Introduction:

We are gathering insights from patients, healthcare providers, and industry operators on the potential impact of the new European Pharmacopoeia (Ph. Eur.) monograph for cannabis flower (3028) and its influence on the Australian medicinal cannabis industry. Your feedback is valuable in understanding the broader implications of these changes.

Novachem has posted an article discussing the Eu. Ph. cannabis monograph changes which survey participants may find useful, including links to the new definitions to be adopted.

Instructions:

Please select the option(s) that best describe your views.

Premise:

In January 2024, the European Pharmacopoeia published a significant update to the monograph for cannabis flower (3028), with the changes set to come into force in June 2024. This update tightens the allowable deviation for cannabinoid content to within 10%, introduces more rigorous requirements for the removal of plant stalk from the cannabis flower, and enforces stricter limits on contaminants such as arsenic, cadmium, lead, and mercury. As the Australian Therapeutic Goods Administration (TGA) aligns with European standards, these changes are poised to have a substantial impact on the Australian medicinal cannabis industry if adopted by the TGA. This could affect product quality and safety, potentially leading to increased production costs and influencing product prices. The survey seeks to gather insights from various stakeholders on their attitudes towards these changes and concerns about their implementation and potential impact on the industry.