Originally implemented in 1920 after the inception of the Federal department of Health in 1919, the Food and Drugs Act (F&DA) underwent drastic revision after the thalidomide crisis of the 1960s. While some amendments have been introduced since then, the F&DA has remained mostly untouched. In 2014, the Regulations Amending the Food and Drug Regulations were passed in order to address several issues that were identified over the previous 50 years.
Many of the 2014 changes allocated to the Minister more power to demand action in the face of identified risk, i.e. the power to request recalls products affected by emergent safety issues, or request immediate package label revisions to include warnings in reaction to newly identified risks in a mandate called Vanessa’s Law. Along with this and other sets of changes, amendments were passed in order to promote consumers’ understanding of drug labels at point of purchase.
The new Plain Language Labeling (PLL) requirements apply these amendments to the regulations. The intention was seemingly simple: to provide important information to consumers in plain language in an easy to read format, so product names are not confusing and it is clear how to report harms cause by the purchased drug.
IMPACT TO INDUSTRY
These PLL requirements for prescription and non-prescription pharmaceutical drugs, biologic drugs, and radiopharmaceuticals were phased in per drug product type. The Regulations took effect for prescription products as of June 13, 2015 and for non-prescription products, more recently as of June 13, 2017.
Overall, much more work must be done upfront before submitting application packages to the regulator for pre-market approval. As such, graphic design work must be done in parallel to submission preparation. Health Canada will no longer accept unformatted label text; however it will accept annotated written text, in lieu of mock-ups, to reflect proposed changes to the inner/outer labels as part of Notifiable Change (NC) submissions or Post-Authorization Division 1 Change submissions (PDCs).
If you plan to submit a new or amend a DIN, NDS, SNDS, or to amend your existing drug product licence, you are affected by this.
Information on the label must be expressed in plain language in a way that does not impede the user’s understanding. Health Canada’s expectation is for all existing labels to be updated with PLL labels over time and for all new drug applications to consider the following aspects of their labeling:
Brand name: Your product’s brand name cannot resemble any other DIN product, a kit or a radiopharmaceutical. HC may request evidence. Look-alike sound-alike (LASA) drug product names refer to names of different drug products that are similar when written or spoken. Such similarities may cause confusion and result in errors when self-selecting, prescribing, transcribing, dispensing or administering a drug product, introducing risk of harming the user/patient/consumer if the wrong medication is prescribed or improperly dosed/administered.
Contact information: Inner and outer labels must display information that allows the consumer to contact party responsible for the product in Canada for guidance if any problems occur. At least one method of contact should be listed, such as a toll-free number, email address or website. The licensee can decide who can be the initial contact. Note that biologic drugs and radiopharmaceuticals are exempt from this requirement.
Mock-up requirement: Mock-up labels of every label to be used for the drug must be provided to Health Canada upfront with the product licence application submissions instead of at the DIN activation stage (i.e. as part of market notification). These labels are market-ready and fully bilingual, in full colour and actual size. This includes package inserts. Health Canada reviewers will review font size and type, colour; and placement (including proximity, overlap, and panel location) of key elements of an inner/outer label. Only editable labels (i.e. not locked PDF files) are accepted, meaning those which enable reviewers to verify the font type and sizes. A locked file impedes reviewers from making annotations to the labels. Provide the font size and type style upfront in Certification doc, required to accompany the submission. When Health Canada label reviewers know the font size and type style of labels at the beginning of a review, they are able to review labels more efficiently. Specific requirements exist for product monographs and various package insert/pamphlet/leaflet formats. Mock-ups must also be submitted with administrative for changes to manufacturer or product name.
Canadian Drug Facts Table (CDFT): A formatted table of required information is mandatory only for non-prescription drugs only so that consumers are fully informed at point of sale. Good Label and Package Practices must be applied, and all formatting rules must be followed.
PLL applies to prescription and non-prescription pharmaceutical drugs, biologic drugs, and radiopharmaceuticals.
To facilitate your adherence to PLL and Health Canada’s review and approval of your drug submissions, consider the following points:
- Research Brand names to ensure they do not resemble other brand names, common names or proper name of products/chemical entities that are currently available for sale in Canada.
- Wording for contact information most often seen is “For questions or to report problems, please contact…” or “Questions or concerns?”, followed by the contact information.
- Provide only editable labels (i.e. not locked PDF files) to the QSS reviewer and as part of the submission.
- Provide the font size and type style used in the label upfront in the accompanying Certification document
- Review the specific formatting requirements for product monographs and package insert/pamphlet/leaflet. Leverage QSS’ expertise for strategic advice your unique circumstance. We believe in a no-nonsense approach to help you navigate regulatory hurdles without sacrificing your business goals.
HOW WE CAN HELP
Our Quality Smart Solutions (QSS) team takes great pride in our client-focused, solutions-oriented approach to resolving issues and challenges. With expertise in OTC, ANDS drug submissions, label review and French translation, we are your solution to ensuring you are compliant with Health Canada’s Drug Regulations. Contact Quality Smart Solutions today at 1-800-396-5144 ext. 4 or fill out our online page by clicking here. To see all we have to offer in regulatory compliance and quality assurance solutions, visit us at www.qualitysmartsolutions.com.