Medicinal Cannabis - Information for Business and Industry in Tasmania

Medicinal cannabis is regulated by both Commonwealth and Tasmanian governments. A person or business interested in entering the medicinal cannabis industry is responsible for ensuring they are aware of the different regulatory frameworks and obtain all required licences, authorisations and / or permits for their proposed activities.

Relevant Tasmanian poisons legislation including the Poisons Act 1971 and Poisons Regulations 2018 are available from www.thelaw.tas.gov.au

TGA Standards

The Therapeutic Goods Administration (TGA) specifies that products supplied in Australia must meet the following:

Cultivation

The Commonwealth Office of Drug Control (ODC) regulate cultivation of cannabis for medicinal purposes or research relating to medicinal cannabis. The ODC administers a national licensing scheme under the Narcotic Drugs Act 1967. Please visit the ODC’s website for further information.

Provided you are granted permission to carry out cultivation by the ODC, you do not need an additional Tasmanian licence or permit to cultivate cannabis plants for medicinal or related scientific purposes.

Import and Export

Import and export of medicinal cannabis is regulated by the ODC.

Please visit the ODC’s website for further information on licences and permits for import and export of medicinal cannabis, and how to apply.

Manufacture

There are both Commonwealth and Tasmanian regulatory requirements that apply to the manufacture of medicinal cannabis products. Before operating in Tasmania a manufacturer must ensure they have obtained all necessary licences and / or permits.

The ODC regulate manufacture of cannabis for medicinal purposes. The ODC administers a national licensing scheme under the Narcotic Drugs Act 1967. Please visit the ODC’s website for further information.

Depending on the manufacturing activity a GMP licence from the TGA may be required. Please visit the TGA’s website for further information.

To manufacture medicinal cannabis in Tasmania a licence is required under Section 16 of the Poisons Act 1971. Applicants must:

  • Complete necessary licence application form(s) and pay fees as applicable.
  • Hold all required Commonwealth licences relating to manufacture activities.
  • Meet the suitability criteria contained in the Act.
  • Be able to provide evidence of planned compliance with the Poisons Act 1971 and Poisons Regulations 2018 for the proposed activities.

Please email pharmserv@health.tas.gov.au if you require an application form or information regarding the application process.

Wholesale dealing

To wholesale medicinal cannabis in Tasmania a licence is required under Section 16 of the Poisons Act 1971. Applicants must:

  • Complete necessary licence application form(s) and pay fees as applicable.
  • Meet the suitability criteria contained in the Act.
  • Be able to provide evidence of planned compliance with the Poisons Act 1971 and Poisons Regulations 2018 for the proposed activities.
  • Be able to provide evidence of planned compliance with the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 as published by the TGA.

Please email pharmserv@health.tas.gov.au if you require an application form or information regarding the application process.

A licence to wholesale scheduled substances allows the licence holder to supply scheduled substance(s) to authorised customers as per the conditions of the licence. This licence to wholesale scheduled substances does not allow the licence holder to supply scheduled substances direct to patients or members of the public.

Research

There are both Commonwealth and Tasmanian regulatory requirements that apply to the possession and use of cannabis for research related to medicinal cannabis or related scientific purposes.

The ODC administers a national licensing scheme under the Narcotic Drugs Act 1967. Please visit the ODC’s website for further information.

Depending on the particulars of proposed research activities and details of associated ODC licence(s) and permit(s), an additional licence or permit under Regulation 6 or Regulation 11 of the Tasmanian Poisons Regulations 2018 may be required.

Please email pharmserv@health.tas.gov.au if you require further information.

Suitability of Applicant

For licences to be issued under the Tasmanian Poisons Act 1971 a natural person or a corporation must meet the suitability criteria contained in the Act.

The responsible licensing authority must not grant a licence to a person, or renew a licence granted to a person, unless satisfied the person is a fit and proper person to hold the licence.

Examples of matters which the licensing authority may consider when applying a fit and proper person test are detailed in Section 3A and 3B of the Poisons Act 1971.

The responsible licensing authority may refuse to grant to a person a licence, or to renew a licence granted to a person, if the person has been found guilty of an offence that, in the opinion of the responsible licensing authority, makes the person unsuitable to be involved in any activity authorised by, or associated with, the licence.

Responsible Officers

For licences to be issued under the Tasmanian Poisons Act 1971, a holder of a licence who is not a natural person is to appoint a natural person as the responsible officer in relation to the licence.

If the holder of a licence fails to appoint a responsible officer in relation to the licence, the person responsible for the direction and management of the business of the holder of the licence is taken to have been appointed as the responsible officer in relation to the licence.

A holder of a licence is to ensure a responsible officer has sufficient authority to perform the duties of a responsible officer under this Act.

A responsible officer must perform the responsibilities of the holder of the licence.

This includes the duties imposed on the holder of a licence under the Act and any conditions or restrictions specified in the licence.