22DMinister’s consent by verification

1. Despite section 22, the Minister may, by notice, consent to the sale, distribution, and advertising of a new medicine if the Minister is satisfied that—

2. any fee payable under regulations in respect of the application has been paid; and
3. the new medicine—
   1. has a full marketing authorisation granted by 2 or more recognised regulatory authorities; and
   2. is identical in all material respects to the medicine that has full marketing authorisation granted by 2 or more recognised regulatory authorities; and
   3. meets the requirements for consent by verification set out in the rules; and
   4. meets the relevant requirements of the Medicines Regulations 1984; and
   5. does not require independent assessment by the Director-General to contextualise the benefit-risk profile of the medicine due to local disease epidemiology, public health considerations, or New Zealand specific health risks; and
   6. is not pending deferral of full marketing authorisation, or has not had full marketing authorisation rejected or withdrawn, by a recognised regulatory authority for quality, safety, or efficacy reasons; and
   7. has not been subject to any regulatory action that may result or has resulted in a suspension or revocation of the market authorisation by a recognised regulatory authority.

4. A decision under subsection (1) may grant consent, refuse consent, or withdraw the application for resubmission as an assessment under section 22 or 23.

5. A decision under subsection (1) may be made subject to any conditions that the Minister considers appropriate in the circumstances.

6. The Minister must make a decision under subsection (1) within the time period specified in the rules, which begins on the date the fee payable under regulations in respect of the application is paid.

7. The Minister may request an applicant to provide further information or to amend an application (or both) if the Minister considers that—

8. further information is required to assess the new medicine under subsection (1); or
9. the information provided indicates that the medicine may not be suitable for use in New Zealand.

10. If the Minister makes a request under subsection (5), the time period specified for decision making in the rules ceases to run from the date the request is made until the date on which the applicant complies with the request.

11. A consent given under this section does not warrant the safety or efficacy of the medicine to which the consent relates.

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