Revised: 31 May 2013

Medicines

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where consent has been revoked under section 35(1)(a) of the Medicines Act 1981.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NMA withdrawn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:

• 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 commencing distribution.
• 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.