Guidance to market authorization holders on issuing health product risk communications: Definitions

Director of regulatory affairs (DRA): The DRA oversees industry-specific practices and ensures all government and company regulations are being met. For the purpose of this document, the director may be the designated contact for the HPRC or a regulatory affairs manager assigned by the company.  

Email request: An email request is an email correspondence sent by the Risk Communication Section of the Marketed Health Products Directorate to an MAH to request the development and eventual dissemination of a Health Canada-approved HPRC.

Health care professional: Health care professionals include physicians, dentists, naturopaths, pharmacists, registered dietitians and other medical and support personnel involved in the delivery of health care.

Health product: Health products include:

• pharmaceutical drugs (prescription and non-prescription pharmaceutical drugs)
• biologics (biotechnology products, therapeutic and diagnostic vaccines, fractionated blood products)
• radiopharmaceutical drugs
• natural health products 
• medical devices

Health Products and Food Branch (HPFB): The HPFB manages the health-related risks and benefits of health products and food by minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food. The HPFB also provides information to Canadians so they can make informed decisions about their health.

Health product risk communication (HPRC): An HPRC is a type of risk communication designed by Health Canada to help MAHs communicate new and clinically significant health-related risk information associated with marketed health products. HPRCs are targeted to health care professionals but generally include a section for public audiences.  

Lead directorate: The lead directorate within Health Canada is responsible for identifying and assessing risk issues, as well as assessing the need for an HPRC. The lead directorate also works with the Risk Communication Section of the Marketed Health Products Directorate to ensure the timely drafting, approval and dissemination of the HPRC.

Market authorization holder (MAH): Also referred to as sponsor or manufacturer, the MAH is the legal entity that:

• holds the notice of compliance, the drug identification number, the medical device licence number, the product licence number or
• has received approval to initiate clinical trials in Canada

Marketed Health Products Directorate (MHPD): The MHPD leads an evidence-based program that works collaboratively with other organizations to assess health product risks and makes regulatory decisions to manage those risks. Once these risks are assessed, they are communicated openly and transparently to help Canadians make informed decisions. MHPD also leads the development of regulations for reporting adverse reactions and works closely with international organizations in the harmonization of regulatory systems to facilitate the sharing of information.

Risk Communication Section (RCS): The section of the Marketed Health Products Directorate, HPFB, is the central body responsible for coordinating and supporting the development and dissemination of HPRCs. Key functions of RCS include:

• liaising with the lead directorate and the MAH
• reviewing and editing draft HPRCs to ensure clear, consistent and accurate messaging
• acquiring appropriate approvals
• planning/implementing dissemination (for example, posting the HPRC on the Government of Canada’s Healthy Canadians website)