product labelling requirements canada

The following policies are available on the Health Canada website. These drug products can be easily accessible by consumers for certain medical conditions or for emergency use (e.g., nitroglycerin, insulin). Therefore, prescription drug products, drug products available in hospitals and clinics only, or drug products for professional use only do not require bilingual labelling. For drug substances in the form of a salt where there is no existing common name for the drug product, the naming conventions outlined in the USP Nomenclature Policy (See Appendix C) are used to determine the common name of the drug product: As the Regulations require that the proper or common names of the drug products must appear on the main panel of the label, the USP Nomenclature Policy and the additional provision above, ensure that the complete salt is also shown on the main panel. It is the manufacturer's/sponsor's responsibility to ensure that they have documentation on file that shows the drug product has obtained the endorsement from this third party organization and that the drug product continues to meet the attesting organization's criteria. For further information regarding the use of abbreviations in drug product labelling, see the resources listed in Appendix C. No reference, direct or indirect, to the Act or to these Regulations shall be made upon any label or in any advertisement for a drug unless such reference is a specific requirement of the Act or these Regulations (section C.01.007). Drug products are formulated to provide an amount of medicinal ingredient in an effective therapeutic range. The following is a list of further labelling guidance documents from third parties or other countries that sponsors may wish to consider when creating effective labelling. The following guidance documents are available on the Health Canada Website. In Section A.01.010 of the Regulations, the inner label is the label affixed to an immediate container of the drug product. For prescription products and those administered or obtained through a health professional, please refer to: Guidance for Industry: Review of Drug Brand Names and the Frequently Asked Questions - Guidance Document for Industry - Review of Drug Brand Names. With the exception of submissions for which there is no previously approved Product Monograph (i.e. Note that with regulatory changes discussed in section 3.5.6, manufacturers/sponsors must declare all colouring agents on the labels of non-prescription drug products effective May 13, 2012. In cases where the improvement refers to some non-therapeutic aspect of the formulation (e.g., taste, colour, texture), this should be specified. Specific requirements of the Food and Drug Regulations for the placement of information on labels are summarized below. Product Line or Product Line Extension: two or more drug products sharing a brand name, part of a brand name, or common identifier as part of the brand or product name that contains additional medicinal ingredients or different strengths and is intended to expand the conditions of use of the initial product. Although there may not be a regular strength version of the same product by the same manufacturer/sponsor on the market, dosage units containing 500 mg of acetaminophen or acetylsalicylic acid (ASA) or more, are considered "extra strength" within the context of the established standards. additional commodity-specific requirements may apply to the product. Health Canada recommends a font sizeof ten points for the consumer information/patient medication information and package insert text and a minimum of nine points for inner and outer labels and tables for the labelling of the consumer information/patient medication information and package inserts, preferably all labelling in Sans Serif type font, to avoid any problems in legibility. Some consumers are concerned with the intake of certain non-medicinal ingredientsin drug formulations (e.g., salt and sugar). Last published date: 2022-08-03 The Canadian Consumer Packaging and Labeling Act requires that all labels be bilingual in English and French, and that the following information appear on the package/label of consumer goods sold in Canada: Product Identity Declaration: describes a product's common or generic name, or its function. A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the. See Section 3.5.1 of this guidance. Things to know Pre-packaged consumer products must comply with labelling requirements, such as generic product descriptions, metric measurement/quantity declarations and manufacturer's or distributor's identity and address - For example. Where the strength is expressed in the terms of a free acid or base, the same acid or base is used in the common name of the drug product, and the name of the complete salt is also shown near this common name, on the main panel of the label. Refer to the appropriate regulation for specific requirements concerning size, colour, and shape of the symbols. Brand Name: "means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership, or individual, in English or French. The extra strength ingredient should be identified in the list of medicinal ingredients as follows: Extra Strength Panacette Cough and Cold Tablets: Drug products with undefined standard strengths will be evaluated on a case-by-case basis with data submitted to support the extra strength claim. The inclusion of a greater amount in a particular preparation or the marketing of more than one product to provide varying amounts of a medicinal ingredient within an acceptable range is undertaken at the manufacturer's/sponsor's discretion. New Drug Submissions). To ensure the proper identification of these drug patches, especially to inform healthcare personnel in cases of inadvertent contact with these discarded patches by children and pets, the patch itself should be labelled with the following minimum information: Labelling for implants (e.g., wafers, capsules, and pellets), should include the total quantitative declaration of the medicinal ingredientsper implant, the mean dose delivered per unit of time (e.g., Xmg/day), and the duration of use (e.g., Y days). Bilingual Labeling Requirements All labels for products sold in Canada must be clearly printed in English and French. In this instance, the symbol "N" is required and, depending on the other ingredients, possibly a "C" symbol or the "Pr" symbol. Manufacturers/sponsors may selectively refer to the absence of certain ingredients under particular conditions (e.g., no ingredient X, no X, non-X, X-free). Claims on drug product labels that include market share, sale, consumer and patient use/ choice, or preference must be supported by adequate studies conducted within the past year which should be kept on file by the manufacturer/sponsor. In the case of official drugs labelled with a brand name, the lettering of the proper name must be in type not less than half the size of the brand name and must immediately precede or follow the brand name. These standards and monographs should be consulted in conjunction with the Act and Regulations, and all other applicable Health Canada guidance and policy documents. Technical information should be presented in terminology that is easily understood by the consumer. (iii) the net content of the drug if it is not in a discrete dosage form. When the label provides the dosage range, the specific dosage for each indication must be detailed in the prescribing information, package insertor product monograph. is the correct wording "packaged on" / "". Failure to disclose the lack of real therapeutic advantage is often deceptive. The manufacturer/sponsor is responsible for having data available on file to support these non-therapeutic claims. additional federal and provincial regulations may apply to the product. that is assigned to the drug by its manufacturer; under which the drug is sold or advertised; and, designated in scientific or technical journals, other than the publications referred to in Schedule B to the. See sections 3.6.2 and 3.6.3 of this guidance document for more information and exceptions. In addition, drug product information in the form of scientific papers, symposia, review articles, reports, or summaries produced by bodies independent of the manufacturer/sponsor (e.g., scientists, researchers, healthcare professionals, patient interest groups, healthcare professional associations, public bodies, and governments), should not be included as the information may not be balanced. The word "new" may be used to describe a drug product that is marketed under its present brand name for the first time in Canada, or in a different version of an existing preparation (e.g., a new pharmaceutical form or strength). Mandatory label information This guidance document came into effect in 1989, was subsequently revised in 1991, and has since been removed from circulation by Health Canada because much of its content was deemed to be out-of-date. broad principles applicable to all drug products for human use regardless of the intended audience (healthcare professionals or consumers); detailed data requirements necessary to support consumer-directed non-prescription drug product advertising and labelling; roles and responsibilities of Health Canada and the sponsor concerning labelling; and. (subsection 10(3)). ", (1.4) When the composition of the drug varies from one lot to another, the outer label must include a reference to all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol "+/-" or "" or the expression "or/ou" or "may contain/peut contenir.". The labelling of small containers is exempt from many of these requirements. Also, it should be read without the need to further manipulate a novel label format (see section 2.1.1 and section 2.1.2). The inner and outer labels should include an instruction to consult the package insert for further directions, such as, "See consumer information [leaflet]. For distinct cities, the province may be omitted and "Canada" used instead. These requirements specify the need for an assessment as to whether there is a likelihood that the drug will be mistaken for any of the following products due to a resemblance between the brand name that is proposed to be used in respect of the drug and the brand name, common name or proper name of any of those products: Look-alike, sound-alike (LA/SA) refers to names of different health products that have orthographic similarities when written or similar phonetics when spoken. It may be misleading to build unwarranted expectations in the consumer's mind by the use of success stories. photograph) of the packagesintended to be used for the sale of the drug, including all presentation/design elements, proposed graphics, fonts, colours and text (with a place holder for expiry date, DIN, and lot number). In cases where no proper nameexists for a single-ingredient parenteral preparation, the common nameshould be written in the following manner: If space is available on the label, concentrated liquid drug products meant for dilution before injection should bear a label warningstating "Concentrate - must be diluted before use." Labelling requirements checklist disclaimer: Adherence to the labelling requirements checklist does not preclude the Canadian Food Inspection Agency from taking regulatory action in cases of non-compliance to regulatory and legislative labelling requirements. Both these changes do not justify the use of the terms, where there is no proven therapeutic benefit for them. The "professed standard" refers only to the label claims for quality and potency, and manufacturers/sponsors are required to set their own standards within certain limits outlined in the Regulations. Eliminate use of dangerous abbreviations, symbols and dose designations ISMP Canada Safety Bulletin, 2006, vol.6, issue 4. For Canadian manufacturers/sponsors, it may suffice to have the name of the city and province. Phrases such as "contains a unique combination of moisturizing ingredients" and "with a unique fragrance" can be used to describe cosmetic elements or the use of descriptions (e.g., "in a unique package design") to describe non-therapeutic factors are acceptable provided the manufacturer/sponsor has the data on file to support these claims. See section 3.5.6 regarding regulatory changes in the declaration of non-medicinal ingredients on the label, effective May 13, 2012. Note that final labels must be submitted at the time of market notification as per section C.01.014.3. No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A. Food products that require a label - Canadian Food Inspection Agency
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