Licenses and authorizations
for zoosanitary products
In Spain, animal health products used in the veterinary sector are legislated according to Royal Decree 867/2020 and Royal Decree 488/2010*.
The following products fall under the umbrella of animal health products:
- Diagnostic reagents for veterinary use: any product, used alone or in association with others, for the study of animal samples or their environment, in order to provide information regarding their pathogens, including those used in diagnostic tests or their genetic characteristics of health interest.
- Physiological parameter control system products: any product, equipment or method used alone or in association with others, intended to provide information relating to one or various physiological parameters of animals or their genetic characteristics of health interest.
- Products intended for the maintenance of animal reproductive material (preservatives and diluents of semen, oocytes and embryos).
- Hygiene, care and handling products for animals and zoosanitary equipment (also known for their acronym in Spanish as: HCM-MUZ).
*HCM-MUZ products were considered zoosanitary products according to Royal Decree 488/2010, but they were not part of Royal Decree 867/2020. The Veredict of January 26, 2023, of the Third Chamber of the Supreme Court, considers article 1 of Royal Decree 867/2020 null and void, which excluded HCM-MUZ from being considered animal health products. For this reason, after this publication, the products considered animal health products according to Royal Decree 488/2010 are reincorporated into this definition, therefore it is required that HCM-MUZ products be registered in the Registry of Entities and Animal Health Products of the Ministry of Agriculture.
UASolucions offers you its services for the management of the following procedures and authorizations:
- Diagnostic reagents for veterinary use
Application for authorization to open and register, change of ownership, modification or renewal of the manufacturing entity or owner of diagnostic reagents for veterinary use.
Application for authorization and registration, change of ownership, modification or renewal of diagnostic reagents for veterinary use.
- Control systems for physiological parameters in animals
Responsible declaration for the commercialization and registration, change of ownership or modification of the registration of control systems of animal physiological parameters.
- Products intended for the maintenance of animal reproductive material
Responsible declaration for the commercialization and registration, change of ownership or modification of the registration of products destined to maintain animal reproductive material.
Responsible declaration for the opening, registration, change of ownership or modification of the entity that owns control systems for physiological parameters in animals or products intended to maintain animal reproductive material.
- Hygiene, care and handling products for animals and zoosanitary equipment (HCM-MUZ)
Responsible declaration for the registration, change of ownership and modification of manufacturing entities, importers and other entities holders of zoosanitary hygiene, care and handling products and animal health material and tools.
Responsible declaration for the registration, change of ownership and modification of hygiene products, care and handling and animal health material and tools.
Please contact us if you wish to have more information of our services.
Information for the processing of personal data for the purpose of providing professional services
URDI SOLE I ASSOCIATS SL is Responsible for treatment of the personal data of The interested party informs him that this data will be processed in accordance with the provisions of Regulation (EU) 2016/679 of 27 April 2016 (GDPR) and is therefore provided with the following information on the processing:
End of treatment: provision of the professional services requested, including communication with you, and billing, collection and accounting of our fees.
Legitimation of the treatment: for the provision of the entrusted service, the contractual relationship established with you (art. 6.1.b GDPR); for the invoicing, collection and accounting of our fees, the fulfillment of our legal obligations (art. 6.1.c GDPR).
Data retention criteria: they will be kept for no longer than is necessary to maintain the purpose of the treatment; when they are no longer necessary for this purpose and the applicable legal time limits have expired, they will be deleted by the appropriate security measures to ensure that the data is anonymised or completely destroyed.
Communication of data: in addition to the necessary assignments by legal obligation, it is planned to transfer your data to the entities related to the provision of the services in charge that are needed, whenever necessary to achieve the purpose of the processing (public administration, notaries, public records, etc.).
Rights of the interested party:
– Right of access, rectification, portability and deletion of your data and limitation or opposition to its processing.
– Right to file a complaint with the Control Authority (aepd.es) if it considers that the treatment does not comply with current regulations.
Contact details to exercise your rights:
URDI SOLE I ASSOCIATS SL. Tr de dalt, 134 – 08024 Barcelona