EUROPE – Micro-organisms: review of guidance document on dossiers preparation

The European Commission has just published a revised version of the guidance document on preparing dossiers for the approval or renewal of approval of a micro-organism in compliance with the Table of Contents described in Part B of the Annex to Regulation (EU) No.283/2013 and Part B of the Annex to Regulation (EU) No.284/2013 (SANCO/12545/2014– rev. 2, March 2016). This Guidance Document addresses the following aspects:

• Data points from OECD Table of Contents to revised EU Table of Contents;
• Electronic Submission (CADDY) Table of Contents;
• Documents to be included in the Submission Dossier.

This revision of the guidance includes some clarifications regarding the Table of Contents and the EU numbering system for the Caddy format. It was noted in March 2016 and should be used for dossiers for which an application for the approval or renewal of approval has been submitted as from 1 October 2016.
The current document should be followed also for the supplementary dossiers submitted according to Regulation (EU) 2016/183 setting the RMS and co-RMS for the AIR4 programme.

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