Marketing authorisations

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null What is the eCTD lifecycle and when should the baseline version of the application be submitted to Fimea?

What is the eCTD lifecycle and when should the baseline version of the application be submitted to Fimea?

The eCTD processing of a product can be started when the case concerns the first processing of a marketing authorisation application, variation application or the renewal of a marketing authorisation. However, the transfer to an eCTD application should not be made in the middle of a pending approval process (i.e. do not submit answers to questions in the eCTD format, if the related application has not been submitted in the eCTD format).

If the occasion where the eCTD application is used for the first time is a variation application or a renewal of a marketing authorisation, the applicants should also deliver the technical baseline version of the product to Fimea.
Technical baseline version: The first electronic application and associated documents delivered to Fimea must be a complete whole and meet the validation criteria. The application may not contain links to documents not included in it. If the applications contains links to previous sequences, the referred sequences must be submitted to Fimea along with the technical baseline versions.
Original baseline version: If the original baseline version of a product, i.e. sequence 0000 is available, it can be delivered to Fimea.

17 Nov 2015