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EMA announcement

This correspondence is to remind everyone of the approaching date of 01 January 2016, from when the use of the electronic Application Form (eAF) will be mandatory for all procedures in the EU (Centralised procedure, MRP, DCP and by default National procedure), for Human and Veterinary products.

In order to support this milestone, a webinar session dedicated to Industry was held by EMA providing information about where to find relevant documents, addressing the most common issues and workaround solutions faced by Industry when filling the forms. It also explained the support structure to be followed for business related queries for MRP/DCP/National applications and Centralised ones.

 

The webinar has been recorded and the video file - including slides – is available. EMA encouraged companies to consultbefore submission of applications and also to regularly consult the eAF website to keep track of updated workarounds and other relevant information.

Furthermore, based on the high interest shown towards this training we are planning to organise a further training session and a follow-up Q&A session in near future. The dates for these sessions will be announced on the eAF website soon.

Please also note that from 01.01.16, the word forms will be removed from the NTA websites (Human and Veterinary) and only a document summarising what should be the content of the application will be available.

Should you encounter any problems with the use of the electronic forms, any comments or change requests, these should be communicated to eaf@ema.europa.eu