Access for peripheral pharmaceutical services
To whom is it addressed?
The Spanish Agency for Medicines and Health Products wants to offer Peripheral Pharmaceutical Services access to the Information Systems of the AEMPS, which may be of interest for the performance of their functions:
- RAEFAR: Computer application of the Registry of Medicinal Products for Human Use.
- Working Groups: Space with several compartments designed to share information.
- Pharmaceutical Laboratories: Database containing information from pharmaceutical laboratories: data on authorizations and certificates of good manufacturing standards.
LosWorking Groupsavailable, by sub-address, are as follows:
- Office of the Deputy Director-General for Drug Inspection and Control
- Foreign trade in non-registered medicines
- Laboratory authorizations and inspections
- Drug laboratories
- General Subdirectorate of Medicinal Products for Human Use
- Foreign trade in registered medicines
- Authorizations of medicines
- General Directorate of Medical Devices
- Inspections and authorizations of manufacturers of Medical Devices.
Request for access
To request access toRAEFARclick here.
To request access toWorking Groupssend an email tomjcalvente@aemps.es
To request access toPharmaceutical Laboratoriescontact our Information Systems Division. (incidencias.labofar@aemps.es)
Documentation
To access the documentation ofRAEFARclick here.
Working GroupsIt has a user manual in the application itself.
If you want documentation ofPharmaceutical LaboratoriesPlease contact the Sub-Directorate General for Drug Inspection and Control to request the user manual.
Documentation
- Order SPI/2136/2011, of 19 Julywhich establishes the modalities of sanitary control at the border by the pharmaceutical inspection and regulates the Computerized System of Pharmaceutical Inspection of External Health.
- Order SSI/2375/2014, of 11 Decemberamending Order SPI/2136/2011 of 19 July, laying down the procedures for border health checks by the pharmaceutical inspectorate and regulating the External Health Pharmaceutical Inspection Computerised System. (BOE No. 306, of 19 December 2014)
- Quick Guide to Use(Version 9 updated to 20/03/2015)
- User Manual(Version 9 updated to 02/06/2014)
- User Request Form
- Document 1403 – Declaration of the importer of products not subject to pharmaceutical control
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)
To access the FAQ section ofRAEFARclick here.
Notification of errors
Data
For notification of errors ofRAEFARclick here.
ForWorking GroupsSend an e-mail to the addressadministrador_sinaem@aemps.es
ForPharmaceutical Laboratories:
- If you experience errors or difficulties with the application, please contact us at the address below.incidencias.labofar@aemps.es
- For other non-IT issues, please contact the email addressconsultas.labofar@aemps.es.
In either case, 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.
Functionality
Follow the same instructions described in the previous section.