G/TBT/N/EU/1008  
14 September 2023  
(23-6123) 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/tbt/en/  
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 addit ion, where applicable):  Medicinal 
products for human use and investigational medicinal products for human use  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Regulation of the European Parliament and of the Council layi ng down Union procedures 
for the authorisation and supervision of medicinal products for human use and 
establishing rules governing the European Medicines Agency, amending Regulation (EC) 
No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulatio n (EC) No 
726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 
(COM(2023)193 final); (182 page(s), in English), (37 page(s), in English)  
6. Description of content:  This Regulation lays down Union procedures for the 
authorisation, supervi sion and pharmacovigilance of medicinal products for human use at 
Union level, establishes rules and procedures at Union and at Member State level relating 
to the security of supply of medicinal products and lays down the governance provisions 
of the Europ ean Medicines Agency established by Regulation (EC) No 726/2004 which 
shall carry out the tasks relating to medicinal products for human use that are laid down 
in this Regulation, Regulation (EU) No 2019/6 and other relevant Union legal acts.  
It revises and replaces Regulation (EC) 726/2004 (general), Regulation (EC) 141/2000 
(rare disease medicines) and Regulation (EC) 1901/2006 (paediatric medicines).  
The Regulation contains both technical regulations and conformity assessment 
procedures.  
1. Tec hnical regulations: The Regulation establishes certain conditions for the marketing 
authorisation of medicinal products for human use at central (EU) level. The Regulation 
also establishes rules at Union and at Member State level relating to the security o f supply G/TBT/N/EU/1008  
 
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  of medicinal products including the monitoring and management of shortages and critical 
shortages.  
2. Conformity assessment procedures: The Regulation establishes the procedures for the 
authorisation of medicinal products for human use at central (EU) level. It also establishes 
procedures at Union and at Member State level relating to the security of supply of 
medicinal products including the monitoring and management of shortages and critical 
shortages.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 
November 2007 on advanced therapy medicinal products and amending Directive 
2001/83/EC and Regulation (EC) No 726/2004  
EUR-Lex - 32007R1394 - EN - EUR-Lex (europa.eu)  
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  
EUR-Lex - 32014R0536 - EN - EUR-Lex (europa.eu)  
9. Proposed date of adoption:  31 December 2024  
Proposed date of entry into force:  18 months days from publication in the Official 
Journal  of the EU  
10. Final date for comments:  90 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.europa.eu/growth/tools -
databases/tbt/en/  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52023PC0193  
https://members.wto.org/crnattachments/2023/TBT/EEC/23 _12355_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_12355_01_e.pdf