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

[F1 Article 95E U.K. Transitional measures simplified authorisation applications

1. This Article applies where—

(a) an application was made to the United Kingdom competent authority before IP completion day under Articles 25 or 26 of Regulation (EU) No 528/2012, and

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

2. Where the application was made to the United Kingdom competent authority as the receiving competent authority, the application is to be treated as having been made under this Regulation and the time limits under Article 26 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.

3. In a case where an application was made but the United Kingdom competent authority was not the receiving competent authority, the application is to be treated as having been made under this Regulation and the time limits under Article 26 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.

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. Anything done before IP completion day by the United Kingdom competent authority as the receiving competent authority is taken as having been done by the competent authority under this Regulation.

6. 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.

7. 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 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)