Draft for consultation: List of drugs for exceptional importation and sale
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About the list
Drugs included on the List of Drugs for Exceptional Importation and Sale would be eligible for exceptional importation and sale as per sections C.10.004 to C.10.013 of the proposed amendments to the Food and Drug Regulations (FDR).These drugs would be intended to help prevent and mitigate the impacts of shortages in Canada.
For information about the exceptional importation and sale of drugs, consult:
Which drugs would be included in the list
Drugs included on the list are called "designated drugs". These drugs would not fully meet Canadian regulatory requirements but would be manufactured to comparable quality standards under foreign authorization. The drugs may be manufactured in Canada or abroad. Designated drugs would be eligible for exceptional importation into Canada (if applicable) before the date listed in the "Date after which drug may no longer be imported" column. Drugs could not be exceptionally imported after this date, but drugs already imported or manufactured in Canada could be sold until their expiry dates.
The list would have 2 parts:
- Part 1. Drugs for exceptional importation and sale
- Subpart 1: Drugs that don't have sale restrictions
- Subpart 2: Drugs that have sale restrictions
- Part 2. Drugs for exceptional sale only
- Subpart 1: Drugs that don't have sale restrictions
- Subpart 2: Drugs that have sale restrictions
How the list would be maintained
This list would be incorporated by reference in the proposed regulations. Health Canada would maintain and update this list as required in line with our Incorporation by Reference Policy.
Part 1. Drugs for exceptional importation and sale | |||||||
---|---|---|---|---|---|---|---|
Subpart 1. Drugs with no sale restrictions | |||||||
Brand name of drug, medicinal ingredient(s) | Dosage form, strength, route(s) of administration | Country of authorization, name of foreign regulatory authority, identifying code or number | Name of importing licensee | Lot number and quantities | Date drug added to this list | Date after which drug may no longer be imported | Information to support safe use made available by the importer |
N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
Subpart 2. Drugs with sale restrictions | |||||||
Brand name of drug, medicinal ingredient(s) | Dosage form, strength, route(s) of administration | Country of authorization, name of foreign regulatory authority, identifying code or number | Name of importing licensee | Lot number and quantities | Date drug added to this list | Date after which drug may no longer be imported | Information to support safe use made available by the importer |
N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
Part 2: Drugs for exceptional sale only | |||||||
Subpart 1. Drugs with no sale restrictions | |||||||
Brand name of drug, medicinal ingredient(s) | Dosage form, strength, route(s) of administration | Country of authorization, name of foreign regulatory authority, identifying code or number | Name of licensee | Lot number and quantities | Date drug added to this list | Date after which drug may no longer be sold by the listed licensee | Information to support safe use made available by the licensee |
N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
Subpart 2. Drugs with sale restrictions | |||||||
Brand name of drug, medicinal ingredient(s) | Dosage form, strength, route(s) of administration | Country of authorization, name of foreign regulatory authority, identifying code or number | Name of licensee | Lot number and quantities | Date drug added to this list | Date after which drug may no longer be sold by the listed licensee | Information to support safe use made available by the licensee |
N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
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