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Medicines Act 1981

Dealings with medicines and medical devices

23C: Circumstances where protection under section 23B or 23BA does not apply

You could also call this:

"When the government can share your secret medicine information"

Illustration for Medicines Act 1981

You have rights to keep some information secret when you apply for a medicine. The Minister can share this secret information in some situations. The Minister can share it if you say they can. You can let someone else say yes for you. This person must have your permission in writing. The Minister can also share the information if it is necessary to keep people safe. The Minister can share the information with some committees and government departments. They can also share it with the World Health Organisation and other similar groups. They must make sure the information is kept secret. The Minister can share the information with people or organisations approved by regulations. This is part of the Medicines Act 1981, which has rules about medicines and medical devices. You can find more information about the Act and its amendments on the New Zealand legislation website.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55087.

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Topics:
Health and wellbeing > Public healthHealth and wellbeing > Healthcare servicesRights and equality > Privacy
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23BA: Protection of confidential supporting information supplied in application for consent by verification, or

"Keeping secret information safe when applying for medicine approval"

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Part 2Dealings with medicines and medical devices

23CCircumstances where protection under section 23B or 23BA does not apply

  1. Despite sections 23B and 23BA, the Minister may, during the protected period or verification protected period in relation to confidential supporting information,—

  2. disclose that confidential supporting information, or use that confidential supporting information for the purposes of determining whether to grant any application other than the application to which it relates or related, as the case may be,—
    1. with the consent of the applicant who made the application to which the confidential supporting information relates or related; or
      1. if that disclosure or use is, in the opinion of the Minister, necessary to protect the health or safety of members of the public; or
      2. if, in the opinion of the Minister, the relevant committee, adviser, government department, statutory body, or person will take reasonable steps to ensure the confidential supporting information is kept confidential, disclose that confidential supporting information to—
        1. an advisory or technical committee appointed under section 8; or
          1. the Medicines Classification Committee appointed under section 9; or
            1. the Medicines Review Committee established under section 10; or
              1. any adviser for the purpose of obtaining advice about the medicine to which the confidential supporting information relates; or
                1. a government department or statutory body for the purposes of the government department or statutory body; or
                2. disclose that confidential supporting information to any 1 or more of the following—
                  1. the World Health Organisation:
                    1. the Food and Agriculture Organisation:
                      1. any regulatory agency of a WTO country:
                        1. any person or organisation, or a person or organisation within a class or classes of persons or organisations, approved by regulations made under this Act.

                        2. The power to grant consent under subsection (1)(a)(i) may be exercised by a person other than the applicant referred to in that subsection if—

                        3. that applicant—
                          1. has notified the Minister in writing that that other person may grant that consent; and
                            1. has not notified the Minister in writing that that person's authority to grant that consent has been withdrawn; or
                            2. that applicant's rights in respect of the relevant confidential supporting information have been transferred to that person and the applicant or that other person has notified the Minister in writing of the transfer.

                              Notes
                              • Section 23C: inserted, on , by section 2 of the Medicines Amendment Act 1994 (1994 No 128).
                              • Section 23C heading: amended, on , by section 10(1) of the Medicines Amendment Act 2025 (2025 No 66).
                              • Section 23C(1): amended, on , by section 10(2) of the Medicines Amendment Act 2025 (2025 No 66).
                              • Section 23C(1): amended, on , by section 10(3) of the Medicines Amendment Act 2025 (2025 No 66).