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New Zealand law explained for everyone

Medicines Act 1981

Dealings with medicines and medical devices

24: Distribution of changed medicines restricted

You could also call this:

"Telling authorities about changes to medicines is required before selling them"

Illustration for Medicines Act 1981

If a medicine is changed, you must tell the Director-General. You do this by sending a written notice in English. The notice must describe the change and say how it might affect the medicine's safety and efficacy. If you import or make medicines, you must pay a fee when you send the notice. The Director-General wants to know about changes to the medicine's use, labelling, strength, or how it is made. You cannot sell or give away the changed medicine until 90 days after you send the notice. The Director-General might ask you for more information about the change. If the Director-General is concerned about the change, they will tell the Minister. You can get in trouble if you do not follow these rules. You might have to pay a fine or go to prison if you break the law.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55089.

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Part 2Dealings with medicines and medical devices

24Distribution of changed medicines restricted

  1. If at any time a material change of a kind specified in subsection (2) is made by the manufacturer of a medicine, whether in New Zealand or elsewhere, and whether or not he was the manufacturer of the medicine before that change, the importer or manufacturer in New Zealand of the medicine shall, unless he is of the opinion that section 20 applies to the medicine by virtue of paragraph (a) or paragraph (b) or paragraph (c) of the definition of the term new medicine in section 3(3), deposit with the Director-General a notice in writing in English describing the change and giving particulars, so far as they are known, of any effect that the change might have on the safety and efficacy of the medicine.

  2. Every notice deposited with the Director-General under subsection (1) shall be accompanied by the prescribed fee.

  3. Subsection (1) applies to every material change in any of the following matters:

  4. the purpose for which the medicine is represented to be used, or the recommended dosage, or the recommended manner of administration:
    1. the labelling of the medicine, or of any container or package in which the medicine is packed, or any descriptive matter accompanying or enclosed in any such medicine, container, or package:
      1. the strength, quality, or purity of the medicine:
        1. the methods of manufacture of the medicine, or the facilities for testing its strength, quality, purity, or safety:
          1. the location of the premises in which the medicine is manufactured.

            1. Except as provided in sections 25, 27, 28, 29, and 30, or with the prior written consent of the Director-General, no person shall—

            2. sell any medicine in respect of which there has been made a material change of which notice is required to be deposited with the Director-General under subsection (1); or
              1. supply any such medicine by way of gift or loan or sample, or in any other way—
                  1. until after the expiry of at least 90 days after the date on which such notice is deposited with the Director-General.

                1. Within 45 days after the receipt of any notice in accordance with subsection (1), the Director-General may, by written notice to the importer or manufacturer, require the importer or manufacturer to supply such further information or particulars, or such samples, as the Director-General may require with respect to any matter set out in the importer's or manufacturer's notice.

                2. If the Director-General, after considering the particulars, information, or samples required by or under subsection (1) or subsection (4), is of the opinion, at any time within the period specified in subsection (3),—

                3. that the change is of such a character or degree that the medicine ought not, without the consent of the Minister,—
                  1. to be distributed in New Zealand; or
                    1. to be represented, recommended, advertised, or labelled in the terms set out in the notice; or
                    2. that he is insufficiently informed, for the purposes of paragraph (a), in respect of—
                      1. the strength, quality, purity, safety, or efficacy of the medicine; or
                        1. the methods of manufacture of, or the facilities for testing, the medicine,—
                          2. he shall refer the medicine to the Minister, and forthwith inform the importer or manufacturer by notice in writing that he has done so.

                        2. Every person commits an offence against this Act who—

                        3. fails to comply with subsection (1) or subsection (4); or
                          1. contravenes subsection (3).

                            1. A person who commits an offence under subsection (6) is liable on conviction—

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

                                Compare
                                • 1969 No 7 ss 14, 39(5)
                                Notes
                                • Section 24(1A): inserted, on , by section 4 of the Medicines Amendment Act (No 2) 1990 (1990 No 97).
                                • Section 24(7): added, on , by section 12 of the Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 (1998 No 20).