Medsafe Logo
Hide menus
Show menus

Medicines

Revised: 31 May 2013

Registration Situation

The regulatory status of the medicinal product is detailed in the Registration Situation and has the following meanings:

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where consent has been revoked under section 35(1)(a) of the Medicines Act 1981.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 another file.
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NMA withdrawn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.
Pending
where an NMA is still under assessment.
Provisional consent
where provisional consent has been granted under section 23 of the Medicines Act 1981.

Notes:

0 1 2 4 5 6 7 9 [ /