Canada’s regulations prevent drugs from being distributed outside the country if this could cause or worsen a shortage

Access to health products plays an important role in people's ability to stay healthy. Difficulty in accessing these products can cause hardships for individuals and their families and strain our health care system.

This is why the Government of Canada makes it a priority to ensure that people in Canada can access the medications they need, when they need them.

In line with this commitment, we have regulatory safeguards in place and continue to protect our country's drug supply. This includes protecting our supply from foreign bulk importation programs. The government's position is that importing large quantities of drugs intended for the Canadian market is not a solution to high drug prices in other countries.

Under the Food and Drug Regulations, prescription medications intended for Canada cannot be sold and exported for use in other countries if this could cause or worsen shortages here. This prohibition applies to businesses such as manufacturers, wholesalers and distributors that hold a drug establishment licence (DEL) from Health Canada.

A DEL holder wishing to sell or export a drug intended for Canada may only do so if they demonstrate that such an exportation will not cause or worsen a drug shortage here in Canada.

Learn more:

• Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada

Health Canada is taking all necessary actions to safeguard our country's drug supply. Companies that do not comply with the regulatory requirements could face a range of enforcement actions from us. We will take immediate action against companies that contravene the regulations.

Related links

• Regulatory requirements prior to distributing Canadian drugs outside Canada  (for industry)
• Drug shortages in Canada: Regulations and guidance
• Statement from Health Canada on FDA decision on Florida bulk drug importation plan
• Readout from Minister of Health's discussions with U.S. officials on bulk importation of drugs
• Infographic: Helping Canadians deal with drug shortages
• Compliance and enforcement policy for health products (POL-0001)