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05:26:322025-08-13

Telematic management of technical data sheet and prospectus

AEMPS HEADQUARTERS > Procedures > Medicinal products for human use > Telematic Management of Technical Data Sheet and Prospectus / Management Application for PIL & SPC
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.agemed.es/registroaemps.

In case of doubt or need more information, you can contact our IT support through our Service Desk application athttps://servicedesk.aemps.es/servicedesk/customer/portal/2.

Likewise, if such management is not possible due to a foreign laboratory or some other exceptional case, please contact our Computer Support application at https://servicedesk.aemps.es/servicedesk/customer/portal/2.

By email, users will be informed of their access code at the time they are registered in the system.

Documentation
Telematic Management of Technical Data Sheet and Prospectus

New application of telematic sending with complement of Word, of variations of technical sheets and leaflets by sections, allows the generation of documents guaranteeing their accessibility as established by the regulations (Law 51/2003).

All applications for fractionation (medicines and variations), can be managed from the new application for fractionation of technical sheets and leaflets, through its main filter of applications.

Documentation

It is recommended to read theManual of the applicationbefore you make use of it. This manual will be available as a pdf file on the home page of the manual.

It also hasseveral video tutorials:

  • Installation.
  • Fractionation of medicines.
  • Fractionation of Variations.
  • Access to the app.

The desktop application of Telematic Management of Technical Data Sheets and Prospectuses can be downloaded from the following link:

Answers to frequently asked questions (FAQs)

Answers to frequently asked questions (FAQs)

In case of doubt or need more information, you can contact our IT support through our Service Desk application athttps://servicedesk.aemps.es/servicedesk/customer/portal/2.

Notification of errors

For the notification of incidents in the application, you must contact our Computer Support application athttps://servicedesk.aemps.es/servicedesk/customer/portal/2.