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03:53:342026-11-02

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 are needed?

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).
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.