Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance) (c. 528)

CHAPTER XVII U.K. FINAL PROVISIONS

[F1 Article 95B U.K. Transitional measures for mutual recognition applications

1. This Article applies where—

(a) an application for mutual recognition of a national authorisation of a biocidal product was made before IP completion day in accordance with Articles 33, 34 or 39 of Regulation (EU) No 528/2012, and

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

2. Paragraphs 3, 4, 7 and 8 apply where the United Kingdom was the reference Member State, before exit day, for an application for mutual recognition under Article 34 of Regulation (EU) No 528/2012.

3. The application for mutual recognition is to be treated as having been made under Article 29 of this Regulation, and the time limits under Articles 29 and 30 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 to the competent authority, the time limits under Articles 29 and 30 of this Regulation apply, less any time which expired between the date of acceptance of the application and data under Article 34 of Regulation (EU) No 528/2012 and exit day.

[F2 4A. But paragraph 4 does not apply so as to shorten—

(a) the deadline in paragraph 1 of Article 29, as it is modified by paragraph 1A of that Article; or

(b) the deadlines in paragraphs 1A, 2A and 4 of Article 30.]

5. Paragraphs 6, 7 and 8 apply where, before IP completion day, the United Kingdom was the Member State concerned in relation to an application for mutual recognition under Articles 33, 34 or 39 of Regulation (EU) No 528/2012.

6. The application is to be treated as having been made under Article 29 of this Regulation, and the time limits under Articles 29 and 30 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.

7. Where the applicant does not meet the requirements of this Article, 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).

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

9. 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.

10. 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.]

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)

F2 Art. 95B(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(6)