New products

This guide is used for application of new products, which have not previously been authorised in Denmark.

Application requirements – new products

Pre-notification

Six months before the submission of an application, you must send a notification form to all countries in which you wish to market your product. You can, among other things, state if you wish for a specific country to undertake the zonal evaluation (the Zonal RMS – Rapporteur Member State). 

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 guidance for evaluation of efficacy in the Northern Zone.  

Download the application form for zonal application.

A plant protection product can only be authorised if:

  • the active substances are approved
  • the product is sufficiently effective
  • it has no harmful effects on human or animal health or on the groundwater
  • it has no unacceptable effects on the environment
  • a maximum residue level (MRL) in foodstuffs or animal feeds has been set.

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.

Once the evaluation is underway, the ZRMS can prolong the process for up to six months if information is missing. If information is still missing, when the six months have been used for prolongation, the application can be rejected.

The application is evaluated based on the data 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 four months to finalize their evaluation, and either authorise or refuse the application.

Processing time and decisions

The Zonal Rapporteur has one year from the date of the application to make their decision, unless it was necessary to request further information from the applicant. In this case, the period can be extended to a maximum of 18 months.
Hereafter, the other Member States in the zone 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 authorisation, if unacceptable health or environmental risks exist in the Member State. This may occur, even where other Member States grant an authorisation.

The EU has prepared guidelines for the processing of your application:

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

For the Northern Zone, a guidance document has been drawn up, which describes how to apply for authorisation and how the application will be evaluated by the ZRMS and with the national requirements:

Guidance on collaboration in the Northern Zone.

  

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