Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and set out in the Schedule hereto:

Schedule

Provisional consent is granted until 14 April 2024.

This consent is given subject to the following conditions.

The New Zealand Sponsor must fulfil the following obligations within the timelines specified, which may be altered by mutual agreement with Medsafe:

1. Provide confirmatory clinical trial data as identified in the sponsor's plan to submit comprehensive safety and efficacy data within six years from consent being granted within five working days of any reports being produced.
2. Provide updates regarding the clinical activity, efficacy, and effectiveness against the current and future Variants of Concern and Variants of Interest identified by the World Health Organization (WHO) within five working days of any reports being produced.
3. Provide further data relating to safety and efficacy in immunocompromised subjects, pregnant women, lactating mothers, paediatric subjects, patients with hepatic impairment as well as additional pharmacology and long-term safety data and information relating to post-market safety and efficacy studies within five working days of any reports being produced.
4. Provide the results from any non-sponsor led clinical studies involving Lagevrio within five working days of any reports being produced.
5. Provide results from a germ cell mutagenicity study in transgenic Fischer Big Blue rats. Due date: 31 July 2023.
6. Provide results of the 6-month Tg RasH2 mouse carcinogenicity study. Due date: 30 September 2022.
7. Provide results from the 7-month follow-up of the MOVe-OUT (P002) study. Due date: 31 December 2022.

Provisional consent is granted until 4 November 2024.

This consent is given subject to the following conditions:

The New Zealand Sponsor must fulfil the following obligations within the timelines specified, which may be altered by mutual agreement with Medsafe:

1. Only batches that have been released for supply by an approved finished product manufacturing or testing site may be supplied in New Zealand.
2. The New Zealand site of batch release will only release batches for distribution in New Zealand once the sponsor has verified that the shipping temperature profile meets specifications.
3. Provide independent batch certification, such as UK National Institute for Biological Standards and Control (NIBSC) certification, EU Official Control Authority Batch Release (OCABR) certification, Australian TGA batch release assessment, or any other certification agreed with Medsafe, on request.
4. Provide updated specifications for non-compendial raw materials used in the manufacture of drug substance at SIIPL that include an identity test method. Due date: 31 December 2022.
5. Develop a CE-SDS method and provide identification of the peaks in the final electropherogram, including a discussion of the data and final confirmation of the molecular weights. Upon completion of successful method development and validation, implement justified acceptance criteria for drug substance and finished product release and stability testing. Due date: 31 December 2022.
6. Provide further efficacy and safety data from the pivotal clinical studies, including the crossover parts of the studies, within five working days of reports being produced.
7. Provide any reports on the requirement for and timing of booster doses within five working days of these being produced.
8. Investigate the ability of the vaccine to neutralise existing and emerging SARS-CoV-2 variants and provide associated reports within five working days of these being produced.
9. Provide any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and results from post-marketing studies, within five working days of these being produced.
10. Provide the final reports for clinical studies 2019nCoV-301 and 2019nCoV-302 within five working days of being produced.
11. Provide the final report for the ICMR/SII Covovax clinical study within five working days of being produced.
12. Provide Periodic Safety Update Reports and any other regular safety reports, according to the same schedule as required by the EMA, as well as all safety reviews they conduct or become aware of.
13. Perform the required pharmacovigilance activities and interventions detailed in the agreed RMP and any agreed updates to the RMP. An RMP should be submitted at the request of Medsafe or whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important milestone being reached.

Dated this 8th day of December 2023.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).