Plant Protection: Product re-authorisations (Article 43)

Article 43 of Regulation 1107/2009 refers to the re-authorisation of plant protection products, necessary after the approval of the active substance used in the product is renewed.

With the exception of resistance issues, a new assessment of efficacy data is generally not required. Consequently, the respective dossier section of an application for re-authorisation of plant protection products (dRR Section B7) should address resistance issues only. The applicant does not need to provide an updated Biological Assessment Dossier (BAD).

Of course, relevant updates due to the active substance renewal, such as modification of the uses (GAP) caused by new active substance endpoints, may require a modification of the efficacy evaluation. This can be handled by a new application according to Article 33 of Regulation 1107/2009 or new efficacy trials supporting the new GAP under the re-authorisation procedure. New efficacy data would have to be classified as so-called category 4, due to the prescribed procedure. Category 4 studies are studies conducted in order to comply with new endpoints for which the timeframe set by the regulation is too short for generation. Options to submit new efficacy studies for re-authorisation require preliminary discussions with the responsible authority.

A proposal for an application rate according to the leaf-wall-area (LWA) dose expression within the Article 43 procedure is also required in order to comply with the decision of the Central Zone Steering Committee regarding the implementation of the LWA concept for high growing crops.