{"id":5451,"date":"2021-10-20T20:12:33","date_gmt":"2021-10-20T20:12:33","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=5451"},"modified":"2023-01-26T16:42:53","modified_gmt":"2023-01-26T16:42:53","slug":"europe-com-update-of-guidance-documents-on-new-active-substance-data-post-approval-on-rules-for-revision-of-assessment-reports-and-on-data-matching","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-com-update-of-guidance-documents-on-new-active-substance-data-post-approval-on-rules-for-revision-of-assessment-reports-and-on-data-matching\/","title":{"rendered":"EUROPE – COM : Update of guidance documents on new active substance data post approval, on rules for revision of assessment reports and on data matching"},"content":{"rendered":"

The Commission published an update of the following guidance documents:<\/span><\/p>\n

– <\/span>SANCO\/10328\/2004<\/b>. The SANCO 10328\/2004 document on the <\/span>evaluation of new active substance data post (renewal of) approval<\/b> 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.<\/span><\/p>\n

– <\/span>SANCO\/10180\/2013<\/b>. The SANCO\/10180\/2013 document on <\/span>rules for revision of assessment reports<\/b> is a complement to the ‘Template to be used for Assessment Reports’ (<\/span>SANCO\/12592\/2012<\/span><\/a>) 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.<\/span><\/p>\n

– <\/span>SANTE\/2016\/11449<\/b>. The SANTE\/2016\/11449 document on <\/span>data matching for applications for PPP authorisations<\/b> according to Art. 33 and 43<\/b> of Regulation (EC) No. 1107\/2009 was initially a \u2018Template for Submission Demonstrating Access to a Complete Package According to Regulation (EU) No. 283\/2013 and for the Data Matching Step\u2019. 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.<\/span><\/p>\n

To download: <\/b><\/p>\n