23 Minister may give provisional consent

(1)

Notwithstanding sections 20 to 22, the Minister may, by notice, in accordance with this section, give provisional consent to the sale or supply or use of a new medicine if the Minister is of the opinion that it is desirable that the medicine be sold, supplied, or used.

(2)

An application for the Minister’s provisional consent under this section shall—

(a)

be made in accordance with paragraphs (b) and (ca) of section 21(1):

(b)

be addressed to the Director-General:

(c)

state, or be accompanied by a statement of, the particulars specified in paragraphs (a) to (h) of section 21(2):

(d)

be determined by the Minister in accordance with section 22.

(3)

On giving his provisional consent under this section, the Minister may impose—

(a)

such conditions relating to the persons to whom the medicine may be sold or supplied; or

(b)

such conditions relating to the area in which the medicine may be distributed; or

(c)

such other conditions, not being inconsistent with the purposes of this section,—

as he thinks fit.

(4)

Subject to subsections (4A) and (5), every provisional consent given under this section shall have effect for 2 years or such shorter period as the Minister may determine, and shall then expire.

(4A)

The Minister may, by notice, from time to time renew any provisional consent given under this section for a period not exceeding 2 years on any one occasion.

(4B)

Subsections (3) and (5) shall apply to any renewal of a provisional consent given under subsection (4A) as if it were a provisional consent given under subsection (1).

(5)

If, during the currency of a provisional consent given in respect of any medicine, the Minister grants a consent under section 20 in respect of the same medicine, the provisional consent shall be deemed to be revoked.

(6)

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

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 23(1): replaced, on 25 May 2021, by section 4 of the Medicines Amendment Act 2021 (2021 No 16).

Section 23(1): amended, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).

Section 23(2)(a): amended, on 8 August 1990, by section 3 of the Medicines Amendment Act (No 2) 1990 (1990 No 97).

Section 23(4): amended, on 23 February 1987, by section 2(1) of the Medicines Amendment Act 1987 (1987 No 9).

Section 23(4A): inserted, on 23 February 1987, by section 2(2) of the Medicines Amendment Act 1987 (1987 No 9).

Section 23(4A): amended, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).

Section 23(4B): inserted, on 23 February 1987, by section 2(2) of the Medicines Amendment Act 1987 (1987 No 9).

Section 23(6): inserted, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).