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Health Canada: Udated Register of Innovative Drugs

The Register of Innovative Drugs is maintained pursuant to subsection C.08.004.1(9) of the Food and Drug Regulations of Health Canada and the register indicates the drugs that are eligible for data protection which was recently updated by Health Canada.

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 submit a submission until six years after 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.

This register consists of a list of medicinal ingredients in innovative drugs that have not been previously approved for use in a drug and which are not variations of previously approved medicinal ingredients.

An update to the register was made in the summer of 2016 to improve the clarity of information regarding each innovative drug's medicinal ingredient, brand name, and manufacturer.

The format of the Register of Innovative Drugs is an electronic table, which is updated weekly.

Click this LINK to see the updated Register of Innovative Drugs.


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