Registration of veterinary medicines RAEVET
Target persons
- Application for registration of new medicines.
- Use of eAF in New Registrations, Marketing Authorisation Variation Applications (MRP/DCP/NP) and Five-Year Revalidation Applications. (27 November 2015)
- New Platform for Sending Documentation of New National Records and Variations, MRP and DC (CESP).
- eAF Application for registration of new veterinary medicinal product.
- Request for variations on authorized medicines.
- Five-year renewal of veterinary medicines.
- Circular 4/2012: Five-year renewal of Veterinary Medicines (entry into force 10/01/2013).
- eAF Request for Renewal
- Application for authorisation of clinical trials and products in the clinical research phase.
- Legislation.
The administrative procedures that can be performed through this application are as follows:
| Code | Name of the Procedure | Object |
|---|---|---|
| 085047 | Marketing authorisation for new veterinary medicinal products. | Obtain the marketing authorization of veterinary medicines. |
| 991857 | Modification requiring evaluation of the marketing authorisation for veterinary medicinal products. | Obtain the authorisation for a 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 centralised medicines that must be notified to the AEMPS. |
| – | Request for national code. | Requests for national codes of those products authorized by mutual recognition or decentralized that have authorized the formats and that are thus included in the technical sheet. |
| – | Telematic sending of documentation. | Telematic sending of documentation for all the procedures described here. |
| 2891514 | Applications for parallel trade in veterinary medicinal products. | Applications for Parallel Import of Veterinary Medicines. |
| 085048 | Clinical research with veterinary medicines. | Applications for Clinical Trials on Medicinal Products for Veterinary Use. |
| 2891333 | Official batch release certificates. | Applications concerning the release of lots of veterinary immunological medicinal products. |
| – | Veterinary medicine export certificates. | 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.aemps.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 theApplication form for access to the AEMPS electronic headquartersby 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.
Documentation
- Guide “Sending electronic files to the AEMPS”. Sending and tracking by electronic records laboratories to the AEMPS
(v3.0 – August 2017) - User Manual Web Application for User Management.
(Version 2.0) - Application Manual for Sending Marketing Information for Medicines.
(V3 – Spanish version – It is recommended to read the manual before using the application) - RAEVET II – AEMPS COMMON REGISTRY “Request for National Code & Communication of Modifications of Medicinal Products Authorized by Centralized Procedure”.
(Version 1.0) - RAEVET II – Application Guide for Batch Release, Clinical Trials, Products in Research Phase and Post-Authorisation Studies of Veterinary Medicines.
(Version 1.0) - RAEVET II – Guía de solicitud de Certificados de Exportación de Medicamentos Veterinarios.
(Version 1.0) - Applicant Help Guide for Creating/Managing Users and Superusers (SPOR Program).
(Version 1.0)
Documentation
- AEMPS User Management Application (User Manual). (Version 2.0)
- Application manual for sending information on the commercialisation of medicines.
(V3 – English version – It is recommended to read the manual before using the application) - RAEVET II – Centralized Procedures «Guide Application for National Code & Notification of changes for medicines authorized by centralized procedure». (Version 1.1)
- Guideline on eSubmission for Veterinary products. (Version 2.6)
Characteristics of the client teams
What authentication methods are needed?
- Digital certificate
- Electronic ID
- Cl@ve PIN
- Cl@ve Permanente
What characteristics should the computer equipment have?
- Updated web browser (Microsoft Edge, Google Chrome, Mozilla Firefox, Safari or similar).
- Any PDF document viewer. Adobe Acrobat Reader can be downloaded at the address https://www.adobe.com/.
-
Application security: enable the JavaScript option in your browser if it is not enabled (this option is enabled by default).
As it is a web application, there are no specific requirements for operating system, memory or storage capacity, beyond those necessary for the operation of the operating system, browser and PDF viewer used.
What are the security elements that the applications incorporate?
- 128-bit SSL communications encryption.
- Autenticación de usuario de segundo nivel, mediante un token único por solicitud que deberá introducirse para su envío.
- Each external user can only access the data of the entity they represent.
- Log of accesses and audit of modifications, which allows to identify who makes each modification and what changes have been made).
- Connection waiting time (timeout).
Answers to frequently asked questions (FAQs)
- * VNeeS Q&A relating to eSubmission for Veterinary Applications. (Spanish Version) September 2018
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 fee-related issues, 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).