Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

[F1 Article 95L U.K. Transitional measures for renewal of an approval of an active substance

1. This Article applies where—

(a) an application for renewal of an approval of an active substance was made before IP completion day in accordance with Article 13 of Regulation (EU) No 528/2012, and

(b) a decision was not made before IP completion day.

2. Where the United Kingdom competent authority was the evaluating competent authority before exit day, the application is to be treated as if it were made under Article 13 of this Regulation, and the time limits under Articles 13 and 14 are suspended until—

(a) the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b) where the application relies on a letter of access, whichever is the later of the following—

(i) the applicant resubmits the application, or

(ii) the data owner resubmits the data.

3. On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 13 and 14 of this Regulation apply less any time which expired between the date of acceptance of the application and data under Article 13 and 30 March 2019.

4. Where the United Kingdom competent authority was not the evaluating competent authority before exit day, the application is to be treated as if it were made under Article 13 of this Regulation and the time limits under Articles 13 and 14 apply from—

(a) the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b) where the application relies on a letter of access, whichever is the later of the following—

(i) the applicant resubmits the application, or

(ii) the data owner resubmits the data.

5. Where the applicant does not meet the requirements of this Article, the approval must not be renewed by the competent authority and Article 52 applies to any biocidal product containing the active substance.

6. Anything done before IP completion day by the United Kingdom competent authority as the evaluating competent authority under Regulation (EU) No 528/2012 is taken as having been done by the competent authority under this Regulation.

7. The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

8. The resubmission of any application and data referred to in paragraph 4 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.]

Textual Amendments

F1 Arts. 95A-95N inserted (31.12.2020) by S.I. 2019/720, Sch. 4 para. 2 (as inserted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 4)