Revised: 18 June 2013

Committees

AGENDA FOR THE 48th MEETING
OF THE MEDICINES CLASSIFICATION COMMITTEE
TO BE HELD IN THE MEDSAFE BOARDROOM,
LEVEL 6, DELOITTE HOUSE, 10 BRANDON STREET, WELLINGTON
on TUESDAY 30 OCTOBER 2012 AT 9:30AM

1

Welcome

2

Apologies

3

Confirmation of the Minutes of the 47th Meeting Held on Tuesday 1 May 2012

4

Declaration of conflicts of interest

5

Matters Arising

5.1

Objections to recommendations made at the 47th meeting

No objections have been received.

5.2

Classification criteria

As suggested by a member at the 47th meeting, the Committee will review the factors when considering a medicine for reclassification for non-prescription sale.

The classification criteria currently used by the Committee can be found on the Medsafe website at www.medsafe.govt.nz/download/How_to_change_medicine_classification.pdf.

5.3

Bifonazole
(Caneston Once Daily Bifonazole Athlete's Foot and Caneston Once Daily Bifonazole Body, Bayer New Zealand Limited)

At the 46th meeting on 15 November 2011, the Committee recommended that a number of medicines, used by Podiatrists and currently classified as pharmacy-only medicines, should include the wording 'except when sold in practice by a podiatrist registered with the Podiatrists Board'.

This is a submission from Bayer New Zealand Limited for the reclassification of bifonazole so that the pharmacy-only classification includes the wording 'except when sold in practice by a podiatrist registered with the Podiatrists Board'.

5.4

Influenza vaccine
(Pharmacybrands Limited)

At the 47th meeting, the Committee recommended that influenza vaccine should be reclassified from prescription medicine to prescription medicine except when administered to an adult by a pharmacist who has successfully completed the New Zealand Qualifications Authority approved vaccinator's training course and is complying with the immunisation standards of the Ministry of Health. On 12 July 2012 the classification of influenza vaccine was gazetted as a prescription medicine; except when administered to an adult in a pharmacy by a registered pharmacist who has successfully completed the New Zealand Qualifications Authority approved vaccinator training course and is complying with the immunisation standards of the Ministry of Health.

Following the gazette notice, Pharmacybrands Limited have requested that the classification wording for the influenza vaccine be reviewed to clarify the adult age (to '18 years of age or over'), to consider whether the words 'in a pharmacy' are necessary and to reword the provider requirements for the vaccinator course (to 'has successfully completed the Immunisation Advisory Centre vaccinator training course'). The Committee will consider this request.

6

Submission for Reclassification

6.1

Diphtheria, tetanus and pertussis (acellular, component) vaccine
(Pharmacybrands Limited)

This is a submission (Adobe PDF file 660kb) from Pharmacybrands Limited (the parent company for Life, Unichem, Amcal, Radius and Care Pharmacies in New Zealand) for the reclassification of diphtheria, tetanus and pertussis (acellular, component) vaccine in a single dose from prescription medicine to prescription medicine except when administered to a person aged 16 years or over by a pharmacist who has successfully completed the Immunisation Advisory Centre vaccinator course and is complying with the immunisation standards of the Ministry of Health.

6.2

Hydrocortisone topical preparations
(Caneston Plus, Bayer New Zealand Limited)

This is a company submission (Adobe PDF File 938kb) from Bayer New Zealand Limited for the reclassification of hydrocortisone from restricted medicine to pharmacy-only medicine when for dermal use in medicines containing 1% or less by weight of hydrocortisone base in combination with an antifungal and in a quantity of 30 g or less or 30 mL or less per container.

6.3

Ibuprofen in liquid sachet unit dose forms
(Reckitt Benckiser (New Zealand) Limited)

This is a company submission (Adobe PDF file 667b) from Reckitt Benckiser (New Zealand) Limited for the reclassification of ibuprofen, when in liquid oral suspension in sachets each containing 200 mg or less of ibuprofen for use in adults or children 12 years of age and older, from pharmacy-only medicine to general sale medicine.

6.4

Melatonin 2 mg prolonged release tablet
(Circadin, Aspen Pharma Pty Limited c/o Pharmacy Retailing (NZ) Limited trading as Health Care Logistics

This is a company submission (Adobe PDF file 656kb) for the reclassification of melatonin 2 mg prolonged release tablets from prescription medicine to restricted medicine, in a pack of up to 30 tablets, when used as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 and over.

6.5

Oseltamivir 75 mg powder filled capsules
(Tamiflu, Roche Products (New Zealand) Limited

This is a company submission (Adobe PDF file 1008kb) for the reclassification of oseltamivir in 75 mg powder filled capsules (Tamiflu) from prescription medicine to restricted medicine, in a pack of up to 10 capsules, for the treatment or prophylaxis of influenza in adults and children aged 13 years and older.

7

New Medicines for classification

8

Harmonisation of New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

8.2

Decisions by the Secretary to the Department of Health and Aging in Australia, or the Secretary's Delegate

8.2.1

Decisions by the Delegate - May 2012

 
  1. Adrenaline
    Preparations for injection should be excluded from the current exemption from scheduling for preparations containing 0.02 per cent or less of adrenaline.
  2. Ciclopirox
    Ciclopirox, in preparations for application to the nail containing 8% or less of ciclopirox, should be rescheduled from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy-only medicine).

8.2.2

Decisions by the Delegate - June 2012

No harmonisation decisions relevant to the Committee were made by the Delegate.

8.2.3

Decisions by the Delegate - August 2012

No harmonisation decisions relevant to the Committee were made by the Delegate.

9

For the next meeting

10

General business

11

Date of Next Meeting

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