Revised: 9 July 2024
Information for Industry
Schedule OF Fees Payable under the Medicines Act 1981 (Effective from 1 July 2022)
- All fees listed are GST inclusive.
- More detailed descriptions of the type of application or change to which a fee applies can be found on the relevant application form (available at medsafe.govt.nz/regulatory/forms.asp).
New Medicines Application (NMA) Fees
New Medicines Application (Abbreviated Evaluation Process) Fees
New Related Product Application (NRPA) Fees
New Medicine Application Provisional Consent Fees
Changed Medicine Notifications (CMN) Fees
- Non-Biological Medicine (CMN Form A)
- Biological or Biotechnological Medicine (CMN Form B)
- Section 24(5) – Automatic Referrals
Change Related Product Notification (CRPN) Fees
Clinical Trial Application Fees
New Medicines Application (NMA) Fees
| Type of application | New fee ($) |
|---|---|
| New higher-risk medicine containing one or more new active substances (NCE) | 106,503 |
| Any other new higher-risk medicine, including biosimilars | 79,877 |
| New intermediate-risk medicine – prescription medicine | 53,251 |
| New intermediate-risk medicine – non-prescription medicine | 26,626 |
| New lower-risk medicine | 10,649 |
| Additional dose form – higher-risk medicine – Grade 1 or 2 | 53,252 |
| Additional dose form – intermediate-risk prescription medicine – Grade 1 or 2 | 53,252 |
| Additional dose form – intermediate-risk non-prescription medicine – Grade 1 or 2 | 26,626 |
| Additional dose form – lower-risk medicine – Grade 1 or 2 | 10,649 |
| New combination product – novel combination of approved active ingredients | 70,292 |
| New combination pack containing two or more currently approved products | 3,835 |
| The following fees apply when the additional products are applied for at the same time as the parent product[1] | |
| Additional name − Grade 1 | 432 |
| Additional name − Grade 2 | 865 |
| Additional classification (with/without new name) | 432 |
| Additional strength − Grade 1 | 1,298 |
| Additional strength − Grade 2 | 1,730 |
| Additional strength − Grade 3 | 3,460 |
| Additional strength − Grade 4 | 10,785 |
| Additional strength − Grade 5 | 16,177 |
| Additional flavour or type of sweetening | 865 |
| The following fees apply when the additional products are subsequent to approval of the parent product (ie, when additional product applications are submitted after approval of the parent product).[1] | |
| Additional name − Grade 1 | 865 |
| Additional name − Grade 2 | 1,730 |
| Additional classification (with/without new name) | 865 |
| Additional strength − Grade 1 | 2,595 |
| Additional strength − Grade 2 | 3,459 |
| Additional strength − Grade 3 | 6,919 |
| Additional strength − Grade 4 | 21,569 |
| Additional strength − Grade 5 | 32,354 |
| Additional flavour or type of sweetening | 1,730 |
- Fees for this category are cumulative. That is, an applicable fee is charged for each additional name, strength, etc.
New Medicines Application (Abbreviated Evaluation Process) Fees
| Type of Application | New fee ($) |
|---|---|
| New higher-risk medicine containing one or more new active substances (NCE) | 53,251 |
| Any other new higher-risk medicine | 39,939 |
| New intermediate-risk medicine – prescription medicine | 26,626 |
| Additional names, strengthens, flavours and classifications must be notified at the same time as the parent application |
New Related Product Application (NRPA) Fees
| Type of Application | New fee ($) |
|---|---|
| New related product | 5,731 |
| Additional names, strengths, flavours and classifications notified at the same time as the parent application | 0 |
| The following fees apply when the additional products are subsequent to approval of the parent product (ie, when additional product applications are submitted after approval of the parent product). | |
| Additional name − Grade 1 | 865 |
| Additional name − Grade 2 | 1,730 |
| Additional strength | 1,730 |
| Additional flavour or type of sweetening | 1,730 |
New Medicine Application Provisional Consent Fees
| Type of Application | New fee ($) |
|---|---|
| Provisional consent to distribute a new medicine (clinical
need) High risk NCE |
70,292 |
| Provisional consent to distribute a new medicine (clinical
need) High risk other |
52,719 |
| Provisional consent to distribute a new medicine (stock
shortage) High risk other |
15,975 |
| Provisional consent to distribute a new medicine (stock
shortage) Intermediate risk |
10,650 |
| Provisional consent to distribute a new medicine (stock
shortage) Low risk |
2,130 |
| Provisional conversion to full approval (clinical need)
High risk NCE |
35,146 |
| Provisional conversion to full approval (clinical need)
High risk other |
26,359 |
| Provisional conversion to full approval (stock shortage)
High risk other |
63,902 |
| Provisional conversion to full approval (stock shortage)
Intermediate risk |
42,601 |
| Provisional conversion to full approval (stock shortage)
Low risk |
8,176 |
| Application for renewal of provisional consent[3] | 11,982 |
Changed Medicine Notifications (CMN) Fees
Non-Biological Medicine (CMN Form A)
Notifying a material change (including self-assessable changes) to an approved Type I product (lower-risk medicine) or a Type II product (intermediate- or higher-risk medicine other than a biological or biotechnological product − but including antibiotics and like substances derived from micro-organisms). Note: In no case will the CMN/Change Related Product Notification (CRPN) fee for a single product exceed the fee for a new medicine application for a product of the same type. Refer to CMN forms to determine whether the fee specified is ‘per change’.
| Type of Application | Fee ($) |
|---|---|
| Product name | |
| Product name | 865 |
| Formulation | |
| Formulation − G1 | 865 |
| Formulation − G2 | 1,730 |
| Formulation − G3 | 2,162 |
| Formulation − G4 | 3,334 |
| Active ingredient | |
| Active ingredient manufacture - G1 | 432 |
| Active ingredient manufacture - G2 | 865 |
| Active ingredient manufacture - G3 | 865 |
| Active ingredient manufacture - G4 | 865 |
| Active ingredient manufacture - G5 | 2,595 |
| Active ingredient manufacture - G6 Lower risk | 3,334 |
| Active ingredient manufacture - G6 Intermediate/High risk | See 24(5) referral fee |
| Active ingredient specifications/test methods − G1 | 432 |
| Active ingredient specifications/test methods − G2 | 865 |
| Active ingredient specifications/test methods − G3 | 1,730 |
| Excipient | |
| Excipient specifications/test methods − G1 | 432 |
| Excipient specifications/test methods − G2 | 865 |
| Finished product | |
| Finished product secondary packing site | 865 |
| Finished product testing and/or primary packing site | 1,730 |
| Finished product manufacture − G1 | 865 |
| Finished product manufacture − G2 | 1,730 |
| Finished product manufacture − G3 | 2,595 |
| Finished product manufacture − G4 | 3,334 |
| Finished product specifications/test methods − G1 | 432 |
| Finished product specifications/test methods − G2 | 865 |
| Finished product specifications/test methods − G3 | 1,730 |
| Product stability and packaging | |
| Shelf life/storage conditions − G1 | 432 |
| Shelf life/storage conditions − G2 | 1,730 |
| Container/closure/packaging − G1 | 432 |
| Container/closure/packaging − G2 | 865 |
| Container/closure/packaging − G3 | 1,730 |
| Container/closure/packaging − G4 | 2,595 |
| Container/closure/packaging − G5 | 3,334 |
| Indications and dosage | |
| Indications/dosage − G1 | 865 |
| Indications/dosage − G2 | 3,334 |
| Indications/dosage − G3 Lower risk | 3,334 |
| Indications/dosage − G3 Intermediate/High risk | See 24(5) referral fee |
| Contraindications, warnings and precautions - G1 | 1,730 |
| Contraindications, warnings and precautions - G2 | 3,334 |
| Data sheet − G1 | 432 |
| Data sheet − G2 | 865 |
| Data sheet − G3 | 3,334 |
| Labelling | |
| Labelling − G1 | 432 |
| Labelling − G2 | 865 |
| Labelling − G3 | 865 |
| Miscellaneous changes | |
| Editorial updates to Module 3 Documents | 432 |
| Sponsor | 432 |
| Change in ownership | 865 |
| Administration Fee | 432 |
| Requests for copies of product labelling and datasheets, of products not currently available or marketed (per product). | 865 |
Biological or Biotechnological Medicine (CMN Form B)
Notifying a material change (including self-assessable changes) to an approved Type III (biological or biotechnological) product (ie, a vaccine, recombinant product, monoclonal antibody or variant thereof, or a medicinal product derived from blood or plasma). Note: In no case will the CMN/CRPN fee for a single product exceed the fee for a new medicine application for a product of the same type. Refer to CMN forms to determine whether the fee specified is ‘per change’.
| Type of Application | Fee ($) |
|---|---|
| Product name | |
| Product name | 865 |
| Formulation | |
| Formulation − G1 | 865 |
| Formulation − G2 | 3,334 |
| Bulk active | |
| Active ingredient manufacturing site | 3,334 |
| Active ingredient testing site | 1,730 |
| Active ingredient method of manufacture – G1 | 432 |
| Active ingredient method of manufacture – G2 | 865 |
| Active ingredient method of manufacture – G3 | 1,730 |
| Active ingredient method of manufacture – G4 | 3,334 |
| Finished product manufacturing site | 3,334 |
| Finished product secondary packing site | 865 |
| Finished product testing site | 1,730 |
| Finished product manufacturing process − G1 | 432 |
| Finished product manufacturing process – G2 | 865 |
| Finished product manufacturing process – G3 | 1,730 |
| Finished product manufacturing process – G4 | 3,334 |
| Test methods and specifications | |
| Test methods and specifications − G1 | 432 |
| Test methods and specifications − G2 | 1,730 |
| Test methods and specifications − G3 | 3,334 |
| Test methods and specifications − G4 | 3,334 |
| Excipient | |
| Excipient manufacturing site | 3,334 |
| Excipient methods of manufacture - G1 | 432 |
| Excipient methods of manufacture - G2 | 865 |
| Excipient methods of manufacture - G3 | 2,595 |
| Excipient specifications/test methods - G1 | 432 |
| Excipient specifications/test methods - G2 | 865 |
| Product stability and packaging | |
| Shelf life/storage conditions − G1 | 432 |
| Shelf life/storage conditions − G2 | 1,730 |
| Shelf life/storage conditions – Reference standard | 1,730 |
| Container/closure/packaging − G1 | 432 |
| Container/closure/packaging − G2 | 865 |
| Container/closure/packaging − G3 | 1,730 |
| Container/closure/packaging – G4 | 3,334 |
| Indications and dosage | |
| Indications/dosage − G1 | 865 |
| Indications/dosage − G2 | 3,334 |
| Indications/dosage − G3 | See 24(5) referral fee |
| Contraindications, warnings and precautions - G1 | 1,730 |
| Contraindications, warnings and precautions - G2 | 3,334 |
| Data sheet - G1 (Self-assessable) | 432 |
| Data sheet - G2 | 865 |
| Data sheet - G3 | 3,334 |
| Labelling | |
| Labelling − G1 | 432 |
| Labelling − G2 | 865 |
| Labelling − G3 | 865 |
| Miscellaneous changes | |
| Sponsor | 432 |
| Change in ownership | 865 |
| Administration fee | 432 |
| Requests for copies of product labelling and datasheets, of products not currently available or marketed (per product). | 865 |
Section 24(5) – Automatic Referrals
| Type of Application | Fee ($) |
|---|---|
| Active ingredient manufacture - G6 | 21,301 |
| Indications/dosage – G3, Lower risk | 3,334 |
| Indications/dosage – G3, intermediate risk | 18,638 |
| Indications/dosage – G3, high risk other | 27,957 |
| Indications/dosage – G3, high risk (NCE) | 37,276 |
Change Related Product Notification (CRPN) Fees
Fees notifying a material change (including self-assessable changes) to an approved related product. Note: In no case will the CMN/CRPN fee for a single product exceed the fee for a new medicine application for a product of the same type.
| Type of Application | New fee ($) |
|---|---|
| Product name | |
| Product name | 865 |
| Formulation | |
| Formulation − G1 | 865 |
| Formulation − G2 | 1,297 |
| Formulation − G3 | 1,297 |
| Formulation − G4 | 2,595 |
| Active ingredient | |
| Active ingredient site | 865 |
| Active ingredient specifications/test methods − G1 | 432 |
| Active ingredient specifications/test methods − G2 | 865 |
| Finished product | |
| Finished product packing site | 865 |
| Finished product testing and/or primary packing site | 865 |
| Finished product manufacture − G1 | 865 |
| Finished product manufacture − G2 | 865 |
| Finished product manufacture − G3 | 1,730 |
| Finished product manufacture − G4 | 2,595 |
| Finished product specifications/test methods − G1 | 432 |
| Finished product specifications/test methods − G2 | 865 |
| Product stability and packaging | |
| Shelf life/storage conditions − G1 | 432 |
| Shelf life/storage conditions − G2 | 1,730 |
| Container/closure/packaging − G1 | 432 |
| Container/closure/packaging − G2 | 865 |
| Container/closure/packaging − G3 | 1,730 |
| Container/closure/packaging − G4 | 3,334 |
| Indications and dosage | |
| Indications/dosage − G1 | 432 |
| Indications/dosage − G2 | 1,297 |
| Indications/dosage − G3 | 3,334 |
| Labelling | |
| Labelling − G1 | 432 |
| Labelling − G2 | 865 |
| Miscellaneous changes | |
| Sponsor | 432 |
| Change in ownership | 865 |
| Administration fee | 432 |
| Requests for copies of product labelling and datasheets, of products not currently available or marketed (per product). | 865 |
Clinical Trial Application Fees
| Type of Application | New fee ($) |
|---|---|
| Application for consent to conduct a clinical trial | 7,500 |
| Additional clinical trial for the same medicine, submitted at the same time | 3,750 |
| Application for consent to conduct a clinical trial – abbreviated approval process | 415 |
Licences and Other Fees
| Type of Application | New fee ($) |
|---|---|
| Appeal to the Medicines Review Committee | 9,000 |
| Issue of a Certificate of Pharmaceutical Product | 261 |
| Licence to Manufacture Medicines | 14,328 |
| Licence to Pack Medicines | 880 |
| GMP Certificates | 186 |
| Licence to Sell Medicines by Wholesale | 1,123 |
| Licence to Sell Medicines by Retail | 900 |
| Licence to Hawk Medicines | 900 |
| Licence to Operate Pharmacy | 1,097 |
| Medical Devices – Regulatory Statements to Foreign Governments (per statement) | 186 |
| Dietary Supplements - Regulatory Statements to Foreign Governments (per statement) | 186 |
| Dietary Supplements – additional copy of original certificate issued at the same time (per statement) | 26 |
| New Zealand Based − Auditing of Non-Licensed Manufacturers − per hour, plus $50 administration fee, plus disbursements | 186 per hour |
Information on the following Licences:
- Licence to Sell by Wholesale
- Licence to Sell Medicines by Retail
- Licence to Hawk Medicines
- Licence to Operate a Pharmacy
- Licence to deal in Controlled Drugs
- Licence to possess Controlled Drugs
- Licence to import Controlled Drugs
- Licence to export Controlled Drugs
can be obtained by contacting Medicines Control.
[1] Fees for this category are cumulative. That is, an applicable fee is charged for each additional name, strength, etc. These fees are applicable to both full and abbreviated applications
[2] Fees for this category are cumulative. That is, an applicable fee is charged for each additional name, strength, etc.
[3] In some cases, where significantly less work is required to evaluate a renewal, it may be appropriate for applicants to apply for a fee waiver.
