Drug shortages in Canada: Information for industry
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Industry's role in addressing drug shortages
Drug shortages are the responsibility of stakeholders throughout the supply chain. Market authorization holders (MAHs) play a key role in providing early signals of shortages through mandatory reporting. For more serious shortages, this important step helps set into motion a series of case management activities that involve bringing the right stakeholders together to gather and share information, seek solutions and mobilize responses.
Health Canada works closely with MAHs and other stakeholders to mitigate any shortages.
This process relies heavily on working together to solve the issue, with everyone recognizing the uniqueness of drugs as a product and the complex factors that impact their availability.
In addition to collaborating on specific drug shortage cases, drug manufacturers and other supply chain players (for example, packagers, wholesalers, distributors, group purchasing organizations) should implement practices to mitigate and prevent drug shortages from occurring. This could include analyzing the risk of drug shortages and taking necessary steps to reduce the identified risk. Examples of such steps include:
- introducing redundancy in manufacturing
- reviewing and addressing risks in manufacturing and across the supply chain
- engaging in business continuity planning to prevent drug shortages
- keeping buffer stock for certain drugs
If a drug is unavailable, MAHs are encouraged to take the necessary actions to preserve supply. This may include implementing a protective allocation scheme and reaching out to Health Canada to discuss potential mitigation measures. Such exceptional measures include allowing temporary access to foreign supply and agreeing to extend the shelf life of a drug.
Refer to the multi-stakeholder toolkit for a description of the roles and responsibilities of supply chain players and the tools and strategies available to address drug shortages.
At the national level, stakeholders along the supply chain come together through the Multi-Stakeholder Steering Committee on Drug Shortages (MSSC), which is co-chaired by Health Canada and a rotating provincial/territorial co-chair.
More information on Canada's regulations regarding drug shortages and related guidance for industry may be found on the Regulations and guidance page.
Drug Shortages Division: Drug.shortages-Penurie.email@example.com
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