In NSW, to supply by wholesale a cannabis medicines in Schedule 4, or to manufacture and/or supply by wholesale a cannabis medicine in Schedule 8, for human therapeutic use, a licence under the Poisons and Therapeutic Goods Regulation 2008 is required. Supply by wholesale is defined as supply for the purpose of re-supply to a third party, such as to a medical practitioner or a pharmacist.
Supply by wholesale of cannabis medicines must comply with NSW Licence conditions, as well as Commonwealth Licence conditions under the Therapeutic Goods Act 1989, and/or the Customs (Prohibited Imports) Regulation 1956, and/or the Narcotic Drugs Act 1967.
Companies with existing wholesale licences for Schedule 8 drugs need to apply to NSW Health for amendment of their licence in order to supply cannabis medicines, and must provide a revised procedure which may include refrigerated storage of Schedule 8 products, where required.
Note that it is not possible for the premises of a pharmacy (or medical practitioner’s place of practice) to also be the licensed premises of a wholesale Schedule 8/Schedule 4 medicine supplier. Separate premises, capable of complying with the provisions of the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 are required.
Assessing the product
Before applying for a NSW Licence, an assessment of the product must be undertaken to ensure that obligations under State and Commonwealth laws are met. The Therapeutic Goods Administration (TGA) has published detailed information on access to unregistered medicinal cannabis products. The Office of Drug Control has also published detailed information on the importation, exportation, cultivation, production and manufacture of medicinal cannabis products. It is recommended that a Regulatory Affairs Consultant is engaged to assist in the process of applying for a licence, including assessing the product for eligibility for supply.
It must be confirmed that the product is a therapeutic good for human therapeutic use, and not a food or a cosmetic. The TGA has established SME Assist, an assessment tool to assist in assessing if a product is a therapeutic good for therapeutic use.
The product must be included in Schedule 4 or in Schedule 8 of the NSW Poisons List, i.e. the Poisons Standard. You will need to furnish a Certificate of Analysis that shows the total cannabinoid content of the product to be able to determine the schedule of the product. A cannabis medicine is in Schedule 4 if the cannabidiol content is >98% of total cannabinoid content. If the product is not for human therapeutic use, it is in Schedule 9 and prohibited under Schedule 1 of the NSW Drug Misuse and Trafficking Act and cannot be manufactured or supplied by wholesale under a NSW Licence.
The product must comply with TGO 93 – Standard for Medicinal Cannabis. The Therapeutic Goods Administration will require a certification of compliance to the Standard before the product can be supplied.
Some governments do not allow the export of cannabis products. Approval must be granted by the national governments of both the importing and exporting countries. Please refer to information published by the ODC to assist you in the import and export of the cannabis product.
Any licence to cultivate, produce and/or manufacture under the Narcotic Drugs Act 1967, or a licence to manufacture in accordance with the Code of Good Manufacturing Practice (GMP) under the Therapeutic Goods Act 1989, or a Customs Licence to import, must be provided with an application for a NSW Licence.
An application for a NSW Licence must be submitted with a full company extract obtained from the Australian Securities and Investment Commission, statutory declaration forms, fitness and probity check forms, and National Criminal Record Check certificates.
Drugs and Poisons Control Procedure
Upon receipt of a completed application form, a Drugs and Poisons Control Procedure template will be provided to the applicant for completion, to describe the proposed handling of the cannabis medicine in compliance with the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2,3,4 and 8 (the Code) and the Poisons and Therapeutic Goods legislation. The Code requires that a Security Risk Assessment of the business premises be prepared by a licensed security service provider, and for a Risk Management Plan to be developed.
Standard requirements for handling Schedule 8 drugs include storage in a strongroom or safe with restricted access, maintenance of a drug register, tamper-evident packaging of products, procedures for signed orders by authorised persons, consignment and receipt procedures, and packaging of orders.
An inspection of any proposed premises by NSW Health is undertaken prior to a licence being issued. On receipt of all satisfactorily completed documents and the proposed premises are found to be suitable, NSW Health will generally issue a licence within 20 business days. Licences are subject to conditions.
The approval process will take up to four weeks from the date the NSW Ministry of Health receives the completed application. This includes the time taken for assessment, interviews and inspection if required. An application for a licence to manufacture or supply cannabis can be refused if the Secretary, NSW Health, is of the opinion that the applicant is not a fit and proper person to hold the licence or that the premises are not appropriate for the manufacture or supply of cannabis by wholesale.
Where an applicant submits an incomplete application or has not provided any further documentation which has been requested, the approval process will be delayed. More information about the approval process including the timeframes for the different phases of the process can be found on the “Processing times” page of the website.
After submission of the completed form, the applicant will be provided with a written acknowledgement of the application. The acknowledgement will include a request for omitted or incomplete documents if required.
Once all documents have been received, assessment of the application will take place and a recommendation will be made to either grant or refuse the application.
If the recommendation is to approve the granting of the licence, the licence will be issued to the applicant. If the recommendation is to refuse the granting of the licence the reasons for the refusal will be provided to the applicant.
All cannabis medicines (including raw materials) supplied by wholesale (i.e. from a manufacturer/importer/sponsor or licensed wholesaler to a wholesaler, pharmacy or medical practitioner) must be labelled in accordance with the Poisons Standard
i.e. as a Schedule 8 medicine ('CONTROLLED DRUG' and 'KEEP OUT OF REACH OF CHILDREN' of the specified size as the only things printed on the top two lines of the main label of both the primary pack and the immediate container of the medicine), and the name and strength of each scheduled drug on the main label
except cannabidiol-only medicines which fit the Schedule 4 definition must be labelled as Schedule 4 medicines ('PRESCRIPTION ONLY MEDICINE' and 'KEEP OUT OF REACH OF CHILDREN' of the specified size as the only things printed on the top two lines of the main label of both the primary pack and the immediate container of the medicine), and the name and strength of each scheduled drug on the main label.