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09:48:062025-06-25

Submission of drug clinical trial applications on CD/DVD

HEADQUARTERS AEMPS > 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 structure of standard folders 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, processing and authorized.

Applications/notifications shall be submitted on CD/DVD with the 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 supporting document for the 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), the procedure (Annex A2) and the authorised clinical trial MR (Annex A3) and the relevant amendment form (Annex 1C).

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

Documentation

Clarifications (click here) on the application of clinical trial regulations as of 1 May 2004(Version No. 6, 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 equipment

What authentication methods will be needed?

  • Digital certificate
  • Electronic DNI
  • 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 (it is known who modifies and what).
  • Time out of connection.
To download the structure of the folders hanging 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. Where there are several documents of the same type, the name of the document must include the abbreviated name of the medicinal product, manufacturer, centre, etc. To which it belongs.
  2. Download from the Electronic Headquarters the folder corresponding to the appropriate type of request.
  3. Delete the ‘EudraCT No’ 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 all possible incident information, 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.