FAQ for Sponsors

General

What is the NZULM

The New Zealand Universal List of Medicines NZULM provides an up-to-date and trusted, one-stop-shop of core and commonly used information about medicines (and other products and devices where appropriate) for New Zealand. The NZULM brings together medicines information from Medsafe, PHARMAC and the Pharmacy Guild into a single standardised product, utilising the “common medicines language” in the New Zealand Medicines Terminology (NZMT). Further detail on the NZULM can be found on www.nzulm.org.nz

What is the difference between the NZULM and NZMT

The NZULM is an aggregation of information that is accessible via this website and which is also provided as a data source for those who provide prescribing or dispensing systems, create medicines information databases, and who analyse and report about medicines. The NZMT is the common language that is shared by people who prescribe, dispense or administer medicines across the health sector in New Zealand. All products that are listed in the terminology named, described and coded in accordance with SNOMED international terminology standards. It covers the generic and trade (brand) names of a medicine, the strength and form of the medicine and the pack size.

Why do we need a NZULM and a NZMT?

We need the NZULM because up until now there has been a lack of single standardised source of commonly used information about medicines in New Zealand. Multiple parties aggregate and disseminate databases of medicines information in varying formats and which contain non-standard names / descriptions for the medicines referred to. The resulting impacts include avoidable medicine errors, duplicated effort and cost, difficulty getting reliable data for clinical, administrative, governance and planning purposes and difficulty advancing key sector strategies such as Medicines New Zealand and other ePharmacy initiatives.

Which products are listed in the NZULM

The NZULM currently covers medicines approved for supply in New Zealand and any products listed in the Pharmaceutical Schedule which fall outside of this category. It also includes medicines imported under Section 29 of the Medicines Act.

Manufacturers and Sponsors

Which products require a NZMT listing?

Every new medicine and every changed medicine where there are changes to brand name, active ingredient, strength, dose form, pack size or container will require a new NZMT listing.

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 become the list that will be used by those prescribing, dispensing and administrating medicines across the health sector.

Will I have to apply for a new NZMT each time there is a change to a medicine?

You will 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.

I would like to get consent from Medsafe to distribute a medicine. What do I need to do?

All you need to do is apply for a NZMT listing by email, or by fax for a listing for every new or changed medicine. Medsafe will ask you to provide listing details with your application for consent to distribute. Refer to the document “Draft instructions for the NZMT application process: What to do, before you apply to Medsafe” for more information.

When will I need to provide a NZMT to Medsafe with applications for consent to distribute?

The NZULM team are ready now to work together with you and Medsafe to ensure future applications to Medsafe for consent to distribute a new or a changed medicine are accompanied with a NZMT listing.

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 will ask that you provide the details of a NZMT listing with applications.

How long will it take for the NZULM to provide a NZMT listing?

The NZULM team will provide you with NZMT listing details within one working day in most cases or within 3 working days in exceptional cases.

Can details about my medicine remain confidential?

It has always been the case that once you apply to Medsafe for consent to distribute, the application details become public knowledge. There will be no change to this.

How much will applications for NZMT listing details cost?

There is no charge for providing the NZMT code and listing for your medicine / product.

What if I forget to provide NZMT listing details with my application to Medsafe for consent to distribute?

Medsafe will ask the NZULM team to contact you and help you get NZMT listing details. In most cases you can obtain listing details within one working day.

Do I still need to apply for Pharmacode®?

Pharmacode® is part of the PHARMAC subsidy process and the ordering/supply process. If your medicine is intended to be subsidised by PHARMAC you will need to apply for a Pharmacode® as you always have.

New NZMT Listings

Test the New Zealand Medicines Terminology listing process before it becomes a normal part of the Medsafe application process.

The New Zealand Universal List of Medicines (NZULM) team have been testing the NZMT listing process with a small number of sponsors. We would now like to test this process further to ensure that the process runs smoothly for all involved.

As part of the testing phase you are simply asked to apply for a NZMT listing and attach the NZMT listing details to the Medsafe application for consent to distribute a new medicine or a changed medicine (where there are changes to brand name, active ingredient, strength, form, pack size and container) . We will then contact you for feedback on your experience of the process.

This is an opportunity to familiarise yourself about the NZULM, test the NZMT listing process and provide valuable feedback to the NZULM team before NZMT applications become a normal part of the Medsafe application process.

The testing phase will last for around two months depending on the feedback we receive. After this time we will make any required changes based on your feedback before finalising the process.

Medsafe have updated their New Medicines Application and Changed Medicine Application forms to provide a space for sponsors to record the date of NZMT application for their records.

The following documents and forms will help sponsors to apply for a new NZMT listing.

When you have completed your from please e-mail it to listings@nzmt.org.nz or fax it to 04 567 8571

Section 29 Applications

Clinicians using Section 29 medicines are asked to apply for a New Zealand Medicines Terminology listing to ensure the database covers all medicines being used in New Zealand. Please use the Section 29 medicine application form (below) which is designed for the purpose.

If you have any questions which are not covered by the instruction sheet please phone the Editorial Team on 04 567 8570. They'll be pleased to help you.