Which products require a NZMT listing?
- Every new medicine or subsidised product.
- Every existing medicine requires a new NZMT listing when there are changes to brand name, active ingredient, strength, dose form, pack size or container.
Why is it important for sponsors to make sure their medicines are listed in the NZULM and conform to international standards for medicines terminology?
It is important that all medicines are listed in the NZULM and that they conform to the standards because the NZULM will be the list used by everyone prescribing, dispensing or administering medicines across the health sector.
Will I have to apply for a new NZMT each time there is a change to a medicine?
Yes. You need to apply for a new NZMT listing each time there are changes to brand name, active ingredient, strength, dose form, pack size or container of a medicine.
If you are uncertain whether you need a new listing please phone the Editorial Team on 04 567 8570. They will be pleased to provide advice.
I would like to get consent from Medsafe to distribute a medicine. What do I need to do about an NZMT listing?
Before lodging an application you'll need to apply for an NZMT listing by email (to listings@nzmt.org.nz) for your medicine. This is because Medsafe asks for a copy of the Listing Certificate provided by NZMT as part of your application.
PHARMAC also asks for details of the product’s NZMT listing as part of the process of applying for a Pharmaceutical Schedule listing. You can use the Listing Certificate as part of your Pharmaceutical Schedule application too.
Has Medsafe’s role in the regulatory process or the regulatory process itself changed?
No. Medsafe’s role in the regulatory process and the regulatory process itself remains unchanged. However, Medsafe asks you to provide the details of a NZMT listing with applications.
How long will it take for the NZULM to provide a NZMT listing?
We will provide NZMT listing details within one working day in most cases. In some exceptional cases we may take up to three working days to provide a listing. If this delay is necessary we will advise you when the application is lodged.
Can details about my medicine remain confidential?
The NZMT will keep details of your medicine’s listing confidential until the Medsafe consenting process is complete and details of the product’s consent are published by Medsafe.
How much will applications for NZMT listing details cost?
There is no charge for providing the NZMT listing.
What if I forget to provide NZMT listing details with my application to Medsafe for consent to distribute?
If you don’t provide NZMT listing details with your consent application the details can be provided while the application is being reviewed.
Do I still need to apply for a Pharmacode®?
Yes. Pharmacode® is still used by community pharmacies and wholesalers, and it is part of the PHARMAC subsidy process.