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Medicines Act 1981

Dealings with medicines and medical devices - Quality and standards

36: Control of established medicines

You could also call this:

"Rules for Selling Safe Medicines in New Zealand"

Illustration for Medicines Act 1981

You can buy medicines that are already available in New Zealand. The Director-General checks if these medicines are safe and work properly. If they think a medicine may not be safe or work properly, they tell the importer or manufacturer. They ask the importer or manufacturer to prove the medicine is safe and works properly. The Director-General can ask for help from a special committee if they are still not sure about the medicine. The Minister can stop the importer or manufacturer from selling the medicine or add conditions to how it is sold. You can get in trouble if you sell or supply a medicine that you are not supposed to, you could go to prison for up to 6 months or get a fine of up to $5,000.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55444.

Topics:
Health and wellbeing > Public healthHealth and wellbeing > Healthcare services
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35: Revocation and suspension of consents, or

"When the Minister stops or pauses a medicine's approval for safety or quality reasons"

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37: Powers of Minister to prohibit import, etc, of medicines, or

"The Minister can ban medicines or devices from being imported, made, or sold for up to a year."

Part 2Dealings with medicines and medical devices
Quality and standards

36Control of established medicines

  1. Without limiting subsection (5) of section 24, if the Director-General has reason to believe that any medicine, not being a new medicine, may be unsafe or ineffective for the therapeutic purpose for which it is sold, he may, by notice in writing to an importer or manufacturer in New Zealand, state the reasons for his belief and require the importer or manufacturer to satisfy him of the safety or efficacy of that medicine.

  2. If the Director-General is not satisfied, by evidence supplied to him pursuant to a notice under subsection (1) or otherwise, of the safety and efficacy of a medicine to which that notice relates, he may at any time after the expiration of 60 days from the date of that notice refer a description of the medicine to the appropriate committee, and shall forthwith by notice in writing inform the importer or manufacturer that he has done so.

  3. In any case to which this section applies, the Minister may, by notice in writing to the importer or manufacturer,—

  4. prohibit the importer or manufacturer, either indefinitely or for such period as may be specified in the notice, from selling or supplying the medicine; or
    1. impose such conditions as may be specified in the notice on the sale or supply of the medicine by the importer or manufacturer.

      1. The Minister may at any time, by a like notice, revoke any notice given under subsection (3), or vary, revoke, or add to any conditions imposed in any such notice.

      2. Every person commits an offence and is liable on conviction to imprisonment for a term not exceeding 6 months or a fine not exceeding $5,000 who sells or supplies any medicine in contravention of a notice given under subsection (3), or of a condition imposed in any such notice or in a notice given under subsection (4).

      Notes
      • Section 36(5): amended, on , by section 413 of the Criminal Procedure Act 2011 (2011 No 81).