G/TBT/N/EU/279  
 
2 April 2015  
(15-1832)  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 telephon e 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: grow-eu-tbt@ec.europa.eu   
Website: http://ec.europa.eu/growth/tools-databases/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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Veterinary medicinal 
products (see description of the detailed proposed scope in Article 2 of the proposal) 
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 veterinary medicinal products 
(COM(2014) 558 final) (114 pages including the legislative financial statement and 22 pages 
of annexes (4 annexes), in English, French and Spanish). All EU languages are available. 
6. Description of content: The proposal aims to cover all provisions regarding veterinary 
medicines, including all authorisation procedures, in one legal act, designed to deal effectively with the specificities of the veterinary sector.  
The main features of the proposal are:  
 possibility of granting a centralised (EU-level) marketing authorisation for all types 
of veterinary medicinal products; 
 simplified rules on post-authorisation procedures; 
 incentives for innovation: longer protection period for the data submitted for 
authorisation of a veterinary medicine in particular for minor species (e.g. bees, fish), and 
 specific measures to address the threat of the development of anti-microbial 
resistance, – streamlining the procedures to authorise veterinary medicines, including centralised, mutual recognition and decentralised procedures. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of public health, an imal health and the environment G/TBT/N/EU/279 
 
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  8. Relevant documents:  This proposal for a new Regulation repeals Directive 2001/82/EC of 
the European Parliament and of the Council on the Community Code Relating to Veterinary Medicinal Products 
The objectives of the proposal are: 
 to increase the availability of veterinary medicinal products, 
 to reduce administrative burden, 
 to stimulate competitiveness and innovation, 
 to improve the functioning of the internal market, and 
 to address the public health risk of antimicrobial resistance. 
http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32001L0082&qid=1426518048263&from=EN 
9. Proposed date of adoption: End 2016 
Proposed date of entry into force: 20 days from publication in the Official Journal of the 
EU (It is proposed that the Regulation applies 24 months after the entry into force of the Regulation. The earliest date of application of the provisions would be end 2018.)   
10. Final date for comments: 90 days from notification 
11. Texts available from: Nati onal 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 Website: http://ec.europa.eu/growth/tools-databases/tbt/   
http://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1426778048357&uri=CELEX:52014PC0558   
https://members. wto.org/crnattachments/2015/TBT/EEC/15_1463_00_e.pdf