Restriction on filing and approval
In accordance with paragraph C.08.004.1(3)(b) of the Food and Drug Regulations, a manufacturer seeking an NOC on the basis of a direct or indirect comparison to an innovative drug will not be issued an NOC before the end of the period of eight years after the day on which the first NOC was issued for the innovative drug.
Where a combination consists of an innovative drug and another medicinal ingredient not covered by data protection, a subsequent manufacturer will not be allowed to file or receive an NOC
Where two or more innovative drugs are sold in combination, a generic manufacturer will not be allowed to file or receive an NOC
An innovative drug manufacturer may consent to the issuance of an NOC during the data protection period, per subsection C.08.004.1(8) of the
Food and Drug Regulations.
The eight years of market exclusivity for Innovative Drugs is enforced through a six-year “no filing” period and an eight year “no approval” period. In the first six years, no one may file a drug submission making a direct or indirect comparison to the innovator’s data.
In the last two years, a drug submission may be filed but the approval (i.e., the Notice of Compliance or NOC) cannot issue until the expiry of the eight-year term. This eight year “no approval” period is extended an additional six months if pediatric studies are filed. The “no approval” period is also engaged when later-filed amendments to a drug submission make reference to an innovator’s data. Drugs that qualify for data protection are listed on Health Canada’s Register of Innovative Drugs.
When it appears that the filing of a submission is prevented, the manufacturer will be provided with a written preliminary decision and an opportunity to make representations in response. If, following consideration of the representations, the TPD remains of the view that the submission cannot be filed, the manufacturer will be notified and the submission will be deleted from Health Canada’s system.
