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eCTD baseline

The end of NeeS in Europe has arrived, what does this mean for national submissions?

From 1 January 2019 onwards, #eCTD will be mandatory for all national procedures. CP, DCP and MRP submissions should already be in eCTD since 1st January 2018, the eSubmission Roadmap has been extended for national procedures. This implementation date set should be strived for by all National authorities (see Annex 2 to the HMA eSubmission Roadmap).

What is a Baseline Submission?

A #Baseline Submission is a submission of all current valid documents accompanied with a statement that the content has not change and that only the format has changed. For transparency purposes it is recommended that baselines are applied when there are no pending activities for the product.

A Baseline Submission can consist of all 5 modules or as a more basic submission of just module 3. In addition, modules can be baselines separately.

Generally, a baseline submission is not mandatory, but it is highly recommended to use it. A baseline is actually a re-submission of previously submitted files and is created at the start of an eCTD lifecycle for an existing dossier. Sequence 0000 will be associated with the baseline submission and next regulatory activity will be sequence 0001.

Though this is not a strict requirement, authorities will request transferring the existing dossier to eCTD format prior to submission of a new variation or update. The advantage is that as a result preparing the individual future submissions will require less work and allow a more efficient planning.

Baseline Submission Planning

To prepare for the upcoming deadline, companies are advised to assess their current situation by following these steps in their National licences:

  • Follow-up on announcements from National Agencies on the implementation of the mandatory use of eCTD in National Procedures on a local level based on the eSubmission Roadmap.

  • List all your products registered nationally and follow the steps above, taking into account that the period for transition is one year longer for these products. However, depending on the number of products and possible different dossiers in different EU member states, creating a work plan on time is still advisable.

  • Having a work plan, the necessary internal/external resources ready and the required it-tools helps you to implement the eCTD conversion strategy, facilitating a timely implementation and compliance with the regulations. Performing proper planning and processing the eCTD conversion correctly from the start is certainly worth the investment.

  • New applications will be submitted only in the upgraded eCTD forma and the best opportunity to switch to eCTD at the beginning of any phase in the life cycle of a product (renewal, variation, extension etc.). Bear in mind that all pending regulatory activities have to be closed. It is important to know that once transition to eCTD have been successfully made, further applications will be submitted only in the upgraded eCTD format.

Managing changes is an essential part of regulatory and our experts have kept abreast new legislation and requirements in this field, keeping track of all changes. This can be overwhelming sometimes. Clients can always rely on us for performing the necessary investigations for them to better draft their strategies.

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