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The European Commission has published a list of questions and answers that has been conceived as a clarification note of the Commission Services to the Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No.1107/2009 (SANCO/2010/13170 rev. 13, 14 July 2015).
Several key issues are covered and updates to the renewal guidance document are suggested such as the demonstration of data access or the submission of data waivers, the process for data matching work and decision on Cat.4 studies, the change of reference source during the review, the agreement of the cMSs following the decision of the zRMS, the product compliance with conditions and restriction in the active substance regulation, the impact of new scientific guidances on dRR revision, the justification of changes from the registered GAP, the evaluation of minor uses (Article 51), the requirements for the efficacy part.
Legal clarification is still needed regarding the evaluation of ongoing zonal applications following renewal of approval: registration obtained in zRMS before date of application of active substance (a.s.) renewal but not yet in cMSs; registration obtained in zRMS after a.s. renewal date of application but before Article 43 submission date; submission of dRR >18 months prior to the date of application of a.s. renewal but no decision before Article 43 submission.
To download:
Our previous article:
Sanco 13170 (14 July 2015) on Renewal of the Authorisation of PPP according to Article 43
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