Regulation 45 Suspension and revocation of manufacturing authorisation

(1)

The licensing authority may by a notice in writing to the holder of a manufacturing authorisation, forthwith or from a date specified in the notice, suspend the authorisation for such period as the authority may determine, or revoke the authorisation, on one or more of the following grounds—

(a)

the holder is not carrying out, or has indicated by a notice in writing that he is no longer to carry out, the manufacturing, assembly or importation operations to which the authorisation relates;

(b)

the particulars accompanying the application in accordance with regulation 38(3), were false or incomplete in a material particular;

(c)

a material change of circumstances has occurred in relation to any of those matters or particulars;

(d)

the holder of the authorisation has failed to any material extent to comply with his obligations under regulation 42 or 43(1);

(e)

the holder has manufactured, assembled or, as the case may be, imported investigational medicinal products otherwise than in accordance with the terms of the authorisation;

(f)

the holder has manufactured or assembled investigational medicinal products otherwise than in accordance with—

(i)

in the case of products manufactured before a request for authorisation to conduct the clinical trial involving those products has been made in accordance with regulation 17 F1or, in the case of an investigational medicinal product manufactured or assembled in Northern Ireland, any equivalent provisions in any EEA State, the specification for the product provided by the person who is to act as the sponsor of the proposed clinical trial,

(ii)

in the case of products manufactured for the purpose of export, the specification for the product provided by the person to whose order the products are manufactured, or

(iii)

in any other case, the specification for the product contained in the investigational medicinal product dossier for that product;

(g)

the qualified person has failed to carry out the duties referred to in regulation 43(2), adequately or at all; and

(h)

the holder of the authorisation does not have the staff, premises, equipment or facilities necessary for carrying out properly—

(i)

the manufacture or assembly operations to which the authorisation relates, or

(ii)

the importation operations to which the authorisation relates,

including any handling, storage or distribution activities relating to those operations.

(2)

The suspension or revocation of an authorisation under this regulation may be—

(a)

total; F2...

(b)

limited to investigational medicinal products—

(i)

of one or more descriptions, or

(ii)

manufactured, assembled or stored on any particular premises or in a particular part of any premises;

F3(c)

in the case of a manufacturing authorisation (MM), limited to modular units specified in an MM (IMP) master file associated with the authorisation; or

(d)

in the case of a manufacturing authorisation (POC), limited to POC (IMP) sites specified in a POC (IMP) master file associated with the authorisation.

(3)

The provisions of Schedule 8 shall have effect where the licensing authority propose to suspend or revoke a manufacturing authorisation in accordance with this regulation.

(4)

Where the licensing authority suspend or revoke a manufacturing authorisation in accordance with this regulation, they shall notify the holder of that authorisation in writing, stating the reasons for their decision to suspend or revoke the authorisation.

F4(5)

If the licensing authority suspends or revokes a manufacturing authorisation (MM) in accordance with paragraph (2)(c) so that manufacturing or assembly is suspended, or no longer authorised, at a modular unit, the holder of the authorisation may not approve that unit for the purpose of manufacturing or assembly of the MM investigational medicinal product other than by way of an application under regulation 44.

(6)

If the licensing authority suspends or revokes a manufacturing authorisation (POC) in accordance with paragraph (2)(d) so that manufacturing or assembly is suspended, or no longer authorised, at a POC (IMP) site, the holder of the authorisation may not approve that site for the purpose of manufacturing or assembly of the POC investigational medicinal product other than by way of an application under regulation 44.

Annotations

Textual amendments

F1: Words in reg. 45(1)(f)(i) substituted (31.12.2020) by S.I. 2019/744, reg. 20 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 6)
F2: Word in reg. 45(2)(a) omitted (23.7.2025) by virtue of The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 47(2)(a)
F3: Reg. 45(2)(c)(d) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 47(2)(b)
F4: Reg. 45(5)(6) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 47(3)