FAQ's

Question: Canada is a participant to Mutual Recognition Agreements (MRAs), covering drug/medicinal products Good Manufacturing Practices (GMP) Compliance Programmes. What is the status of these Agreements?

Answer:

  • The European Community (EC): Start date of operational phase: February 2003
  • Switzerland: Agreement operational
  • The European Economic Area - European Free Trade Association (EEA EFTA) States: the Republic of Iceland, the Principality of Liechtenstein and the Kingdom of Norway: Start date of operational phase: November 2002
  • Australia: under negotiation

Question: All Canadian drug establishments must hold an establishment licence to fabricate, package, label, distribute, import, wholesale, or test a drug since ...?

Answer: The Canadian drug establishments must hold an establishment licence since January 1, 1998

Question: Is it acceptable for a company to export a licensed drug for charity once it has expired?

Answer: No. While it is recognized the dire need for drugs in distressed parts of the world, once the expiration date has passed there is no assurance that the drugs have the safety, identity, strength, quality and purity characteristics they purport or represent to possess. As such, Health Canada considers the sale of expired drugs to be the sale of unlicensed drugs, and that the export of unlicensed drugs is not permitted.

Question: What are the standards other than the USP that have official status in Canada?

Answer: Section 10 of the Food and Drugs Act sets out requirements "Where Standard Prescribed for Drug", i.e.. Division 6 Canadian Standard Drugs , "Trade Standards" i.e.. Schedule B of the Food and Drugs Act , and "Where No Prescribed or Trade Standard".

Question: Is an establishment licence required when a company wants to import medical devices into Canada?

Answer: Yes, section 44 of the Medical Devices regulations states that no person shall import or sell a medical device unless they hold an establishment licence. This requirement came into effect January 1, 1999.

Question: Does the Medical Devices Regulations ask a manufacturer to have data proving the safety and effectiveness of its Medical Devices sold in Canada whatever their risk class?

Answer: Yes, the Medical Devices Regulations require from the manufacturer that he ensures the safety and effectiveness of its medical devices sold in Canada in accordance with sections 10 to 20 of these regulations.

Question: What is an Export Certificate for drugs and are there any related costs?

Answer: A certificate, in the format recommended by the World Health Organization (WHO), establishes the status of the pharmaceutical, biological or radiopharmaceutical product listed on the certificate, and the GMP status of the applicant for the certificate, in the exporting country. It is for a single product only since manufacturing arrangements and approved information for different strengths can vary.

The fee for the first copy of each certificate is $50.00 plus tax. For supplemental copies of the same certificate the fee is $25.00 plus tax.

A certificate is issued for each product as well as for each country of consignment.

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