Consultation on the Food and Drug Regulations for public health emergency drugs guidance: Notice to stakeholders
Date: December 17, 2022
On December 17, 2022, Health Canada pre-published amendments to the Food and Drug Regulations (FDR) in Canada Gazette, Part I (CGI). These amendments are titled Regulations Amending Certain Regulations made under the Food and Drugs Act (Agile Licensing).
The proposed amendments include expanding provisions that were introduced for COVID-19 to “COVID-19 or a condition referred to on the List of Conditions that Threaten Public Health in Canada (list).” Drugs that relate to COVID-19 or a condition on the list would be referred to as public health emergency drugs.
Provisions for public health emergency drugs would come into force immediately upon registration in Canada Gazette, Part II (CGII), with some exceptions.
There are 2 exceptions:
- At the time of registration in CGII, the Minister would have the authority to impose or amend terms and conditions (T&Cs) on the drug identification number (DIN) of any public health emergency drug, at any time, if certain considerations are met. However, 1 year after registration, the T&C provisions for public health emergency drugs and opioids would be replaced with a broad authority to impose or amend T&Cs on the DIN of any drug, at any time, after certain factors have been considered. Transition provisions would ensure that existing T&Cs imposed on a drug would continue to apply after the amendments come into force.
- Amendments related to risk management plans (RMPs) for certain human drugs would also come into force 1 year after registration in CGII. The amendments would require sponsors seeking authorization or market authorization holders for public health emergency drugs to provide an RMP if certain considerations are met.
For more information on the proposed amendments for T&Cs and RMPs, please refer to the following guidance documents:
- Draft guidance document on terms and conditions (T&Cs) for human and veterinary drugs
- Submitting risk management plans guidance document
The scope of the Guidance on the Food and Drug Regulations for public health emergency drugs applies to drugs for human and veterinary use. Health Canada’s Health Products and Food Branch regulates these drugs in accordance with the Food and Drugs Act and its regulations.
Feedback was requested on the draft Guidance on the Food and Drug Regulations for public health emergency drugs from December 17, 2022 to April 26, 2023. For more information, please visit the consultation page.
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