Article 43 – Renewal of authorisation
Date: 15 April 2020
Article 43 is the re-authorisation of plant protection products and necessary after the active substance is renewed (Annex I renewal). To differentiate it from the a.s. (re-) approval we refer to it as (re-) authorisation.
For this approach strict deadlines apply:
Within two months following the publication of the EFSA-conclusion (a.s. AIR procedure), the pre-notification should be provided to the zonal Rapporteur Member State (zRMS) and copied to the concerned Member States (cMSs). This pre-notification should also contain information on data matching (see academy Article “Data matching”)
Within three months from the renewal of the approval of the active substance(s) contained in the plant protection product, the applicant has to apply for the re-authorisation of the product.
With the application a dossier (dRR) must be submitted if no Category 4 studies are requested (see academy Article “Category 4 studies”). In the dossier new product data should be indicated (required as a result of new data requirements, new or changed endpoints/ criteria or necessary to amend original conditions of approval). The assessment shall be coordinated by the zRMS.
With the application a dossier (dRR) must be submitted if no Category 4 studies are requested (see academy Article “Category 4 studies”). In the dossier new product data should be indicated (required as a result of new data requirements, new or changed endpoints/ criteria or necessary to amend original conditions of approval). The assessment shall be coordinated by the zRMS.
Within twelve months of the renewal of approval of the active substance, the Member States (where the plant protection product is authorised) have to decide on renewal of authorisations. In these twelve months, the deadline for the zRMS evaluation is six months after submission of the application. The cMS(s) has three months after the re-authorisation in the zRMS for their decision on renewal of authorisation.
For products containing more than one active substance, specific approaches for submission and dossier preparation apply, depending on the time frame between the a.s. expiry dates. A detailed guidance can be found in the SANCO/2010/13170.
Karin Lauber