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 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/.
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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)
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.