PART 11Pharmacovigilance

Enforcement

Infringement notices206

F21

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.

2

An infringement notice may include directions as to the measures to be taken by P to ensure that the contravention does not continue or, as the case may be, does not recur, including the different ways of securing compliance.

3

If an enforcement authority serves an infringement notice in accordance with paragraph (1) F3in relation to a product authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI) or THR(UK), it shall as soon as is reasonably practicable inform—

a

the EMA; and

b

the European Commission.

F14

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

a

this Part;

F4aa

Schedule 12A;

b

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

c

the Implementing Regulation.