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1.This Article applies to authorisations granted by the United Kingdom competent authority before IP completion day under Articles 19, 26, 30, 31, 33, 34, 36, 39 or 44 of Regulation (EU) No 528/2012.
2.The authorisation is to be treated as if it were authorised by the competent authority under the relevant Article of this Regulation.
3.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 after 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 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.]
Textual Amendments