On15/09/2015, DG SANTE launches a consultation on the revision of Annex 17: RealTime Release Testing.Stakeholders - and other interested parties - are invited to comment on this consultation document.

Commentsshould be sent at the latest by 11 December 2015 by e-mail to: sante-pharmaceuticals-D6@ec.europa.euand ADM-GMDP@ema.europa.eu.

Whensubmitting your response to the mailbox, please identify yourself with yourname and e-mail address and specify if you respond as an individual or as a representativeof an organisation. If you represent an organisation, please indicate the nameand category of the organisation (Company/Business; Public Authority (local,regional, national, international) ; NGO; other) as well as the registrationnumber of the Transparency Register (if relevant).Received contributions will be published on the Internet. In view of this publication,please indicate in your e-mail one of the following options:

Yourcontribution:

1. Can be directly published with my     personal/organisation information  (I consent to publication of all     information in my contribution in whole or in part including my name/the     name of my organisation, and I declare that nothing within my response is     unlawful or would infringe the rights of any third party in a manner that     would prevent publication)


2. Can be directly published provided that I/my     organisation remain(s) anonymous (I consent to publication of any     information in my contribution in whole or in part (which may include     quotes or opinions I express) provided that this is done anonymously. I     declare that nothing within my response is unlawful or would infringe the     rights of any third party in a manner that would prevent publication).


3. Cannot be directly published but may be included     within statistical data (I understand that my contribution will not be     directly published, but that my anonymised responses may be included in     published statistical data, for example, to show general trends in the     response to this consultation) Note that your answers may be subject to a     request for public access to documents under Regulation (EC) No 1049/2001.

Forfurther information on the protection of personal data, please followthe link: https://europa.eu/geninfo/legal_notices_en.htm .