Classification of Medicines
Classification Process
General policies
From time to time the Medicines Classification Committee (MCC) makes general policy statements which are intended for long-term application. The following such policy statements have been made since 1990:
Subject: Presentation of submissions
Date: 6 July 2009
Policy: Presentation of submissions to the MCC should be as one electronic copy on CD (in either MS Word format or comment enabled PDF format) and as one hard copy.
Electronic copies should contain the full text of the submission including any supporting data and references. Please note, supporting data and references will not be published on the Medsafe website. Commercially sensitive material should be identified and may be withheld from public release. The nature of the commercially sensitive material should be declared in the application together with the relevant section of the Official Information Act 1982 that you propose to use to justify withholding the data from release.
Hard copies should be presented in a secure fashion.
Submissions which do not meet these requirements will not be considered by the MCC.
Comments and objections to the MCC should be provided in electronic form. If more than five pages long, one hard copy should also be provided.
Subject: Scope of Committee Recommendations
Date: 25 May 2000
Policy: The MCC should make recommendations only about those medicines which it has been asked to consider and which have undergone consultation not other medicines in the same therapeutic group.
The MCC should make recommendations only on the classification status sought in a submission and not recommend an alternative classification. It may, however, indicate its willingness to consider a classification change other than that sought initially.
Subject: Requirements for Reclassifying NSAIAs to General Sale
Date: 20 May 1998
Policy: Before any non-steroidal anti-inflammatory agent (NSAIA) will be considered for general sale availability the MCC will require both utilisation data to show that it is safe in a general sale environment, and also post-marketing surveillance data from its use in a general sale environment.
Note: It was recognised that these requirements will prevent New Zealand from taking an initiative in making NSAIAs available as general sale medicines as this sort of information can be obtained only after a medicine has been marketed at that level over a number of years in another country.
Subject: Use of Prescription Medicines by Optometrists
Date: 25 November 1993
Policy: Any classification changes concerning access by optometrists to prescription medicines used in the eye should be made only after consultation with both the New Zealand Society of Optometrists and the Ophthalmological Society of New Zealand.