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:
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
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.
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:
Send electronic information
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:
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
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 EMA, for further information:
División de Sistemas de Información
Telf. +34 91 822 50 03