EUROPE – COM : Update of guidance documents on new active substance data post approval, on rules for revision of assessment reports and on data matching

Published by Tanalou Djae at 20 October 2021

The Commission published an update of the following guidance documents:

– SANCO/10328/2004. The SANCO 10328/2004 document on the evaluation of new active substance data post (renewal of) approval gives a systematic overview on the different reasons for submissions of further active substance data after its (renewal of) approval. The new version 9 replaces revision 8 dated 2012 and clarifies in great detail the assessment process taking into account the kind of new active substance data submitted. This updated version applies to submissions made from 1 November 2021.

– SANCO/10180/2013. The SANCO/10180/2013 document on rules for revision of assessment reports is a complement to the ‘Template to be used for Assessment Reports’ (SANCO/12592/2012) as it provides guidance on when and how to update assessment reports and also presents a way to keep track of the different versions and how to name files to identify them in a unique way. In the new version 2, the condition to incorporate new data and/or new assessments during the processes of evaluation of new active substance data post (renewal of) approval under Regulation (EC) No 1107/2009 have been added. This updated version should be used for assessment reports prepared for active substances submitted to the Commission as from 1 November 2021.

– SANTE/2016/11449. The SANTE/2016/11449 document on data matching for applications for PPP authorisations according to Art. 33 and 43 of Regulation (EC) No. 1107/2009 was initially a ‘Template for Submission Demonstrating Access to a Complete Package According to Regulation (EU) No. 283/2013 and for the Data Matching Step’. Between 2019 and 2021, many reviews have contributed to elaborate a detailed guidance on how to build a data matching request in connection to the renewal of an existing product, or a Cat. 4 extension. In this last version 1.5, some minor text clarifications have been added after commenting in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) including a table of contents and some minor additions to appendix 1 (email template), in line with the agreements in the guidance document.

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