Article 34 of EU Regulation 1107/2009 addresses the topic of mutual recognition and the possibility for an applicant to apply for authorization of a plant protection product based on another product’s dossier.

1. Kölcsönös Elismerés Elve: A 34. cikk rögzíti a kölcsönös elismerés elvét az Európai Unióban. Ennek értelmében, ha egy növényvédőszer már engedélyezett egy tagállamban (a “referencia tagállam”), egy másik tagállamnak (az “érintett tagállam”) el kell ismernie azt az engedélyezést.

2. Application for Authorization: The article allows an applicant to apply for authorization of a plant protection product in a concerned member state based on the dossier of a reference plant protection product. The applicant may request that the concerned member state recognize the evaluation and decision made by the reference member state.

3. Validity and Scope: The mutual recognition applies when the reference product has been authorized within the EU under Regulation 1107/2009 and remains valid in the reference member state during the mutual recognition process. The scope of the application in the concerned member state should be the same as that of the reference product.

4. Information Provided: The applicant is required to provide the concerned member state with specific information, including the reference product’s authorization number, a copy of the reference product’s label and summary of product characteristics, and the relevant parts of the reference product’s dossier.

5. Evaluation by the Concerned Member State: The concerned member state evaluates the provided information and compares it with the corresponding evaluation in the reference member state. The evaluation ensures that the conditions of use, product composition, and risk assessments of the reference product are applicable and acceptable within the concerned member state.

6. Decision-Making: Based on the evaluation, the concerned member state decides whether to authorize the plant protection product within its territory. The decision should be made within a specified timeframe and communicated to the applicant.

7. Restrictions or Prohibitions: The concerned member state may impose restrictions or prohibitions on the authorized product if it identifies legitimate reasons based on its specific conditions. These restrictions should be justified and communicated to the reference member state and the European Commission.

The mutual recognition process outlined in Article 34 facilitates the efficient authorization of plant protection products within the EU, minimizing duplicative evaluations while ensuring that products meet the required safety and efficacy standards in each member state.