G/SPS/N/EU/312  
 
18 March 2019  
(19-1674) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member: EUROPEAN UNION  
If applicable, name of local government involved:  
2. Agency responsible: European Commission, Health and Food Safety Directorate -
General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable): Veterinary medicinal products  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Regulation (EU) 2019/6 of the European Parliament 
and of the Council Of 11 December 2018 on veterinary medicinal products and repealing 
Directive 2001/82/EC . Language(s): English, French and Spanish.  Number of pages: 
125 
https://members.wto.org/crnattachments/20 19/SPS/EEC/19_1546_00_e.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_1546_00_f.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_1546_00_s.pdf  
6. Description of content: Regulatory framework for authorisation and use of veterinary 
medicinal products, obligations of applicants, marketing authorisation holders, regulatory 
authorities. Date of application: 28 January 2022.  
7. Objective and rationale: [X]  food safety, [X]  animal health, [  ] plant protection, 
[X] protect humans from animal /plant pest or disease, [  ] protect territory from 
other damage from pests.  
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant internationa l standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:  G/SPS/N/EU/312  
 
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  9. Other relevant documents and language(s) in which these are available:   
10. Proposed date of adoption (dd/mm/yy) : 18 December 2018 
Proposed date of publication (dd/mm/yy) : 7 January 2019  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 28 January 2022 The regulation will apply from 28 January 2022.  
[ ] Trade facilitating measure  
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X ] National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:  
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2)  29 98090  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2-Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu