Information on Drug Shortages
Notification and communication of drug shortages by drug manufacturers and importers is an essential component of preventing and mitigating shortages. Timely and public information on drug shortages can help the drug supply chain and the healthcare system respond appropriately and to minimize the impact on patients. It can also help healthcare practitioners and patients make timely and informed choices about treatment.
Mandatory Drug Shortage Reporting
On June 20, 2015, the Minister announced the regulatory proposal for mandatory drug shortage reporting. The proposal introduces changes to the Food and Drug Regulations that will include new drug shortage and discontinuance reporting requirements for the manufacturers of specific types of marketed drugs in Canada.
Final regulations are now posted in the Canada Gazette on June 29, 2016 and come into force in March 2017. These regulations incorporate feedback received during consultations on the regulatory proposal, which included feedback from health care professionals, patients, Provinces/Territories, and industry. When in force, the regulations will require drug manufacturers to:
- report on a public website an anticipated drug shortage or discontinuation of sale no less than 6 months in advance or any unanticipated shortage expected to occur within less than 6 months, within five days of learning about it;
- notify Health Canada of the interruption of the sale of certain drugs when they have not been sold in Canada for 12 consecutive months; and,
- provide additional information when they notify Health Canada that a drug has been discontinued, including the Drug Identification Number (DIN), the latest expiration date, and corresponding lot number(s).
A new third party reporting website Drug Shortages Canada will launch to coincide with the coming into force of the regulations. Canadian Drug Shortage Website.
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