G/TBT/N/EU/875  
28 February 2022  
(22-1871) 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:  EUROPEAN UNION   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  European Commission  
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 above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tb t/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Regulation of the European Parliament and of the Council amending Regulation (EU) No 
536/2014 as regards a derogation from certain obligations c oncerning investigational 
medicinal products made available in the United Kingdom with respect to Northern Ireland 
as well as in Cyprus, Ireland and Malta (COM(2021) 998 final) (8 page(s), in English)  
6. Description of content:  The notified draft measure provides for derogations from EU 
pharmaceutical law to ensure the continued supply of and access to medicines in Northern 
Ireland, Cyprus, Malta and Ireland. Upon fulfilment of certain conditions as applicable, 
amendments to Regulation (EU) No 2014/536 wou ld allow imports of medicines without 
EU manufacturing and import authorisation from parts of the United Kingdom other than 
Northern Ireland.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of this pro posal are to address the issues related to 
investigational medicinal products, to prevent an adverse impact on their supply and, as 
a result, on the execution of clinical trials authorised under Regulation (EU) No 536/2014 
in Northern Ireland, Cyprus, Irel and and Malta.; Protection of human health or safety  
8. Relevant documents:   
• Regulation (EU) No 536/2014 of the European Parliament and of the Council of 
16 April 2014 on clinical trials on medicinal products for human use, and 
repealing Directive 2001/20/EC Text with EEA relevance EUR-Lex - 32014R0536 
- EN - EUR-Lex (europa.eu)  G/TBT/N/EU/875  
 
- 2 - 
 
  9. Proposed date of adoption:  1st quarter 2022  
Proposed date of entry into force:  1st or 2nd quarter 2022 with retroactive application 
from 31 January 2022  
10. Final date for comments:  30 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:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
 
The text is available on the EU -TBT Website : http://ec.euro pa.eu/growth/tools -
databases/tbt/en/  
 
EUR-Lex - 52021PC0998 - EN - EUR-Lex (europa.eu)  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_1849_00_e.pdf