Notice of Compliance - Drug Products
Definition: A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission.
All Notices of Compliance with conditions (NOC/c) will be included in this listing. A notation "issued under the NOC/c policy" will be made after the Brand Name to indicate this type of NOC. For further information, please see the NOC/c Fact Sheet.
There are two ways to find information about NOCs.
A searchable database of NOCs issued since 1994
A listing of NOCs issued since 1991
The online NOC Data Extract will be updated weekly, every Friday.
For general questions about the contents of the NOC Database contact: email@example.com
For technical support about the database contact: NOC Database Administrator@hc-sc.gc.ca
Post Authorization Links:
For current market status the complementary Drug Products Database (DPD) is also available on Health Canada's website. It lists those drugs that are commercially available in Canada and reflects the drug sponsor's decision to market a drug.
The Advisories and Warnings webpage posted by the Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) contains safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties.
The Veterinary Drugs Directorate (VDD) maintains a webpage on both the safety and efficacy of authorized veterinary drugs used in animals, and the safety of humans who either handle these products, or consume food derived from animals that have been treated with them. Follow the link to the Pharmacovigilance webpage for further information.
A note on how new drugs are authorized for sale in Canada:
New drugs are regulated under Part C, Division 8 of the Food and Drug Regulations. Companies are granted market authorization by Health Canada in several ways. Regardless of the method of authorization, a manufacturer receives a Notice of Compliance (NOC) when it has met Health Canada's regulatory requirements for the safety, efficacy and quality of a product. The following provides a brief overview of three of the most common routes by which new drugs are authorized for sale in Canada.
- Innovator drugs ("brand name drugs"): Manufacturers receive authorization to sell these products in Canada by submitting a New Drug Submission (NDS) pursuant to section C.08.002 of the Food and Drugs Regulations.
- Subsequent entry drugs ("generic drugs"): Health Canada often authorizes manufacturers to market these drugs by requiring them to submit an Abbreviated New Drug Submission (ANDS) pursuant to section C.08.002.1 of the Food and Drug Regulations. These products will receive a declaration of bioequivalence to a Canadian Reference Product (pursuant to Section C.08.004 (4)), which will be stated on the NOC.
- The Health Canada Changes in Manufacturer's Name and/or Product Name Policy outlines another option for manufacturers wishing to receive authorization through an NOC to market brand name and generic drug products. This policy applies to eligible drug submissions submitted to Health Canada for a change in the manufacturer's name and/or product name subsequent to a merger, buy-out or other corporate restructuring or the establishment of a licensing agreement.
Products that receive an NOC according to one of these mechanisms have met Health Canada's regulatory requirements for safety, efficacy and quality.
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