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Medicines Act 1981

Dealings with medicines and medical devices

23A: Interpretation

You could also call this:

"What words mean in the Medicines Act"

Illustration for Medicines Act 1981

When you read this part of the law, you need to know what some words mean. An applicant is a person who makes an application or has someone make it for them. An application is when you ask the Minister for consent to do something with a medicine, like sell it or advertise it. You also need to know what confidential information is. This is information that is secret, like trade secrets or things that would lose value if people knew about them. There are rules about how long this information must be kept secret, and this is called the protected period. Some medicines are special, and these are called innovative medicines. When you apply to sell or advertise one of these medicines, you might give the Minister some confidential information. This information is kept secret for a certain amount of time, which is called the protected period or the verification protected period. The law also talks about something called a WTO country. This is a country that is part of the World Trade Organization, which is a group of countries that work together on trade rules. The Minister is the person in charge of making decisions about medicines. They get to decide who can sell or advertise medicines, and they need to keep some information secret to protect the people who make the medicines. The commencement date is when this part of the law started, and it's used to figure out when the protected period starts and ends. The protected period is usually five years, but it can be different depending on what happens with the application.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55065.

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"The Minister can give temporary approval for a new medicine to be sold or used."

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23B: Protection of confidential supporting information about innovative medicines, or

"Keeping secret information about new medicines safe"

Part 2Dealings with medicines and medical devices

23AInterpretation

  1. In this section, and in sections 23B and 23C, unless the context otherwise requires,—

    applicant means—

    1. a person who makes or has made, as the case may be, an application; and
      1. a person on whose behalf an application is, or has been, made, as the case may be

        application means an application for the consent of the Minister under section 20, or for the provisional consent of the Minister under section 23, in relation to a medicine

          application for consent by verification means an application for consent to be granted under section 22D allowing the sale, distribution, and advertising of a new medicine

            commencement date means the date this section and sections 23B and 23C come into force

              confidential information includes—

              1. trade secrets; and
                1. information with a commercial value that would, or would be likely to, be diminished by disclosure of the information

                  confidential supporting information means confidential information given—

                  1. in, or in relation to, an innovative medicine application; and
                    1. about the medicine that is or was, as the case may be, the subject of that application or an application for consent by verification

                      ingredient includes a chemical or biological entity

                        innovative medicine application means,—

                        1. in relation to an application made after the commencement date, an application that refers to an active ingredient—
                          1. that is an active ingredient of the medicine to which the application relates; and
                            1. that has not, before that application is received by the Minister, been referred to in any other application (except in an application by the applicant for provisional consent for that medicine) as an active ingredient of a medicine; and
                            2. in relation to an application made before the commencement date, an application that referred to an active ingredient—
                              1. that is or was, as the case may be, an active ingredient of the medicine to which the application related; and
                                1. that had not, before that application was received by the Minister, been referred to in any other application (except in an application by the applicant for provisional consent for that medicine) as an active ingredient of a medicine

                                protected period means—

                                1. in relation to confidential supporting information, relating to an innovative medicine application, received by the Minister after the commencement date, a period commencing on the date that information is received by the Minister and ending,—
                                  1. where—on the date 5 years after the date of that notification or refusal; or
                                    1. the Minister has given notice of consent, not being provisional consent, under section 20, or refused to give consent, in relation to the medicine that is the subject of the innovative medicine application; and
                                      1. the date of publication of the notice of consent or the date of the refusal is not more than 5 years after the Minister received an application in relation to that medicine,—
                                      2. in any other case, on the date 5 years after the innovative medicine application to which that information relates is or was, as the case may be, received by the Minister:
                                      3. in relation to confidential supporting information, relating to an innovative medicine application, received by the Minister not more than 5 years before the commencement date, a period commencing on the commencement date and ending,—
                                        1. where—on the date 5 years after the date of that notification or refusal; or
                                          1. the Minister has given or gives notice of consent, not being provisional consent, under section 20, or refused or refuses to give consent, in relation to the medicine that was the subject of the innovative medicine application; and
                                            1. the date of publication of the notice of consent or the date of the refusal is or was, as the case may be, not more than 5 years after the Minister received an application in relation to that medicine,—
                                            2. in any other case, on the date 5 years after the innovative medicine application to which that information related was received by the Minister

                                            verification protected period means, in relation to confidential supporting information relating to an application for consent by verification, a period—

                                            1. commencing on the date that information was received by the Minister; and
                                              1. ending on the date 5 years after the date of—
                                                1. notification of consent; or
                                                  1. refusal of consent

                                                  WTO country means a country that is a party to the Agreement establishing the World Trade Organization adopted at Marrakesh on 15 April 1994.

                                                  Notes
                                                  • Section 23A: inserted, on , by section 2 of the Medicines Amendment Act 1994 (1994 No 128).
                                                  • Section 23A application for consent by verification: inserted, on , by section 8(1) of the Medicines Amendment Act 2025 (2025 No 66).
                                                  • Section 23A confidential information: replaced, on , by section 11 of the Agricultural Compounds and Veterinary Medicines Amendment Act 2016 (2016 No 82).
                                                  • Section 23A confidential supporting information paragraph (b): amended, on , by section 8(2) of the Medicines Amendment Act 2025 (2025 No 66).
                                                  • Section 23A(a)(i)(A) protected period: replaced, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).
                                                  • Section 23A(a)(i)(B) protected period: amended, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).
                                                  • Section 23A(b)(i)(A) protected period: replaced, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).
                                                  • Section 23A(b)(i)(B) protected period: amended, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).
                                                  • Section 23A verification protected period: inserted, on , by section 8(1) of the Medicines Amendment Act 2025 (2025 No 66).