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

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

13.  In regulation 31A(4)(b)(1)—

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

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

(1)

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