. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/246 
6 February 2009  
 (09-0550) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  EUROPEAN COMMUNITIES
  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:   
 
European Commission, EC-TBT Enquiry Point, 
Fax:  +(32) 2 299 80 43, 
E-mail:  ec-tbt@ec.europa.eu Website: http://ec.europa.eu/enterprise/tbt/
  
 
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 [   ], 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):   
Pharmaceuticals, active pharmaceutical ingredients. 
5. Title, number of pages and language(s) of the notified document:   
Proposal for a Directive of th e European Parliament and of the Council amending Directive 
2001/83/EC as regards the prevention of the entr y into the legal supply chain of medicinal 
products which are falsified in relation to their identity, hi story or source (COM(2008) 668) 
(26 pages, in English, French and Spanish).  
6. Description of content:   
Proposal to amend the Community Code for medicines for human use, in order to address the 
risk of falsified medicinal pr oducts entering the legal supply chain. The proposal addresses 
also issues of API quality and compli ance with good manufacturing practices.  
A summary of the proposed amendments is set out in the explanatory memorandum 
accompanying the proposal. G/TBT/N/EEC/246 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:   
Protection of human health and sa fety. Falsified medicines are a ma jor threat to public health 
and safety. As falsification methods become more sophisticated the risk that falsified 
medicines enter the EU increases every year. For a more extensive elaboration of the objective and rationale see the explanatory memorandum accompanying the proposal and the 
corresponding impact assessment report.  
8. Relevant documents:    
Directive 2001/83/EC of the European Parliame nt and of the Council on the Community code 
relating to medicinal products for human use: 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2001:311:0067:0128:EN:PDF  
Impact assessment:  http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=SEC:2008:2674:FIN:EN:PDF
  
9. Proposed date of adoption:   
 
Proposed date of entry into force:    To be determined (adoptio n is expected for end 
2010/2011). 
The Commission proposes a deadline for 
transposition of the amending Directive into the national laws of the EU Member States within 18 months, plus an additional period for application of certain provisions (see Article 2 
of the proposal for further details). 
10. Final date for comments:  90 days from date of notification. 
11. Text available from: National enquiry point [  ], or addre ss, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
European Commission, 
EC-TBT Enquiry Point, Fax:  + (32) 2 299 80 43, E-mail:  ec-tbt@ec.europa.eu  
The text is available on the EC-TBT Website: 
   http://ec.europa.eu/enterprise/tbt/
 
   and at: 
 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2008:0668:FIN:EN:PDF;
 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2008:0668:FIN:FR:PDF ;  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2008:0668:FIN:ES:PDF . 
 
http://members.wto.org/crnatt achments/2009/tbt/EEC/09_0358_00_e.pdf .