified document:  The Human 
Medicines (Amendments Relating to the Windsor Framework) Regulations 2024  
6. Description of content:  The Regulations provide that a "UK marketing authorisation" 
comprises the following different types of authorisation: UKMA(UK)(Category 1) and 
UKMA(Category 2), whi ch 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. These Re gulations make amendments to the 2012 Regulations ensure that the 
correct type of authorisation is referred to.  
The Regulations make provision to transition existing marketing authorisations with an 
authorisation with a territorial limit of Great Britain to be converted to authorisations valid 
across the UK.  
The Regulations also make provision for a new requirement, for each of the above 
categories of authorisation, for products to be labelled "UK only"; and provision to 
disapply the product identification  and anti -tampering device rules contained in 
Commission Delegated Regulation (EU) 2016/161.  
The changes made by the Regulations mean that the same products, in the same packs 
with the same labels, will be available across the whole of the UK  G/TBT/N/GBR/86  
 
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  7. Objective  and rationale, including the nature of urgent problems where 
applicable:  These amendments will facilitate a UK wide system of licensing and 
regulation of human medicines, helping to secure the long -term supply of human 
medicinal products in Northern Irela nd. Ensuring the proper functioning of the UK internal 
market; Consumer information, labelling  
8. Relevant documents:   
Labelling and packaging of medic inal products for human use following agreement of the 
Windsor Framework - GOV.UK (www.gov.uk)  
UK-wide licensing for human medicines - GOV.UK (www.gov.uk)  
9. Proposed date of adoption:  1 July 2024  
Proposed date of entry into force:  1 January 2025  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
UK TBT Enquiry Point  
Trade Policy, Implementation and Negotiations  
Department for Business and Trade  
Old Admiralty Building  
London  
SW1A 2DY  
tbtenquiriesuk@businessandtrade.gov.uk