Health Canada Therapeutic Products Directorate, Health Products Food Branch is the governing regulatory body over the marketing of drug products in Canada.
The actual marketing of a drug in Canada is becoming increasingly complicated and subject to close scrutiny by the governing regulatory body.
What is the first step to take before marketing a drug in Canada?
The process begins with the submission for the Drug Identification Number (DIN), the number that is issued by the governing regulatory body for each drug product. The DIN number is the marketing authorization for the drug product to be sold in Canada. The firm that holds the DIN number is not required to be located in Canada.
What is required in a DIN submission?
The DIN submission consists of several pages of forms and includes specific information on the drug product itself. These include such criteria as claims, directions for use, indications, dosage form, formula (stating actives, inactives, preservatives and colorants), and warnings. In addition, the submission must contain the verbiage that is to be included on all packaging including inserts.
Once the DIN is issued, the process of marketing the drug in Canada begins.
What is required of a Canadian firm in order to handle a drug in Canada?
There must be a firm in Canada who is responsible for the marketing of the drug in Canada. This firm must hold a Drug Establishment Licence (DEL) for the activity that pertains to their operation. The criteria of receiving a DEL is that the firm is in compliance with the Canadian Good Manufacturing Practices (GMP).
There are several scenarios as to the marketing (sale) of the drug in Canada and there is an activity under the DEL for each of these scenarios. The activities are fabricate, package/label, test, import, distribute and wholesale.
What activities can a firm conduct under the DEL?
The firm that physically makes the drug product performs the fabricate activity and the firm that puts the product into the packaging and labels the drug product performs the package/ label activity. The firm that tests the actual drug product or tests the raw materials for the drug product performs the test activity. The firm that has a contract company that is not located in Canada make the drug product performs the import activity.
If the firm that holds the DIN number is located in Canada, this firm performs the distribute activity, regardless of the logistics of the actual physical distribution of the drug product.
If a firm markets a drug product but that firm’s name does not appear on the label then the firm performs the wholesale activity.
What does a firm have to do to import drug products into Canada?
For the firm that performs the import activity, the site(s) at which the product is fabricated, packaged/labelled and tested must be added to the firm’s DEL. These sites are referred to as authorized foreign sites. In order to have the site qualified by the governing regulatory body specific regulatory information must be supplied to Health Canada. The process of adding a site to the firm’s DEL is slow at a time period of 250 days.
What happens after the DEL is applied for?
Once an application for a DEL is made, the HPFBI will send an inspector to perform an initial GMP audit of the firm. If the audit is successful then the firm will be issued a DEL. The firm can then start marketing the drug product in Canada. The HPFBI inspector will return in approximately one year and perform a full regular GMP audit. The outcome of this audit will determine if the firm can continue their activity (activities) under the DEL.
The DEL must be renewed on an annual basis and maintained at all times. This is the responsibility of the Quality Control department of the firm.
In summary, the issuance of a DIN for a drug product is just the beginning of a long process of marketing the drug product in Canada. The firm must be aware of the DEL activities and GMPs and be in a continued state of compliance.
Terry Pilkey has worked in the industry for over 30 years in the Laboratory Testing, Quality and Regulatory areas. Terry has worked in the Quality and Regulatory areas of Drugs, Medical Devices and Natural Health Products for the last 20 years with Experchem Laboratories.