19 Sep TGA Approves Vantage Hemp’s Botanically Sourced CBD APIs and Finished Goods

In Australia, recent updates to cannabis laws reflect ongoing efforts to ensure the quality and safety of medicinal cannabis products. The Therapeutic Goods Administration (TGA) has mandated that both domestically produced and imported medicinal cannabis must adhere to strict GMP standards, aligning them with the requirements outlined in Therapeutic Goods Order No. 93 (TGO 93). These regulations emphasize the importance of consistent quality across all medicinal cannabis products, whether they are manufactured locally or imported.

Key updates include:

1. GMP Requirements for Imports: Medicinal cannabis products imported into Australia must meet the same GMP requirements as those produced within the country. This change, which took effect from July 2023, ensures that all steps in the manufacturing process, including those conducted overseas, comply with GMP standards recognized by the TGA. For products manufactured in countries outside of Australia, with the exception of a few countries, the TGA requires inspection and certification of the manufacturing facilities.
2. Labeling and Packaging: There are new guidelines regarding the labeling and packaging of medicinal cannabis products to ensure they meet the requirements of the Poisons Standard and TGO 93. These include mandatory child-resistant closures for high-risk products and specific requirements for microbiological testing.
3. Compounding Exemptions and Manufacturing: The TGA is reviewing the regulations surrounding the compounding of medicinal cannabis products. This review aims to clarify when and how products can be compounded, ensuring they meet safety and quality standards without pre-empting specific patient prescriptions.

These regulatory updates are part of broader reforms aimed at providing greater assurance to medical practitioners and patients regarding the quality and safety of medicinal cannabis products in Australia.

Botanically-sourced CBD APIs and finished goods certified by the Therapeutic Goods Administration.

Vantage Hemp is a North American CBD manufacturer with PIC/S certification from the TGA and two Drug Master Files (DMFs) filed with the FDA for its botanically-sourced CBD Distillate and Isolate. This significant milestone positions Vantage Hemp as a key player in the global market for botanically-sourced CBD APIs.

Australia’s updated regulations, effective as of July 2023, require that all medicinal cannabis products—whether produced domestically or imported—comply with stringent GMP standards. Vantage Hemp’s TGA GMP certification positions us as one of the few entities capable of navigating these challenges.

With this certification, Vantage Hemp is not only authorized to supply high-quality medicinal cannabis to the Australian market but also stands out as potentially the only US-based company capable of providing APIs and finished goods that can be imported to and exported from Australia. This dual capability offers Australian licensed producers an unprecedented opportunity to access global markets.

In a rapidly evolving global cannabis industry, Vantage Hemp’s achievement of TGA GMP certification underscores its commitment to quality, safety, and global market integration. Australian licensed producers looking to expand their reach internationally can now do so confidently through Vantage Hemp, knowing they are partnered with a company that meets the highest regulatory standards worldwide.

For more information, book a meeting with Vantage Hemp’s Director of Sales, Christian Santi.