Plain Language Labelling Summary



Plain Language Labelling Summary


Posted: Monday July 24th, 2017

Author: Pinky Madhur

A few years ago on June 13th, 2015, the Plain Language Labelling Regulations became effective for prescription drugs in Canada. This new regulation affected pharmaceutical drugs, biologic drugs, and radiopharmaceutical drugs, but it did not apply to medical devices, veterinary drugs, or natural health products. This year on June 13th, 2017, the Plain Language Labelling Regulations became effective for non-prescription drugs as well.

As stated in the Questions and Answers: Plain Language Labelling Regulations guidance, the purpose of the Plain Language Labelling Regulations is to improve the understanding of information provided on drug labels and packages, by making them easier to read and understand. This would help prevent confusion on how to use drug products and enhance the safe use of drugs in Canada. To carry out its purpose, the Plain Language Labelling Regulations introduced multiple new requirements for drug product submissions received on or after their respective effective dates. Some of these requirements include:

·         Ensuring that the information provided on the drug product label is expressed in “plain language” and prominently displayed. This requirement applies to both prescription and non-prescription drug products, to help patient/consumer/target audience comprehension of labels for safe drug use. This also requires labels and packages to be formatted and presented in a manner that does not prevent understanding of the information.

·         Assessing the brand name of the drug product against similar drug products to prevent confusion and reduce patient risk. Health Canada is concerned with Look-alike sound-alike names of drug products and enforces this requirement to prevent errors due to similar drug names when self-selecting, prescribing, transcribing, etc., medication for patient use. Errors in these activities could result in patient harm and even be fatal. A brand name assessment of the drug product would help towards patient safety.

·         Providing contact information for adverse events on the inner and outer labels of drug products. This will allow patients/consumers to contact the appropriate contact person if there is an adverse event (e.g. adverse reaction, medication error, etc.) or if they have a question about the drug product. The contact information could be provided as a toll-free number, email, or website, as these are the recommended methods of contact. The contact person is required to be located in Canada, but their name does not have to be listed.

·         The submission of mock-ups of labels and packages for Health Canada to review. The review will consider the font size, type, colour, and placement of the information on the label to check if they prevent legibility or understanding of the information. The Questions and Answers: Plain Language Labelling Regulations guidance suggests that labels be submitted for review as unlocked PDF files, to allow reviewers to check the font type and size of the information on the labels.

It is important to note that some of the Plain Language Labelling requirements differ for different drug product types. Please refer directly to the Health Canada guidance and regulations for complete and original information on these regulatory requirements for compliance. A link to the guidance can be found in the reference below.

Reference:

Questions and Answers: Plain Language Labelling Regulations

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/pll_qa_fin_qr_elc-eng.pdf

Thank you for reading Regulated Affairs, the CAPRA blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.