Meeting the Terms and Conditions of a Compulsory Licence
If an application for a
compulsory licence is successful, the pharmaceutical
company must ensure that it meets all the terms and conditions of the licence. The terms and conditions are
outlined below, with links to more detailed information:
- Comply with the Conditions of Compulsory
Licences and Anti-diversionary Measures.
- Before the first manufacturing run of the drug or medical device, and 15 days before the export of
subsequent lots of the product, notify Health Canada. Health Canada may inspect the shipment before export.
- Within 15 days before each shipment, provide a notice to the patent holder, the importing country and
the purchasing contact (for example, a non-governmental
organization), specifying the quantity to be shipped and every known party that will be handling the product
while in transit. The notification must be made via certified or registered mail.
- Within 15 days of the day on which the compulsory licence was granted or the supply agreement was signed,
whichever is later, submit a statement to the patent holder and the Commissioner of Patents of the
monetary value and number of units sold. The
statement must be accompanied by a copy of the sales agreement.
- Determine and pay a
royalty fee to the patent holder.
- Comply with pre-export inspections that may be performed to verify that the
anti-diversionary features are included on all
products and labels.
For an illustration of the terms and conditions, see the
process map for meeting
the terms and conditions.
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