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Letter to Stakeholders

Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
Holland Cross Complex
Ground Floor, Suite 14
11 Holland Avenue
Ottawa, Ontario, K1A 0K9

December 30, 2008

Release of the Final Report of the Task Force on Own Use Importation of Veterinary Drugs: Request for Comments

Dear Stakeholder:

Health Canada is pleased to release the final report of the Task Force on Own Use Importation of Veterinary Drugs. The Task Force, which was made up of representatives of interested and affected stakeholders, was struck to review issues relating to personal importation of veterinary drugs in the context of existing provisions in the Food and Drugs Act and Regulations. The Task Force was asked to provide a final report outlining concrete recommendations and strategies to address the issue of personal use importation of veterinary drugs. Health Canada welcomes this report and will review it carefully in order to determine the best strategy to address the issue. In the meantime, the report is being released by Health Canada for broader consultation and to solicit comments from all stakeholders. Comments should be forwarded to the Veterinary Drugs Directorate no later than March 5, 2009.

What is the Issue?
In the context of the Food and Drugs Act and Regulations, all veterinary drugs sold in Canada must undergo a thorough assessment of their quality, safety and efficacy prior to being marketed in Canada. In exceptional circumstances, unapproved drugs may be imported for medical reasons under the Emergency Drug Release (EDR) program; for experimental use under an Experimental Studies Certificates (ESC), or for clinical trials under the provisions for Investigational New Drugs (IND). Therefore, when they are to be sold in Canada, veterinary drugs must be imported with Health Canada oversight. However, under the Food and Drug Regulations, unapproved drugs may be imported into Canada when the drugs will not be sold or further distributed. This is referred to as "personal use importation" or "own use importation".

Under the existing personal use importation policy, which applies to human-use drugs, Canadians are able to import a 90-day supply of most drugs for their own personal use or the use of another individual in that person's care or guardianship, based on the directions for use or reasonable intake, unless prohibited by law. Currently there is no personal use importation policy for veterinary drugs. However, Health Canada applies the same approach as the human drugs policy. Therefore, Canadians are able to import a 90-day supply of most drugs for their own personal use or the use of another individual in that person's care or guardianship, based on the directions for use or reasonable intake, unless prohibited by law. Livestock producers in Canada have been purchasing animal health products through this policy in order to give them access to less expensive drugs and generic product not available in Canada.

Health Canada is concerned with the potential risks to human health and food safety when unapproved drugs are administered to food-producing animals. Public health risks associated with the use of unapproved drugs in food-producing animals include the presence of potentially harmful drug residues in food of animal origin (such as meat, milk, honey, and eggs), environmental contamination, occupational safety hazards, and increased risk of antimicrobial resistance development.

Since 2004, Health Canada has been exploring a variety of options to address the current situation. Between 2005 and 2007, Health Canada consulted with stakeholders regarding a regulatory amendment restrict the importation of drugs for food-producing animals to drugs having a Drug Identification Number (DIN) or drugs authorized by Health Canada pursuant to the ESC, IND, or EDR. However, the proposed amendment needed further elaboration and stakeholder consultation.

Moving Forward...
Health Canada recognizes that the issue of personal use importation of veterinary drugs has various implications for different stakeholders and it is important for Health Canada to be aware of the perspectives of all interested parties in order to develop lasting solutions to address this issue.

The attached document is the Final Report of the Task Force on Own-Use Importation of Veterinary Drugs. Health Canada would appreciate receiving your comments or concerns regarding the recommendations of the Task Force, from the perspectives of your organizations.Written feedback should be submitted not later than March 5, 2009 and should be sent by regular mail, e-mail or fax to:

Consultations - Veterinary Drugs Directorate
Policy, Regulatory and International Affairs Division
Veterinary Drugs Directorate,
Health Products and Food Branch, Health Canada
Holland Cross Complex
Ground Floor, Suite 14
Ottawa, Ontario
K1A 0K9

ConsultationVDD-DMV@hc-sc.gc.ca

Fax: 613-957-3861

Sincerely,

Ian Alexander
A/Director General
Veterinary Drugs Directorate