Published: 14 February 2013
Revised: 6 April 2018

Medicines

Introductory Regulatory Guidance

The information and links below provide a starting point if you plan to market a product in New Zealand that may have a therapeutic benefit.

Is my product a medicine?
What do I need to do to sell my medicine in New Zealand?
Frequently asked questions


Is My Product A Medicine?

The first thing you need to do is work out if your product is a medicine.

If your product is not a medicine, it may be a:

View further guidance on how to decide if your product is a medicine.

  • Does your product have a therapeutic purpose or do you want to state a therapeutic claim?

    If your product has a therapeutic purpose or makes a therapeutic claim then it is a medicine, related product or medical device. Go to What do I need to do to sell my medicine in New Zealand? or medical devices to find out what to do next.

    A therapeutic purpose is defined in section 4 of the Medicines Act 1981. It includes the treatment, diagnosis and prevention of disease, or the modification of a physiological function. It also includes effecting contraception or inducing anaesthesia.

    It can be difficult to determine whether a claim implies a therapeutic purpose. For advice on this, the Association of New Zealand Advertisers website has guidelines on therapeutic claims and provides examples of claims that do not imply a therapeutic purpose.

    For further advice, there are a number of regulatory consultants who can help.

  • Does your product contain a scheduled ingredient?

    If your product contains a scheduled ingredient then it is a medicine. Go to What do I need to do to sell my medicine in New Zealand? to find out what to do next.

    Medicines are generally scheduled (ie, classified) according to their active ingredients. The First Schedule to the Medicines Regulations 1984 is a list of ingredients classified as prescription, restricted or pharmacy-only medicines.

    You can check your ingredients using our searchable database. Search by both the name you know the ingredient by and any synonyms. If you do this and get a 'no substances were found' result, it is unlikely that the ingredient is scheduled under the Medicines Regulations 1984.

    Note - if you find the ingredient is not scheduled, your product may still be a medicine if the ingredient has a therapeutic purpose. For example, certain strengths of paracetamol are unscheduled but this ingredient has a therapeutic purpose and so the product is a medicine.

    Controlled drugs are scheduled under the Misuse of Drugs Act 1975, and are not included in the First Schedule to the Medicines Regulations 1984. You can check whether your ingredients are controlled drugs by searching the Schedules at the end of the Misuse of Drugs Act 1975. Some medicines may contain substances that are controlled drugs. However, products containing substances that are controlled drugs cannot be related products, medical devices, dietary supplements, foods, cosmetics or psychoactive products.

  • A related product is a product that is primarily a food, dentifrice or cosmetic, but has a secondary therapeutic use.

    The consent of the Minister of Health is required before a new related product can be sold in New Zealand.

    View Part 1 of the Guideline on the Regulation of Therapeutic Products in New Zealand for further guidance on related products. Also go to What do I need to do to sell my medicine in New Zealand? to find out what to do next.

    Note - some related products may be excluded from the legislation and may not need the consent of the Minister of Health before being sold. View Part 1 of the Gudideline on the Regulation of Therapeutic Products in New Zealand for further guidance on excluded products.

  • Food

    A food falls under the jurisdiction of the Food Act 1981 and is regulated by the Ministry for Primary Industries.

    There are numerous Food Standards that apply to foods (eg, the New Zealand Food (Supplemented Food) Standard 2010). The Ministry for Primary Industries publishes a New Zealand Supplemented Food Standard - User Guide which will help you.

    For further information on food and supplemented food regulations, contact the Ministry for Primary Industries .

  • Cosmetics

    A cosmetic is a product used to cleanse, protect or beautify the hair or skin. Cosmetics must not have a therapeutic purpose or contain a scheduled ingredient.

    A product marketed as a cosmetic must comply with the Cosmetic Products Group Standard 2006 , which is published by the Environmental Protection Authority. Further information on Cosmetics can be found on the Environmental Protection Authority website.  Regulations 24 and 26-36 of the Medicines Regulations 1984 also have requirements that apply to cosmetics.

    There is no approval or registration process in New Zealand for cosmetics that meet these requirements. It remains the responsibility of the sponsor (ie, you) to ensure the cosmetic is made to an acceptable quality and is safe to use.

    View Part 1 of the Guideline on the Regulation of Therapeutic Procuts in New Zealand for further guidance on cosmetics, or contact the Environmental Protection Agency for further advice.

  • Psychoactive Products

    A psychoactive substance is anything that is capable of inducing a psychoactive effect in an individual who uses the psychoactive substance. Controlled drugs, medicines, herbal remedies, dietary supplements, foods, alcohol and tobacco are excluded from the definition of a psychoactive substance.

    Psychoactive products must meet the requirements of the Psychoactive Substances Act 2013 and are regulated by the Office of the Psychoactive Substances Regulatory Authority.

    Psychoactive products require approval from the Psychoactive Substances Regulatory Authority before they can be marketed in New Zealand. Only products that are approved psychoactive products should make claims that imply a psychoactive or mood altering effect.

    For further information on psychoactive products, contact the Psychoactive Substances Regulatory Authority.


What do I need to do to sell my medicine in New Zealand?

Medicines and related products need consent from the Minister of Health before being sold in New Zealand. As part of this process, an application needs to be submitted to Medsafe.

In order to submit an application you will need to think about all of the following factors:

View the Guideline on the Regulation of Therapeutic Products in New Zealand for further guidance on submitting an application to Medsafe.

For information on what happens after you have submitted your application view Medsafe's Evaluation and Approval Process.

  • Type of application

    If your product is a medicine, you will need to submit a New Medicine Application together with supporting data. Go to Is my product a medicine? to find out if your product is a medicine.

    If your product is a related product, you will need to submit a New Related Product Application together with supporting data. Go to Is my product a medicine? to find out if your product is a related product.

    View Part 2 of the Guideline on the Regulation of Therapeutic Products in New Zealand for further guidance on the type of application you will need to submit.

  • Forms

    You will need to submit a New Medicine or Related Product Application Form.

    Medsafe has developed guidance on how to complete this form.

    View documents 14 to 22 in the of Forms for further guidance.

  • Supporting data

    Information required in your application includes data demonstrating the safety, efficacy and quality of the ingredients and of your final product. Efficacy is a technical term used to describe how well a medicine works.

    You will need to show the safety and efficacy of your product in the treatment of humans. Evidence will need to be provided from clinical trials or by providing robust, scientific peer reviewed literature. Medsafe cannot accept evidence of traditional use or testimonials to support your efficacy claims.

    Data to show the quality of your product during its shelf-life will also need to be submitted.

    Supporting data can range in size from a few hundred pages to a few hundred boxes, depending on the type of your application.

    View Part 2 of the Guideline on the Regulation of Therapeutic Products in New Zealand for further guidance on supporting data.

  • Good manufacturing practice (GMP)

    Your product will need to be made in a facility that complies with good manufacturing practice.

    Good manufacturing practice describes the systems manufacturers of medicines are required to have in place to ensure products are consistently safe, effective and of acceptable quality. The requirements are described in a code of practice called the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods.

    If your product is not made in New Zealand, you will also need to think about the requirements for commercial importation. The New Zealand Customs Service is able to advise you on this.

  • The sponsor is the person or company legally responsible for placing the product on the market in New Zealand (ie, you).

    As sponsor you must have a physical address in New Zealand.

    For further guidance on sponsor responsibilities, view:

 

0 1 2 4 5 6 7 9 [ /