The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 No. 744

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

I1 Reg. 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

M1 Regulation 31A was inserted by S.I. 2006/1928.