Revised: 9 July 2024
Information for Industry
Schedule OF Fees Payable under the Medicines Act 1981 (Effective from 1 July 2022)
Medsafe will give applicants the option of staggering the payment of the increased fee for new medicine applications (NMA). Under this option the new NMA (including applications for additional dose forms) fees will be applicable from 1 July 2022, however, this can be paid in two parts. From 1 July to 31 December 2022 it will be possible to select to pay the existing fee when the application is submitted, with the remaining balance being invoiced by Medsafe in January 2023. This option will be available until 31 December 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.
