Basic information
Outline of the system
From 22 April 2021, an Order issued under the COVID-19 Public Health Response Act 2020 took effect. This order prohibits a person from importing, manufacturing, supplying, selling, packing, or using a point-of-care test for SARS-CoV-2 or COVID-19 unless the Director-General of Health has:
• authorised the person's activity; or
• exempted the point-of-care test from the prohibition.
This order replaces the previous Notice Under Section 37 of the Medicines Act 1981 (Gazette 2020-go1737) and broadens the group of Point-Of-Care tests the restrictions apply to.
Information about the Order and about the process to apply for Director General authorisation can be found at: https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-nov....
Product coverage
As above. The scope of the Order is as follows:
- Act means the COVID-19 Public Health Response Act 2020;
- manufacture has the meaning given by section 2(1) of the Medicines Act 1981;
- pack has the meaning given by section 2(1) of the Medicines Act 1981;
- point-of-care test means any kit or other material that is intended to:
(a) be used to test for SARS-CoV-2 or COVID-19 infection or immunity (whether current or historical) in an individual; and
(b) produce a result without analysis at a laboratory.
- sell has the meaning given by section 2(1) of the Medicines Act 1981.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The purpose of this order is to prevent and limit the risk of the outbreak or spread of COVID-19 and to otherwise support the purposes of the Act by preventing testing for COVID-19 using unverified or unaccredited methods or tools and prevent the misinterpretation of any results. (This equates to risk management).
Questions for products under restriction as to the quantity or value of imports
Not applicable.
The system applies to products originating from which country?
With respect to import controls, the order applies to goods originating in, and arriving from, all countries.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The measures are maintained under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021. As above, this Order is introduced under the COVID-19 Public Health Response Act 2020 and replaces the previous Notice Under Section 37 of the Medicines Act 1981 (Gazette 2020-go1737).
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Product designation is determined by the Order, per (2) above.
Is it possible for the government to abolish the system without legislative approval?
The order cannot be abolished without legislative approval.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
There are no restrictions relating to the eligibility of an importer to apply for authorisation
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
As per the application form available at:
https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-nov...
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
No.
Issuing the license
Can a licence be granted immediately on request?
No. An application to import, manufacturer, supply, sell, pack, or use must be made before an authorisation can be granted.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
An authorisation must be granted before a product can be released by Customs. An application for authorisation normally takes up to 25 days to process.
Which administrative body is responsible for approving application of licences?
The Ministry of Health is the sole administrative body responsible for managing an application.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
Importers can only supply the authorised tests to users who have been similarly authorised as users by the Director General of Health. The Director General of health may impose other conditions on the authorisation approved, on a case-by-case basis.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
There is no fee or charge associated with an application for authorisation to import.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
No.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
An application may be refused if:
• a product is evaluated and is determined to not meet relevant selection criteria; or
• a decision is made to limit the number of authorised products available for use.
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Importation
Are there any limitations as to the period of year during which importation may be made?
No.
What documents are required upon actual importation?
Once approved, the Ministry of Health provides letters of authorisation to Customs New Zealand and the Ministry for Primary Industries, for goods clearance purposes.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Importers must ensure that all other legislative requirements for importing test kits and consumables are met, for example, requirements under the Biosecurity Act 1993.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
There is no fixed period of validity associated with an authorisation to import.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Authorisations to import are not transferable between importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.