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The EU Module 1 v2.0 enables marketing authorisation application in Croatia and has been in use since July 2013. The EU Module 1 v2.0 required by EMA and National Competent Authorities has been manadatory since 1 September 2013.

See related documentation for submissions in centralised procedure here.

  EU M1 v1.4.1 EU M1 v2.0 EU M1 v3.0

EU M1 v3.0.1 NEW

Status For reference only Approved and mandatory since Sept 2013 Entering into force 1st July 2016 Entering into force 1st July 2016
Release Notes

View Specification Release Notes

View Annex Release Notes

View View View
Specification View
View View View - Updated (17/05/2016)
Annex View View View View
DTD Download      
Examples Download      
Package Download Download Download Download - Updated (17/05/2016)
Implementation Guide   Download Download Download - New
Checksum of        
eu-regional.dtd   91654e96e3bafc5e89df7f892477b246 9dc9debb051a9e5762fc19a1f55132da 667C7387EE1D4C61D5EA840299BD2A70 290503BF171E7E2E80EF90F0BDE5D91E(new version number)
eu-envelope.mod 664a76e3f31a9553d3375d3b21815904 0ebe02fcdff7e40eff94a88074ca21 BB838F3FF8446CDA93BAA62A1F55BA25 D0727AE0FB68B19EDAE49AB9E2E22A4A(new version number)
eu-leaf.mod 2e976bc60658a964affa5026369a371e 23b854174e61c68044b9f53c0009af95 23B854174E61C68044B9F53C0009AF95 23B854174E61C68044B9F53C0009AF95
eu-regional.xsl 54f9889822e1d08cc23b902fc6a66aaa bf40b657579356c7b4d6c866625d8171 3ABF1FE58FB6C8118DEF52EBAB947E0B 7403F0A91BED5232B0CA73D3E6B6039A (modified)

Updated EU M1 eCTD specificiation

To accommodate several change requests submitted since version 2.0 entered in to force in September 2013, a revision of the EU eCTD Module 1 Specification has taken place. The published version 3.0 has been subsequently updated when errors were detected in the checksums and an updated version 3.0.1 is now available. Both versions v3.0 and v3.0.1 will enter into force on 1st July 2016. The versions 3.0 and v3.0.1 will replace v2.0 on 1 October 2016 after which submissions in v2.0 will no longer be accepted. Submissions following versions 3.0 and 3.0.1 will both be accepted from 1st October 2016 for a parallel period of 6 months until 1 April 2017. The use of version 3.0.1 will be mandatory from 1 April 2017.

 



 

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