15 July 2016
Canada Considers More Stringent Requirements for Anti-microbial Drugs, Issues New Guidance for Health Product Labels
The Canadian government is seeking input from interested parties by 8 September on a proposal to strengthen the rules governing the importation, sale and use of anti-microbial drugs in livestock. The government is concerned about anti-microbial resistance, which occurs when an anti-microbial drug – an anti-biotic, anti-fungal or anti-viral drug – is no longer effective at controlling an infection it was once used to treat. This can cause an increased risk of infection, longer infection times and a greater risk of death. Canadian authorities indicate that the decreasing effectiveness of anti-microbial drugs is having a significant impact on their ability to protect Canadians from infectious diseases. Moreover, anti-microbial resistance is negatively impacting the Canadian healthcare system as a whole, global trade, the environment, and the agricultural and health sectors.
The proposed changes to the Food and Drug Regulations would restrict the importation of certain veterinary drugs, require drug manufacturers to follow stricter rules, require provision of sales information to regulators to allow for improved monitoring of anti-microbial use, and introduce an easier way for manufacturers to sell lowrisk veterinary health products. The government notes that this proposal is a priority under the Federal Action Plan on AntiMicrobial Resistance.
In a separate action of potential interest, the Canadian government has issued a new guidance document for industry aimed at advancing the safe use of health products in the country. The guidance is provided in two “Good Label and Package Practices” guides, one for nonprescription (i.e., overthecounter) drugs and natural health products and the other for prescription drugs. Together, they are intended to provide industry with direction for designing clear and effective health product labels and packages.
As part of the guidance, instructions are provided for a new standardised Facts Table that will be required on the outer labels of nonprescription drugs, such as cough syrups, pain and fever relievers and allergy remedies. Canadian authorities observe that using the new Facts Table will make it easier for Canadians to read, understand and use overthecounter health products safely and find important product safety information like ingredients, directions and warnings. The table is modelled after the Canadian Nutrition Facts table for foods and a similar table used for nonprescription drugs in the United States and is a requirement that will be phased into the Canadian marketplace starting June 2017.
The guides form part of Health Canada’s Plain Language Labelling Initiative, under which important action has been taken to make product labels and packaging information easier to read and understand. This includes introducing the Plain Language Labelling Regulations with new requirements for clear, understandable labels – including the Facts Table for nonprescription drugs that are being phased into effect.