The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug Regulations. The register indicates the drugs that are eligible for data protection. Under C.08.004.1 (3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug. In addition, the notice of compliance cannot be issued before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator.
The initial format of the Register of Innovative Drugs will be a pdf document, with the medicinal ingredients listed in alphabetical order. The electronic version will be updated weekly.
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