Revised: 31 May 2013
The regulatory status of the medicinal product is detailed in the Registration Situation and has the
- Approval lapsed
- where consent has lapsed due to a product being not available and there being no
regulatory activity on it for more than five years, or where provisional consent has expired or where
a sponsor has advised in writing that the product is no longer distributed in New Zealand.
- Clinical trial
- where a product is for clinical trial only.
- Consent given
- where a product has been granted consent to market in New Zealand under section 20 of the Medicines
Act 1981 and is actively marketed or is available upon request.
- Consent refused
- where a product has been refused consent under section 20 of the Medicines Act 1981.
- Consent Revoked
- where consent has been revoked under section 35(1)(a) of the Medicines Act 1981.
- Excluded product
- where a product is declared by regulation 58A of the Medicines Regulations 1984 not to be a medicine
or related product.
- Export only
- where a product is for export only and is not to be marketed in New Zealand.
- File closed
- where a product has been rationalized. This may mean that some of the previous product history is on
- Never approved
- where an application is still pending but it is no longer possible to contact the applicant to
either obtain additional information or confirmation of withdrawal.
- NMA withdrawn
- where the applicant has advised in writing that they no longer want to proceed with the application.
- Not available
- where a product has been granted consent but the company has advised in writing that they
do not supply the product upon request or actively market it.
- where an NMA is still under assessment.
- Provisional consent
- where provisional consent has been granted under section 23 of the Medicines Act 1981.
- If approval has lapsed consent to the distribution of a new medicine needs to be granted before the
product can be reintroduced onto the New Zealand market.
- If a product is not available, a CMN is required to reintroduce it into the market or a
justification submitted in writing demonstrating that the regulatory file is current, prior to the
registration situation being updated. CMNs or justifications must be submitted 90 days prior to
- For prescription or restricted medicines a CMN must be submitted for evaluation that includes a
revised data sheet to demonstrate that all required updates have been included. Self-assessable change
notifications will not be accepted.