Overview of Electronic Applications for Marketing Authorisations in the EU


Electronic processing of marketing authorisation activities has taken leaps forward during the last few years on the European level. Paper submissions are almost in the past and different kinds of electronic portals have replaced them. Introduction of electronic application forms and eCTD needs more technical approach, but on the other hand, practical work has become more straightforward and faster.

The year 2019 has brought tightened rules to the use of the eCTD format as national applications will also have to be in the eCTD format in the EU (eSubmission Roadmap v. 2.1). In practice this means that the marketing authorisation documentation can finally be forced into a life cycle model. This makes it easier to maintain the documentation after it has been submitted to the authorities. The technical life cycle of eCTD and documents enable better traceability and follow-up of data which is essential on the way to better data integrity. Both the authorities and industry can benefit from this.

We at Medfiles can help you both in the planning of a comprehensive solution and in the compilation of individual eCTD sequences. We offer a competitive response time and safe channels to transfer documentation without compromising quality and client satisfaction.

Did you get interested? Ask for quotation!

Jesse Salonen
Support Operations Manager
+358 40 131 6789

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