PART 2Amendment of the Human Medicines Regulations 2012

Amendment of regulation 20623

1

Regulation 206 (infringement notices) is amended as follows.

2

For paragraph (1) substitute—

1

If an enforcement authority has objective grounds for considering that any person (“P”) has contravened any relevant provision, it may serve upon P a notice in writing (referred to in this Part as an “infringement notice”)—

a

informing P of the authority’s grounds for considering that P has contravened one or more relevant provision;

b

specifying the relevant provision;

c

specifying the measures which P must take in order to ensure that the contravention does not continue or, as the case may be, does not recur;

d

requiring P to take those measures, within such period as may be specified in the notice;

e

specifying the further action (if any) that the enforcement authority may take.

3

After paragraph (3) insert—

4

In this regulation “relevant provision” means a provision of—

a

this Part;

b

Chapter 3 of Title II of Regulation (EC) No 726/2004; or

c

the Implementing Regulation.