PART 11U.K.Pharmacovigilance

EnforcementU.K.

Infringement noticesU.K.

206.—[F1(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.]

(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), it shall as soon as is reasonably practicable inform—

(a)the EMA; and

(b)the European Commission.

[F2(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.]

Textual Amendments