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Medicines Act 1981

Dealings with medicines and medical devices - Exemptions

29B: Reporting sale or supply of new medicine exempted under section 29 or 29A

You could also call this:

"Telling the government about selling new medicines before they're approved"

Illustration for Medicines Act 1981

You sell or supply a new medicine before it is approved. You must tell the Director-General about it every month. You have to provide details like the medicine's name and how much you sold. You have to keep a record of who asked for the medicine and who got it. You must also keep a record of where the medicine was supplied. The Director-General can ask you for this information. You have to follow these rules if you are an importer or manufacturer of medicines. This is because of section 29(1) and 29A(1). The rules are in place until the Minister's approval is published under the Legislation Act 2019.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=LMS1555709.

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Part 2Dealings with medicines and medical devices
Exemptions

29BReporting sale or supply of new medicine exempted under section 29 or 29A

  1. Subsections (2) and (3) apply to an importer or manufacturer who, for the purposes of section 29(1) or 29A(1), sells or supplies any medicine that is a new medicine by virtue of paragraph (a) of the definition of new medicine in section 3(3) before the notice of consent of the Minister to the distribution of that medicine has been published under the Legislation Act 2019.

  2. The importer or manufacturer must, as soon as practicable after the end of every month in which they have sold or supplied the medicine, provide the following details to the Director-General in writing:

  3. the trade name and generic name of the medicine:
    1. the dose form:
      1. the strength:
        1. the pack size:
          1. the month and year of supply:
            1. the quantity sold or supplied.

              1. The importer or manufacturer must—

              2. keep a record of the name of the authorised prescriber who requested the medicine, the name of the patient, and the place of supply; and
                1. provide the names and the place of supply to the Director-General on request.

                  Notes
                  • Section 29B: inserted, on , by section 12 of the Medicines Amendment Act 2025 (2025 No 66).