#Australia’s Department of #Health, preparing to overhaul its #medical #cannabis regulations, is poised to require that all products imported into the country’s small but #growing market be produced in accordance with Good #Manufacturing Practice (#GMP).
The move would effectively shut out non-GMP-compliant manufacturers operating overseas by bringing production rules governing imported medical cannabis products into line with those produced domestically. The proposed rules, which also cover labeling and packaging, are currently before the #World #Trade Organization (#WTO), where member countries have until late #February to submit comments.
One of the most meaningful changes involves imported medical cannabis products, which currently don’t have to adhere to the same strict quality production requirements as locally made ones. Furthermore, the government currently requires Australian medical cannabis manufacturers to comply with Good Manufacturing Practice (GMP) standards. However, a similar requirement does not apply to products imported into Australia. Moreover, that has led to charges of unfair competition favoring internationally produced medical #marijuana. Now, the companies importing the goods, known as sponsors, will have to maintain evidence to show compliance for each batch of medical cannabis products they import.
The #Therapeutic Goods #Administration (TGA), which oversees access to unapproved medical cannabis treatments in Australia via the Special Access Scheme, said it will provide “clear guidance” on the GMP practices and evidence that will be required. The government has pledged an unspecified “reasonable” transition period so companies can adapt to the new requirements.