New format requirements for applications for authorisation of medicinal products

13 July 2015

On 1 July 2015, the rules governing applications for marketing authorisations for medicinal products were amended in three areas as a result of new requirements from the European Medicines Agency (EMA).

The amendments form part of the work towards more electronic and automated case processing as described in eSubmission Roadmap

The most important changes are: 

Use of eCTD in DCP is mandatory

As from 1 July, applications for a new marketing authorisation for a medicinal product for human use under the decentralised procedure (DCP) must be submitted in the eCTD format. The NeeS submission format in DCP will be eliminated.

At present, eCTD is the submission format for largely all human applications in DCP, so we do not expect that this amendment will have any considerable practical impact on the applicants.

eAF in CP is mandatory

From 1 July, it is mandatory to use the electronic application form (eAF) for all submissions in the centralised procedure (CP). This applies to applications for a new marketing authorisation, variations and registration renewals - both human and veterinary use.

Today, it is possible to use the electronic application form (eAF) – also in DCP, MRP and NP. Currently, we do not have the required systems and processes in place to benefit from eAF, but we hope that applicants will use the validation function, so that both applicants and authorities will experience fewer validation errors.

Use of Common Repository is mandatory

From 1 July, it is mandatory for drug regulatory authorities to collect applicants' documentation from the Common Repository. This applies to applications for a new marketing authorisation for a medicinal product for human use, variations, registration renewals etc. under the centralised procedure (CP).

This means that from 1 July applicants only need to submit the above types of application (and any additional material to this application) to EMA via the eSubmission Gateway.

We recommend that submissions made available to us in the Common Repository via the eSubmission Gateway are not submitted via other channels as well, because it will require additional resources to handle the same material several times and identify any differences between the two versions to determine which version is the correct one.

External links

EMA eSubmission Roadmap

Report from CMDh, January 2015, see ”Electronic submissions” (at the bottom of page 1)

EU Electronic Application Forms

EMA eSubmission

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