Update on the Reform Process
Following on from the Interim Statement below, we can provide a further update on the proposed reforms to medicinal cannabis, labelling and packaging requirements.
The reforms remain on track for commencement in March 2022.
We have
- Consulted with the Office of Best Practice Regulation (OBPR) regarding the regulatory impact of the proposed reforms. The OBPR determined that a Regulatory Impact Statement is not required.
- Notified the World Trade Organisation, in accordance with the WTO Agreement on Technical Barriers to Trade (TBT Notification). The notification was made in late December 2021 and WTO Members have until 20 February 2022 to submit comments. It is publicly available on the WTO website: World Trade Organization - TBT Notification.
- Agreed on implementing the following changes under this reform program:
- A requirement that medicinal cannabis products imported to Australia under the Special Access Scheme/Authorised Prescriber Scheme (SAS/AP) be manufactured in accordance with specified Good Manufacturing Practice (GMP) suitable for medicinal products. There will not be a formal clearance process, however Australian sponsors will be required to retain evidence of compliance. This requirement extends broadly the same standards to offshore manufacturers currently required of Australian manufacturers.
- A new requirement for SAS/AP approval from the TGA prior to extemporaneous compounding of medicinal cannabis products by medical practitioners and pharmacists. In parallel, new regulations will be put in place to allow Australian medicinal cannabis manufacturers to supply to compounders.
- New labelling and packaging requirements which will improve the safe presentation of medicinal cannabis products and assist both prescribers and patients.
We are
- Drafting an updated TGO 93 and associated guidance documents.
- Preparing amendments to the Therapeutic Goods Regulation 1990 and the Narcotic Drugs Regulation 2016.
- Finalising the length of transition periods needed to introduce the new requirements.
Feedback or queries can be directed to the reform team at medicinalcannabisreforms@health.gov.au
Interim statement
We asked
The TGA asked for feedback on potential reforms to medicinal cannabis manufacturing, labelling and packaging requirements. The aim is to:
- protect patients and level the playing field for domestic suppliers and importers by introducing Good Manufacturing Practice (GMP) requirements for imported medicinal cannabis products, equivalent to those that already apply to goods manufactured domestically; and
- improve the safe presentation of medicinal cannabis products by introducing new labelling and packaging requirements, including child-resistant closures and clearer label statements to identify the active ingredients.
You said
We received 48 submissions in response to the consultation, with broad support for measures designed to ensure uniformity of GMP requirements regardless of the place of manufacture. There was also general support for measures to reform labelling and packaging requirements for medicinal cannabis products, including mandatory child-resistant closures.
We have
Put in place some changes to the way in which medical practitioners apply for approval to supply medicinal cannabis products under the Special Access Scheme (SAS) and Authorised Prescriber scheme. These include the removal of the requirement to submit Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 declaration forms. While a declaration of conformity will no longer be required, products must continue to meet the requirements described in TGO 93, as well as all other relevant legislative requirements. These changes take effect from 22 November 2021. Further details are available on the TGA website.
Considered information from a range of stakeholders with concerns about extemporaneous compounding of medicinal cannabis. In response, we are developing a mechanism to require a SAS approval from a medical practitioner before compounding can take place. This new approach will include provisions to allow domestic as well as imported medicinal cannabis to be used in extemporaneous compounding.
We are
Undertaking the next steps in the reform process for the more substantive changes, taking into account the results of the consultation and wider policy objectives.
As a guide, we are required to:
- Identify the most appropriate mechanism to implement agreed changes and draft the required regulatory amendments.
- Undertake consultation with the Office of Best Practice Regulation (OBPR) on a Regulatory Impact Analysis (RIA) for the proposed regulatory changes.
- Undertake consultation with the Department of Foreign Affairs and Trade to determine if the proposed changes would create any barriers to trade.
- Undertake further consultation on new regulations, amended legislative instruments and updated documentation.
- Complete due process to approve any regulatory amendments and register new legislative instruments.
The RIA is a requirement of Government and provides for an independent consideration of TGA's proposed changes by the OBPR. We anticipate there will be some further targeted consultation with industry participants and interest groups once the RIA process is complete.
It is intended that the reforms, including GMP requirements for imported products, will be in place by March 2022. This timeframe is subject to the consultations across government on outcomes of the Regulatory Impact Statement and on Technical Barriers to Trade.
18 December 2020
This consultation closed on 29 January 2021.
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.
The TGA is looking at potential reforms principally intended to enhance the quality and safety of medicinal cannabis products by introducing equivalent GMP requirements for imported medicinal cannabis products to those that are domestically manufactured, introducing labelling requirements for imported medicinal cannabis, clarifying certain matters in the applicable standard, and requiring child-resistant closures to be used on products. Also the potential reforms would include removing extemporaneously compounding exemptions for 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, and further clarifications regarding active ingredients, labelling and packaging matters. in the interest of quality and public safety.
We invite you to review the consultation paper and provide a response using the response template, accessible through our Consultation Hub.