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

[F1 [F2 Article 95FA U.K. Transitional measures for applications for same biocidal product authorisations under the simplified procedure

1. This Article applies where—

(a) an application was made to the United Kingdom competent authority before IP completion day under Article 4a of Commission Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council; and

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

2. The application is to be treated as having been made under Article 4a of Regulation (EU) 414/2013.

3. The applicant must—

(a) resubmit the application and any supporting data to the competent authority; or

(b) where the applicant relies on a letter of access—

(i) resubmit the application; and

(ii) ensure that the data owner resubmits the data.

4. 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).

5. For the purposes of this Article, data resubmitted by the applicant or the data owner must include relevant data for the reference product.

6. The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 before 31 January 2023.]]

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. 95FA inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(8)