Ann: HL Pharma Submits Australian Import Licence Appllication, page-38

No timeframe but some useful information regarding importation.

Sponsored importation of medicinal cannabis products
The Department of Health has recently reviewed the process of importing medicinal cannabis products for doctors to prescribe under the Special Access Scheme Category B (SAS B) and Authorised Prescriber (AP) pathways.

Medicinal cannabis products are currently only available through importation while the Australian domestic cultivation scheme is being developed. Importation 'prescription by prescription' is not efficient.

The Department of Health has agreed to allow an importer to seek import approval of medicinal cannabis products before SAS B approvals and AP requests, which will allow for supplies of medicinal cannabis products to be available in a more timely fashion. This does not change the requirements for approval through SAS B or AP, but reduces time taken from approval to supply. Supply of medicinal cannabis products will remain a controlled process and there are a number of strict conditions that will be placed on importers and suppliers around what types medicinal cannabis products may be imported and supplied, and how.

As per the requirements of Schedule 5A, item 1, of the Therapeutic Goods Regulations 1990, the imported medicinal cannabis must be held under direct control of the importer until the goods are authorised for supply under SAS-B or AP.

It is envisaged that these imports will provide a temporary solution to improve the timeliness of supply while the domestic cultivation and manufacture scheme comes into effect. Therefore, the requirements around security, quality of products and compliance with appropriate Australian expectations around manufacturing practice and secure distribution are expected to be mirrored for sponsored importers.

Sponsors (importers) will be expected to be able to demonstrate compliance with a number of conditions in obtaining an import licence under this exemption. These conditions arise from a number of regulatory requirements under therapeutic goods, narcotic drugs and customs legislation and the requirements of the Single Convention on Narcotic Drugs 1961. Sponsors will need to be able to demonstrate a potential supply chain through SAS-B and AP, and meet any State or Territory Requirements.

As well as conditions standard to that for all imported drugs under Regulation 5 of the Customs (Prohibited Imports) Regulations 1956, sponsors who intend to import in advance of SAS-B and AP will have the following statutory conditions imposed under Item 1 of Schedule 5A of the Therapeutic Goods Regulations 1990:

1. Supply of medicinal cannabis must be in accordance with the relevant notification, approval, authorisation or prescription - SAS B, AP, clinical trials or through state or territory controlled public hospital pharmacies.
2. Storage of medicinal cannabis must be in a secure warehouse or other properly secured area under the control of the sponsor
3. Destruction of unused medicinal cannabis products must occur 12 months after importation.
4. Records of all activity relating to the source, supply, storage and destruction of medicinal cannabis products must be maintained and provided to the Department of Health when requested, as well as quarterly. The records will include SAS B approval and, if necessary, prescriptions. The Department of Health will review these records.

In addition the importer/supplier may be subject to audits by the Department with respect to quality of the products imported. It is expected that, when requested, sponsors will be able to demonstrate that product imported has been manufactured or prepared to an equivalent standard of quality. The Therapeutic Goods Administration, which is part of the Department of Health, has published a Guidance on GMP compliance for the manufacture of medicinal cannabis for supply under 'approved Access' provisions that governs the quality of medicinal cannabis products manufactured in Australia.

The importer must also be aware that cannabis is strictly controlled under international drug treaties. Where possible the importer should check that the company/person who intends to export to Australia is licensed by the overseas government at the Federal level. The Department of Health may not be able to process applications if the export is not permitted by the overseas government.

If you have any questions concerning import, manufacture or cultivation please review the information on our website at www.odc.gov.au

For matters concerning import and manufacture email the Drug Control Section at [email protected]. For matters concerning cannabis cultivation or production email the Medicinal Cannabis Section at [email protected]