Plain language law

New Zealand law explained for everyone

Medicines Act 1981

Dealings with medicines and medical devices

20: Restrictions on sale or supply of new medicines

You could also call this:

"Rules for Selling New Medicines in New Zealand"

Illustration for Medicines Act 1981

You cannot sell or give away new medicines until the Minister has given consent. The Minister can set conditions for the medicine. You must follow these conditions. You cannot advertise new medicines until the Minister has given consent. If you break this rule, you can get in trouble. You might have to pay a fine or go to prison. The Minister will tell the EPA about any new medicines they consent to. This is in addition to other laws about medicines. If there is a conflict, this law will prevail. A notice about a new medicine is secondary legislation, which means it has to be published in a certain way, as outlined in Part 3 of the Legislation Act 2019.

This text is automatically generated. It might be out of date or be missing some parts. Find out more about how we do this.

This page was last updated on

View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55054.

Topics:
Health and wellbeing > Public healthHealth and wellbeing > Healthcare services
Previous

19: Administering prescription medicines, or

"Following a doctor's instructions when giving prescription medicines"

Next

21: Applications for Minister's consent, or

"How to Ask for Permission to Sell or Give Out Medicines"

Part 2Dealings with medicines and medical devices

20Restrictions on sale or supply of new medicines

  1. Except as provided in sections 25, 26(4), 28, 30, 31, and 32, this section applies to new medicines.

  2. No person shall—

  3. sell; or
    1. distribute by way of gift or loan or sample or in any other way; or
      1. advertise the availability of—
          1. any medicine to which this section applies before the consent or provisional consent of the Minister to the distribution of the medicine has been given by notice, or otherwise than in accordance with such conditions as may be imposed by the Minister on giving his or her consent or provisional consent and set out in the notice.

        1. No consent given under this section shall be deemed to warrant the safety or efficacy of the medicine to which the consent relates.

        2. A person who contravenes subsection (2) commits an offence, and is liable on conviction—

        3. in the case of an individual, to imprisonment for a term not exceeding 6 months or a fine not exceeding $20,000:
          1. in the case of a body corporate, to a fine not exceeding $100,000.

            1. In any proceedings for an offence against subsection (4) in which it is alleged that this section applies to a medicine by reason of subsection (1), it shall be presumed that the medicine is a medicine to which this section applies until the contrary is proved.

            2. The provisions of this section are in addition to, and not in substitution for, the provisions of any other enactment prohibiting, regulating, or restricting the sale or distribution of medicines, and nothing in any such other enactment shall authorise any person to act in contravention of the provisions of this section; but in the event of any conflict, the provisions of this section shall prevail.

            3. The Minister, after having given consent or provisional consent to the distribution of any medicine in accordance with this Act, shall give written notification to the EPA of the consent or provisional consent and any condition attached to that consent.

            4. Any consent that was given in respect of any medicine by the Minister under section 12(2) of the Food and Drug Act 1969 and in force immediately before the commencement of this Act shall be deemed for the purposes of this section and section 35 to have been given under this section.

            5. A notice under subsection (2) is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

            Compare
            • 1969 No 7 s 12
            Notes
            • Section 20(2): amended, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).
            • Section 20(4): substituted, on , by section 11 of the Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 (1998 No 20).
            • Section 20(6A): inserted, on , by section 149 of the Hazardous Substances and New Organisms Act 1996 (1996 No 30).
            • Section 20(6A): amended, on , by section 53(1) of the Environmental Protection Authority Act 2011 (2011 No 14).
            • Section 20(8): inserted, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).