G/TBT/N/ ESP/40  
  
25 February 2019  
(19-1080) Page: 1/2 
Committee on Technical Barriers to Trade  Original: Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member:  SPAIN  
If applicable, name of local government involved (Articles 3.2 and 7.2):        
2. Agency responsible: Ministerio de Agricultura, Pesca y Alimentación  (Ministry of 
Agriculture, Fisheries and Food)  
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:  
Dirección general de Sanidad de la Producción Agraria (Directorate -General of Ag rarian 
Health)  
Tel.: (+34) 91347 5042  
Fax: (+34) 91347 8248  
Bzn-dgspa@mapama.es  
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):  
HS codes 28, 29 (excluding 29.35, 29.36, 29.37, 29 .39 and 29.40), 30.0610, 
30.06.20.00 and 38.22 . 
5. Title, number of pages and language(s) of the notified document: Proyecto de Real 
Decreto por el que se Regulan los Productos Zoosanitarios  (Draft royal decree regulating 
animal health products). (51 page s, in Spanish)  
6. Description of content:  Requirements are established for the authorization, registration, 
marketing and use of animal health products.  
The following items are excluded: veterinary medicines; homeopathic veterinary 
medicines; medicated feeding stuffs; biocides used in livestock settings; biocidal animal 
hygiene, care and handling products; animal health supplies and devices; those related to 
reproduction (except preservatives and diluents for semen, ova and embryos); animal 
feeding stuff s and animal identification products, which will be subject to specific 
regulations.  
Also excluded are all health products for which there has been a communication or 
authorization under Royal Decree No. 414/1996 of 1 March, on the regulation of health 
products, and which are intended for use in veterinary settings or in animals, with the 
same composition, packaging and labelling as when communicated or authorized by the 
Spanish Agency for Medicines and Health Products; importation of live animals not su bject 
to harmonized European Union regulations and having Spain as their final destination, 
including invasive species  G/TBT/N/ ESP/40 
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  The reagents used to diagnose animal diseases are a key element in 
safeguarding animal health and, consequently, food security and public health. To that 
end, adoption of the notified decree (in the framework of the OIE codes) is necessary to 
provide adequate assurance of their proper use (appropriate sen sitivity and specificity).  
Furthermore, adoption of the decree is necessary in order to regulate the authorization 
procedure for diagnostic products for animal diseases, particularly zoonotic diseases, 
including for their importation into Spain in the abse nce of harmonized European Union 
sanitary regulations.  
8. Relevant documents:  - 
9. Proposed date of adoption: 30 June 2019  
Proposed date of entry into force: 2 July 2019  
10. Final date for comments: 60 days from the date of notification  
11. Texts available from: National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
https://www.mapa.gob.es/es/ganaderia/participacion -
publica/proyecto_rd_productos_zoosanitarios.aspx  
https://members.wto.org/crnattachments /2019/TBT/ESP/19_0972_00_s.pdf