New Zealand codeine restrictions set for November

NZX and Media release 29 July 2020
New Zealand codeine restrictions set for November
AFT Pharmaceuticals (NZX:AFT, ASX:AFT) today welcomes Medsafe’s announcement that
all codeine and codeine-containing medicines will become prescription only from 5
November 2020.
Medsafe, which made the decision to reschedule all codeine and codeine-containing
medicines last year, announced the timetable to give effect to the decision in a letter to
the pharmaceutical industry released earlier this week.
The letter is attached to this release.
AFT Pharmaceuticals Managing Director Dr Hartley Atkinson said: “We are pleased
Medsafe has set a firm date for the rescheduling of codeine. We expect the move, which
is aimed at reducing codeine overdoses and poisonings, will increase demand for
alternative pain relief treatments including, AFT’s patented paracetamol and ibuprofen
combination treatment Maxigesic.”
“In the 12 months after Australia rescheduled codeine containing medicines in 2018, sales
of Maxigesic tablets increased by more than 50%. While it is unclear whether the New
Zealand market will respond in a similar way, we expect the move to assist the growth of
Maxigesic in New Zealand in the current financial year.”
- Released for and on behalf of AFT Pharmaceuticals limited by Chief Financial Officer
Malcolm Tubby

For more information
Investors Media
Dr Hartley Atkinson Richard Inder
Managing Director The Project
AFT Pharmaceuticals +64 21 645 643
Tel: +64 9 488 0232
About AFT Pharmaceuticals
AFT is a growing multinational pharmaceutical company that develops, markets and
distributes a broad portfolio of pharmaceutical products across a wide range of
therapeutic categories which are distributed across all major pharmaceutical distribution
channels: over the counter (OTC), prescription and hospital. Our product portfolio
comprises both proprietary and in-licensed products, and includes patented, branded
and generic drugs. Our business model is to develop and in-license products for sale by
our own dedicated sales teams in our home markets of Australia and New Zealand and
in certain Southeast Asian markets, and to out-license our products to local licensees and
distributors to the rest of the world.

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27 July 2020

To Whom It May Concern,
Reclassification of Codeine
As you are aware, Medsafe has been looking further into the implementation of the
reclassification of codeine subsequent to the 63rd meeting of the Medicines Classification
Committee on 10 October 2019. Medsafe has been working with the pharmaceutical
industry and pharmacy and the Ministers' Delegate has decided to support the
recommendation that all codeine products are reclassified as prescription medicines. As
codeine-only products (Controlled Drugs C2) are already prescription medicines, the
reclassification affects only products that combine codeine with one or more other active
ingredients (Controlled Drugs C6).

The minutes of the 63
rd
meeting and the rationale behind the recommendation can be
found on the Medsafe website (https://www.medsafe.govt.nz/profs/class/Minutes/2016-
2020/mccMin10Oct2019.htm).

Medsafe will gazette this change on 5 November 2020. On this date, codeine and
codeine-containing combination products will only be able to be supplied in accordance
with a prescription.

Regulation 15(4) and (5) of the Medicines Regulations 1984 allow some transition
periods for the relabelling of stock. At wholesale level, the Regulations allow for three
months from the date of notification of a classification change for stock to be relabelled,
and for stock at retail level the Regulations allow for 6 months for relabelling. However,
from 5 November, regardless of how stock is labelled and regardless of the
labelling transition period, stock will only be able to be supplied on a prescription.
This gives affected sponsors of product and healthcare professionals until 5 May 2021 to
transition to fully compliant prescription labelled codeine-containing products.

Please note that as codeine in combination is a Class C6 Controlled Drug under the
Misuse of Drugs Act, it cannot be granted any labelling exemptions under the Medicines
Act 1981 except for the transitional arrangements for labelling under Regulations 15(4)
and (5) of the Medicines Regulations. Any consequential changes in labelling will have to
be achieved through a Changed Medicine Notification.

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Products on pharmacy shelves will have to be removed from self-selection or pharmacist
recommendation on or before 5 November 2020.

New labelling should be available at wholesale level by 5 February 2021.
Yours sincerely

Jacinta Patel
Secretary
Medicines Classification Committee