The TGA consultation paper Potential reforms to medicinal cannabis manufacturing, labelling and packaging requirements states
The Therapeutic Goods Administration (TGA) is seeking feedback on proposed reforms to the regulation of medicinal cannabis manufacturing, labelling and packaging. The reforms are principally intended to enhance the quality and safety of medicinal cannabis products by introducing equivalent GMP requirements for imported and domestic medicinal cannabis, introducing labelling requirements for imported medicinal cannabis, clarifying certain matters in the applicable standard, and requiring child-resistant closures to be used on products. ...
Over recent years, there has been increasing interest in the use of medicinal cannabis. Governments at Commonwealth, State and Territory levels have implemented legislative and policy changes to allow the cultivation, manufacture and supply of medicinal cannabis for patients in Australia.
Representation of active ingredients, amendments to labelling requirements and reporting of heavy metal results
Regulation of medicinal cannabis in Australia
The Department of Health, through the TGA and the Office of Drug Control (ODC), regulates the manufacture, importation, exportation and supply of medicinal cannabis in Australia.
The Office of Drug Control (ODC) administers the Narcotic Drugs Act 1967. The Narcotic Drugs Act gives effect to Australia’s international obligations under the Single Convention on Narcotic Drugs (1961), and provides controls to prevent the diversion and illicit use of narcotic drugs. Principally, the Narcotic Drugs Act establishes a licensing and permit system for the cultivation, production and manufacture of cannabis (and cannabis resin) for medicinal purposes.
The ODC also administers the Customs (Prohibited Imports) Regulations 1956 and the Customs (Prohibited Exports) Regulations 1958 to control the importation or exportation of cannabis or cannabis resin. Under these Regulations, importers and exporters require licences and permits. The TGA administers the Therapeutic Goods Act 1989. The Therapeutic Goods Act establishes a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. The general rule is that therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) or otherwise subject to an exemption, approval or authority before those goods may be lawfully supplied in, imported into, or exported from Australia.
Therapeutic goods that are not included in the ARTG are known as ‘unapproved products’. Most medicinal cannabis products are unapproved products, which means that they are not included in the ARTG and have therefore not been evaluated by the TGA for quality, safety, or efficacy. The Therapeutic Goods Act provides a number of mechanisms to enable access to unapproved products, such as medicinal cannabis. These products may be accessed through the following pathways:
• Authorised Prescriber Scheme (AP)
• Special Access Scheme
• Clinical trials.
In addition to these controls, the regulation of medicinal cannabis under the Therapeutic Goods Act includes the scheduling of cannabis substances, the application of certain quality standards (most notably, TGO93) and the licensing of manufacturers under Part 3-3. Each of these matters is discussed further below.
The proposed reforms should not be interpreted to imply that there are concerns with the general quality of medicinal cannabis products currently supplied in Australia. The proposed reforms would extend equivalent manufacturing standards for medicinal cannabis products (applied in Australia to licence holders under Part 3-3 of the Therapeutic Goods Act) to imported medicinal cannabis products.
The objective would be to provide greater assurance for medical practitioners and patients regarding the quality and safety of medicinal cannabis products that are imported and supplied in Australia. The proposed reforms would also seek to provide clarity to the stated content of active ingredients and further clarity on the quality standard and to introduce the requirement for child-resistant closures in the interest of public safety.
Quality standard measures
The TGA is responsible for specifying standards for medicinal cannabis products imported, produced and/or utilised in Australia. Standards are made under section 10 of the Therapeutic Goods Act and may be specified by reference to the quality of the therapeutic goods, or the procedures to be carried out in the manufacture of the therapeutic goods, among other matters. Therapeutic Goods Order (TGO) 93 is a standard for medicinal cannabis products that provides appropriate regulatory controls to enable medicinal cannabis products and the ingredients used in the manufacture of those products to meet minimum quality requirements.
TGO 93 applies to both domestic and overseas manufacturers to enable all medicinal cannabis products imported, manufactured or supplied in Australia meet the quality controls provided by the standard. In practice, TGO 93 ensures consistency and provides assurance to medical practitioners and patients that medicinal cannabis products manufactured in accordance with the standard meet minimum quality requirements. TGO 93 includes requirements in relation to physical and chromatographic identification, assay tolerances, decontamination treatment, and tests for certain impurities.
There are criminal offences and civil penalties provisions that apply under the Therapeutic Goods Act to persons who import, export or supply therapeutic goods that do not conform to an applicable standard. Unless the Secretary of the Department of Health has given consent in relation to the importation, exportation or supply of particular medicinal cannabis products, those products must conform to the applicable standard. ...
Manufacture of medicinal cannabis Domestic manufacture of medicinal cannabis
To manufacture medicinal cannabis in Australia, a manufacturer must obtain:
• licences and associated permits under the Narcotic Drugs Act from ODC
• a GMP licence under Part 3-3 of the Therapeutic Goods Act
• relevant state or territory government licences or approvals.
A manufacturing licence under the Narcotic Drugs Act is granted on the condition that the medicinal cannabis is only supplied in particular circumstances (see current sections 11K and 12L of the Narcotic Drugs Act 1967).
A GMP licence is granted on the condition that the manufacturer conforms to any applicable standard that applies in relation to the goods (to which the licence is issued). It is also granted on the condition that the manufacturer complies with the manufacturing principles determined by the Minister under the Therapeutic Goods Act. The manufacturing principles provide that applicable procedures and requirements in the Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practices for Medicinal Products (version 14, 1 July 2018) (PIC/S Guide to GMP) must be observed in the manufacture of certain therapeutic goods.
There are exemptions from the requirement to hold a GMP licence in some circumstances, including in relation to the manufacture of certain starting materials and in relation to certain specified persons, such as medical practitioners and pharmacists (see Schedules 7 and 8 to the Therapeutic Goods Regulations).
GMP inspections are performed to ensure the manufacturer is conforming to applicable standards and complying with the relevant manufacturing principles (PIC/S Guide to GMP). ...
GMP clearance and certification for overseas manufacturers of products on the ARTG
A GMP licence is only required in relation to the manufacture of therapeutic goods at Australian manufacturing sites.
A GMP licence is not required in relation to the manufacture of therapeutic goods at manufacturing sites outside Australia. In those situations, the sponsor must obtain a GMP clearance for the overseas manufacturing site before the goods may be included in the ARTG. This can be done through three different pathways:
• Mutual Recognition Agreement (MRA) desktop assessment
• Compliance Verification (CV) desktop assessment
• TGA on-site inspection (GMP certification)
GMP certification is usually requested if it is not possible to obtain GMP clearance via the MRA or CV pathways (for example, due to lack of evidence). GMP certification applications are required to be submitted by the Australian sponsor or an agent acting on the Australian sponsor's behalf.
Obtaining GMP Clearance is necessary in the context of an application to include medicines in the ARTG that have been manufactured overseas, as the TGA must evaluate whether the manufacturing and quality control procedures used in the manufacture of such goods are acceptable. GMP clearance assesses requested evidence from a recognised regulatory agency as well as procedure and records from the manufacturer.
However, GMP clearance is not required where medicinal cannabis products are manufactured overseas and supplied as unapproved products via the SAS B, AP or clinical trial pathways. Therefore, while domestic medicinal cannabis products must be manufactured in accordance with licences issued under the Narcotic Drugs Act and the Therapeutic Goods Act, medicinal cannabis products manufactured overseas and supplied as unapproved products are only required to demonstrate conformity with TGO 93. The options outlined below seek to address this uneven treatment of domestically and overseas manufactured medicinal cannabis products.
Australian manufacturing licences and overseas GMP certification guidance provides more information about the process for applying for a manufacturing licence or GMP certification.
Current situation with manufacturing quality (GMP) of imported cannabis
Under the Customs (Prohibited Imports) Regulations, all forms of cannabis, cannabis resins, extracts (including extracts from hemp) and cannabinoids require a licence and permit to import to Australia. Ordinarily, the importer would apply for an import permit with a declaration of reason of import and product use. The application would include evidence provided to ODC in relation the relevant SAS B approval or authorised prescriber authority. Where the sponsor is a manufacturer, evidence of licensing under the Narcotic Drugs Act is also required.
Importantly, the import permit process does not require verification as to compliance with the manufacturing principles or equivalent GMP in the manufacture of the imported goods.