Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products

Due to an increasing number of requests, we would like to point out the phasing-out plan for NeeS and the transition to eCTD/VNeeS as outlined in the eSubmission Roadmap. The format requirements apply to applications for marketing authorisations for medicinal products as well as maintenance of these (variations, renewals etc.). The changes do not apply to parallel import and parallel distribution.

Only acceptable electronic formats for the human and veterinary domains

In the human domain, eCTD will be the only acceptable electronic format.

In the veterinary domain, VNeeS will be the only acceptable electronic format. This has been a requirement since 2010 when we started to accept electronic-only applications.

eCTD in the human domain and VNeeS in the veterinary domain are already the only acceptable formats for several of the common European procedures and case types, and decisions have been made to implement similar format requirements for the remaining procedures and case types – see below.

On a European level, no common plan has been made for the phasing-out of the NeeS format in the national procedure (NP). To simplify our format requirements and to avoid national maintenance of the NeeS format, we have decided to apply the same format requirements for NP as for the mutual recognition procedure (MRP).

If a common European plan is made for the format requirements for NP, we intend to follow the plan in order to simplify the regulatory authorities’ requirements for industry. In that case, we will make an announcement on our website.

Time frame for full phasing-in of eCTD and VNeeS

The full phasing-in of eCTD and VNeeS as the only acceptable electronic formats will take place as follows:

• From 1 January 2017, NeeS will no longer be accepted in applications for new marketing authorisations (including switch from NP to MRP as well as Repeat Use Procedure (RUP))
• From 1 January 2017, VNeeS will be the only acceptable electronic format in the veterinary domain (all procedures and case types).
• From 1 January 2018, eCTD will be the only acceptable electronic format in the human domain (all procedures and case types).

You are encouraged to switch to eCTD/VNeeS

Until further notice, you can still send paper-based applications to us according to our guidelines. However, the receipt and assessment of paper-based applications are very resource-demanding. Consequently, we encourage applicants to switch to the eCTD/VNeeS formats, to the extent possible, to help us reduce our overall review time.