CHAPTER XVII

FINAL PROVISIONS

Transitional measures for ongoing applications to change or amend authorisations
Article 95M
1
This Article applies where—
a
an application was made before IP completion day to the United Kingdom competent authority under Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised 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
An application referred to in paragraph 1 is to be treated as having been made under Regulation (EU) No 354/2013 and the time limits under that Regulation 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.
3
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority.
4
For the purposes of this Article, data submitted by the applicant or the data owner for changes to authorisations issued under Commission Implementing Regulation (EU) No 414/2013 must include relevant data on the reference product.
5
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 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)