eAF Release notes - esubmission.ema.europa.eu

1 30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 16th February 2018 Information Technology EMA/94046/2018 eAF Release notes This document lists and briefly describes the new features and fixed issues included in the Release of the electronic application form: Application for Variation to a Marketing Authorisation.

2 The most recent Release appears first. Table of Contents Version ( Release Date: 16/02/2018) .. 7 Version content .. 7 Issues fixed for this version .. 7 Known issues .. 7 Version ( Release Date: 15/12/2017) .. 8 Version content .. 8 Issues fixed for this version .. 8 Known issues .. 9 eAF Release notes EMA/94046/2018 Page 2/65 Version ( Release Date: 20/06/2017) .. 10 Version content .. 10 Issues fixed for this version .. 10 Known issues .. 11 Version ( Release Date: 23/02/2017) .. 12 Version content .. 12 Issues fixed for this version.

3 12 Known issues .. 12 Version ( Release Date: 07/02/2017) .. 13 Version content .. 13 Issues fixed for this version .. 13 Known issues .. 14 Version ( Release Date: 18/10/2016) .. 16 Version content .. 16 Issues fixed for this version .. 16 Known issues .. 16 Version ( Release Date: 19/08/2016) .. 17 Version content .. 17 Issues fixed for this version .. 17 Known issues .. 17 Version ( Release Date: 30/06/2016) .. 18 Version content .. 18 Issues fixed for this version .. 18 Known issues .. 18 Additional information .. 23 Version ( Release Date: 14/06/2016).

4 24 Version content .. 24 Issues fixed for this version .. 24 Known issues .. 29 Additional information .. 34 eAF Release notes EMA/94046/2018 Page 3/65 Version ( Release Date: 23/02/2016) .. 35 Version content .. 35 Issues fixed for this version .. 35 Known issues .. 35 Additional information .. 36 Version ( Release Date: 03/11/2015) .. 37 Version content .. 37 Issues fixed for this version .. 37 Known issues .. 39 Additional information .. 40 Version ( Release Date: 07/07/2015) .. 41 Version content .. 41 Issues fixed for this version.

5 41 Known issues .. 42 Additional information .. 42 Version ( Release Date: 23/03/2015) .. 43 Version content .. 43 Issues fixed for this version .. 43 Known issues .. 45 Additional information .. 45 Version ( Release Date: 02/10/2014) .. 46 Version content .. 46 Issues fixed for this version .. 46 Known issues .. 46 Additional information .. 46 Version ( Release Date: 26/09/2014) .. 47 Version content .. 47 Issues fixed for this version .. 47 Known issues .. 48 Additional information .. 48 eAF Release notes EMA/94046/2018 Page 4/65 Version ( Release Date: 10/06/2014).

6 49 Version content .. 49 Issues fixed for this version .. 49 Known issues .. 50 Additional information .. 50 Version ( Release Date: 22/04/2014) .. 51 Version content .. 51 Issues fixed for this version .. 51 Known issues .. 51 Additional information .. 51 Version ( Release Date: 06/02/2014) .. 52 Version content .. 52 Issues fixed for this version .. 52 Known issues .. 52 Additional information .. 52 Version ( Release Date: 09/10/2013) .. 53 Version content .. 53 Issues fixed for this version .. 53 Known issues .. 53 Additional information.

7 53 Version ( Release Date: 10/09/2013) .. 54 Version content .. 54 Issues fixed for this version .. 54 Known issues .. 54 Additional information .. 54 Version ( Release Date: 02/09/2013) .. 55 Version content .. 55 Issues fixed for this version .. 55 Known issues .. 55 Additional information .. 55 eAF Release notes EMA/94046/2018 Page 5/65 Version ( Release Date: 25/07/2013) .. 56 Version content .. 56 Issues fixed for this version .. 56 Known issues .. 57 Additional information .. 57 Version ( Release Date: 12/06/2013).

8 58 Version content .. 58 Issues fixed for this version .. 58 Known issues .. 58 Additional information .. 58 Version ( Release Date: 31/10/2012) .. 59 Version content .. 59 Issues fixed for this version .. 59 Known issues .. 59 Additional information .. 59 Version ( Release Date: 31/08/2012) .. 60 Version content .. 60 Issues fixed for this version .. 60 Known issues .. 60 Additional information .. 60 Version ( Release Date: 16/07/2012) .. 61 Version content .. 61 Issues fixed for this version .. 61 Known issues .. 61 Additional information.

9 61 Version ( Release Date: 03/04/2012) .. 62 Version content .. 62 Issues fixed for this version .. 62 Known issues .. 63 Additional information .. 63 eAF Release notes EMA/94046/2018 Page 6/65 Version ( Release Date: 14/03/2012) .. 64 Version content .. 64 Issues fixed for this version .. 64 Known issues .. 64 Additional information .. 65 eAF Release notes EMA/94046/2018 Page 7/65 Version ( Release Date: 16/02/2018) Version content Functionality / use case comments Implementation as electronic form of the document: APPLICATION FOR VARIATION TO A MARKETING AUTHORISATION, June 2014.

10 This Release note is for the Release , for the eAF forms. Issues fixed for this version id Description comments EAF-2812 Declaration and Signature section proof of payment - LogID/OrgID missing in the within the pdf once saved and reopen. In Declaration and Signature section Proof of payment - LogID/OrgID is visible after saved and reopen. EAF-2810 Empty Tag <rdm:org-modifiedDate> in eAF MAA should be removed. Empty Tag <rdm:org-modifiedDate> in eAF MAA has been removed from schema. EAF-2809 Missing timestamp in loc-modifiedDate when copy contact details button is clicked in section 1.