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New versions of the electronic Application Forms are now available

electronic Application Forms

New versions of the electronic Application Forms (eAF v. are now available and can be found here. These versions of the Initial Human MAA and Veterinary MAA forms and the Renewal form provide fixes to defects found after the release of the v. 01.19 on 9 November 2015.

The version v. of the eAFs can be used from 30 November 2015 and will replace the current version of eAF v. 01.18 after a transitional period on 11 January 2016. Versions 01.18 and 01.19 will continue being accepted until 11 January 2016. Previous versions of the forms (v 01.18 and v 01.19 before the hotfix) will no longer be accepted after this date.    

The use of the eAFs will become mandatory for all European procedures covered by the eAFs including Mutual Recognition, Decentralised Procedure and the national applications from 1 January 2016 as per the HMA eSubmission Roadmap. The use of the eAFs is mandatory for all centralised procedure for human and veterinary submissions since 1 July 2015.

Source: EMA

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