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02:37:062025-09-29

Import and export of medicines in authorised clinical trials in Spain

AEMPS HEADQUARTERS > Procedures > Medicinal products for human use > Import and export of medicines in authorised clinical trials in Spain
Access to the app
Target persons
The application “Import/Export of Medicines for Human Use” allows laboratories, manufacturers and clinical trial promoters to request electronically the necessary prior authorization for the import and export of investigational medicines, including their intermediate products and bulk, destined for clinical trials authorized in Spain.

To make any telematic request through this system, the promoter must have an electronic ID card (eID) or a digital certificate recognized by the Ministry of Health’s Electronic Headquarters.

Currently, through this application you can manage the following administrative procedure:

Code Name of the Procedure Object
085058 Autorización de importación o exportación de medicamentos para utilizar en ensayos clínicos autorizados en España Obtain authorization for the import or export of medicines to be used in clinical trials authorized in Spain
Documentation

Regulations:

Manuals:

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.
Notification of errors
Inquiries regarding import or export authorizations for investigational drugs can be directed to the Clinical Trials Division mailbox: aecaem@aemps.es. For technical incidents with the application, the channel is available Request/Incident Management.