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Registry of medicinal products / Relevant Regulatory Information for Marketing Authorization in electronic format


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Introducing eCTD in the AEMPS as a standard electronic format will bring important changes regarding the generation of dossiers by the pharmaceutical industry, but also in the communication and interchange of data between the industry and the authorities such as AEMPS.

Two electronic formats are accepted:

  • eCTD: It is an electronic version, where structure, folders and files correspond to the Common Technical Document (CTD) format. eCTD contains extra features that allow to manage the medicament life cycle more effectively. eCTD format has the following components: standard folder structure, file content and a XML backbone. The XML backbone (recognizable as ‘index.xml’ at the root level of the submission folder) of the eCTD provides two useful functions: 1) It provides a hyperlinked table of contents to the entire submission when viewed in web browser with a suitable style sheet 2) It provides descriptive information (‘meta-data’) on the files that make up the actual content of the eCTD.
  • This is the only supported format in centralized procedures as well as new applications for marketing authorization for medicinal products for human use decentralized procedures

  • NEES (Non-eCTD Electronic Submissions): A non-eCTD electronic submission is formatted as a simple set of electronic files and folders, usually now broadly organized in module folders as per the paper CTD guidance. The structure of folders, their names as well as the names of the files contained in the CD/DVD will have to adjust to standard ICH eCTD Specification V 3.2.

IMPORTANT: Switching from paper to electronic format can be made at the beginning of any phase in the life cycle of a product (initial application for new product or any new variation) Whenever the change to electronic is made it is mandatory that further applications and responses relating for that particular medicinal product are submitted in electronic format.

Previously authorized data does not have to be re-submitted in an electronic format.

For more information regarding electronic formats:

If an eCTD structure is submitted for certain product, every subsequent data sent to the Spanish Agency must be sent in the same format.

For new marketing authorizations only one root folder is allowed in the CD/DVD.



Instructions for generating electronic submissions


First of all it is necessary to create the Nees/eCTD dossier and validate it with a right validator as LorenzEvalidator for example LorenzEvalidator - FREE TOOL

The folder structure for module 1 can be downloaded from: eCTD EU Module 1 (V.3.0.1) - zip file

The folder structure for modules 2-5 can be downloaded from: http://estri.ich.org/eCTD .

Once the eCTD or NEES Dossier has been elaborated using the guide, there are two possible ways to send the data to the Spanish Agency:

  1. For companies with no local representative in Spain:

    Send electronic information

    • CD/DVD devices - To AEMPS together with the required paper documentation:

      The electronic media CD/DVD devices - should be packed adequately to prevent damage and the package should include a cover letter in paper with a handwriting signature and the following paper documents:

      • Depending on the submission type, it will be necessary
        • For new marketing authorizations: The first page of the application form with a handwriting signature, for each product included in the submission.
        • For variations and renewals: The whole application form, with a handwriting signature in the last page.
        • The remaining submission types do not need application form.
      • Proof of payment.
    • CESP (New plattaform to submit applications for marketing authorisations and variations in the national*, MRP or DCP procedures through the improved Common European Submission Platform).

      Companies with no local representative in Spain can use CESP as plattaform to submit submission. In this case where the application form can not be loaded in the national portal (RAEFAR) the eAF Electronic Application Form will be mandatory

    • National only when the submission is bigger than 40MB. Link to http://cesp.hma.eu/ - CESP FAQs
  2. For companies with a local representative in Spain: Register new authorizations and variations in the AEMPS Regulatory Tool: RAEFAR. (Click here to get the form needed to request user/password).

    To access RAEFAR it is also necessary to acquire an electronic certificate type 2ca from the Spanish authorities. Requesting an electronic certificate...

    Register all requests/submissions related to new marketing authorizations/variations in our Regulatory Tool (RAEFAR) Mandatory until January 1st start day for eAF applicability . Once the applications have been submitted, the procedure numbers returned by RAEFAR will be inserted in the cover letter.

    It is also possible to send the information by post, following the headlines indicated above for a company with no local representative in Spain.

Contact


Contact EMA, for further information:

División de Sistemas de Información

Telf. +34 91 822 50 03

E-mail: edossier@aemps.es