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Canada Opens Consultation on New Prescription Drug List

Health Canada has announced the release of the Draft Guidance Document –Determining Prescription Status for Human and Veterinary Drugs for a 75-day stakeholder consultation. The Government amended the Food and Drugs Act to give the Minister of Health certain powers, including the power to establish a list that sets out prescription drugs. On December 22, 2012, Health Canada published in Canada Gazette. This proposal establishes a list of prescription drugs and includes broad principles for determining prescription status for human and veterinary drugs. 

The draft guidance document Determining Prescription Status for Human and Veterinary Drugs supports the regulatory proposal by explaining the broad principles and factors that Health Canada considers when deciding whether a drug would be best sold as a prescription or non-prescription product. The principles and factors are derived from Health Canada’s existing policy document “Factors for Listing Drugs in Schedule F”(reposted 1999). The draft guidance is designed to help the public, industry and healthcare professionals, including veterinarians, as well as other stakeholders, better understand and predict when a drug will be authorized as a prescription or non-prescription product. 

This draft document applies to both human and veterinary drugs regulated under theFood and Drugs Act. It applies to all additions and removals from the proposed list of prescription drugs. This document does not explain the approach to decisions on whether a drug should be a controlled substance regulated under the Controlled Drugs and Substances Act. Once finalized, this guidance document will replace the policy “Factors for Listing Drugs in Schedule F”.

question-and-answer document has also been released to assist the public in understanding the changes mandated by the Jobs, Growth and Long-term Prosperity Act (Bill C-38), which received Royal Assent on June 29, 2012.  The deadline for comments is 7 March 2013.