G/SPS/N/ESP/10  
3 July 2023 
(23-4511) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  NOTIFICATION  
1. Notifying Member : SPAIN 
If applicable, name of local government involved:  
2. Agency responsible : Ministerio de Agricultura, Pesca y Alimentación/Dirección General de 
Sanidad de la Producción Agraria  (Ministry of Agriculture, Fisheries and Food/Directorate -
General of Agrarian Health)  
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 applicabl e): 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 : Real Decreto por el que se regula  la distribución, 
prescripción, dispensación y uso de medicamentos veterinarios  (Royal Decree regulating 
the distribution, prescription, dispensation and use of veterinary medicinal products) 
Language(s) : Spanish . Number of pages : 67 
https://members.wto.org/crnattachments/2023/SPS/ESP/23_10754_00_e.pdf  
6. Description of content : The notified decree seeks to regulate the obligations of 
wholesale distribution, r etailing and online sales of medicinal products not subject to 
prescription, conditions for veterinary prescriptions and restrictions on the use of 
antimicrobials, as well as to establish the obligations on the use of medicinal products on 
livestock farms.  
7. Objective and rationale : [X] food safety, [X]  animal health, [ ] plant protection, [ 
] 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 Organisation for Animal Health (OIE) (e.g. T errestrial or Aquatic 
Animal Health Code, chapter number) : 
[ ] International Pla nt Protection Convention (e.g. I SPM No.) : 
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes [ ] No 
If no, describe, whenever possible, how and why it deviates from the G/SPS/N/ESP/10  
- 2 - 
  international standard:  
9. Other relevant documents and language(s) in which these are available : 
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.  
10. Proposed date of adoption (dd/mm/yy) : By the end of 2023.  
Proposed date of publication (dd/mm/yy) : By the end of 2023.  
11. Proposed date of entry into force : [ ] Six months from date of publication, and/or 
(dd/mm/yy) : The day following publication in the Official Journal.  
[ ] Trade facilitating measure  
12. Final date for comments : [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 1 September 2 023 
Agency or authority designated to handle comments : [X] National Notification 
Authority, [X]  National Enquiry Point . Address, fax number and email address (if  
available) of other body:  
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels, Belgium  
Tel.: (+32 2) 29 54263  
Email: sps@ec.europa.eu  
13. Text(s) available from : [X] National Notification Authority, [X]  National Enquiry 
Point . Address, fax number and email address (if available) of other body:  
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels, Belgium  
Tel.: (+32 2) 29 54263  
Email: sps@ec.europa.eu