Medicines Act 1981

Dealings with medicines and medical devices

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

You could also call this:

"When your confidential medicine information is not protected"

Illustration for Medicines Act 1981

You have some protection under section 23B when you give confidential information about medicines. The Minister can disclose or use this information without your consent if it is necessary to protect public health or safety. The Minister can also disclose this information to certain committees, advisers, or government departments if they will keep it confidential. You can give consent for the Minister to disclose or use your confidential information. If you want someone else to give consent on your behalf, you must notify the Minister in writing. The Minister can disclose your confidential information to international organisations like the World Health Organisation. The Minister can also disclose your confidential information to regulatory agencies of other countries or to people or organisations approved by regulations. You can transfer your rights to confidential information to someone else, and they can then give consent for the Minister to disclose or use it. The Minister must be notified in writing of this transfer.

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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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"Keeping secret information about new medicines safe"


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Part 2Dealings with medicines and medical devices

23CCircumstances where protection under section 23B does not apply

  1. Notwithstanding section 23B, the Minister may, during the 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).