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07:31:422025-06-25

Registration of veterinary medicines RAEVET

HEADQUARTERS AEMPS > Procedures > Veterinary medicinal products > Raevet
Target persons
To the pharmaceutical laboratories to do the following procedures:

The administrative procedures that can be carried out through this application are the following:


Code: Name of the Procedure Object
085047 Marketing authorisation for new veterinary medicinal products. Obtain the marketing authorization of veterinary medicines.
991857 Amendment requiring assessment of the marketing authorisation for veterinary medicinal products. Obtain authorisation for the major amendment to the marketing authorisation for a veterinary medicinal product.
991847 Marketing of veterinary medicines.
991850 Cancellation of the authorisation or registration of veterinary medicinal products. Cancellation of the authorisation or registration of veterinary medicinal products.
991851 Suspension of marketing of veterinary medicines. Suspension of marketing of veterinary medicines.
Modification of centralized. Notification of the modification of centralized medicines that must be notified to the AEMPS.
Request for national code. Requests for national codes for products authorised by mutual or decentralised recognition that have the formats authorised and that are included in the technical sheet.
Telematic sending of documentation. Telematic sending of documentation for all the procedures described here.
2891514 Applications for parallel feeding of veterinary medicinal products. Applications for Parallel Import of Veterinary Medicines.
085048 Clinical research with veterinary drugs. Applications for clinical trials on medicinal products for veterinary use.
2891333 Official batch release certificates. Applications concerning batch release of veterinary immunological medicinal products.
Export certificates for veterinary medicines. Applications for export certificates for veterinary medicines.
Request for access

AEMPS User Management

It has been put into production, an application, so that the administrators of the laboratories can manage to register/unregister the users of their laboratories. The application has a user manual with the necessary instructions.

User Management Portal:https://sinaem.agemed.es/registroaemps.

In case of incident or consultation you can contactedossierv@aemps.es.

If such management is not possible because it is a foreign laboratory or some other exceptional caseYou can fill in theAEMPS Electronic Headquarters Access Request Formby legal representative of the company and send it by email to the addresssoporte_aplicaciones@aemps.es.

By email, users will be informed of their access code at the time they are registered in the system.

Characteristics of the client equipment

What authentication methods will be needed?

  • Digital certificate
  • Electronic DNI
  • Cl@ve PIN
  • In some cases it will not be necessary to have any method of authentication

What characteristics do the client teams have to have?

  • Next generation browser: Edge, Chrome, Firefox, Safari or similar.
  • The use of Internet Explorer is not recommended.
  • Any PDF document viewer. You can download the Adobe Acrobat Reader at the address http://www.adobe.com/.
  • User authorization and password of RPS.
  • Application security: activate the Java Script option in the browser if it is not active (this option comes by default).

Since it is a Web application, there are no operating system or memory or disk requirements beyond those necessary for the operating system, browser and PDF viewer chosen.

What are the security elements that the applications incorporate?

  • 128-bit SSL communications encryption.
  • User authentication using USER and password.
  • Autenticación de usuario de segundo nivel, mediante TOKEN UNICO por solicitud que el usuario debe introducir para el envío de las mismas.
  • Each external user can only access the data of the entity it represents.
  • Log of accesses and audit of modifications (it is known who modifies and what).
  • Time out of connection.
Answers to frequently asked questions (FAQs)
Notification of errors

If you experience errors or difficulties with the application, please let us know by registering a request at the following link:https://servicedesk.aemps.es/servicedesk/customer/portal/2/.

Include as much information as possible about the incident, including screenshots, error messages, etc. To make it easier for our technicians to detect and resolve the problem.

Rates

For issues related to fees, if you experience errors or difficulties regarding the payment of fees, please let us know by registering a request at the following link:https://servicedesk.aemps.es/servicedesk/customer/portal/2/(Incidents – Application FEES).