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02:04:212026-09-29

Submission of drug clinical trial applications on CD/DVD

AEMPS HEADQUARTERS > Procedures > Medicinal products for human use > Submission of drug clinical trial applications on CD/DVD
Application

When the telematic sending through the ECM Portal is not possible the Spanish Agency of Medicines and Health Products allows as an alternative the presentation of all the documentation on a CD/DVD, using a standard folder structure that can be downloaded from the attached table where the folders are organized in the different states in which the clinical trial is located: initial, procedure and authorized.

Applications/notifications shall be submitted on CD/DVD with documentation in electronic format attached to each folder together with the accompanying letter on paper (signed by the applicant) and in the case of applications for a new clinical trial the proof of payment of fees on paper.

When sending an application on CD/DVD it is necessary to attach the forms and accompanying letters validated in the clinical trials portal:the EU form (Annex 1A), the accompanying letters (initial (Annex A1 and A1B), procedure (Annex A2) and authorised clinical trial MR (Annex A3) and the relevant amendment form (Annex 1C).

In order to be able to generate the accompanying letter in progress or the letter corresponding to a modification relevant to an authorized EC and the relevant modification form when no previous request regarding that EC has been previously sent to the AEMPS through the ECM portal, an email must be sent to the mailboxincidensayos@aemps.es, indicating the EudraCT number of the EC to which the shipment to be prepared refers.

Documentation

Clarifications (click here) on the application of the clinical trial regulations from 1 May 2004(Version No. 6, of May 2008)(An updated version will be released shortly).

Frequently asked questions document (FAQs)

Presentation "Submission of a clinical trial application on CD/DVD"

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).
To download the structure of the uploaded folders in the virtual office:
  1. Download the file to your desktop.
  2. Place the mouse over it and press the button on the right.
  3. Choose the option“Open with”and in the pop-up menu that appears choose«Compressed folders in zip»
  4. In the window that appears, drag the included folder to the desktop or where you want to leave the structure definitively.
Prepare the shipment of a CD/DVD correctly

The following steps should be followed:

  1. Include in a root folder all the documents in electronic format that are to be sent with the request. When there are several documents of the same type, the name of the document should include the abbreviated name of the drug, manufacturer, center, etc. to whom it belongs.
  2. Download from the Electronic Headquarters the folder corresponding to the appropriate type of request.
  3. Delete the “EudraCT Number” from the root folder of the type of request that has been downloadedand include the EudraCT number for the clinical trial without otherwise changing the name.
  4. Delete the empty folders.
  5. Attach each of the previously prepared documents (in step 1) to each of the typed folders.
Notification of errors

If you experience errors or technical difficulties in submitting the request/notification using the CD/DVD folder structure please contact us atincidensayos@aemps.es. Include as much information as possible about the incident, including screen impressions, error messages, etc. To make it easier for our technicians to detect and resolve the problem.

For questions related to business logic, the operation of the application or any query you wish to make, contact us at the addressincidensayos@aemps.es.

In any case, prior consultation of the documents and presentations included in the Documentation section is recommended.