New products - Articles 33 - 37 and 39

This guide is for applications for 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). Read more about the co-operation between member states in the zones in the section Zonal and interzonal collaboration.

Download the notification form for intended zonal applications.

Application

There are specific requirements to the composition of the application and dossier in the final application.
Download Requirements for submission of documentation in the Northern Zone

In the application for new products, the following must be submitted:

  • A cover letter stating which countries are zRMS and cMS, the type of application, what are the uses of the product applied for, and a list of documents submitted including an overview of the structure of the submitted documents
  • A complete application form. Download Application form
  • A complete product dossier (Annex III dossier) including studies on the formulation and a draft Registration Report (dRR). Please note that all applications for authorisation of new products have to be submitted in the dRR format from 2015. Download dRR format (version 2015)

 The dossier must be prepared in accordance with the Northern zone guidance document and the Danish Framework for the Assessment of Plant Protection Products. In addition, a list of new studies and a justification for the new data submitted must be included in the application submission.

  • A complete Annex II dossier for every active substance in the product (unless this information has already been submitted). The applicant is encouraged to submit the dossier in an easy to read format, as for example Caddy XML format
  • A list of the intended uses (GAP table) in the zone and in the Member States where an application has been submitted. For zonal applications, the GAP table and the dRR should only cover the Northern Zone (not countries in the other zones)
  • Complete detailed compositions of the formulation and co-formulants (including full composition of mixtures). 
  • A draft label/instructions for use of the product. The requirements for a master label are described in the Guidance for evaluation of efficacy in the Northern Zone
  • Letters of Access if the applicant does not own data used in the evaluation

General requirements for preparing product dossiers:

  • The assessment must be based on latest active substance endpoints
  • The assessments must be based on guidance in place at the time of the dossier submission
  • The sections of the dRR must be targeted and transparent
  • Only information and data relevant for the concerned countries/Northern Zone must be presented
  • National requirements must be met

Article 34

Article 34 in the Pesticide Regulation 1107/2009 allows an applicant to apply for authorisation of a Plant Protection Product based on another products dossier. This is possible if the Plant Protection Products are similar allowing for the studies for one product to be used in the risk assessment of another product (bridging principles). Data protection must have expired for the active substance in the EU and for the product in the Member State where the product has been applied for, otherwise the applicant must have “Letters of Access”.

Please note, the composition of the formulation remains confidential even though data protection has expired in the specific Member State. Thus, it is often not possible for the applicant of the new product after Article 34 to know if the formulations are similar enough for the bridging principles to apply.

As the specific product would be new to DK, we require a full registration report in accordance with the current data requirements (Reg. EU 284/2013) and with the current frameworks. Your product will be handled as a new product in DK, but as an applicant you are not required to submit the studies (except for phys/chem and analytical methods if applicable) if already available to DEPA. The fee for a new product will apply.

The Danish EPA will determine if bridging is possible in each case and will assess if the new Plant Protection Product and the authorised Plant Protection Product are similar such that bridging principles can apply. This assessment will not be shared with the parties.

The application must be complete

Please note, it is important that the application is complete and meets all the requirements for the specific type of application. The evaluation will only begin when all relevant material and information is received. If the application is repeatedly found to be incomplete, it will be rejected. See examples of frequent deficiencies here: link

A completeness check of the application of new products will be initiated before the actual evaluation of the application begins. Thus, the Danish EPA will check if the abovementioned requirements are fulfilled. If the application contains minor deficiencies, a request for supplementary material will be sent to the applicant via email. If the requested data is not delivered in due time the application will be rejected. The evaluation of the application will only commence when it is assessed as being complete.

To make sure that the application is complete, it is recommended to fill out a completeness check form. A completed form can be submitted along with the application form and dossier. Be aware that the form does not contain national requirements and you should therefore refer to Guidance on cooperation in the Northern Zone and The Danish evaluation framework with regard to the environment and health.

Submission of the application

The application must be submitted in electronic format (CD) to:

The Environmental Protection Agency, Pesticides and Biocides 
Tolderlundsvej 5 
DK-5000 Odense C

Att. Pesticides “Application for authorisation of pesticide”

Or through email (link to email address)

Processing of your application

The application is evaluated based on the data requirements specified in Regulation (EU) No 284/2013.

The zRMS produces a draft zonal evaluation of the Registration Report (draft Registration Report - dRR), which is sent to all Member States in the zone and the applicant for commenting. Upon receipt of comments, the zRMS will finalise the evaluation. The evaluation is performed in accordance with the Uniform Principles set out in Annex VI of the Plant Protection Product Directive and referred to in Regulation (EC) No 1107/2009.

The zRMS must complete the evaluation within 6 months and submit the final core registration report (RR). The cMS have four months from the date of receipt of the RR to finalise their evaluation and either authorise or refuse the 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.

Processing time and decisions

The application process will be paused if additional information is required from the applicant (clock stop procedure). The clock stop will be in place until the applicant has submitted the requested information. The application process will recommence when the requested information and/or material has been submitted.

CMS in the zone have the option to:

  • accept the evaluation without changes
  • accept the evaluation, but impose other risk mitigation measures, for instance relating to distance from the aquatic environment
  • refuse authorisation, if it is concluded that unacceptable health or environmental risks cannot be excluded in the Member State. This may occur, even if other Member States grant an authorisation

Pesticide application fees

Fees are charged for the processing and evaluation of applications of pesticides. The fees cover all expenses related to the assessment and authorisation carried out in accordance with Regulation 1107/2009. Further information can be found under the menu item Fees.

In addition to the pesticide application fee, the authorisation holder must pay an annual tax of DKK 500 per authorisation and the relevant pesticide tax to the Danish Tax and Customs Administration.

 

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.

Relevant links to applications for new products

Notification form for intended zonal applications

Application form for zonal application

Completeness check form (2015)

Requirements for submission of documentation in the Northern Zone

dRR format (version 2015)

Cooperation in the Northern Zone

Guidance document for evaluation of efficacy in the North zone

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

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

The Danish evaluation framework

The Danish evaluation framework with regard to the environment and health