Here’s what they say.
Overview
The Department of Health through the Therapeutic Goods Administration (TGA) is seeking comments from interested parties on a review of the regulatory processes for the manufacturing, labelling and packaging of medicinal cannabis products.
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.
Why we are consulting
As part of the review, the TGA is seeking your views. The perspectives and experiences of stakeholders are valued and will be important in informing the review’s outcomes.
The TGA is considering 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 providing clarity for manufacturers;
- providing clarity regarding the sourcing and regulation of active materials;
- requiring child-resistant closures to be used on products, and;
- reviewing extemporaneously compounding exemptions for medicinal cannabis products.
The overall objectiveis 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.
We invite you to review the consultation paper and provide a response using the response template, accessible under “Related” below.
The TGA is particularly interested in your feedback on the proposed approach for the reform of medicinal cannabis regulations, including any transitional issues to be considered.
In providing feedback, please provide examples of circumstances in which you think the proposed approach may be problematic or ask specific questions about how the proposed approach would be applied to your specific circumstances.
Submissions may address any, or all of the matters contained in the Potential reforms to medicinal cannabis manufacturing, labelling and packaging requirements – consultation paper under ‘Related’, below.
All submissions should be made via this online portal. Questions should be directed to GMP@health.gov.au.
Read analysis piece published by Cannabiz Australia
Analysis: what the Government’s proposed reforms mean for Australia’s medicinal cannabis industry
DOCUMENT
Potential reforms to medicinal cannabis manufacturing- labelling and packaging requirements
RESPONSE SHEET
Reponse template - Potential reforms to medicinal cannabis Response
