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Classification of Medicines

Classification Process

Medicines Classification Committee
Classification categories
First Schedule to the Medicines Regulations 1984
Classification of controlled drugs
Classification of medicines
Classification criteria
General policies
Classification process
Submissions for reclassification

Medicines Classification Committee

The Medicines Classification Committee (MCC) is a Ministerial advisory committee whose terms of reference are to make recommendations to the Minister of Health regarding the classification of medicines as prescription medicines, restricted medicines or pharmacy-only medicines. The Committee will also consider and report to the Minister on any matter concerning the classification of medicines and access to medicines by health professionals and the public.

The MCC meets twice a year (usually in April and October) to discuss classification issues and to consider changes in the classification of medicines. Secretarial support is provided by Medsafe.

The Committee comprises two nominees from each of the New Zealand Medical Association and the Pharmaceutical Society of New Zealand and two members of the Ministry of Health, one of whom is to be appointed as chairperson. Nominees are appointed for a three-year term and may be re-appointed for one further term of office. Ministry members retain their appointments "during the pleasure of the Minister".

Classification categories

The Medicines Act defines three classification categories for medicines:

Prescription Medicine

Prescription medicines may be supplied only on the prescription of a medical or dental practitioner, midwife or veterinary surgeon. They may also be used by a registered member of another specified health profession when permitted in the First Schedule to the Medicines Regulations or amendments.

Restricted Medicine (also referred to as Pharmacist Only Medicine)

Restricted medicines may be sold without a prescription, but the sale must be made by a registered pharmacist, in a pharmacy, and details of the sale must be recorded.

Pharmacy-Only Medicine (also referred to as Pharmacy Medicine)

Pharmacy-only medicines may only be sold in a community or hospital pharmacy, or a shop in an isolated area that is licensed to sell that particular medicine. The sale may be made by any salesperson.

Medicines in each of these classification categories are listed in the First Schedule to the Medicines Regulations 1984 and amendments. Medicines not listed in the classification schedules are deemed to be unclassified, and are referred to as General Sale Medicines. These medicines may be sold from any outlet.

Note: To avoid confusion, the full term should be used when referring to a medicine’s classification. Avoid using acronyms (PM, POM, etc.).

First Schedule to the Medicines Regulations 1984

Medicines are classified according to their active ingredients. The international non-proprietary name (INN) is the name of choice. If the medicine has more than one active ingredient, the active with the most restrictive classification determines the classification of the product. The First Schedule to the Medicines Regulations is a list of active ingredients grouped under their respective classifications.

Classification changes occur approximately every six months. Updates may occur either through an amendment to the Medicines Regulations or through publication of a notice in the New Zealand Gazette. The most recent version of the First Schedule is Medicines Amendment Regulations 2006. When checking a classification, refer to the latest amendment to the Regulations and any subsequent updates published in the Gazette. Alternatively, check the classification on the Listing of Classifications .

Classification of controlled drugs

Narcotics and certain psychotropic agents are regulated under the Misuse of Drugs Act 1975 as controlled drugs. The Act defines three classes of controlled drugs. These are Class A, Class B (further subdivided into Parts I, II & III) and Class C (further subdivided into Parts I to VII). The controlled drugs in each class are listed in the Schedules to the Misuse of Drugs Act.

The Misuse of Drugs Act and Regulations contain the requirements for the manufacture, sale, supply, prescribing and labelling of controlled drugs. Controlled drugs that are also medicines are required to meet the requirements of both the Misuse of Drugs legislation and the Medicines legislation. Where there is any inconsistency between the two sets of legislation the Misuse of Drugs legislation takes precedence over the Medicines legislation.

Any controlled drug named in Part VI of the Third Schedule to the Misuse of Drugs Act and fulfilling the specified requirements is by definition a pharmacy-only medicine and can be labelled as such in accordance with the Medicines legislation. All other controlled drugs must be labelled in accordance with the Misuse of Drugs Regulations.

Classification criteria

To qualify for a shift from prescription to over-the-counter (OTC) status, a prescription medicine should:

Note: The three-year period of use need not have been in New Zealand. However, it must have been in a country with a well-developed pharmacovigilance system.

The MCC uses the following definition adopted in 1990 by the Commission of the European Communities for suitability for OTC sale:

Medical products which may be available without prescription shall show a substantial safety in use in the treatment of minor ailments or symptoms, usually capable of rapid and spontaneous relief, which are easily identifiable by users and do not justify a medical consultation.

The Committee considers the following factors when reviewing a medicine for reclassification for OTC sale. The list is not ranked in any order of importance. The criteria may vary in importance according to the medicine being considered for reclassification. In some cases one factor alone may be sufficient to outweigh all others in determining whether or not a medicine should be reclassified.

General policies

From time to time the Medicines Classification Committee makes general policy statements which are intended for long-term application. The following such policy statements have been made since 1990:

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.

Subject:
Requirements for Reclassifying NSAIAs to General Sale
Date: 20 May 1998
Policy: Before any non-steroidal anti-inflammatory agent will be considered for general sale availability the Committee 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:
Scope of Committee Recommendations
Date: 25 May 2000
Policy: The Committee 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 Committee 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:
Presentation of submissions
Date: 9 June 2005
Policy: Electronic submissions to the MCC should contain the full text of the submission including a list of references. Commercially sensitive material may be withheld but the nature of the material should be declared together with the relevant section of the Official Information Act to justify its withholding. Submissions which do not meet these requirements will not be considered by the Committee.

Hard copies of submissions should be presented in a secure fashion on file pins, in spiral binding or any other method to minimize their bulk. Small submissions may be presented in folders. Ring binders or arch lever files are not acceptable and may be returned to the sender. 8 hard copies of references should be submitted if the applicant wishes these to be considered by the Committee. 

Classification process

It takes approximately six months from the date a submission is lodged until the resulting classification change is notified in the NZ Gazette. A maximum of 6 further months is allowed in the legislation for companies to amend labelling to reflect classification changes.

There are nine phases in the classification process, as outlined below.

1. Submission

Closing dates for submissions to the MCC are the end of January and the end of July each year.

While applications usually come from sponsor companies, anybody may make a submission to the MCC for the reclassification of a medicine using the format provided in Submissions for reclassification. Submissions are received both in hard copy and electronically and are placed on the agenda for the next meeting. Because of the need for a full consultation period, late items cannot usually be accepted. Submissions are sometimes allocated to Medsafe evaluators for independent review. The resulting reports are peer reviewed to ensure that they reflect Medsafe's view rather than that of an individual evaluator. The reports may involve extensive literature searches as well as assessment of the material submitted.

2. Consultation

Soon after the closing date for submissions for each meeting, the agenda for the next meeting is published on the Medsafe web site. Links to company submissions are provided and to Medsafe reports when these have been completed.

The consultation period provides an opportunity for interested parties to comment on the proposed agenda items. Eight copies of comments should be supplied. Pharmaceutical companies and other interested bodies are expected to watch the web site to check whether any of their products are likely to be affected by a proposed change. Medsafe provides a weekly email service notifying updates to the web site. Approximately six weeks is available for the preparation of comments. Closing dates are provided on the web site in Dates and deadlines.

During this period Medsafe may also seek independent advice from experts or specialist organisations.

Submissions, comments on agenda items and Medsafe reports are sent to MCC Committee members 3 to 4 weeks before the date of a meeting. As Committee members need this time to prepare for meetings, late comments on agenda items cannot usually be accepted.

3. Recommendation

The MCC meets around April and October of each year to make recommendations to the Minister. Responsibility for this function has been delegated to the Deputy Director-General, Public Health who acts as Minister's Delegate. Minutes containing the recommendations are drafted and sent to members for comment. The final minutes are then forwarded to the Minister's Delegate together with a report from Medsafe. If Medsafe does not agree with any recommendation made by the Committee, Medsafe's view will be included in this report together with justification for that view.

4. Decision

The Minister's Delegate accepts or declines the recommendations made by the Committee. The minutes are returned to Medsafe for further action.

5. Communication

During the period between a meeting and acceptance of the recommendations made at that meeting it is not normal practice to make the Committee's recommendations known.

As soon as the recommendations have been accepted, the full minutes of the meeting are published on the Medsafe web site in Minutes of Medicines Classification Committee meetings. If the Minister's Delegate accepts the advice of Medsafe rather than the MCC, the reasons for this will be published on the web site. Those who have made submissions to the Committee receive individual letters explaining the outcome. A period of four weeks' advance notice is provided before changes are put into effect by a notice in the NZ Gazette. This allows for lead-in time for preparation of new labelling and for pharmacists to prepare for marketing under the new classification. Time is also allowed to lodge objections.

6. Objection

Notice of intention to object to a classification recommendation and the grounds for that objection should be lodged with the Secretary by the date given on the web site. Approximately 10 working days are allowed.

This is an opportunity to object to the recommendation made by the Committee rather than to the initial proposal. If Medsafe considers that an objection has been made on valid grounds, the medicine in question will be removed from the Gazette notice until the matter has been resolved.

Objections to recommendations on the classification of medicines should be made only on safety issues and should contain new safety data not available to the Committee at the time the recommendation was made. Eight copies of supporting data for an objection should be submitted to the Secretary by the closing date which will be published on the web site. Financial or commercial reasons are not acceptable grounds for objection.

Medsafe will consider the evidence submitted in support of an objection and will decide whether or not the matter should be referred back to the Committee. Normally objections will be referred back to the Committee only when there is substantial new safety evidence to support the objection.

Medsafe will advise the objector of the outcome and give the original applicant a chance to comment to the Committee about the objection.

7. Confirmation

After the closing date for objections, the Minister's Delegate signs a notice prepared by Medsafe for publication in the NZ Gazette in order to implement those recommendations for a change of classification which have been accepted earlier and which have not been the subject of a valid objection.

8. Notification

Approximately 4 weeks after the results of a meeting have been published on the web site, classification changes are published the NZ Gazette. They take effect from that date. The classification list on the web site is updated and a copy of the Gazette notice is published on the web site. Changes are subsequently incorporated into an amendment to the First Schedule to the Medicines Regulations 1984.

9. Implementation

When a classification change takes place a change of labelling will be required. Other changes may also be necessary. Companies need to consult the NZ Regulatory Guidelines for Medicines to see whether they are required to submit a self-assessable change, a changed medicine notification or a new medicine application.

Changes to data sheets may be necessary or new data sheets may be required.

Section 16 (2) and (3) of the Medicines Regulations allows three months from the date of notification of a classification change for stock labelled with the old classification to be replaced at wholesale level and six months for replacement of stock at retail level. However, any existing stock must be sold at the new level of classification from the date on which the change comes into effect. Companies should contact Medsafe if they are unable to meet the timeframes specified in the Regulations.

Submissions for reclassification

Submissions to the 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 NZ 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 NZ
  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.

The Committee 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.

Eight copies of each submission are required. Eight copies of key references should also be supplied if they are intended for consideration by the Committee. As copies of submissions need to be distributed to Committee members and filed at Medsafe, it is preferable that they are bound with a simple codafile pin. Do not use bulky ring binders. Spiral binding is acceptable.

In addition to the 8 paper copies of each submission required by Medsafe and the MCC, please submit an electronic copy (in MS Word format) on a floppy disk. The electronic copy should contain Parts A and B as specified above. An executive summary may also be included. Please do not send the supporting data in electronic copy.

An electronic copy of the submission is required, as Parts A and B (but not the supporting data) of all submissions since March 2000 are published on Medsafe’s web site under “Agenda Items”. Any reports written for the MCC by Medsafe are also published.

Submissions, and all other communications on classification matters, should be addressed to the:

Secretary
Medicines Classification Committee
Medsafe
PO Box 5013
Wellington