Description - Guidance Document - Fees for the Right to Sell Drugs

Figure 1

This diagram shows the right to sell fee deferral time line for a drug that began sale in May 2011.  Fees for the right to sell in the years 2011-2012 and 2012-2013 are deferred to the end of the product’s first calendar year on the market (2012) or as indicated January 2013.  As shown the fee for right to sell in 2013-2014 is not deferred and is payable at the time of notification in October.  The diagram also shows August as the expected time for the return of the annual market notification form.

Figure 2

Figure 2 shows an example of a deferred dormant DIN where the Right to Sell Drugs Fee Remission Request and Attestation Form should be provided if the right to sell fee is greater than 1.5% of the manufacturer’s AGR from the sale of the drug, in Canada.

Figure 3

Figure 3 shows an example of a deferred dormant DIN where the Right to Sell Drugs Fee Remission Request and Attestation Form is not required.