New Zealand Acts

MEDICINES ACT 1981 - SECT 23C

23C Circumstances 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,—

a) 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,—

i) with the consent of the applicant who made the application to which the confidential supporting information relates or related; or

ii) 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

b) 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—

i) an advisory or technical committee appointed under section 8 ; or

ii) the Medicines Classification Committee appointed under section 9 ; or

iii) the Medicines Review Committee established under section 10 ; or

iv) any adviser for the purpose of obtaining advice about the medicine to which the confidential supporting information relates; or

v) a government department or statutory body for the purposes of the government department or statutory body; or

c) disclose that confidential supporting information to any 1 or more of the following—

i) the World Health Organisation:

ii) the Food and Agriculture Organisation:

iii) any regulatory agency of a WTO country:

iv) 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—

a) that applicant—

i) has notified the Minister in writing that that other person may grant that consent; and

ii) has not notified the Minister in writing that that person's authority to grant that consent has been withdrawn; or

b) 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.

History: Section 23C: inserted, on 1 January 1995, by section 2 of the Medicines Amendment Act 1994 (1994 No 128).