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Classification of Medicines

Classification Process

Submissions for reclassification

Submissions to the Medicines Classification Committee (MCC) are usually made by pharmaceutical companies, health professional organisations or Medsafe. Individuals or groups making submissions are advised to liaise with the pharmaceutical companies who market the medicines for which a change of classification is sought. A submission for the reclassification of a medicine should include:

Part A

1. International Non-proprietary Name (or British Approved Name or US Adopted Name) of the medicine
2. Proprietary name(s)
3. Name of company/organisation/individual requesting reclassification
4. Dose form(s) and strength(s) for which a change is sought
5. Pack size and other qualifications
6. Indications for which change is sought
7. Present classification of medicine
8. Classification sought
9. Classification status in other countries (especially Australia, UK, USA, Canada)
10. Extent of usage in New Zealand and elsewhere (e.g. sales volumes) and dates of original consent to distribute
11. Labelling or draft labelling for the proposed new presentation(s)
12. Proposed warning statements if applicable
13. Other products containing the same active ingredient(s) and which would be affected by the proposed change

Part B
Reasons for requesting classification change.

This section should be supported where relevant by the following:

1. A statement of the benefits to both the consumer and to the public expected from the proposed change
2. Ease of self-diagnosis or diagnosis by a pharmacist for the condition indicated
3. Relevant comparative data for like compounds
4. Local data or special considerations relating to New Zealand
5. Interactions with other medicines
6. Contraindications
7. Possible resistance
8. Adverse events - nature, frequency etc
9. Potential for abuse or misuse

All claims made in a submission should be supported by researched data. Only key papers need be supplied. References are adequate for other material. An executive summary may also be included.

The MCC does not make recommendations to the Minister on moral or ethical matters or on financial matters other than in terms of access for consumer convenience.

One electronic copy of each submission is required including any supporting data or references. The electronic copy should be submitted on a CD (in either MS Word format or comment enabled PDF format). Copies of submissions are circulated to MCC members on CD and this format enables comments to be included during the review process.

Parts A and B of all submissions since March 2000 are published on Medsafe's website under Agenda Items. Any reports written for the MCC by Medsafe are also published. 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.

In addition to the electronic copy, one hard copy of each submission is also required. As submissions need to be filed at Medsafe, it is preferable that they are presented in a secure fashion. Submissions, and all other communications on classification matters, should be addressed to the:

Secretary
Medicines Classification Committee
Medsafe
PO Box 5013
Wellington 6145