G/TBT/N/EU/1006  
14 September 2023  
(23-6118) 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 
Directive of the European Parliament and of the Council on th e Union code relating to 
medicinal products for human use, and repealing Directive 2001/83/EC and Directive 
2009/35/EC (COM(2023)192 final); (184 page(s), in English), (103 page(s), in English)  
6. Description of content:  This Directive lays down rules for  the placing on the market, 
manufacturing, import, export, supply, distribution, pharmacovigilance, control and use 
of medicinal products for human use. It repeals and replaces Directive 2001/83/EC and 
Directive 2009/35/EC and it incorporates relevant part s of Regulation (EC) No 1901/2006;  
The Directive contains both technical regulations and conformity assessment procedures.  
1. Technical regulations: The Directive establishes standards of quality, safety and 
efficacy for the authorisation of medicinal products as it establishes the conditions for the 
marketing authorisation of medicinal products for human use at central (EU) and national 
(in different Member States) levels. The Directive also establishes the conditions for the 
manufacturing au thorisation and wholesale distribution authorisation. It moreover 
establishes requirements on labelling and packaging.  
2. Conformity assessment procedures: The Directive establishes the procedures for the 
authorisation of medicinal products for human use a t central (EU) and national (in 
different Member States. It also establishes procedures for the manufacturing 
authorisation and wholesale distribution authorisation. The Directive moreove establishes 
procedures for controls, supervision and inspections.  G/TBT/N/EU/1006  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
Directive 2001/83/EC  
EUR-Lex - 32001L0083 - EN - EUR-Lex (europa.eu)  
Directive 2009/35/EC  
EUR-Lex - 32009L0035 - EN - EUR-Lex (europa.eu)  
Regulation (EC) No 1901/2006  
EUR-Lex - 32006R1901 - EN - EUR-Lex (europa.eu ) 
9. Proposed date of adoption:  31 December 2024  
Proposed date of entry into force:  18 months 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:52023PC0192  
https://members.wto.org/crnattachments/2023/TBT/EEC/ 23_12354_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_12354_01_e.pdf