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06:07:282026-03-12

Information on sending Electronic Files to the AEMPS

AEMPS HEADQUARTERS > Procedures > Medicinal products for human use > Information on sending Electronic Files to the AEMPS

For medicinal products for human use and within the context of the International Conference on Harmonisation (‘ICH’), an electronic exchange standard has been developed for the submission of regulatory information by applicants for marketing authorisations for medicinal products to the relevant competent authorities.

Based on the ICH Common Technical Document (CTD), the ICH M2 Expert Working Group has developed the CTD Electronic Specification (eCTD) and version 3.2 published in February 2004. The European Union applies the eCTD Specification in the European region and completes it with the European Module 1.

In addition to the continued development and maintenance of electronic filing standards, and to properly implement eCTD from the perspective of the EMA and National Competent Authorities, there are several prerequisites. These include the development of business processes necessary to receive and handle electronic submissions (particularly eCTD); policy development, particularly those related to electronic archiving; and development and implementation of appropriate technical infrastructure and systems implementation. Most notable here is the requirement for a tool that allows Competent Authorities who choose to implement it to receive, validate, store and make available for review marketing authorisation applications and supporting documents submitted electronically by applicants using the eCTD (commonly known as the European Review System or EURS).

Accepted electronic formats:

  • eCTD:It consists of an electronic version of the CTD but with an added technical value that allows us to manage the life cycle of the drug. The eCTD format has the following components: the folder structure, the content of the files and the xml backbone that will allow us to easily navigate and access the entire file (index.xml) as well as provide a series of useful information about each file (for example, indicate if it is new, if it is replaced, etc…).

    Only accepted format in centralized procedures, as well as in European procedures (MRP/DCP) from next July 2018 for new applications for authorization by national procedure, and from 01 January 2019 for the rest of regulatory activities by national procedure.

  • NEES (Non-eCTD Electronic Submissions): Consists of a set of folders and electronic files normally grouped in modules according to the structure defined in the CTD (paper) guide. The folder structure, its name and the names of the files contained in the CD/DVD must conform to the ICH eCTD Specification V 3.2 standard.
Instructions for the preparation and submission of electronic files
  1. Prepare the file according to the specifications of the followingInformative Guide to Aid to the Industry.Important:In the shipmentsNeeS(Non-eCTD Electronic Submissions) andeCTD, once the file structure that was part of the DVD/CD or telematic shipment has been developed and before the shipment, the use of a validation tool is recommended. (such asLorenzEvalidator–Free License).eCTD:The folder structure for module 1 can be downloaded from:eCTD EU Module 1 (V.3.0.1) – zip fileto be used in accordance with the validation criteriaeCTD Validation Criteria v7.1(ONLY SUPPORTED FORMAT FOR NEW APPLICATIONS FOR AUTHORISATION OF MEDICINAL PRODUCTS FOR HUMAN USE).

    Modules 2 to 5 –Appendix 4of:http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf.

    NEES (Non-eCTD Electronic Submissions):For Nees dossiers, it will be necessary to adjust, as appropriate, to the established validation criteriaNees Validation Criteria v.4.3following the guidelines set out in theNeeS eGuidance Document v4.

    Fill in the eAF (electronic application form)in the case of Marketing Authorisations for a New Medicine, Variations of the Marketing Authorisation and Revalidations of the Authorisation.

    Fill in the corresponding eAF, making sure you are finalizing the latest version, and save it in digital format. (no escanear documento imprimido previamente) e incluirlo en la correspondiente secuencia eCTD/Nees(m1\eu\12-form\common\common-form)It is recommended to validate the form before proceeding to the shipment as well as to enter the corresponding signature to block the document and facilitate the subsequent XML export.

    Such eAF forms are available for download oneSubmission. Or in theElectronic headquarters of AEMPS.

    In case of missing any Term/Organization included in the drop-down lists of the eAF form you can request it directly from the portalSPOR.

  2. Presentation or sending of the documentation to the AEMPS.2.1. Telematic sending of the request.
    • In the case of applicationseAF(Marketing Authorisations of a New Medicine, Variations of the Marketing Authorisation, Revalidations of the Authorisation) The shipment of these, will be made from the platformCESP(Common European Platform for Submission of Applications) compressing the root folder of the submission of the documentation in formatNeeSoreCTD.
      • Remediation documentation, answers to questions, additional information, final translated texts…, which generates an eCTD/Nees sequence, can also be sent telematically via Internet.CESP, being able to alternatively use the Additional Information option ofRaefar II, compressing the root folder of the dispatch, and clearly indicating the procedure to which it relates.

      Access to the portalhttp://cesp.hma.eu/Home(requires prior registration).

    • The rest of the requests, not contemplated in the previous section, (Transfers, Suspensions, Cancellations, Corrections of Errors, Parallel Imports…) will be made from the new web application ofRaefar II.The documentation relating to these procedures can be sent in their corresponding eCTD/Nees sequence also telematically through Reafar or alternatively by CESP in certain procedimientos.Acceso to the portalhttp://cesp.hma.eu/Home(requires prior registration).

    2.2 Delivery in On-Site Registration

    • As an alternative to online submission, Nees/eCTD documentation may be submitted on CD or DVD produced in accordance with the AEMPS Guide in the agency’s registry along with a cover letter and supporting documents for the payment of fees.
    • The documentation presented in the AEMPS will not be taken into account by other means such as e-mail, fax….
Presentations
New regulation for national variations
  • From October 13, 2010, Regulation 1234/2008/EC of November 24, 2008 will apply both to National variations and to those of MRP.Para the case of variationsGroupingorWorksharingaffecting different dossiers in eCTD,a shipment must be made for each affected file.
Answers to frequently asked questions (FAQs)
Links of Interest

Related documentation can be found at the following addresses:

Contacts and suggestions

For doubts and incidents contact with:

AEMPS Information Phone:902 101 322. Cost of the call 0.067€.

E-mail: edossier@aemps.es.