Quality and standards

35 Revocation and suspension of consents

(1)

The Minister may at any time, by notice, revoke, or suspend for such period as he may determine, any consent given under section 20 or section 23, if he is of the opinion that—

(a)

the medicine can no longer be regarded as a medicine that can be administered or used safely for the purposes indicated in the application for consent, or in a notice deposited under section 24; or

(b)

the specifications and standards with respect to the manufacture of the medicine that were included in the terms of a consent can no longer be regarded as satisfactory; or

(c)

the efficacy of the medicine can no longer be regarded as satisfactory.

(2)

Where a consent is suspended under this section, it shall be deemed for the purposes of subsections (2) and (4) of section 20 not to have been granted.

(3)

A notice under this section is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

Compare: Medicines Act 1968 s 28, Schedule 2 (UK)

Legislation Act 2019 requirements for secondary legislation made under this section
PublicationThe maker must publish it in the GazetteLA19 ss 73, 74(1)(a), Sch 1 cl 14
The Ministry of Foreign Affairs and Trade considers that the secondary legislation may have international transparency obligations under the CPTPP. As a result the maker may also have to comply with s 75 of the Legislation Act 2019LA19 ss 74(2), 75
PresentationIt is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 of the Legislation Act 2019LA19 s 114, Sch 1 cl 32(1)(a)
DisallowanceIt may be disallowed by the House of Representatives LA19 ss 115, 116
This note is not part of the Act.

Section 35(1): amended, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).

Section 35(3): inserted, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).