Further information on use of electronic application forms for granting a marketing authorisation, renewal or variation
19.11.2015
Following to the Notice on the beginning of use of electronic application forms (eAFs)for granting a marketing authorisation, renewal or variation, we would like to offer further information to marketing authorisation holders:
- For the documentation in eCTD or NeeS form, eAF is part of Module 1. For the documentation submitted in written, eAF should be submitted in addition on CD, as well as the summary of product characteristics, package leaflet and labelling.
- Before submitting it to HALMED, eAF should be finalised and concluded in order to prevent a further involuntary change of entered data.
- In order to fulfil the obligation of submitting original form as set out in the Ordinance on granting a marketing authorisation (Official Gazette 83/13), every application should have a printed finalised (locked) eAF version that should be signed by hand.
- The European Medicines Agency (EMA) organises a webinar for pharmaceutical industry representatives for granting a marketing authorisation, renewal or variation for medicines for human and veterinary use. The webinar will be held on 1st December 2015 from 2 to 3.30 p.m. During the webinar, participants will be informed where they can find relevant documents and to whom they may send their questions that they most frequently face while completing applications. In addition, the procedure for handling question will be presented with regard to MRP, DCP and national procedures and centralised procedures. It is important to mention that the procedure for completing the application will not presented within the webinar. All interested participants are kindly asked to register for participation at the webinar and for sending all questions to eAFwebinar-registration@ema.europa.eu by 26th November 2015. In the case that more staff members from the same company wish to attend the webinar, it is recommended to send only one registration application and that participants take part from the same room. The webinar will be recorded and released soon after on the webpages eAF e submission.
- Application forms, notice to applicants, technical instructions and questions and answers that should be studied in advance in order to complete correctly the application form, are accessible on the webpages eSubmission, or here.
