Part 2Dealings with medicines and medical devices
22AInterpretation
In this section and in sections 22C to 22F, unless the context otherwise requires,—
full evaluation does not include an evaluation that is abbreviated, abridged, made in reliance on another evaluation, or simplified in any way
full marketing authorisation—
- means an authorisation that permits the sale, distribution, and advertising of a medicine that is based on a full evaluation of the medicine by a recognised regulatory authority; but
- does not include a provisional, conditional marketing, emergency, or export-only authorisation
recognised regulatory authority means a person or body declared to be a recognised regulatory authority by notice given in accordance with section 22B
rules means rules made by the Minister under section 22E.
- means an authorisation that permits the sale, distribution, and advertising of a medicine that is based on a full evaluation of the medicine by a recognised regulatory authority; but
Notes
- Section 22A: inserted, on , by section 7 of the Medicines Amendment Act 2025 (2025 No 66).


