Published: 4 August 2026
Medicines
Update to guideline to include extension of the types of medicine labels eligible for a general labelling exemption
Background
Extension of the product/packaging types eligible for a general labelling exemption
Scope
Updated GRTPNZ: Labelling of Medicines and Related Products
How will the general exemptions be applied in practice?
Medsafe has extended the groups of products/packaging types eligible for a general (non-time-limited) labelling exemption. We have updated the Guideline on the Regulation of Therapeutic Products in New Zealand (GRTPNZ): Labelling of Medicines and Related Products to reflect this extension. In consequence, Medsafe has also updated the New Medicine Application (NMA) and Changed Medicine Notification (CMN) forms.
Background
Section 44 of the Medicines Act 1981 (the Act) requires that all medicine containers are labelled ‘in the prescribed manner’. The full labelling requirements are outlined in regulation 13 of the Medicines Regulations 1984 (the Regulations). For a limited number of products, namely those supplied in blisters or single-dose containers not more than 20 mL in volume, reduced labelling requirements apply under certain conditions, as outlined in regulation 15.
Regulation 12(5) of the Regulations allows the Director-General of Health to grant an exemption from compliance with all or some medicine labelling requirements for medicines in a container of a specified type. Labelling exemptions are in practice granted for a period of up to two years; however, they can also be granted for the lifetime of the product, as is currently the case for medical gases. Where a labelling exemption is granted for a group of products or a specific container type and is not time-limited, this is referred to as a general labelling exemption.
Extension of the product/packaging types eligible for a general labelling exemption
Following an internal review and risk assessment of current labelling exemptions, Medsafe has extended the product/packaging types eligible for a general labelling exemption (listed below). These general labelling exemptions will remain in force until a decision is made to change them, or the relevant labelling requirements in the Regulations are amended.
This extension will support patient access to medicines by reducing unnecessary regulatory burden, streamlining Medsafe processes, and promoting harmonisation of regulatory requirements between Australia and New Zealand.
Scope
The general labelling exemption now applies to the following products/packaging types:
- medical gases
- single dose small containers not made of sheet material, with a volume of 20 to 25 millilitres (applies to any dose form) and multi-dose small containers not made of sheet material, with a volume of 25 millilitres or less (applies to injectable products only)
- multi-dose small containers supplied without a separate information sheet
- multivalent vaccines
- general sale parenteral solutions or injections that are only administered under the care of healthcare professional within a healthcare facility
- personalised prescription medicines that are administered under the care of healthcare professionals
- whole blood and blood components (excludes fractionated blood products such as immunoglobulins, albumin and clotting factors)
- intermediate packaging
- transparent packaging
- fixed-dose combination products where only the active moiety can be displayed because the full drug substance INNs do not fit on a single dose container made of sheet material (blister) or principal display panel of a container or package
- sample or starter packs.
Controlled drugs or related products are not eligible for a general labelling exemption.
Updated GRTPNZ: Labelling of Medicines and Related Products
Medsafe has updated the GRTPNZ: Labelling of Medicines and Related Products (Edition 2.0, August 2026) to include the general labelling exemption extension. Section 2.9 details the specific products/packaging types and the sections of the Regulations from which they are now exempt. GRTPNZ: Labelling of Medicines and Related Products (Edition 2.0, August 2026) is available for download from the Current Guidelines section of the Medsafe website. In consequence, Medsafe has also updated the NMA and CMN forms. These are available for download from the Forms and Templates section of the Medsafe website.
How will the general labelling exemptions be applied in practice?
The general labelling exemptions will apply to the specific products/packaging types effective from 11 August 2026.
We have provided possible scenarios for products/labels affected by this update below, but please send any additional questions to medsafeapplications@health.govt.nz.
I have a product/label that has a current labelling exemption and is eligible for a general labelling exemption:
- No action is required. The current labelling exemption will remain valid until its expiry, at which point the general exemption will take effect. If there are any changes to the label, notify these to Medsafe according to standard Changed Medicine Notification (CMN) procedures. We have updated the CMN forms to allow the sponsor to select the Labelling – G2 change category and declare that their product/label is eligible for a general exemption.
- To reduce administration burden, the sponsor is not required to request removal of the existing labelling exemption from the TPDR. Please note, the exemption will disappear automatically once it has expired.
I have an ongoing CMN for a labelling exemption renewal, what do I do?
- Evaluation begins following payment of the invoice. During the evaluation, the evaluator will change the category to Labelling – G2 and a general exemption will apply if eligible. General labelling exemptions do not need to be renewed.
- If the invoice has not been paid and there are no changes proposed to the label, please contact medsafeapplications@health.govt.nz with your App ID and the CMN can be withdrawn.
My product meets the eligibility for a general exemption:
- If this is a NMA, please submit the label to Medsafe using standard processes and select the appropriate declaration in the corresponding application form.
- For an already approved product label:
- if there are no changes to the current label, no action is required.
- if there are changes, submit the label to Medsafe via CMN using Labelling – G2 category.
My product meets the eligibility for multiple general exemption groups:
- Submit the label to Medsafe using standard processes (CMN and NMA) and select the appropriate declaration in the corresponding application form.
- Medsafe will evaluate the label in accordance with the general exemption group with the least requirements.
I have a product that fits the criteria for one of the groups eligible for a general exemption, but the label does not meet the minimum requirements.
- Submit the label to Medsafe using standard processes (CMN and NMA) and select the appropriate declaration in the corresponding application form.
- If the label does not meet the minimum requirements, then either:
- (A) the label is not eligible for the general exemption and a standard labelling exemption could be considered with appropriate justification (note these require renewal every 2 years), or
- (B) the label will need to be updated to meet the minimum requirements for a general exemption. This can be done prior to submission, or during evaluation, the evaluator may request changes to the label to meet minimum requirements.
I need to update my product’s label that has a general exemption, what CMN category do I use?
- Submit the label to Medsafe using standard processes for submitting a CMN and select the appropriate declaration in the form.
- The correct CMN category is Labelling – G2. This category should be used for any changes, no matter how minor.
- Labels with a general exemption are not eligible for the Labelling – G1 (self-assessable) category.
How will the general labelling exemption appear on the TPDR?
- The TPDR does not display products with a general labelling exemption, unlike a standard (time-limited) labelling exemption, where a labelling exemption appears with an expiry date.
