. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/EU/28 
2 March 2012  
 (12-1189) 
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 :   
European Commission, 
EU-TBT Enquiry Point, Fax:  +(32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
Website:  http://ec.europa.eu/enterprise/tbt/   
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):  Medicinal products for 
human use and veterinary medicinal products. 
5. Title, number of pages and language(s) of the notified document:  Draft Commission 
Regulation amending Regulation (EC) No 1234/2008 concerning the examination of 
variations to the terms of mark eting authorisations for medici nal products for human use and 
veterinary medicinal products (21 pages, in English). 
6. Description of content:  The draft Commission Regulation amending Regulation (EC) No 
1234/2008 provides for procedures to vary mark eting authorisations granted in one EU 
Member State only.  Some adjustments to pr ocedures to vary the terms of marketing 
authorisations granted by the European Co mmission under Regulation (EC) No 726/2004 are 
also made; none of these adju stments impose additi onal new obligations from the holders of 
the marketing authorisations concerned.  
7. Objective and rationale, including the nature of urgent problems where applicable:  The 
draft Regulation will ensure that variations to marketing authorisations granted in a single EU 
Member State are subject to the same procedures ; thereby simplifying the introduction of 
variations for marketing authoris ation holders that operate in more than one Member State.  G/TBT/N/EU/28 
Page 2  
 
  8. Relevant documents:   Commission Regulation (EC) No 1234/2008 of 24 November 2008 
concerning the examination of variations to the terms of marketing authorisations for 
medicinal products for human use and veteri nary medicinal products (OJ L 334, 12.12.2008, 
p. 7–24) 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2008:334:0007:0024:EN:PDF  
Regulation (EC) No 726/2004 of the European Parliament and of th e Council of 31 March 
2004 laying down Community procedures for the au thorisation and supervision of medicinal 
products for human and veterinary use and esta blishing a European Medicines Agency (OJ L 
136, 30.4.2004, p. 1–33) 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2004:136:0001:0033:EN:PDF  
Directive 2001/82/EC of the European Parliame nt and of the Council of 6 November 2001 on 
the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p 1-66) 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2001:311:0001:0066:EN:PDF  
Directive 2001/83/EC of the European Parliame nt and of the Council of 6 November 2001 on 
the Community code relating to medicinal products for hu man use (OJ L 311, 28.11.2001, 
p. 67–128) 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2001:311:0067:0128:EN:PDF  
9. Proposed date of adoption:   
Proposed date of entry into force:    June 2012. 
20 days from publication in  the Official Journal 
of the EU (about a month after adoption 
approx.).   
10. Final date for comments:  60 days from date of 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/  
http://members.wto.org/crnatt achments/2012/tbt/EEC/12_0829_00_e.pdf