Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilDangos y teitl llawn

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

Article 37U.K.Period for examination

1.The [F1competent authority] examining the application shall decide within 12 months of receiving it whether the requirements for authorisation are met.

Where the [F1competent authority] needs additional information, it shall set a period for the applicant to supply it. In that case, the 12-month period shall be extended by the additional period granted by the [F1competent authority]. That additional period shall be a maximum of 6 months and shall cease at the moment when the additional information is received by the [F1competent authority]. Where at the end of that period the applicant has not submitted the missing elements, the [F1competent authority] shall inform the applicant that the application is inadmissible.

2.The time limits provided for in paragraph 1 shall be suspended during the application of the procedure set out in Article 38.

3.For an application for authorisation of a plant protection product containing an active substance not yet approved, the [F2competent authority] examining the application shall start the evaluation as soon as [F3the draft assessment report for that active substance is circulated in accordance with Article 12(1)(a)]. In case the application concerns the same plant protection product and the same uses as contained in the dossier referred to in Article 8, the [F2competent authority] shall decide on the application at the latest within six months of the active substance being approved.

[F43A.Where Article 35(2) applies in relation to an application, the requirement in paragraph 3 to decide on the application within 6 months of the active substance being approved is to be read as a requirement to decide on the application within 6 months of the earliest date on which the active substance is approved by one of the competent authorities which received the application for authorisation.]

4.[F5Where Article 35(2) applies in relation to an application, the competent authorities which received the application for authorisation] shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the [F6competent authority] examining the application decide on the application as referred to in Article 36(2) and (3).

Textual Amendments