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 medicine set out in the Schedule hereto:

Schedule

Note: This consent is given subject to the following conditions:

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

1. Evidence of current GMP that authorises quality control testing at Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried Germany (BN-M) must be provided. Due date 31 October 2024.
2. Changes to the primary reference standard must be submitted as a Changed Medicine Notification pursuant to section 24 of the Medicines Act 1981.
3. Reports of leachable studies performed on the drug substance and/or drug product stored in the container closure system must be provided. Due date 31 March 2025.
4. Provide an explanation as to why the drug product shelf-life specifications do not include an aggregation/particle size test. Due date 31 March 2025.
5. Batches manufactured after 2022 and are for distribution in New Zealand must be accompanied with assurance from the finished product manufacturing site, that they were manufactured and tested according to the same exact same process and specifications, at the same sites, as batches manufactured in 2022. Any changes made to the product since 2022, must be submitted as a Changed Medicine Notification pursuant to section 24 of the Medicines Act 1981. This includes changes to manufacturing sites and process, changes to testing or release specifications, introduction of additional pack sizes, changes to master/working viral seed bank manufacture/qualification, and changes to the primary reference standard.
6. The sponsor must provide PBRERS to Medsafe within one month of these being submitted to the EMA.
7. The sponsor must ensure that they receive information on safety signals from the manufacturer and will provide these to Medsafe in a timely fashion.
8. The sponsor will ensure that they can collect suspected adverse reactions (CARM reports) and provide these to the Centre for Adverse Monitoring.
9. The sponsor should provide the results of the efficacy study required by the EMA. Due date 31 March 2025.

Note: This consent is valid for six months from the date of publication of this notice.

Dated this 11th day of September 2024.

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