Regulation (EU) No 528/2012 of the European Parliament and of the CouncilDangos y teitl llawn

[F1 Article 95C U.K. Renewal of authorisations subject to mutual recognition under Regulation 492/2014

1. This Article applies where—

(a) an application for the renewal of a biocidal product authorisation subject to mutual recognition was made before IP completion day in accordance with Article 3 of Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014 supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for renewal of authorisations of biocidal products subject to mutual recognition, and

(b) a decision on the renewal of the authorisation was not made before IP completion day.

2. Paragraph 3 applies where, before exit day, the United Kingdom was the reference Member State for an application for renewal.

3. The application is to be treated as having been made under Article 31 of this Regulation and the time limits under Article 31 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 applicant 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.

4. On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 30 and 31 (where applicable) of this Regulation apply less any time which expired between the date of acceptance of the application and data under Articles 3 and 4 of Regulation (EU) No 492/2014 and exit day.

5. Paragraph 6 applies where, before IP completion day, the United Kingdom was the Member State concerned for an application for renewal.

6. The application is to be treated as having been made under Article 31 of this Regulation, and the time limits under Articles 30 and 31 apply from—

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

(b) where the applicant 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.

7. Anything done before IP completion day by the United Kingdom, either as the Member State concerned or as the reference Member State, is taken as having been done by the competent authority under this Regulation.

8. The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

9. The resubmission of any application and data referred to in paragraph 6 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

10. Where the applicant or authorisation holder does not meet the requirements of this Article—

(a) the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9), and

(b) the authorisation must be cancelled by the competent authority and Article 52 applies.]

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)