Draft guidance on terms and conditions for human and vet drugs: Notice

From: Health Canada

December 17, 2022

Health Canada published amendments to the Food and Drug Regulations (FDR) in Canada Gazette, Part I, on December 17, 2022. The amendments are entitled "Regulations amending certain regulations made under the Food and Drugs Act (Agile Licensing)".

This regulatory proposal includes new authorities that allow us to impose and amend terms and conditions on the drug identification number (DIN) of any human or veterinary drug. Currently, the FDR allows the Minister to impose and amend terms and conditions only on opioids and COVID-19 drugs.

To accompany the proposed regulations, we developed a Draft guidance on terms and conditions (T&Cs) for human and veterinary drugs. The draft guidance document:

• gives an overview of the proposed regulatory requirements for terms and conditions (T&Cs) and explains their purpose
• gives direction and guidance to drug manufacturers and our staff on the use of T&Cs in accordance with the proposed Part C, Division 1, section C.01.014.21 of the FDR
• describes the process to be used to impose and amend T&Cs
• explains how they will be applied fairly and consistently and give regulated parties an opportunity to be heard

Health Canada has experience in imposing or amending terms and conditions on opioids and COVID-19 drugs. We have used this knowledge, and that of the notice of compliance with conditions (NOC/c) policy, to develop the proposed process for implementing the T&Cs regulatory requirements.

The existing regulatory requirements for opioids and public health emergency drugs, which include COVID-19 drugs, will be repealed 1 year after the Agile Licensing Regulations are published in Canada Gazette, Part II, as the proposed requirements will apply to all drugs.

Manufacturers who currently have T&Cs on their opioid and public health emergency drugs must continue to meet these conditions under the new requirements. Any changes to existing T&Cs will be made under the new requirements. At this time, a new terms and conditions letter will be issued as needed.

Consideration is also being given to the NOC/c policy, as the proposed regulations will take effect 1 year after they are published in Canada Gazette, Part II.

We will let stakeholders know how we plan to proceed with drugs that are authorized under the NOC/c policy when the final Agile Licensing Regulations are published in Canada Gazette, Part II.

Feedback was requested on the Draft guidance on terms and conditions (T&Cs) for human and veterinary drugs. For more information, please visit the consultation page.