Distributing Drugs in Canada
Selling drugs in Canada requires compliance with Health Canada’s Food & Drug Regulations. Facilities involved in the distribution of drug products must operate in compliance with Good Manufacturing Practices which are contained within the regulations. Health Canada has unique titles for the specific roles within the drug supply chain and the terminology can cause some confusion, especially when it comes to the definition of a distributor. “Distribute” when used in association with drug products is defined in Part C, Division 1A [C.01A.003] of the Food & Drug Regulations. Health Canada considers a distributor to be the group that sells drug products in Canada for which they have received a DIN. While “selling” drug products for some DIN holders may not necessarily involve any physical storage or delivery to end users, the DIN holder is still the official distributor in Canada.
A distributor or seller of drugs in Canada may contract out the storage and order fulfillment of their drugs to a third-party logistics group. In these situations, the Drug Establishment License holder (distributor) and their contracted service provider are required to maintain written and executed contracts covering GMP. These contracts, often referred to as quality technical agreements identify which party will be responsible for each of the GMP requirements over the entire supply chain. Third party logistics companies while not required to hold a Drug Establishment License are still required to be GMP compliant. All storage warehouses and order fulfillment centres used by the official distributor must be listed on the distributor’s Drug Establishment License (DEL).
Health Canada will ensure and enforce adoption of GMP compliance at all facilities through their routine inspections and review of DEL renewals. As per Section 11 of the Food & Drugs Act “No person shall manufacture, prepare, preserve, package or store for sale any drug under unsanitary conditions”. Distributors as DEL holders are responsible for ensuring that requirements for storage of drugs are being met by contract logistic sites and their commercial carriers. Third-party logistics groups that enlist the services of outside carriers must ensure that required storage conditions for drugs are maintained by carriers at all times during transport. Third party sites are recommended by Health Canada to establish written agreements with carriers in order to ensure they fulfill their obligations for maintaining product integrity. Health Canada guidance document [GUI-0069], Guidelines for Environmental Control of Drugs during Storage and Transportation provides insight into Health Canada’s expectation for storage and transport of drug products.
Maintaining records is an important and often overlooked responsibility for DEL holders. At any time Health Canada may request evidence to confirm that products are stored and transported according to recommended label conditions. Distributors who are not performing any physical storage or transport of drugs must receive and review records generated from contracted parties on an ongoing basis. Any agreements entered into by DEL holders and contractors should require contractors to provide records to license holders on an ongoing basis in order for DEL holders to maintain evidence of GMP compliance throughout their entire supply chain.
