Canada | Amending Certain Regulations Concerning the Sale of Drugs

Title of document
Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) and Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) (43 pages, available in English and French)

Description
The Food and Drug Regulations (FDR) contains emergency provisions, which can be used in certain circumstances to provide Canadians with access to human and veterinary drugs in medical emergencies when the drug is not authorized in Canada.  These provisions are administered through the Special Access Program (SAP), for human drugs and through the Emergency Drug Release Program (EDR) for veterinary drugs. There is a need for the FDR to clearly address the stockpiling of drugs by public health officials and requests for immediate use in a public or military health context. The proposed regulations would provide clarity on the application requirements for public health officials, as well as reporting, record keeping and drug labelling requirements.  Sale of a New Drug for Emergency Treatment This regulatory proposal seeks to make amendments to the “Sale of New Drug for Emergency Treatment” provisions in Division 8 of the FDR. The proposed amendments would better reflect current operations and provide enhancements to the current processes administered by Health Canada’s SAP and EDR program. Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling A proposed new regulatory framework in Division 11 (Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling) would allow public health officials at all levels of government to request a specific quantity of an unauthorized drug in the following two scenarios: 1. for immediate use in a military or public health emergency or event or incident; 2. for the purposes of stockpiling in anticipation of a public or military health emergency or event or incident.

Notifying member: Canada

Notification: G/TBT/N/CAN/587

Objective tag
Reducing trade barriers and facilitating trade; Other

Objective
The objective of this proposal is to facilitate access to drugs for Canadians by modernizing the emergency provisions in the FDR to arrive at less burdensome processes for drugs accessed through the SAP or EDR program; and facilitating access to unauthorized drugs to address public or military health emergencies through an appropriate regulatory mechanism.

Agency responsible
Health Canada

Timing:

• Submission: 13/05/2019
• Reception: 13/05/2019
• Distribution: 14/05/2019
• Final date for comments: 19/07/2019
• Proposed date of adoption: N/A