IN BRIEF - INTERIM SUPPLY FROM INTERNATIONAL SOURCES ALLOWED TO
MEET SHORT-TERM DEMAND
Federal Health Minister Greg Hunt announced on 22 February 2017
that the Federal Government would move to facilitate faster access
to medicinal cannabis for patients with the pre-existing Special
Access Scheme or Authorised Prescriber Scheme approvals.
Under the new import scheme, the Office of Drug Control will
authorise controlled importation of medicinal cannabis products by
approved companies (called "sponsors") from approved
international sources for interim supply in Australia, until
domestic production meets local needs.
AMENDMENTS AIM TO SPEED UP AND FACILITATE ACCESS FOR APPROVED
PATIENTS UNDER THE NARCOTIC DRUGS ACT
Amendments to the Narcotic Drugs Act 1967 (Cth) in November 2016
provided for the legal cultivation, production and manufacture of
medicinal cannabis in Australia. While some production and
cultivation licenses have been granted to Australian companies, the
domestic supply is still some months away.
The delay in domestic supply has meant that patients with
approval through the Federal Government's Special Access Scheme
or the Authorised Prescriber Scheme, and the relevant state access
schemes, have been sourcing medicinal cannabis from overseas
suppliers with approval from the Therapeutic Goods
Administration. This is a case-by-case approval process which
is reportedly slow, costly and difficult to comply with.
As a result, many patients have been forced to go without
medication or source medicinal cannabis on the black market. The
new amendments seek to prevent this.
SPONSORS OF MEDICINAL CANNABIS MUST COMPLY WITH REGULATIONS AND
Sponsors who intend to import medicinal cannabis products will
need to be able to demonstrate a potential supply chain through the
Special Access Scheme and Authorised Prescriber Scheme, and meet
any state or territory requirements. They will also have statutory
conditions imposed upon them in respect of the supply, storage and
recording of the medicinal cannabis products.
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