Business Case

Publishing & Regulatory Affairs Support

Project: Publishing & Regulatory Affairs Support

Summary of Project:

The client had nationally authorised product in an EU country under renewal procedure, which was submitted back in 2013. The renewal and all the previous variations and RFI responses were prepared in the old NeeS format (without proper module structure). In 2015 there were RFI submission for renewal and new Type IB variation (deadline Jun 2015), but all the submission were not accepted due to the technical invalidation.

Issues:

The client did not face any issues regarding the format of the dossier with the Health Agency before as the initial variations/renewal sequences were submitted before 2014. At that time, you could ask for an exception and submit documents in CTD structure without any technical validation. The applicantĀ“s duty of submitting the dossier in NeeS or eCTD format was applicable from 1st January 2014.  For this reason, there was no possibility to convert the sequences to eCTD or NeeS as a renewal procedure was pending, but simultaneously we had a deadline for the QRD text update.  The usual approach from us would be to create a baseline sequence in new format (eCTD) and proceed with further variations submission. But it was not possible as renewal procedure was pending.

Solution:

We contacted the Health Agency and explained the situation. After a number of days discussion with several members of the agency, we reached an agreement:

-              The first variation could be submitted as sequence 0000 (eCTD or NeeS), without baseline.

-              The second variation could be submitted as sequence 0001 or the following sequence (depended on responses which were supposed to be submitted during the first variation.)

-              After all variations and renewal will be approved, the baseline could be submitted.

Conclusion

Our approach with this project was to break it down into its component parts and then work back form there how we may solve the issues.  We felt that the best approach was to give potential solutions to the agency so that they could simply assess the credibility rather than us expecting them to solve everything.  It helped a lot and was mainly down to experience from our publishing team that we solve the issue we faced jointly.  The result was a satisfied client and Health Agency!