Consultation: Draft guidance on terms and conditions for human and veterinary drugs

Health Canada is seeking feedback on the Draft guidance on terms and conditions for human and veterinary drugs. This document, previously consulted on in 2022 during the pre-publication of the Agile Licensing draft regulations in Canada Gazette Part I, has been substantially revised. It outlines the scope and application of the new terms and conditions authorities which will come into effect on April 1, 2027.

Read the notice and draft guidance for consultation.

Join in: How to participate

Send an email to policy_bureau_enquiries@hc-sc.gc.ca with your ideas or comments. In the subject line of the email, use "Comments on Draft guidance on terms and conditions for human and veterinary drugs".

Who is the focus of this consultation

We will engage with:

• industry
• healthcare professionals

Key questions for discussion

Your input is being sought to answer the following questions:

• Do you believe that specific sections or statements would benefit from greater clarity (if so, please identify)?
• Do you wish to share any other general suggestions or questions for consideration?

Related information

• 2022 Draft guidance document on terms and conditions (T&Cs) for human and veterinary drugs (Canada Gazette Part 1 pre-publication)
• Canada Gazette, Part 2, Volume 158, Number 26: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing)

Contact us

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada

Email: policy_bureau_enquiries@hc-sc.gc.ca