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Amendment of regulation 31A (trial master file and archiving)U.K.

13.  In regulation 31A(4)(b) M1

(a)for “applicable”, substitute “ relevant ”; and

(b)for the words “Directive 2001/83/EC” to the end, substitute “ these Regulations ”.

Commencement Information

I1Reg. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1Regulation 31A was inserted by S.I. 2006/1928.