CHAPTER XVII

FINAL PROVISIONS

Transitional measures for ongoing applications for Union authorisations
Article 95H
1
This Article applies where—
a
an application for Union authorisation was made before IP completion day in accordance with Articles 42, 43 or 45 of Regulation (EU) No 528/2012, and
b
a decision was not made before IP completion day.
2
Paragraph 3 applies where, before IP completion day, the United Kingdom competent authority was the evaluating competent authority for applications for Union authorisations made under Regulation (EU) No 528/2012.
3
The application is to be treated as being made under Articles 29 or 31 of this Regulation and the time limits under Articles 29, 30 or 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 to the competent authority, the time limits under Article 29, 30 or 31 of this Regulation apply less any time which expired between the date of acceptance of the application and data under Articles 43, 44, 45 or 46 of Regulation (EU) No 528/2012 and exit day.
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
Paragraph 6 applies to those ongoing Union authorisation applications made under Regulation (EU) No 528/2012 where the United Kingdom competent authority was not the evaluating competent authority.
6
The application is to be treated as having been made under Articles 29, 30 or 31 of this Regulation, and the time limits under those Articles 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 or authorisation holder 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 as the evaluating competent authority 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.
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)
Art. 95H(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(9)