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NeeS to eCTD deadline for National Procedures is approaching – are your Dossiers ready?

The extended deadline for National Procedures within the eSubmission Roadmap is coming to an end by kick-off of 2019 and NeeS will become a thing of the past. NeeS roadmap will end on 1 January 2019 with eCTD becoming required for all submissions, including those for nationally registered products.

Although not mandatory, it is strongly recommended by the competent authorities that pharmaceutical companies transfer the existing dossier to eCTD and submit the baseline eCTD sequence of their Dossiers, especially covering the quality part, i.e. Module 3. This should be also a goal for the pharmaceutical companies as this way they can obtain a well-structured overview of the information already contained in the dossier and thus ease the planning as well as reduce work with any future submissions.

Although nice it may sound, for some it may be actually a challenge. The baseline submission requires resubmission of currently valid documents that have already been provided to an agency but in another format (NeeS or paper). Due to various reasons, such as changes in responsible persons or loss of internal archives, identifying the Dossier documentation and classifying it as being currently valid may not be an easy task. At BalticCRO we have the local presence and all means for recovering your NeeS and paper submissions from the authority archives, so you can have your national Dossiers ready in an up to date baseline eCTD. Contact us for local support now!

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