Consultation on the regulatory amendment regarding 123I-ioflupane

From Health Canada

Current status: The public consultation is now closed. Thank you for your interest.

You are invited to provide comments on the proposal to remove 123I-ioflupane from the Controlled Drugs and Substances Act.

Why

123I-ioflupane is an ingredient in the radioactive drug DaTscan™, which is sold in the United States, and DaTSCAN™, which is sold in the European Union. DaTscan™ and DaTSCAN™ are used for medical tests in adults. These tests help tell the difference between Parkinsonian Syndrome(s) and Essential Tremor conditions.

123I-ioflupane is similar to cocaine and is captured in the Controlled Drugs and Substances Act and the Narcotic Control Regulations as a derivative of coca. The Controlled Drugs and Substances Act provides a framework for the control of substances that:

  • can alter mental processes
  • may cause harm to the health of an individual or to society when misused

At this time, only authorized persons may engage in the following activities with 123I-ioflupane:

  • sell
  • send
  • import
  • export
  • deliver
  • provide
  • possess
  • produce
  • package
  • transport

We are proposing to remove 123I-ioflupane from the application of the Controlled Drugs and Substances Act because:

  • it has a legitimate medical purpose
  • it has a low risk to be used for illegal purposes
  • there is no evidence that suggests 123I-ioflupane has been misused

Who

Comments from all interested persons and organizations are welcome.

What

The purpose of this consultation is to ask for comments on our intent to remove 123I-ioflupane from the Controlled Drugs and Substances Act.

When and where

Between April 21 and May 20, 2017, we will be engaging with Canadians and stakeholders regarding this proposed change. A Notice to Interested Parties, providing more details on the proposal, will be available at the Canada Gazette during this time.

How to participate

You are encouraged to read the Notice to Interested Parties.

Send us your comments by:

  • email
  • mail to the address listed below in the "Contact us" section

Related information

Contact us

Office of Legislative and Regulatory Affairs
150 Tunney's Pasture Driveway, Main Stats Building - 2605A
Ottawa ON K1A 0K9

Email: ocs_regulatorypolicy-bsc_politiquereglementaire@hc-sc.gc.ca

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