Published: 29 April 2021
Archived: 21 August 2024
Medicines
Unapproved COVID-19 vaccines – restriction on importation, manufacture, supply and use
This prohibition will remain in place until 27 April 2022.
- What are unapproved COVID-19 vaccines?
- Why is this action being taken?
- What restrictions are being imposed?
- Which COVID-19 vaccines can be supplied in New Zealand?
- How are vaccines regulated in New Zealand?
From 27 April 2021, the importation, manufacture, packing, sale, supply, possession, administration or use of unapproved COVID-19 vaccines is prohibited, unless authorised by Medsafe.
What are unapproved COVID-19 vaccines?
Vaccines, as for all medicines, must be approved for use before they can be generally supplied in New Zealand. There are some tightly controlled exemptions to this requirement. An unapproved vaccine for immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 is one that has not been approved through the assessment and approval process operated by Medsafe.
An approved vaccine must have been imported by or under the authority of the organisation / company that holds the relevant approval. A parallel imported vaccine (one with the same brand that is imported by someone other than the supplier that has been granted approval) would be an unapproved vaccine.
Why is this action being taken?
The government’s goal is to ensure that safe and effective vaccines are available to the New Zealand public to protect the community against COVID-19. Vaccines that have not been approved for use in New Zealand may not meet the required standards for safety and quality – they could be unsafe or ineffective and possibly counterfeit. In order to ensure the public has a reliable supply of vaccine, it is considered important to close off other supply routes that may increase the risk that a vaccine will be unsafe or ineffective. Unsafe or ineffective vaccines would reduce New Zealand’s protection against COVID-19, both for people at high risk and for the whole community.
What restrictions are being imposed?
COVID-19 vaccines are regulated under the Medicines Act 1981 (the ‘Act’) as medicines. Section 37 of the Act the Minister of Health (or his delegate) to place certain restrictions on specified medicines.
Medsafe, as the Minister’s delegate, has issued a section 37 notice to prohibit the importation, manufacture, packing, sale, supply, possession, administration or use of unapproved COVID-19 vaccines, unless authorised by Medsafe. The section 37 notice came into force on 27 April 2021.
The penalty for breaching this requirement is, on successful prosecution:
- a period of imprisonment not exceeding three months, or
- a fine not exceeding $500, and
- if the offence is continuing, a fine not exceeding $50 per day for every day the offence continues.
Breaching may result in other breaches of the Act. For instance, supply of a vaccine that has not been approved may be a breach of section 20 of the Act for which, on successful prosecution, the penalties include:
- in the case of an individual, a term of imprisonment not exceeding 6 months or a fine not exceeding $20,000
- in the case of a body corporate, a fine not exceeding $100,000.
This restriction applies to importers, manufacturers, suppliers, health care practitioners and the public. It does not apply in specific cases approved by Medsafe.
This restriction means that possible routes for supply of unapproved COVID-19 vaccines into New Zealand will be closed off. For instance, it will not be possible for authorised prescribers to use section 25 of the Act to import or administer an unapproved COVID-19 vaccine, or for anyone to import or supply an unapproved COVID-19 vaccine under section 29 of the Act. Members of the public will not be able to import personal supplies of the vaccine.
Read the section 37 gazette notice
Notice:
https://gazette.govt.nz/notice/id/2021-go1533
Corrigendum:
https://gazette.govt.nz/notice/id/2021-go1624
Which COVID-19 vaccines can be supplied in New Zealand?
Only COVID-19 vaccines approved for use by Medsafe can be supplied in New Zealand.
How are vaccines regulated in New Zealand?
Vaccines are medicines and are regulated under the Medicines Act 1981. Vaccines must first be assessed and approved under a process operated by Medsafe, as delegated by the Minister of Health (unless an exemption exists under the Act). Medsafe makes its assessment and decisions based on internationally agreed standards for medicines and vaccines.
