Controlled substance licence restrictions: Licences for controlled substances

This page is for holders of a controlled substances licence (dealer's licence). You should be familiar with the definitions of controlled substances and the subcategory of restricted drugs listed in Part J of the Food and Drug Regulations.

The Controlled Drugs and Substances Act and its associated regulations establish the framework for access to controlled substances. The goal of this regulatory framework is to minimize the risk that they will be used for illegal purposes.

To legally conduct activities with controlled substances, you must apply for a controlled substance licence (dealer's licence).

Once you're licensed, depending on the substance and the applicable regulatory requirements, you may be permitted to sell or provide the substances listed on your licence to:

  • hospitals
  • pharmacists
  • practitioners
  • other controlled substance licensed dealers
  • holders of a subsection 56(1) exemption for research or medical purposes where the sale by a licensed dealer is contemplated in the exemption itself

There are additional restrictions depending on the type of controlled substance (e.g., some narcotic drugs and restricted drugs have additional restrictions).

You're responsible for reading and understanding regulatory requirements as a licensed dealer. You must also comply with all the terms and conditions listed on your licence.

If you're importing or exporting controlled substances, you must have a valid permit issued by Health Canada. Only authorized licensed dealers are eligible to apply for an import or export permit.

Even with a licence, you're not allowed to sell or advertise any controlled substances to the general public.

Licences for restricted drugs

Restricted drugs are a type of controlled substance, such as:

  • MDMA
  • psilocybin, including magic mushrooms

They are regulated under Part J of the Food and Drug Regulations.

As restricted substances have no approved therapeutic uses, they can only be used for clinical testing or laboratory research. If you're licensed to conduct activities with restricted drugs, you must follow specific regulatory requirements.

These include:

  • obtaining approval in writing from Health Canada before any sale or provision takes place, which could include but is not limited to the issuance of a licence, a permit, or a Part J authorization only selling or providing to a dealer's licence holder or the holder of an authorization issued under subsection J.01.059(4) of Part J of the regulations
  • only selling or providing for clinical testing by qualified investigators for the purpose of:
    • determining the hazards and efficacy of the drug
    • laboratory research

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