Renewals - Article 43

This guide is used for renewal of products, which previously have been authorized in Denmark.

Renewals after Article 43

The EU Commission has prepared a guidance document for the renewals of applications, which can be found here.

As supplement to this guidance document, the member states in the Northern Zone have prepared an annex to the Northern Zone Guidance document, where more specific information on the procedures for submission of application for renewals can be found. DEPA's requirements for applications and dossier can be found in the following guidance.

Within two months from the publication of the EFSA conclusion authorisation holders must submit:

  • The pre-notification form to notify intended zonal applications
  • Indication of agreement on the studies which are needed and where possible an expected timeframe; If there are CAT 4 studies, this has to be approved by the ZRMS and CMS
  • Indication of which parts of the risk assessment need updating (to be agreed upon at pre-submission meetings with ZRMS)
  • Indication of amendments of the GAP or formulation changes (to be agreed upon at pre-submission meetings with ZRMS);
  • A "data matching list" regarding references relied upon (where relevant).

Six months before the date of application for renewal the notification form, including the GAP, should be submitted to the proposed ZRMS and all CMSs. If the applicant wants to apply for changes in connection with the renewals, the information should be submitted at least six months before the date for application of renewal. The changes must be discussed with ZRMS and, if needed, with the CMSs. 

Download the notification form for intended zonal applications

Final application

An application form must be completed and submitted together with other documents including a complete "Annex III dossier" (studies on the product), a "Draft Registration Report" and an "Annex II dossier" for each active substance in the product (unless this has already been submitted). Furthermore, a list must be attached of the intended uses (GAP table) in the zone and in the Member States in which authorisation has been applied. A draft label/instructions for use of the product must also be submitted. The requirements for a master label are described in the guidance for evaluation of efficacy in the Northern Zone.

Download application form for zonal application

Processing of your application

The ZRMS begins by carrying out a completeness check of your application. This means that your application will be checked to see, if the information necessary to proceed with the evaluation has been submitted. If the information is considered sufficient, you will receive a notification of completeness.

The application is evaluated based on the requirements specified in Regulation (EU) 284/2013.

The ZRMS produces a draft evaluation, which is sent to all Member States in the zone and the applicant for their comments. After that, the ZRMS will finalize the evaluation. The evaluation is conducted based on the Uniform Principles, which have been transferred from Annex VI of the Plant Protection Product Directive to the Regulation (EC) No 1107/2009.

The Concerned Member States now have three months to finalize thair evaluation, and either authorise or refuse the application. 

Processing time and decisions

The Zonal Rapporteur has nine months from the date of the application in which to make their decision. Hereafter, the other Member States have various options:

  • to accept the evaluation without reservation
  • to accept the evaluation, but to impose new risk mitigation measures, for instance relating to distance from the aquatic environment
  • to refuse an authorisation, if unacceptable health or environmental risks exist in the Member State. This may occur, even where other Member States grant an authorisation.

 

Regulations

The requirements for zonal authorisations are described in Articles 33-39 of Regulation (EC) No 1107/2009.

The requirements for renewals of zonal authorisations are described in Article 43 of Regulation (EC) No 1107/2009.

Links

Cooperation in the Northern Zone

Guidance document on zonal evaluation and mutal recognition under Regulation (EC) No 1107/2009

Guidance from EU on renewal of authorisation after Article 43

Guidance from the Northern Zone on Article 43 renewals

dRR format (version 2015) – for new applications after the 1st of January 2016

dRR format (following SANCO/6895/2009)

Notification form for intended zonal applications

Application form for zonal application

Completeness check form (2015) (following the new dRR format from 2015)

Completeness check form (following the dRR format according to SANCO/6895/2009)

Guidance document on the preparation and submission of dossiers for plant protection products according to the “risk envelope approach”

Requirements for application and dossier

The Danish evaluation framework

The Danish evaluation framework with regard to the environment and health

Guidance document for evaluation of efficacy in the North zone