PART 16Enforcement
Validity of decisions and proceedingsC1322
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.