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Paragraph 5

United Kingdom

The holder of the authorisation shall provide such information as may be requested by the licensing authority for the purposes of these Regulations or F1the 2012 Regulations—

(a)

about the products currently being manufactured or assembled under his authorisation; and

(b)

of the operations being carried out in relation to such manufacture or assembly.

Annotations

Textual amendments

F1

Words in Sch. 7 Pt. 2 para. 5 substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 62(a)(i) (with Sch. 32)