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Manufacture of medicinal cannabis for supply under 'approved access' provisions
Guidance on GMP compliance
Medicinal cannabis manufacture for supply under the provisions for approved access
Generally, medicines supplied in Australia must be approved for general use through entry in the Australian Register of Therapeutic Goods (ARTG). However, the Therapeutic Goods Act provides several pathways for approved access to medicines that are not registered on the ARTG. These pathways are:
As the only medicinal cannabis product currently registered on the ARTG is not marketed in Australia, medicinal cannabis is currently only available through one of these 'approved access' pathways.
Medicines (including medicinal cannabis) supplied in Australia must also be manufactured in compliance with the PICS Guide to Good Manufacturing Practice (GMP) by a manufacturer that either:
- holds a current licence to manufacture therapeutic goods (if in Australia)
- is covered by a current GMP clearance (if overseas).
However, the Therapeutic Goods Act provides a number of ways to gain approved access to medicines that are not registered on the ARTG, i.e. medicines that have not been approved for general use in Australia. With the exception of personal import, these pathways also apply to medicinal cannabis products.
Requirements for pharmacists
Pharmacists manufacturing medicinal cannabis products for approved access under the Special Access Scheme (Category B) or the Authorised Prescriber Scheme are required to hold a licence to manufacture therapeutic goods and comply with GMP unless they meet the exemption(s) under Schedule 8 of the Therapeutic Goods Regulations 1990. Currently, the only exemption to this is for pharmacists working in public hospital pharmacies. Their compliance with appropriate manufacturing requirements is managed by the hospital in the State or Territory.
Requirements for clinical trials manufacture
Pharmacists manufacturing medicinal cannabis products for supply as clinical trial materials are required to hold a licence to manufacture therapeutic goods and comply with GMP unless they meet the exemption(s) under Schedule 7 of the Therapeutic Goods Regulations 1990.
If you want to become involved in the manufacture of medicinal cannabis for approved access purposes, you should ensure that the following approvals, licences and permits under each of the relevant legislative frameworks have been provided:
- the relevant state or territory government licences or approvals
- ODC manufacture licence under the Narcotic Drugs Act in combination with the associated ODC permit(s)
- TGA approval for use under either of the following pathways:
Terminology and definitions
Definitions for terminology used in relation to the manufacture of medicinal products including medicinal cannabis can be found at either:
Terminology used under the Narcotic Drugs Act may differ from terminology used in the context of the Therapeutic Goods Act. For example:
In the context of the Therapeutic Goods Act the term 'production' refers to the actual preparation of an active pharmaceutical ingredient or a finished medicinal product. As such, 'production' is considered a subset of 'manufacture'.
In the context of the Narcotic Drugs Act the term 'production' refers exclusively to the harvesting of the specified plant parts and collecting these into containers for subsequent processing, which is termed 'manufacture'. As such 'production' is a separate step that is followed by 'manufacture'.