If an authorisation holder wishes to continue to place its plant protection product, after the expiry date of its authorisation, on the market, an application for renewal is required. According to the Regulation (EC) No. 1107/2009 the period of authorisation of a product is based on the period of approval of the active substances contained therein, this subsequent application shall be submitted within 3 months of the renewal of the approval of the active substance. The procedure differs for authorisations issued for 10 years supported by the previous legislation (Directive 91/414/EEC and the Plant Protection Act (PflSchG) based on this Directive), irrespective of the end of the approval of the active substance. As a result the two systems will coexist in Germany for a transitional period.

If the authorisation of a plant protection product issued on the basis of the previous legislation expires before the end of the approval of one of the active substances contained therein, a new zonal application for authorisation must be submitted. This zonal application will be assessed under the auspices of Germany. As a rule, the other Member States will not be involved in this assessment, since the expiration of authorisation has already been adapted to the duration of the approval of the active substances ("DE-only applications"). The closer the submission of this application for renewal comes to the end of the approval of the active substance, the more probable it is that processing cannot be completed in time before the renewal of the approval of the active substance. The application dossier would then have to be amended against the backdrop of potentially new knowledge arising from the approval of the active substance and be subject to re-examination in order to be able to issue an authorisation based on the current state of science and technology.

In order to avoid such complications and to benefit from the advantages of European processing based on a division of labour, the Federal Office of Consumer Protection and Food Safety (BVL) is introducing a procedure for old authorisations that results in the synchronisation of the work to a great extent, as provided for in Regulation (EC) No 1107/2009:

A subsequent application for authorisation must be submitted in the zonal procedure, with Germany as the Rapporteur Member State (DE-only application), one year before expiry of the authorisation issued supported by the previous legislation at the latest. In addition to a fully completed electronic application form, the application should also include a declaration that the applicant is not aware of any knowledge of potentially harmful or unacceptable effects in accordance with Article 56 of Regulation (EC) No 1107/2009 that could justify the immediate review or even the withdrawal of existing authorisations in accordance with Article 44. No further documents (draft Registration Report (dRR), dossier) are to be submitted at this point. Following this approach the existing authorisation will be extended for a maximum of one year after the end of the approval of the active substance which is in accordance with the Regulation (EC) No 1107/2009. The aforementioned subsequent application shall not be included in the processing of content.

The provision is limited to authorisations issued according to previous law for which the approval of the active substance contained in the plant protection product will, as a rule, expire within 3 years of the end of the authorisation. The status at the time of the DE-only application submission is decisive for the calculation of the 3-year deadline. Foreseeable renewals of the approval of active substances will be taken into consideration (example: the proposal amending the regulation on the approval of active substances has already been submitted). Later postponements of deadlines do not lead to a revision of the decision that has already been made via a DE-only application. The decision on the further extension of the authorisation is possible if for example, the renewal of the approval of the active substance is postponed. This decision will be made half a year before the expiration of authorisation at the earliest.

Within 3 months of the adoption of the regulation for the renewed approval of an active substance a new application, supported by all necessary documents and in accordance with Article 43 of the Regulation (EC) No. 1107/2009, with Germany as evaluating member state or as concerned member state, must be submitted. In the process, any data gaps which were already known from previous evaluations should have been addressed and closed. A full evaluation report has to be submitted (dRR based on the current data requirements and guidance documents in place at the time of the submission of the application in accordance with Article 43) since the plant protection product will be assessed, zonally, with German involvement for the first time. The changes made during the renewed approval of the active substance have to be clearly indicated. This also applies to the area of efficacy. The efficacy of the plant protection product has to be examined and should be presented and described in the dRR based on existing data and data that has been accepted in the past (91/414/EEC). Generally, no new studies to prove efficacy have be presented. The assessment necessary for the area of resistance may, however, have to be supplemented by new test results. A Biological Dossier (BAD) need not be presented.

The application number is further incremented with this application for renewal. The application initially submitted (DE-only application), resulting in the extension, will be closed upon the submission of the application in accordance with Article 43. In the event of a delay in the processing of the application, a further extension of the existing authorisation is possible in accordance with Article 43 (6). It is stressed that only existing authorisations will be reviewed based on Article 43. New applications or GAP amendments that are not necessary due to changes in the approval of the active substance will therefore have to be applied for separately via applications for amendments.

The possibilities of combining assessments in the case of products containing several active substances, as described in the Guidance Document on Article 43 (Guidance Document SANCO/2010/13170 rev. 14, 7 October 2016), also apply for the procedure described here, as does the further postponement of the assessment until certain studies have been submitted (Cat. 4).