The Human Medicines Regulations 2012

Validity of decisions and proceedings U.K.

322.—(1) The validity of a decision of the licensing authority under Parts 3 (manufacturing and wholesale dealing), 5 (UK marketing authorisations), 6 (certification of homoeopathic medicinal products), 7 (traditional herbal medicinal products) or 8 (Article 126a authorisations) is not to be questioned in any legal proceedings.

(2) The validity of a licence, authorisation, certificate or registration granted or issued, or other thing done, in pursuance of a decision of a kind mentioned in paragraph (1) is not to be questioned in any legal proceedings.

(3) Paragraphs (1) and (2) are subject to the following provisions of this regulation.

(4) A person to whom notice of the decision is given may make an application to the High Court to challenge the validity of the decision on the grounds that—

(a) the decision is not within the powers conferred on the licensing authority; or

(b) a requirement of these Regulations in connection with the matter to which the decision relates has not been complied with.

(5) An application under paragraph (4) must be made within the period of three months beginning immediately after the day on which notice of the decision is given to the applicant.

(6) On an application under paragraph (4) the High Court may—

(a) make an interim order suspending the operation of the decision to which the application relates until the final determination of proceedings; or

(b) quash the decision, if satisfied that—

(i) the decision is not within the powers conferred by these Regulations, or

(ii) the interests of the applicant have been substantially prejudiced by a failure to comply with a requirement under these Regulations.

(7) If a decision to grant a licence, authorisation, certificate or registration is quashed under this regulation—

(a) a licence, authorisation, certificate or registration granted in pursuance of the decision is void; and

(b) the application process for the grant of the licence, authorisation, certificate or registration may be continued as if the decision had not been made.

(8) In the application of this regulation to Scotland, references to the High Court are to be construed as references to the Court of Session.

Modifications etc. (not altering text)

C1 Reg. 322 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))