Importers familiar with the requirements for testing have long voiced their frustration with obligations to perform confirmatory testing on drugs received in Canada. Because of the broad regulations covering drug products of all risk levels, low risk drugs were required to undergo the same level of testing as high risk prescription drugs, even though many […]
Since Health Canada announced their expedited licensing process for hand sanitizers to help combat COVID-19, they have provided additional notices to assist industry with the registration process. Updates have provided further clarification on correct forms to use for notifying Health Canada regarding importation, acceptable label statements, and correct application procedures. The most recent notice is […]
The sustainability of supply chains has become a global issue introduced by the COVID-19 pandemic. Drug product supply chains in particular face increased challenges given the need for all sites in the supply chain to maintain controlled, specific environmental conditions for drugs stored and transported in Canada. Health Canada, in recognizing the difficulty faced by […]
Good manufacturing practices (GMP) is the quality standard that must be met by companies manufacturing, importing and distributing drugs in Canada. In order to ensure compliance with GMP, Health Canada has a unique and targeted license process for applicants which involves an initial on-site inspection, vetting of foreign supply sites and renewal and reinspection according […]
In response to the increasing demand for hand sanitizers in Canada during the current COVID-19 pandemic, Health Canada has implemented an interim expedited licensing procedure to help businesses obtain the required authorizations to produce and distribute hand sanitizers. An unprecedented demand for hand sanitizer products has created global shortages for USP and food grade ethanol. […]
On March 20, Canada’s Health Minister signed an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. This interim order allows certain drugs that may not fully meet regulatory requirements to be imported and sold in Canada. Drugs included on the List of Drugs for Exceptional Importation […]
The Natural and Non-prescription Health Products Directorate of Health Canada has adopted an interim licensing approach to support companies that intend to use their facilities to manufacture, package, or label alcohol-based hand sanitizers in response to the COVID-19 pandemic. Alcohol-based hand sanitizers containing ethanol and isopropanol are classified as natural health products (NHPs) in Canada. […]
Health Canada has one of the most rigorous systems in place for importing drug products from outside of Canada. The governing regulations known as the Food & Drug Regulations set out the requirements and standards that must be met by importers and their foreign sites in order to confirm that foreign supply sites operate in […]
In light of the unprecedented demand and urgent need for disinfectants and hand sanitizers during the COVID-19 pandemic, Health Canada is temporarily permitting the importation of some supplies that may not fully meet Canadian regulatory requirements under the Food and Drugs Act and its Regulations. In Canada, disinfectant products are classified as non-prescription drugs and […]
Importing and selling drugs in compliance Good Manufacturing Practices in Canada requires a substantial effort due to the requirement for organizations to successfully apply for and receive a Drug Establishment License. On-site inspections are a necessary component of the application process for a Drug Establishment License. In an unprecedented move, Health Canada has announced that […]
Regulatory Compliance Just Got Easier
