Multiple-dose packs, such as: blister packs, strips, push-through cards, ampoules, or vials attached by a plastic strip; and. Where a standard of manufacture is to be shown on a label (see subsections 10(1) and (2) of the Act), this standard should be declared near the prescribed or proper name of the drug product. Therefore, informative or qualifying statements regarding these ingredients may be acceptable. If the caution or warning does not appear within quotation marks, the wording may be altered but the meaning must be retained. There may be more than one outer label in a multiple packaging scheme (e.g., a vial packaged in a pouch, pouch enclosed in a carton, several cartons enclosed in a larger carton). C.01.005(2)) indicating that the definition of 'label' in the Food and Drugs Act is considered to encompass these labels. In addition, on July 2, 2014, Health Canada published in Canada Gazette, Part II, other amendments to the Food and Drug Regulations. (. Where the original state of an ingredient is altered or changed, the use of the term "natural" in describing such a drug product would be false, misleading, or deceptive, and likely to create an erroneous impression regarding the character, composition, merit, or safety of the drug. Where federal regulatory limits for non-prescription drug product availability exist, qualified statements accompanying the term maximum strength (e.g., "The highest level of benzoyl peroxide that you can buy without a prescription") have been accepted as statements of fact. "Unique" and "special" may be acceptable when used to accurately describe the cosmetic or non-therapeutic aspects of a drug product. Health Canada's policy Non-medicinal Ingredients Nomenclature outlines the accepted nomenclature used in naming the non-medicinal ingredients in drug product formulations. See Appendix B. Such representations include: pictures of the heart, EEG recordings, medical equipment, scientific reports, or medical lab test results. When ADS is less than 15cm2, the product is always exempt. Guidelines for Drug Packaging and Labelling for Manufacturers. Proper or common name, and potency or quantitative list of the medicinal ingredients; Standard of manufacture where required by the. Labelling should clearly indicate that the product is a drug. Canada - Labeling/Marking Requirements Canada - Labeling . A nonmedicinal ingredient which forms part of the brand name should be clearly identified with the cosmetic, non-therapeutic purpose within the brand name (e.g., Sunscreen X with moisturizing aloe) unless the non-therapeutic benefit is obvious (e.g., Antiseptic Raspberry Mouthwash [raspberry flavour]). a statement to the effect that any injury to a person's health that is suspected of being associated with the use of the drug may be reported to the contact person. For example, drowsiness is a side effect perceived to be frequently associated with the use of non-prescription cough and cold products. In scope: Medicinal products (Generics) within Sandoz portfolio. 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. have the ingredients been declared using an appropriate common name? The use of terms such as "strong" or "extra strength" may be erroneous. Due to the constant evolution of medical and scientific knowledge, claims that were once acceptable for a drug product may become invalid over time. Labels should generally state the route of drug administration. However, the words "complete" or "total" have been accepted in the brand names of drug products to indicate that they treat several symptoms of a temporary condition (e.g., cough/cold products treating several symptoms of a cold) or have an additional medicinal ingredient than the reference product in the same product line. To distinguish these products from similar consumer-available non-prescription drug products (e.g., fluoride products), and to avoid unintentional diversion to consumer markets, the labelling should state "For professional use only.". (a) For Division 8 drugs (i.e. 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). Canadian name and principal place of business, grouped with the geographic origin, or preceded by the expressions "Imported by /. For small inner labels of these products, where space is limited, abbreviated statements such as "dilute before use" may be used. is it rounded to 3 figures, unless below 100? In addition, special labelling may be required to show the total osmolar concentration of the final formulation. Information regarding a disease that provides a comprehensive, balanced, and complete discussion of treatment options and does not emphasize a particular drug product or therapy is not considered labelling. is all of the above information readily discernible? Herbs used as Non-medicinal Ingredients in Non-prescription Drugs for Human Use. The principal display panel (that is (i.e.) Changes in Manufacturer's Name and/or Product Name. If the drug product bears a "C" or "Pr" symbol, then a prescription is still required. The use of terminal (trailing) zeroes following a quantitative declaration of the medicinal ingredient should be avoided. Some consumers wish to avoid some specific side effects that can occur with some non-prescription drug products, but not others within the same product class (e.g., some antihistamines have a likely somnolent side effect while others are non-drowsy). This term is considered to be indefinable for most drug products and understood to mean the single or total daily dosage or both. As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. In most cases, the term "extra strength" can be used only if there is a regular strength reference product on the market containing the same medicinal ingredients. For more information on section 10 of the Act, please refer to section 3.4.3 of this guidance. However, if such testimonials are consistent with the expected benefits of the product and the terms of market authorization, they can be accepted following critical review, provided the testimonial does not otherwise violate the Act and Regulations. Drug products packaged in a disposable metal container designed to release pressurized contents by the use of a manually operated valve must show the cautionary statements, hazard symbols, and signal words as outlined in sections A.01.061 to A.01.063 of the Regulations. Division 1 drug: a drug that was submitted to Health Canada as a Drug Identification Number application (DINA) and approved pursuant to the requirements of Division 1 in Part C of the Food and Drug Regulations. a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug; a drug that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or, a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug" (. Moreover, the term "maximum strength" may create an erroneous impression of a greater (or maximum) therapeutic benefit to the consumer. Note that for these products only, as of June 13, 2015, the regulatory requirement in C.01.014.3 to submit final labels after the drug is available for sale, is repealed. (viii) the identification of special characteristics of the dosage form if they are not evident from the name of the drug under sections (i) or (ii). In these cases, the prescription drug labelling may be abbreviated provided that there is direction to refer to the package insert or product monograph (e.g., "For dosage and administration: see package insert or product monograph"). Additionally, certain non-prepackaged foods require a label when sold in Canada. Manufacturers/sponsors may also choose to include the other side effects, without citing the comparison with the placebo. This recognition must be consistent with the terms of market authorization of the product. Code of Federal Regulations, Title 21, Volume 4. If the route of administration differs from the usual route associated with a pharmaceutical form, the label should specify the actual route (e.g., vaginal tablets, powder for inhalation, oral spray, or ophthalmic ointment). "For intravenous injection") or other product attributes are generally discouraged in consumer labelling and most product monographs, prescribing information documents and prescription labels. The address must be sufficient to ensure delivery of a letter through the various postal systems involved in the delivery. Drug Identification Number: A Brand Name Product with Different Fragrances, Flavours or Colours. The net amount of the drug product in the container in terms of weight, measure or number (for example (e.g.) Statements regarding the absence of a side effect are permitted provided the following conditions are met: Scientific evidence exists to support the statement, such that the incidence of a side effect is comparable to when a placebo is taken. The statement "Dextromethorphan provides a clinically proven cough relief" would be acceptable, whereas, the statement "Product Y is clinically proven" would not be acceptable. The manufacturer/sponsor should perform an analysis and risk assessment for any proposed product name to support its use. The unqualified term "antioxidant," when used in labelling, is considered to imply some vague therapeutic benefit of the drug product that is usually misleading, generally unsupported by the lack of available data, and should not be used. Comparisons exaggerate the importance of the alleged advantages of the drug product (e.g., speed of action, quantity of medicinal ingredient, or extent or duration of action). For special labelling of pharmacy bulk vials, see Section 5.4.3.8. "Pharmacy Bulk Package (Vial) - not for direct infusion. is the serving size aligned with the regulated reference amount (RA)? The standards of each individual ingredient should not be declared on the main panel of the label of a multi-ingredient drug product as it misleadingly implies a pharmaceutical standard for the combination. if single-serving container, does the package contains less than 200% of the, are energy and the 12 core nutrients declared, unless conditions for use of simplified format and single-serving simplified format have been satisfied? exempt from declaring a list of ingredients, exempt from declaring name and principal place of business, as printed in bold face type, but not in italics, in the FDR or in the, the name by which the food is generally known or a name that is not generic and that describes the food, if the name is not so printed or prescribed, or, if the food is likely to be mistaken for another food, the common name must include words that describe the food's. However, some acceptable terms include "Expiration" or "Expiration date" in English, and "Expiration" or "Date d'expiration" in French. Guidance on appropriate storage conditions assists patients, consumers and healthcare professionals in maintaining product quality and safety. See also Section 4.8, "Cosmetic Claims". For drug products that carry a recommended single or daily dose or statement of concentration above the limits provided by section C.01.021 of the Regulations, the inner and outer labels must state that the product is to be used only on the advice of a physician (section C.01.025). Labels that may be considered in violation of section C.01.007 are those that make any mention of Health Canada or a component of Health Canada. An appropriate designation for a lot number should be shown on all submitted draft labels to clearly indicate the manufacturer's/sponsor's intent to add the lot number to the label at the time of packaging (e.g., filling). Labels for tablets, capsules, and some liquids intended for oral administration may not require a separate statement, as the route of administration is often obvious. 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.