Statement from the Health Canada: Plain Language Labelling Regulations come into force for non-prescription drugs

Wednesday, June 14, 2017 Drug News
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OTTAWA, June 13, 2017 /CNW/ - Canadians use non-prescription drug products to treat a wide

range of concerns, such as fevers, wounds, headaches or joint pain. Clear, understandable labels on non-prescription drug products are important because they help consumers make informed decisions. This helps consumers use the appropriate medications
correctly and avoid potentially dangerous medication errors.

As of today, the Plain Language Labelling Regulations come into force for non-prescription drug products. The regulations provide key safeguards, such as:

  • clear, understandable and plain language;
  • a standardized table format for outer labels (similar to nutrition labels on food packaging) to help users find and understand important information;
  • mandatory contact information so that users can report problems and adverse drug reactions; and
  • a requirement for manufacturers to provide mock-ups of labels for review by Health Canada.

As well, manufacturers must provide evidence that drug product names will not be confused with brand names that Health Canada has previously authorized.

The Regulations will apply as of June 13, 2017. By June 30, 2021, labels and packaging of all non-prescription drug products on the market will reflect the new requirements.

Plain Language Labelling Regulations are already in place for prescription medications and drug products that are administered or obtained through a health professional.

Related information: Industry guidance for health product labels Fact Sheet – Drug Facts Table for Non-Prescription Drugs Drug Facts Table 

 

SOURCE Health Canada



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