Revised: 15 August 2014

Committees

AGENDA FOR THE 52nd MEETING OF THE MEDICINES CLASSIFICATION COMMITTEE TO BE HELD IN THE MEDSAFE BOARDROOM, LEVEL 6, DELOITTE HOUSE, 10 BRANDON STREET, WELLINGTON on TUESDAY 21 OCTOBER 2014 AT 9:30am

1

Welcome

2

Apologies

3

Confirmation of the minutes of the 51st meeting held on Tuesday 8 april 2014

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 51st meeting

No valid objections have been received.

5.2

Reclassification of rizatriptan from prescription medicine to restricted medicine following a recommendation at the 43rd meeting

At the 43rd meeting on 13 April 2010, the Committee recommended that rizatriptan 5 mg wafers should be reclassified from prescription medicine to restricted medicine for the acute treatment of migraine with or without aura.

The current classification of rizatriptan is:

  • prescription medicine; except when specified elsewhere in this schedule
  • restricted medicine; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms, when in wafers containing 5 milligrams or less per wafer and when sold in a pack containing not more than 2 wafers approved by the Minister or the Director-General for distribution as a restricted medicine.

The Committee noted at the last meeting that, since this reclassification, the company had not produced an approved pack.

The Committee will discuss potential options.

6

Submissions for reclassification

6.1

Beclomethasone – proposed reclassification from pharmacy-only medicine to general sale medicine
(Beconase Allergy & Hayfever 12 Hour, Pharmaceutical Solutions)

This is a company submission (Adobe Acrobat document, 2032 KB, 24 pages) for the reclassification of beclomethasone, in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less, from pharmacy-only medicine to general sale medicine for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age.

6.2

Omeprazole - proposed reclassification from pharmacy-only medicine to general sale medicine
(Losec, Bayer New Zealand Limited)

This is a company submission (Adobe Acrobat document, 990 KB, 52 pages) for the reclassification of omeprazole, in solid dose form containing 10 mg or less, from pharmacy-only medicine to general sale medicine for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and older.

6.3

Paracetamol in combination with phenylephrine
(Maxiclear Sinus and Pain Relief and Maxiclear Cold and Flu Relief, AFT Pharmaceuticals)

This is a company submission (Adobe Acrobat document, 1650 KB, 22 pages) for the reclassification of paracetamol in combination with phenylephrine in packs containing:

  • any number of solid dose units containing paracetamol 500 mg in combination with more than 2.5 mg phenylephrine per dose unit from general sale or pharmacy-only medicine to restricted medicine
  • more than 20 solid dose units containing paracetamol 500 mg in combination with 2.5 mg phenylephrine or less per dose unit to remain a pharmacy-only medicine
  • 20 or less solid dose units containing paracetamol 500 mg in combination with 2.5 mg phenylephrine or less per dose unit to remain a general sale medicine
  • any number of sachets of powder containing 1000 mg paracetamol in combination with more than 5 mg phenylephrine per sachet from general sale or pharmacy-only medicine to restricted medicine
  • more than 10 sachets of powder containing 1000 mg paracetamol in combination with 5 mg phenylephrine or less per sachet to remain a pharmacy-only medicine
  • 10 or fewer sachets of powder containing 1000 mg paracetamol in combination with 5 mg phenylephrine or less per sachet to remain a general sale medicine.

Confidential information has been redacted by the company.

Secretary’s note – For the paracetamol and phenylephrine combinations stated to remain as general sale or pharmacy-only medicine, it has been assumed that the combination also complies with the relevant requirements for phenylephrine (eg, a product containing phenylephrine cannot be general sale if it is indicated for the treatment of the symptoms of cough and cold in children aged 6-12 years).

7

New medicines for classification

8

Harmonisation of the 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 - April 2014

Decisions also included under agenda item 8.1.

  1. Esopmeprazole
    A new Schedule 3 (restricted medicine) entry should be created for esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply.
  2. Macrogols
    A new Schedule 2 (pharmacy-only medicine) entry should be created for macrogols in preparations for oral use as a liquid concentrate for laxative use.

8.2.2

Decisions by the Delegate - May 2014

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

8.2.3

Decisions by the Delegate - July 2014

Decisions also included under agenda item 8.1.

  1. Naproxen
    A new Schedule 3 (restricted medicine) entry should be created for naproxen when in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age.

8.2.4

Decisions by the Delegate - August 2014

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

9

Agenda items for the next meeting

10

General business

11

Date of next meeting

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