Consequences eSubmission Roadmap as of 1 July 2015

A number of important steps have been implemented as of 1 July 2015 in line with the eSubmission Roadmap. As a result of this roadmap, three obligations enter into force as of 1 July 2015. These apply to medicinal products for human use and (partly) to veterinary medicinal products.

Compulsory submission of new applications for DCPs (human) in eCTD

New applications for Decentralised procedures (DCPs) (human) that are submitted after 1 July must be in eCTD format. As of 1 July, the Medicines Evaluation Board (MEB) will no longer accept new DCP applications that are not submitted in eCTD format or non-valid eCTDs. This applies to applications in which the Netherlands has the role of Reference Member State (RMS) or Concerned Member State (CMS). The applicant will of course be informed of this.

The MEB will also follow the other procedures for the eSubmission Roadmap as far as the eCTD obligations are concerned. This ends the project where the MEB technically validates submissions without consequences.

Compulsory use of eAF for CAPs (human and veterinary)

As of 1 July, it is compulsory to use the electronic Application Form (eAF) for submissions for Centralised procedures. The MEB will not play any role in the validation of this form. The responsibility for this rests with the European Medicines Agency (EMA).

The introduction of the eAF has no direct consequences for the MEB. However, the MEB applauds the developments in this regard. The eAF makes it possible to provide information to databases in an automated manner instead of having to enter this information manually.

Compulsory use of Common Repository for CAPs (human) by NCAs

Vanaf 1 juli zal het CBG gebruik maken van de Common Repository voor de ontvangst van registratiedossiers voor geregistreerde of aangemelde geneesmiddelen in de centrale procedure. Het CBG verzoekt dan ook voor de aanlevering hiervan alleen nog gebruik te maken van de EMA eGateway. Rechtstreeks aanlevering via CESP of per cd/dvd is niet meer nodig en zelfs niet meer gewenst. Dit om dubbele invoer van gegevens in onze systemen te voorkomen.

As of 1 July, the MEB will use the Common Repository for the receipt of authorisation dossiers for authorised or registered medicinal products in the Centralised procedure. Therefore, the MEB requests that only the EMA eGateway be used for the submission of these in future. Direct submission via CESP or on CD/DVD is no longer necessary and no longer desirable. This in order to avoid double entry of data in our systems.

eSubmission Roadmap

A schematic summary of the eSubmission roadmap is provided below. This illustration and more background information is available on the EU eSubmission website.

150701 eSubmission Roadmap

Questions

In case you have questions about this subject after consulting the EU eSubmission website, please contact the MEB via the contact form on the MEB website.