CHAPTER XVIIFINAL PROVISIONS
F1Article 95JTransitional measure for active substance applications made to the United Kingdom competent authority before 30 March 2019 and subsequently reallocated
(1.
This Article applies where—
(a)
an application was made to the United Kingdom competent authority as evaluating competent authority before 30 March 2019 under Article 7 of Regulation (EU) No 528/2012,
(b)
the competent authority had not completed its evaluation of the application before IP completion day due to the evaluation being reallocated at EU level, and
(c)
a decision was not made before IP completion day.
(2.
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 in Articles 7 and 8 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 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.
On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 7 and 8 apply, less any time which expired between the date of acceptance of the application and data under Article 7 of Regulation (EU) No 528/2012 and—
(a)
30 March 2019 for active substances listed in the Annex to Commission Delegated Regulation (EU) 2019/227, or
(b)
exit day for other substances.
(4.
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority.
(5.
Anything done before exit day by the competent authority as the evaluating competent authority under Regulation (EU) No 528/2012 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.