Renewals - Article 43

Authorisations for plant protection products are time limited and depend on the approval of the active substance at EU level. Upon EU renewal of approval of an active substance, registration holders of plant protection products containing that active substance must apply for renewal of authorisation in order to keep the product on the Danish market.

Application requirements - Renewals under Article 43

The EU Commission has prepared a guidance document for the renewals of authorisations under Article 43, which can be found here.

In addition to this guidance document, chapter 9 in the Northern Zone Guidance document has been prepared by the member states in the Northern Zone containing detailed, specific information on the procedures for submission of application for renewals, which changes are acceptable in the Northern Zone and general documentation requirements. DEPA's requirements for applications and dossier can be found in the following guidance.

Within two months of the publication of the EFSA conclusion concerning the renewal assessment of the active substance in the EU, authorisation holders must submit:

  • The pre-notification form to notify Member States of intended zonal applications
  • Indication of possible category 4 (CAT. 4) studies that the applicant considers necessary and an expected timeframe for submission. In the Northern Zone, CAT. 4 studies must be approved by the zRMS and cMS. Further information on CAT. 4 studies can be found in the EU Commission's Guidance document for renewals of authorisation after Article 43 and in chapter 9.2 of the Northern Zone Guidance document. 
  • An overview of which parts of the risk assessment need updating (to be agreed upon with the zRMS prior to submission)
  • A summary of amendments to the GAP, formulation changes or any other desired changes (to be agreed with zRMS prior to submission)
  • A "data matching list" containing references used (where relevant)

Pre-notification

Six months before the submission date of the application for renewal, the notification form, including the GAP, should be submitted to the proposed zRMS and all cMS. If changes are requested, it must be discussed with zRMS and, if relevant, with the cMS. 

Download the notification form for intended zonal applications

Application

The final application for renewal must be submitted within three months after the renewal approval for the active substance is published. There are specific requirements regarding the structure of the application and dossier. Download Requirements for submission of documentation in the Northern Zone.

The following must be submitted foran Article 43 product renewal application:

  • A cover letter summarising what documentation has been supplied and an overview of the structure of the submitted documents and data

  • A complete application form. Download Application form for Article 43 renewals

  • A complete product dossier (Annex III dossier) and a draft Registration Report (dRR)

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. Download dRR format (version 2015)

  • A complete Annex II dossier for every active substance in the product (unless this information already has 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 in the zone for all the Member States for which an application has been submitted (GAP table). For zonal applications, the GAP table and the dRR should only cover the Northern Zone (not countries in the other zones). The uses must not deviate from the uses in the current authorisation unless this has previously been agreed on at the pre-notification stage as described above. If additional changes in the uses are desired, a separate Article 33 application must be submitted. More information can be found in Amendment of authorisations
  • Complete detailed composition of the formulation and co-formulants (including full composition of mixtures). Changes to the composition of formulation and co-formulants is not allowed unless previously agreed at the pre-notification stage. If any further changes are desired, an Article 33 application must be submitted separately. More information can be found in Amendment of authorisations
  • 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 rules 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

 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 for renewals under Article 43 will be initiated before the actual evaluation of the final application begins. Thus, the Danish EPA will check if the abovementioned requirements for the application are fulfilled. If the application contains deficiencies, a letter of request for supplementary material will be sent to the applicant via email. The requested data must be submitted within a short deadline for renewals of authorisations. If the requested data is not delivered in due time the application will be rejected and the product authorisation revoked. The evaluation of the application will only commence when it is assessed as being complete.

To ensure that the application is complete, we recommend that the applicant fill out a completeness check form. The completed form can be submitted with the application form and dossier. Please note that the form does not contain the national requirements and you should therefore consult the Guidance on cooperation in the Northern Zone.

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 renewal of authorisation of product name”

Or through email (link to email address)

Processing of your application

The application is evaluated based on the data requirements specified in Regulation (EU) 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 comments. Upon receipt of comments, the zRMS will finalise the evaluation. The evaluation is conducted 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 complete core registration report (RR).

The Concerned Member States have three months from the date of receipt of the RR to finalise their evaluation and either authorise or refuse the application. 

Processing time and decisions

The zRMS has nine months from the date of the application to make their decision, provided the data received was complete.

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.

Concerned Member States 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 an 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 in the zone grant an authorisation

Renewal of products with more than one active substance

If a plant protection product contains more than one active substance, and only one of the substances has been renewed, the evaluation will only cover the renewed substance. If there are less than 12 months between the renewal of one active substance and the expiry of another active substance at the time of application, the assessment of the renewal of both active substances must be coordinated. The risk assessment of the product is based on the guidelines in force at the time of submission of the dossier.

If the product contains more than one active substance up for renewal within 12 months or if it is necessary to submit CAT. 4 data, there are specific rules regarding when the application and relevant documentation should be submitted (further information can be found in Annex III of the EU Commission's Guidance document for renewals of authorisation after Article 43 and in chapter 9 of the Northern Zone Guidance document).

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.

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 Renewals under Article 43

Notification form for intended zonal applications

Application form for Renewals under Article 43

Completeness check form (2015) 

Requirements for application and dossier

dRR format (version 2015)

Cooperation in the Northern Zone

Guidance document for evaluation of efficacy in the North zone

Guidance from EU on renewal of authorisation after Article 43

Guidance from the Northern Zone on Article 43 renewals

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