Computer application of Pharmacovigilance of Veterinary Medicines
Target persons
The VIGÌA-VET database is aimed at both the laboratories that hold veterinary medicines and health professionals (be they veterinarians, pharmacists, doctors, nurses, etc. ), since both groups have an obligation to notify alleged adverse reactions of which they are aware, as well as to send periodic safety reports on veterinary medicines.
The objective of the VIGIA VET application is to house all information on adverse reactions of veterinary medicines as well as periodic safety reports, both in animals and humans, in order to be able to have elements to make decisions in the use of these medicines.
The administrative procedures that can be performed through this application are as follows:
| Code | Name of the Procedure |
|---|---|
| 991841 | Individual reporting of suspected adverse reactions to veterinary medicinal products |
| 991854 | Periodic safety reports for veterinary medicines. |
Request for access
Entities wishing to perform the procedures referred to in the previous section electronically must request access credentials (username and password) by sending an access request through the following link:
https://servicedesk.aemps.es/servicedesk/customer/portal/2/, option “Access Management – Access Request”, indicating as data of the application “Vigiavet”.
The following data will be provided(1):
-
User Data:
- Name
- Surnames
- NIF. In the case of foreigners, the tax identification code is required
- Email address
-
Data of the entity, or entities, to which it must be associated
- Name
- CIF. In the case of foreigners, the VAT (European) or the tax identification code is required
Multiple users can be provided by each entity, if applicable, by all people in the organization who must access the application.
The entity shall be responsible for the custody and management of the use of these credentials within its organization. To prevent fraudulent use by people who have lost the ability to access the application, the password must be changed each time these circumstances occur.
(1)Se informa de que sus datos personales serán incorporados a un fichero informático que será custodiado por la Agencia Española de Medicamentos y Productos Sanitarios. No está prevista la comunicación de los datos personales a terceros. En cualquier momento puede ejercitar sus derechos de acceso, rectificación, supresión y portabilidad de sus datos, de limitación y oposición a su tratamiento dirigiéndose por escrito a la AEMPS, c/ Campezo 1, edificio 8, Parque Empresarial Las Mercedes, 28022, Madrid, o en la dirección de correo electrónicodelegado_protecciondatos@aemps.es, de acuerdo con lo establecido en el Reglamento (UE) 679/2016, del Parlamento Europeo y del Consejo, de 27 de abril de 2016, relativo a la protección de las personas físicas en lo que respecta al tratamiento de datos personales y a la libre circulación de estos datos y la Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales.
Documentation
User manual.
Once the user has identified the application and it has given him access in the menu on the left, in the Help section he has a Tutorial Manual where the operation of the application is explained.
Characteristics of the client teams
What authentication methods will be needed?
- Digital certificate
- Electronic ID
- 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 (you know who modifies and what).
- Time out of connection.
Answers to frequently asked questions (FAQs)
I do not have access to the medicine
One of the most common errors is that the person in charge of pharmacovigilance appointed by the laboratory to make the notifications does not have access to the drug (do not see the product when displaying the application's drug vademecum). In general, this is due to the fact that the drug is not yet recorded in the Product Database (RAEFAR), in which case it would have to be registered by the notifier according to the process established for the purpose, or that the drug is owned by a subsidiary of that laboratory. In this case, it should be remembered that each subsidiary has its own entity in the application, so the notifier must have the corresponding access permissions.
I don't have a certificate
An FNMT certificate is a file that authenticates the person and can be obtained in 24 hours completely free of charge.
How to get the FNMT certificate: Link tohttp://www.cert.fnmt.es
Notification of errors
If you experience errors or difficulties with the application or its functionality, please contact us at the following link:https://servicedesk.aemps.es/servicedesk/customer/portal/2/