Article 37 Period for examination
United Kingdom
The F1competent authority examining the application shall decide within 12 months of receiving it whether the requirements for authorisation are met.
Where the competent 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 competent 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 competent authority. Where at the end of that period the applicant has not submitted the missing elements, the competent authority shall inform the applicant that the application is inadmissible.
The time limits provided for in paragraph 1 shall be suspended during the application of the procedure set out in Article 38.
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 competent authority shall decide on the application at the latest within six months of the active substance being approved.
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.
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).
Annotations
Textual amendments
- F1
Words in Art. 37(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(13)(a) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in Art. 37(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(13)(a) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
- F3
Words in Art. 37(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(13)(b) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
- F4
Art. 37(3A) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(13)(c) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
- F5
Words in Art. 37(4) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(13)(d)(i) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
- F6
Words in Art. 37(4) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(13)(d)(ii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Notes on Section 1
Textual amendments
- F1
Words in Ch. 3 Section 1 Subsection 3 heading inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(16)(a) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Ch. 3 Section 1 Subsection 3A inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(21) (with Sch. 1) (as amended by S.I. 2020/1376, regs. 1(4), 3(5)(f)); 2020 c. 1, Sch. 5 para. 1(1)