Mutal recognition

Mutual recognition is a simplified authorisation procedure which means that you can quickly receive an authorisation of your product if it has already been authorised, either in the zone or in another zone. Your application should be processed in 120 days. It is possible to apply for mutual recognition within one authorisation zone or across all authorisation zones.

Generally speaking, you are ENTITLED to mutual recognition if

• you are the holder of an authorisation granted in another Member State of the same zone
• you are the holder of an authorisation from another Member State of a product for use in greenhouses, as post-harvest treatments, for treatment of empty storage rooms, or for seed treatments.

A Member State may refuse authorisation if there are substantiated reasons that the product poses an unacceptable risk to health or the environment. Moreover, the Member State to which you apply may impose other risk-mitigation measures than those stipulated in the original authorisation. For example, other requirements relating to distance from the aquatic environment.

Generally speaking, you are NOT ENTITLED to mutual recognition if

• you are the holder of an authorisation granted by a Member State in another zone.
• the authorisation granted by another Member State is provisional.
• the product contains an active substance that is a candidate for substitution.
• the product contains an active substance that does not meet the new cut-off criteria.

Application requirements
A new element of the application for mutual recognition is an application form that must be submitted, along with an Annex III dossier (studies on the product) and an 'Annex II dossier' for each active substance in the product (unless this has already been submitted).
Download Application form for mutal recognition 

The evaluation in question must fulfil the following requirements:

• The format and level of detail must be sufficient to underpin the evaluation (for example in the format of a Registration Report).
• Danish documentation requirements (e.g., groundwater modelling).
• Danish agricultural and environmental aspects must be taken into account.
• Danish measures with regard to risk mitigtion must be observed.

Until now, the data requirements for applications for approval of active substances and authorisation of plant protection products have been described in Annexes II and III respectively of Directive 91/414. These have been transferred to the Pesticide Regulation and continue to apply until the amendments that are in progress have been adopted.

To simplify the application procedure, there is now a completeness check form which allows the applicant to verify that all the requirements are in place. Once completed, the completeness check form must be submitted together with the application form, etc. Note that the form does not include national requirements for applications. For these, please refer to the Guidance document for collaboration in the North zone.
Download completeness check form

Case processing time
The case processing time is 120 days.

The cost of applying
The application for mutual recognition in Denmark is free of charge. The holder of the authorisation must however pay an annual fee of DKK 500 per authorisation together with the relevant duties due to the Danish Tax and Customs Administration.

Regulations
The requirements for mutual recognition are described in Articles 40-42 of Regulation No 1107/2009.

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LINKS
The requirements for the application form, procedure and documentation when seeking mutual recognition are described in the following sources. 

Guidelines on collaboration and in particular re-evaluations ind the North zone

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

Application forms for mutal recognition   
Application form for mutal recognition

Documentation, compilation of dossier, etc.
Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report

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

Guidance document for evaluation of efficacy in the North zone