Pursuant to section 37 of the Medicines Act 1981, the Minister of Health hereby prohibits the importation, manufacture, packing, sale, possession, supply, administration or use of any vaccine for immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 unless, in respect of a vaccine:
- the Minister of Health, or the Group Manager Medsafe (pursuant to delegation given by the Minister of Health) has given consent or provisional consent pursuant to sections 20 or 23 of the Medicines Act 1981; and
- the importation of the vaccine is made in accordance with all the conditions imposed by the Minister on giving consent or provisional consent and notified in the New Zealand Gazette.
The importation of the consented or provisional consented vaccine is, if relevant, subject to:
- the Director-General of Health, or the Group Manager Medsafe (pursuant to delegation given by the Minister of Health), giving their approval pursuant to section 24 of the Medicines Act 1981.
This notice does not apply to:
- a vaccine distributed for the purpose of obtaining clinical and scientific information with respect to its safety and efficacy approved pursuant to section 30 of the Medicines Act 1981.
- activities carried out by pharmacists in relation to packing, labelling and supply of the consented or provisional consented vaccine pursuant to section 26(1) of the Medicines Act 1981.
- a vaccine supplied in accordance with conditions that have been approved by the Group Manager, Medsafe, Ministry of Health under the Medicines Act 1981.
Note: This notice is valid for one year from the date of publication of this notice.
Dated this 27th day of April.
DEREK FITZGERALD, Acting Group Manager, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).