This note is not part of the regulations, but is intended to indicate their general effect.
These regulations, which come into force on the day after the date of their notification in the Gazette, replace Schedule 1 of the Medicines Regulations 1984 and correct some references to medicines in those regulations.
Classification of medicines under Schedule 1
Schedule 1 relates to the classification of medicines for the purposes of the Medicines Act 1981 (the Act). Schedule 1 has 3 Parts as follows:
Part 1—prescription medicines (which, in general terms, may be supplied only under a prescription given by a medical practitioner, dentist, registered midwife, veterinarian, or designated prescriber—the prescription medicines that designated prescribers may be authorised to prescribe are specified by regulations under section 105(1)(l) of the Act); and
Part 2—restricted medicines (which, in general terms, may be supplied without a prescription, but only by a registered pharmacist in a pharmacy or a hospital, and with certain details of the supply being recorded); and
Part 3—pharmacy-only medicines (which, in general terms, may be supplied without a prescription, by a registered pharmacist or by another person, at a pharmacy or a hospital, or at a shop in an isolated area that is licensed to sell the medicine).
Minister may classify or reclassify medicines by notices in Gazette
Medicines may also be quickly (if temporarily) classified or reclassified for the purposes of the Act by Gazette notices issued by (or on behalf of) the Minister of Health under section 106 of the Act.
The notices do not amend Schedule 1, but Schedule 1 ceases to have effect to the extent that it is inconsistent with them.
The notices are temporary because they cease to have effect 6 months after the date on which they come into force. However, classifications and reclassifications made by a Gazette notice are usually continued (through later Gazette notices) until they can be recognised permanently through amendments to Schedule 1.
New Schedule 1 recognises classifications and reclassifications by Gazette notices
To the extent that it does not cease to have effect because of later Gazette notices, new Schedule 1 recognises, permanently, temporary classifications and reclassifications of medicines done by Gazette notices issued since Schedule 1 was last replaced on 24 July 2006 by regulation 7 of the Medicines Amendment Regulations 2006. For the details of those classifications and reclassifications, see the notice of 12 February 2009 (Gazette 2009, p 405), which contains and continues all changes before that date, the notice of 26 February 2009 (Gazette 2009, p 579), which contains corrections to the notice of 12 February 2009, and the notice of 19 March 2009 (Gazette 2009, p 941), which contains the latest changes.
At the time these regulations were made, the Gazette notices of 12 February 2009, 26 February 2009, and 19 March 2009 were (with other information relating to the classification of medicines) available from the website of the New Zealand Medicines and Medical Devices Safety Authority (or
“Medsafe”, a business unit of the Ministry of Health), at the following address: http://www.medsafe.govt.nz/profs/class/recent.asp.