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Regulation (EC) No 1107/2009 Subsection 3 — Mutual recognition of authorisations

Article 40–Article 42 · 3 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Mutual recognition

Article 40

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1.   The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone; (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone; (c) the authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference Member State belongs. 2.   Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply, with the consent of the authorisation holder, for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1. In that case the applicant must demonstrate that the use of such a plant protection product is of general interest for the Member State of introduction. Where the authorisation holder refuses its consent, the competent authority of the Member State concerned may accept the application, on grounds of public interest.

Authorisation

Article 41

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1.   The Member State to which an application under Article 40 is submitted shall, having examined the application and the accompanying documents referred to in Article 42(1), as appropriate with regard to the circumstances in its territory, authorise the plant protection product concerned under the same conditions as the Member State examining the application, except where Article 36(3) applies. 2.   By way of derogation from paragraph 1, the Member State may authorise the plant protection product where: (a) an authorisation under point (b) of Article 40(1) was applied for; (b) it contains a candidate of substitution; (c) Article 30 has been applied; or (d) it contains a substance approved in accordance with Article 4(7).

Procedure

Article 42

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1.   The application shall be accompanied by the following: (a) a copy of the authorisation granted by the reference Member State as well as a translation of the authorisation into an official language of the Member State receiving the application; (b) a formal statement that the plant protection product is identical to that authorised by the reference Member State; (c) a complete or summary dossier as required in Article 33(3) when requested by the Member State; (d) an assessment report of the reference Member State containing information on the evaluation and decision on the plant protection product. 2.   The Member State to which an application under Article 40 is submitted shall decide on the application within 120 days. 3.   Where requested by the Member State, the applicant shall submit the application in the national or official languages of that Member State or one of those languages.

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