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.