Article 95K Transitional measure for active substance applications made before IP completion day pursuant to Article 93 where the United Kingdom competent authority was not the evaluating competent authorityF1
This Article applies where—
an application to approve an active substance was made before IP completion day under Article 7 of Regulation (EU) No 528/2012 and in compliance with point (a) of Article 93,
the United Kingdom competent authority was not the evaluating competent authority, and
a decision was not made before IP completion day.
An application referred to in paragraph 1 is to be treated as if it were made under Article 7 of this Regulation, and the time limits under Articles 7 and 8 apply from—
the date on which the applicant resubmits the application and any supporting data to the competent authority, or
where the application relies on a letter of access, whichever is the later of the following—
the applicant resubmits the application, or
the data owner resubmits the data.
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority.
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.
Annotations
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)