Sifaex External Health Pharmaceutical Inspection Computer System
Target persons
On July 29, 2011, Order SPI/2136/2011, of July 19, 2011, was published in the BOE, which establishes the modalities of sanitary control at the border by the pharmaceutical inspection and regulates the Computerized System of Pharmaceutical Inspection of External Health. This allows the electronic processing of applications, writings and communications relating to the sanitary control procedure, in relation to international traffic. It is aimed at Economic Operators and the Pharmaceutical Industry that manage or carry out Import and Export operations of Medicines, Raw Materials, Health Products and Cosmetics.
Request for access
Economic Operators who wish to access SIFAEX must first contact the units of the Pharmaceutical Inspection Services of the Areas of Health and Social Policy of their province where they will present the User Request Form that appears in the Documentation section requesting the authorization of access to the application.
It is recalled that each of these people must be in possession of their own recognized and accessible digital certificate on their equipment. For more information, see the sectionCharacteristics of the client teams.
The entity shall be responsible for the custody and management of the use of these credentials within its organization.
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)
- User Manual(Version 10 updated to June 2022)
- User Request Form
- Document 1403 – Declaration of the importer of products not subject to pharmaceutical control
- Document 1404 – Importer/Exporter Declaration for Operations with Switzerland and Andorra
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)
For any questions you may have about the SIFAEX application, send your query through the link:https://servicedesk.aemps.es/servicedesk/customer/portal/2/.
Notification of errors
Data
If you experience errors or difficulties with the application, please contact us at the following link:https://servicedesk.aemps.es/servicedesk/customer/portal/2/.
Functionality
Follow the same instructions described in the previous section.