Notice to stakeholders: Additional guidance on product monograph and patient medication information leaflet for non-prescription drugs
In advance of a regulatory proposal amending the Food and Drug Regulations to simplify market access for non-prescription drug products, Health Canada has developed a Non-prescription Drug (NPD) Action Plan. This Action Plan advances the concepts of the Self-Care Framework to reduce burden where possible and to align the level of oversight of NPDs based on their level of risk. This Action Plan introduces policy and operational-based solutions to remove barriers for getting NPDs (excluding ethical drugs, controlled substances, and biocides) to market.
Through this notice, and effective immediately, Health Canada is providing additional guidance on the acceptable format and content flexibilities of Product Monographs and Patient Medication Information (PMI) leaflets for NPDs regulated under Division 8 of the Food and Drug Regulations. Health Canada is also introducing optional headings for use in Product Monographs and Patient Medication Information leaflets for NPDs. The guidance provided in this Notice should be used in conjunction with the Guidance document: Product Monograph (2020) (the Guidance document).
Patient Medication Information Leaflet Format
Flexibilities outlined in the Guidance document should be used to ensure that the label information as it appears on the leaflet/package insert is clear and easy to read to the patient under the customary conditions of purchase and use.
Division 8 drug package inserts are not required to follow the Canadian Drug Facts Table (CDFT) format, but instead follow the PMI format, which aligns with the principles of Plain Language Labelling in terms of legibility and clarity of messaging.
- A sponsor may use columns to display and organize information (maximum of three columns permitted);
- A sponsor may use an innovative booklet label instead of a traditional leaflet. The references to leaflets in the Guidance document should be interpreted as synonymous to “booklet label”;
- In situations where a smaller font may be necessary due to packaging constraints or printing limitations, a 6 point font size may be used;
- Dimensions of paper/margin:
- Paper: 10.16 x 12.7 cm (4 x 5") minimum portrait orientation
- Margins: 0.32 cm (1/8") top, bottom and sides
- Line spacing: single.
Optional headings for a pediatric subpopulation
Health Canada is introducing the following flexibilities, applicable to both Product Monographs and PMI leaflets, supplementing the information presently available in the Guidance document:
- For products authorized for a pediatric population, sponsors can use “pediatric-directed” headings, as applicable (e.g., “Do not use [Brand name] if your child…” instead of the currently recommended “Do not use [Brand Name] if…”).
If applied, headings should be adjusted to a pediatric population consistently throughout the Product Monograph, the PMI leaflet, and the product labels.
Pediatric-directed headings may only be used for NPDs approved solely for pediatric populations. Products intended for both adults and children should apply the conventional headings as listed on the Product Monograph master template.
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