Revised: 2 May 2013

Medicines

Introductory Regulatory Guidance

  1. What does Medsafe do?
  2. I need help with my medicine application. Where can I get further advice?
  3. I want to run a clinical trial. Who can help me with funding?
  4. I want to set up a business in New Zealand. Where do I start?
  5. The product I'm importing contains plant / animal material. What will I need to do?
  6. I am a natural health practitioner. Can I supply unapproved medicines?
  7. I want to import a dietary supplement. What do I need to do?
  8. What are the manufacturing requirements for dietary supplements in New Zealand?
  9. I can't find the answer to my question. Who can I contact in Medsafe to ask?

  1. What does Medsafe do?

    Medsafe is responsible for regulating medicines and medical devices in New Zealand. For further details view About Medsafe.

  2. I need help with my medicine application. Where can I get further advice?

    As the regulator, Medsafe cannot provide advice on how to prepare an application. However, Medsafe publishes a list of regulatory consultants who can provide independent advice.

  3. I want to run a clinical trial. Who can help me with funding?

    Medsafe does not fund clinical trials or research. Contact the Health Research Council of New Zealand for advice on funding opportunities.

    For guidance on obtaining regulatory approval for clinical trials using new medicines, view Clinical Trials on our website.

  4. I want to set up a business in New Zealand. Where do I start?

    Contact New Zealand Trade and Enterprise for help on how to start a new business.

  5. The product I'm importing contains plant / animal material. What will I need to do?

    You will need to contact Biosecurity who will advise you on any action you need to take. You may need to meet a Biosecurity Import Health Standard.

  6. I am a natural health practitioner. Can I supply unapproved medicines?

    View the Guidance for Natural Health Practitioners on our website.

  7. I want to import a dietary supplement. What do I need to do?

    If you want to sell your product as a dietary supplement please be aware that, as dietary supplements fall under the Food Act 1981, you should list your details with the Ministry for Primary Industries (which has responsibility for administering the Food Act 1981).

    Information on how to list with the Ministry for Primary Industries is available on their website. There is no charge for this.

    For further details, view the Regulation of Dietary Supplements on our website.

  8. What are the manufacturing requirements for dietary supplements in New Zealand?

    As the Dietary Supplements Regulations 1985 fall under the Food Act 1981, dietary supplements should be manufactured / packed in a manner that complies with the Food Hygiene Regulations 1974 and Food Act 1981.

    This may involve, for instance, registration with your local council under the Food Hygiene Regulations 1974 or registration with the Ministry for Primary Industries through a Food Safety Programme.

    For further information on the registration process via a local council, contact the environmental health section of your local council. Further information on Food Safety Programmes can be found on the Ministry for Primary Industries website.

    For further details, view the Regulation of Dietary Supplements on our website.

  9. I can't find the answer to my question. Who can I contact in Medsafe to ask?

    Telephone 04 819 6800.

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