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Regulatory News | 11 June 2015 | By Michael Mezher
Canada's Minister of Health Rona Ambrose has just announced a series of amendments to the country's Controlled Drugs and Substances Act (CDSA) intended to curb illegal drug manufacturing and use.
The amendments are part of The Protection of Communities from the Evolving Dangerous Drug Trade Act, which increase the government's ability to police and regulate active substances, both legal and illegal.
While the amendments are geared toward combating illicit drug trade, some of the provisions will affect regulated drugmakers.
To help authorities keep pace with the proliferation of new active substances, including "designer drugs such as synthetic cannabinoids, cathinones such as methylone and analogues of fentanyl," the proposed amendments would grant the minister of health the power to rapidly schedule new substances, banning their "import, export, product and distribution" for one to two years.
The amendments would also make it illegal to own chemicals and equipment used to manufacture any controlled substance without a "legitimate purpose for possessing those materials."
If the amendments are passed, Health Canada inspectors would see their jurisdiction expanded from authorized manufacturers to places "where activities related to controlled substances or precursors only suspected to be taking place." This would allow Health Canada to perform inspections at places other than licensed manufacturers, such as ports of entry and "vehicles used to transport controlled substances."
In cases of non-compliance, the amendments would provide the minister of health with the ability to impose fines of up to $30,000 (CAD) per day, "without resorting to a criminal prosecution." According to the government press release, this would provide a medium between issuing a warning letter and criminal prosecution.
Additionally, the amendments will expand Health Canada's ability to require tamper-resistant packaging for drugs that have a high risk of abuse.
Press Release, Key Features
Tags: Controlled substances, inspections, tamper-resistant packaging