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Notice to the reader: The online consultation is now closed.
The Health Products and Food Branch is pleased to announce the release of the Draft Good Label and Package Practices Guide for stakeholder consultation.
Developed in collaboration with the Institute for Safe Medication Practices Canada (ISMP Canada), the objective of the Good Label and Package Practices Guide is to provide direction to sponsors in designing safe and clear labels and packages.
The information provided in this guide will aid sponsors in the organization of information required by the Food and Drug Regulations and Natural Health Products Regulations. It will provide additional recommendations to support the design and development of labels and packages that are clear, effective and support proper identification of the product to minimize the risk of errors causing harm.
Recommendations presented are drawn from regulatory documents, professional standards and guidelines, safety literature, documented medication and health product incident reports, and experience in Canada and other jurisdictions.
Through the Plain Language Labelling Initiative, new regulations amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) have been introduced with the intention of improving the safe use of drugs by making drug labels and packages easier to read and understand. These amendments include a requirement for a standard table format for outer labels of over-the-counter (OTC) drugs and submission of label and package mock-ups. The content presented in this guide will provide information with respect to meeting these two new requirements. Note that while Natural Health Products (NHP) are not covered under the PLL regulations, the guide offers guidance to NHP sponsors as best practices.
This guide focuses on the inner and outer labels and package across the range of health products for human use: prescription and non-prescription pharmaceuticals, biologics, and natural health products (NHP).
This is not applicable to whole blood and its components under the Blood Regulations; cells, tissues and organs under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations; disinfectant drugs (except contact lens disinfectants); drug products for veterinary use; and drug products used in clinical trials.
The guide complements Health Canada’s Guidance Document: Labelling of Pharmaceutical Drugs for Human Use and the Labelling Guidance Document for Natural Health Products. It respects the Food and Drugs Act, Food and Drug Regulations, and the Natural Health Products Regulations. It is essential that all regulatory requirements are met in the design of a label and package.
Aspects of product labelling that are not covered include the naming of health products, layout, content and design of product monographs, other package inclusions, other material distributed with the product (e.g., package inserts, patient medication information, consumer information, and prescribing information).
To obtain an electronic copy of the document, Draft Good Label and Package Practices Guide, please send an email to firstname.lastname@example.org with the subject heading "Request Document-Draft Good Label and Package Practices Guide" or contact the Therapeutic Effectiveness and Policy Bureau.
This consultation is open from March 3, 2015 to May 4, 2015.
Stakeholders are invited to provide input on the Draft Good Label and Package Practices Guide using the Comment Template.
Please submit your comments via e-mail, fax or by mail.
Patient Safety Section
Therapeutic Effectiveness and Policy Bureau
Marketed Health Products Directorate
200 Tunney's Pasture Driveway
Address Locator 0701L
Ottawa, Ontario K1A 0K9
Fax: (613) 948-7996