CHAPTER XVII

FINAL PROVISIONS

Transitional measures for simplified notification procedure
Article 95A
1
Where, before IP completion day, a product was authorised in a country which was a Member State of the EU other than the United Kingdom in accordance with Article 26 of Regulation (EU) No 528/2012, and was placed on the market in the United Kingdom in accordance with Article 27 of Regulation (EU) No 528/2012—
a
it is to be treated as if it were authorised by the competent authority under Article 26 of this Regulation, and
b
the competent authority must grant an authorisation under Article 26 of this Regulation.
2
The authorisation must be cancelled and Article 52 of this Regulation will apply where—
a
the authorisation holder is not established in the United Kingdom within 12 months from IP completion day, or
b
the authorisation holder does not supply the competent authority with relevant scientific and authorisation data by whichever is the earlier of the following—
i
the date of any application for renewal or the date of any application for amendment of the authorisation under Article 50 of this Regulation, or
ii
within 60 days of any request made by the competent authority to the authorisation holder.
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)