Issue link: http://clhia.uberflip.com/i/406567
21 THEREFORE, THE CLHIA RECOMMENDS THAT: • DURING THE UPCOMING REVIEW OF THE PATENT ACT THAT AMENDMENTS BE MADE TO REDUCE THE NEED FOR UNNECESSARY LITIGATION IN ORDER FOR GENERICS TO GAIN ENTRY INTO THE MARKET; AND • IN THE INTERIM, THAT CANADA INTRODUCE A 180-DAY EXCLUSIVITY PERIOD FOR THE FIRST GENERIC COMPANY TO SUCCESSFULLY FILE A GENERIC APPLICATION WITH A CHALLENGE TO A BRAND PATENT. b.3.2 Generic Interchangeability To market a generic drug, the manufacturer must file an Abbreviated New Drug Submission (ANDS) with Health Canada, containing data that demonstrates the drug's bio-equivalence with a reference product. The ANDS must contain sufficient information for Health Canada to assess the bio-equivalence of the generic to the reference product, as well as evidence of tests conducted on potency, purity and stability of the new generic drug.