Canada’s Guide Intended for the Canadian Market for Consumption or Use Outside Canada

Introduction:

Health Canada is responsible for developing, researching, and marketing safe and quality medications inside the territories of Canada. This federal or national agency aims to  protect the Canadian Drug supply and to ensure that people can access the medications. The main purpose of this guidance (Canada’s Guide Intended for the Canadian Market), GUI-0145, is to reduce the drug shortage that Canada is facing in the current stages. An Interim Order respecting drug shortages was processed and took effect on November 27, 2020. The primary purpose of the amendment was to prevent the candidates with Drug Establishment License (DEL) from distributing drugs that are intended to be marketed inside Canada to be marketed solely outside of Canada, which causes the central issue of drug shortage.

Inclusion and Exclusion Criteria :

The GUI-0145 guidance published by the government is intended for the products which are:

• Non-prescription drugs, administered on an observational basis
• Prescribed Drugs
• Schedule C drugs: Radiopharmaceuticals
• Schedule D drugs: Aprotinin, Pituitary extracts, rDNA products, Blood-derived products, Insulin, and Snake Venom
• Schedule I, II, III, and IV drugs

Natural products are usually excluded from this guidance. This is also the case for any products sold by personnel who do not hold any DEL license, Products meant solely for export, and drugs that are imported for exporting from CANADA.

Regulations Mandated As Per GUI-0145:

1. Prohibiting of Exporting:

As mentioned in the context, a person with DEL cannot export any drugs that are meant for use inside Canada. Before exporting the medications outside of Canada, the DEL holder must extensively study the impact of the specified distribution on the market and economy. The prohibition includes shipping, selling, and/or delivering a drug.

The DEL holder must evaluate the potential impact of the Canadian drug supply. This needs to be submitted/made available at the time of export/distribution. This includes publicly available information such as sales history, current inventory, impact on the product’s availability, overall national sales, alternatives for the drug, and significant environmental factors to be considered. Considering these facts, the distribution would be permitted or denied if there are reasonable grounds to believe that the export will not make or cause any drug shortages.

2. Requirements for Making and Retaining Records:

The person who holds the DEL license distributes a drug for consumption of the drug outside the country. The licensee shall retain the records for at least a year after the expiration date of the distributed product. Health Canada requires the submission of a detailed analysis of the impact of the drug exportation to the agency at the time of export. These data must be retained where the apparent justification of the conclusion about the shortage concerns and the sources of the information and the data must be retained. Under Section C.01.014.12, Health Canada may have to provide information on the drug shortage.

Conclusions:

The shortage of drugs in Canada is drastic and increasing day to day. This puts a serious concern to the public since the essential medications are not available yet, whether they be pediatric or adult medications. Luckily, Health Canada has the initiative to prohibit the export of essential medications from the country. Therefore, this could bring a downfall of increasing drug shortages. However, the government can encourage production of the essential medications.

The guidance document GUI-0145 is a crucial tool for safeguarding the Canadian drug supply. It ensures a continuous access to essential medications for Canadians. By outlining the responsibilities of Drug Establishment License (DEL) holders and providing a framework for assessing the potential impact of drug distribution on the Canadian market, the guidance document helps prevent or mitigate drug shortages. Compliance and enforcement activities by Health Canada further ensure that DEL holders adhere to the regulations and guidelines, ultimately protecting the health and well-being of Canadians.

References:

• Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145). (2021, November 28). Canada.ca. https://www.canada.ca/en/public-health/services/publications/drugs-health-products/guide-distributing-canadian-market-consumption-outside-canada.html
• Consolidated federal laws of Canada, Food and Drugs Act. (2023, December 22). https://laws-lois.justice.gc.ca/eng/acts/f-27/page-11.html#h-234799
• Consolidated federal laws of Canada, Food and Drugs Act. (2023, December 22). https://laws-lois.justice.gc.ca/eng/acts/f-27/page-12.html#h-234806

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