The myriad of substances used in many pharmaceutical products makes transparency an essential part of this sector. Customers and medical professionals need to be able to spot important information about a product immediately, and this is done by following official Canadian guidelines.
Pharmaceutical quality professionals ensure compliance by following this thorough set of rules. Knowing which information to place on product labels can be tricky, so here’s a helpful guide for those considering a career in this industry.
Health Canada’s Guidance Document Sets Labelling Standards
A comprehensive breakdown of labelling guidelines is set down in a Health Canada guidance document. This aims to assist industry professionals on how to comply with laws and regulations concerning pharmaceutical drugs for human use. It contains important information from the Food and Drugs Act and Food and Drugs Regulations, as well as related acts and regulations. The guidance document doesn’t have force of law, and a certain degree of flexibility is afforded to the rules if adequate justification is provided.
Graduates of quality control courses know that Health Canada’s labelling requirements are designed to provide safe and effective use of drug products by healthcare professionals and consumers. The guidance document doesn’t, however, relate to many pharmaceutical products including disinfectants, drugs for veterinary use, or drugs used in clinical trials.
Different Requirements Are set for Particular Product Labels
These rules dictate that drugs shouldn’t be labeled in a false, misleading, or deceptive manner, thus causing potential harm to the patient or consumer. Labelling requirements differ for the principal display panel (main panel) and any other panel on the product. The main panel must normally show information including the brand name/common name of the product, the standard of the product (if any), and the Drug Identification Number (DIN).
Any other inner or outer labels on the product should include the name and address of the manufacturer, the lot number, the expiration date, directions for use of the product, and a quantitative list of the medicinal ingredients. Outer labels should specifically include information such as the weight and the quantity of drug product in the container.
Plenty of guidance is also offered to ensure that such information is sufficiently legible. Regulations state that information on the label must be “clearly and prominently displayed”, and “readily discernible” to the purchaser. Graduates of pharmaceutical training even know to focus on important labelling considerations like colour, contrast, and spacing. Health Canada also recommends use of Sans Serif type font and a minimum of nine points font size on inner and outer labels.
Grads of Pharmaceutical Training Are Aware of Specific Rules for Prescription Products
Pharmaceutical quality control professionals take into account further specific considerations for the labelling of prescription products. Labels of these drugs must include information for a contact person in Canada (telephone number, email address, postal code, etc), and a statement which advises that alleged harms arising from the use of the drug can be reported to that person. The additional complexities of these prescription products mean that such precautions are necessary to protect the health of the consumer.
Language requirements are also different for prescription drugs. Freely available products for the general public must have directions for use printed in both French and English on labels. Manufacturers of prescription drugs, however, simply need to ensure that labels are printed in the customer’s language of choice.
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