Plain Language Initiative for Labeling
- April 28, 2015
- Posted by: AXSource
- Category: Blog, Regulatory and Quality
Plain language is a clear writing style designed to be easy to read and understood by the intended audience. The plain language initiative of Health Canada is intended to ensure that information on labels can be easily understood by the target audience. Health Canada will evaluate plain language for drugs for human use through several key elements including a review of label text and design, review of package design, brand name assessment for look-alike sound-alike attributes, provision of contact information and a drug facts table.
Label & Package Mock-Ups
A mock-up is a full color, actual size copy of the labels and a color representation (i.e. photograph) of the packages intended to be used for the sale of the drug, including all presentation/design elements, proposed graphics, fonts, colors and text. Sponsors will be required to submit mock-ups of every label and color representations of the package used in connection with the drug at the time of submission. Mock-up labels and packages must be submitted for each product size and configuration in each container type.
LASA Brand Name Assessment
Look-alike sound-alike (LASA) drug product names refer to names of different drug products that are similar when written or spoken. These similarities may cause confusion and result in errors when self-selecting, prescribing, transcribing, dispensing or administering a drug product. The end result of a name confusion error is that the patient/consumer gets the wrong product. Wrong product errors harm patients by depriving them of the benefit of the correct treatment and by subjecting them, unknowingly, to the risks, pharmacological and /or adverse effects of the mistakenly selected health product. Such errors can and do cause serious harm, up to and including death.
A LASA brand name assessment will be required for all submission and Drug Identification Number (DIN) application types wherein a new brand name is being proposed or where a change to an existing brand name is being proposed.
The contact person must be someone in Canada who has the responsibility of collecting and reporting information on harms associated with the use of drug products. The manufacturer can decide who the contact person will be. The contact information should be on the inner and outer labels as well as on the product monograph to ensure that consumers and health care professionals have access to the information even if the packaging has been discarded.
Drug Facts Table
The drug facts table is required for non-prescription drug products for human use in dosage form. However, the following are exempt: nonprescription drug products administered or obtained only through health professionals, hard surface disinfectants, radio-pharmaceuticals, biologics, and products submitted as extraordinary use new drugs.
The Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) have made these new regulatory provisions applicable to submissions received after the coming into force dates:
- For prescription products and products administered or obtained through a health care professional, submissions received 12 months after the registration of the Regulations in Canada Gazette Part II (June 13, 2014);
For nonprescription (OTC) products, submissions received 3 years after the registration in Canada Gazette Part II (June 13, 2014).