. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/EU/63 
12 Septembre 2012  
 (12-4872) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local governme nt 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 :    
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [ X ], 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):  Medicinal products for 
human use and investigational me dicinal 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 on clinical trials on medicinal 
products for human use, and repealing Dire ctive 2001/20/EC (COM(2012) 369) (107 pages, 
in English, French and Spanish).      
6. Description of content:  This draft Regulation concerns all aspects of the conduct of clinical 
trials in the European Union.  It aims to replace the existing Clinical Trials Directive 
2001/20/EC. The proposal introduces in particular changes in the authorisation procedure for 
clinical trials c onducted in several EU  Member States.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of subject rights and safety, as well as reliability and robustness of data generated 
in a clinical trial.  
8. Relevant documents:   Directive 2001/20/EC of the European Parliament and of the Council 
of 4 April 2001 on the approximation of the laws , regulations and admini strative provisions of 
the Member States relating to the implementa tion of good clinical prac tice in the conduct of 
clinical trials on medicina l products for human use (OJ L 121, 1.5.2001, p. 34)  
http://eur-lex.europa.eu/LexUriSe rv/LexUriServ.do?uri=CELEX:02001L0020-
20090807:EN:NOT   
Impact assessment report: 
http://ec.europa.eu/health/f iles/clinicaltrials/2012_07/impa ct_assessment_part1_en.pdf   
http://ec.europa.eu/heal th/files/clinicaltrials/2012_07/impa ct_assessment_part2_en.pdf    G/TBT/N/EU/63 
Page 2  
 
   
9. Proposed date of adoption:   
Proposed date of entry into force:    Mid 2014 
Mid 2016 
10. Final date for comments:  90 days from Notification 
11. Text available from:  National enquiry point [  ], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
European Commission, 
EU-TBT Enquiry Point, Fax:  + (32) 2 299 80 43, E-mail:  mailto:eu-tbt@ec.europa.eu  
The text is available on the EU-TBT Website :  http://ec.europa.eu/enterprise/tbt /   
and at 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2012:0369:FIN:EN:PDF  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2012:0369:FIN:FR:PDF  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2012:0369:FIN:ES:PDF  
http://members.wto.org/crnatt achments/2012/tbt/EEC/12_3574_00_e.pdf