is the location of the date acceptable (anywhere on the label, including the bottom if a reference is made elsewhere on the label indicating the date is present on the bottom)? Some drug products require a qualification on repeat doses (e.g., "may be repeated in X hours if required"). Manufacturers/sponsors wishing to add therapeutic comparisons to labelling, which is generally discouraged if the overall effect is considered promotional, should seek pre-approval of the label claims through the submission and approval of an appropriate change to labelling. For drug product lines containing ophthalmic or parenteral drug product formulations, and where two products differ only in the presence or absence of a preservative, the label should clearly identify the presence or absence of a preservative, either by reference in the brand name or directly and prominently on the label. Most drug products are part of a product class with similar product attributes, where it is difficult to identify any particular drug product as "advanced," compared to another in its class. Advertising complaints concerning these non-therapeutic comparative claims can be forwarded to the sponsor, the courts (for complaints brought under the Competition Act) or may be considered by industry or voluntary pre-clearance agencies. Note: When ADS is less than 100cm2, a small package NFt exemption may apply to products containing added acesulfame-potassium, aspartame, neotame or sucralose that qualify for a "sugar-free" claim provided certain additional requirements are met. (unless it falls under one of the. ", Proper Name: "means, with reference to a drug, the name in English or French. ", (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.". Services and information Consumer packaging and labelling Federal requirements for labelling prepackaged consumer goods. However, in the context of providing adequate directions for use, the word "safe" may be part of the directions (e.g., "for safe use, do not exceed two tablets daily"). If Part I (professional information) and Part III (consumer information/patient medication information) are included together in a package insert, then the label should indicate "See enclosed insert and consumer information/patient medication information." Doctors are also responsible for distributing this information for samples given to patients. For other injectable drug products such as powdered or special products (e.g., products stored in a droplet of oil under nitrogen in an ampoule) that must be reconstituted or diluted before use, the label warning can state "Reconstitute (dilute) before use.". These claims may be significant in the labelling of older drug products that have not been recently updated. Labelling of Professional Samples of Drugs. 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? that the person advertises 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. Only those preparations sold under section 36 of the Narcotic Control Regulations are available to the general public without a prescription because their potential for abuse or misuse is limited. Guidelines for Cosmetic Advertising and Labelling Claims. 1) Everything must be translated Advertisement Food products being sold in Canada must meet bilingual language requirements. The manufacturer/sponsor would be responsible for ensuring the continued suitability of the term as applied in the labelling of a particular drug product, especially in response to similar products entering the market. it has been defined in the Health Canada policy document Labelling of Professional Samples of Drugs as "a package of drug provided free of charge. ), may also be included on the label in addition to the required metric units. 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. Guidance on appropriate storage conditions assists patients, consumers and healthcare professionals in maintaining product quality and safety. Indications; this section must clearly indicate the function of the drug product in either the treatment, prevention, or diagnosis of a recognized disease entity or a significant manifestation of disease, or in the relief of symptoms associated with a recognized disease, condition, or syndrome, or as an adjunct in the treatment of some condition; Contraindications, precautions, warnings, and adverse effects, drug/drug interactions, and drug/food interactions; Dosage and administration instructions for each indication and age group or other patient categories, as applicable; Mode of reconstitution and storage, if applicable; Identification of manufacturer/sponsor; and. Part 201 - Labelling: Subpart B - Labelling Requirements for Prescription Drugs and/or Insulin. The Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) introduced targeted amendments to emphasize the importance of plain language labelling. The proper name for a drug product includes the dosage form and is the name assigned to that final product in one of the Schedule B publications (e.g., Azithromycin Capsules). Where no standard has been prescribed, but a pharmacopoeial standard exists (see Section 3.4.3.2, "Pharmacopoeial Standard") and it applies to the standard proposed by the manufacturer for the specific drug product, the principal display (main) panel of the inner and outer labels shall name the publication containing the standard used. Pursuant to section C.01.004 (1) (b) of the Regulations, the appropriate symbol for drug products listed in the Schedule to Part G to the Regulations, the schedules to the NarcoticControl Regulations and the Benzodiazepines and Other Targeted Substances Regulations or containing an ingredient listed in the Prescription Drug List must appear in the upper left quarter of the principal display (main) panelof the label. The name and address of the manufacturer/sponsor and of the distributor if the manufacturer/sponsor is not Canadian; Adequate directions for use of the drug product; and. Note: After June 13, 2015, these products are subject to new requirements for their labels, which include contact information to report harms (see section 2.1.2 of this guidance document), legibility of information (section 2.3), the submission of mock-ups of labels and packages instead of draft text (section 2.10) and brand name assessment of the labels (section 4.5). 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. The guidance document reflects comments from the draft posted to the Health Canada website on July 7, 2010 with a 120 day external stakeholder comment period ending November 7, 2010. (1) Subject to subsection (2), a pharmacist may, without a prescription, supply a preparation containing not more than 8 mg or its equivalent of codeine phosphate per tablet or per unit in other solid form or not more than 20 mg or its equivalent of codeine phosphate per 30 mL in a liquid preparation if: Such drug products are usually pain medications containing combinations of ingredients such as acetaminophen or acetylsalicylic acid, caffeine, muscle relaxants, and codeine. For additional information see Section 4.2, "Absence of Ingredients," and Section 4.3, "Absence of Side Effects.". Health Canada does not accept complaints concerning overall impression of comparative, non-therapeutic claims unless these claims interfere with the therapeutic aspects of the drug product. In other cases, the context and use of this information must be examined on an individual basis to determine whether the material is labelling or other information, such as advertising or general disease information which is not considered appropriate. is the serving size aligned with the regulated reference amount (RA)? Alternatively, it is recommended that the new format as outlined for Part I of the Guidance for Industry: Product Monograph is followed where possible. a non-therapeutic aspect at the expense of the therapeutic purpose (e.g., cleansing ability of a medicated shampoo). 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.". 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. In some circumstances, manufacturers/sponsors may include an offer or guarantee of product quality (e.g., consistency, flavour, and colour) or other non-therapeutic benefit, if it is clearly worded. (See Appendix B). The following statement would not be acceptable: "Product Y is a clinically proven cold relief" because the product is likely to alleviate only two cold symptoms, not the whole range of cold symptoms that may be present. This section refers to the standard to which a drug product is manufactured and represented. In addition, labels for these products should indicate the availability and distribution of this consumer information/patient medication information, by wording such as: Note: For new drugs in the old PM format where there is Information for the Consumer (i.e. For prescription products and those obtained or administered through a health professional, as of June 13, 2015, C.01.004.01(1) requires contact information in Canada to report 'harms' that may be associated with the product. is the information on any label panel except solely on the bottom (except ornamental containers)? For the purposes of section C.01.004 (2) (b) of the Regulations, which requires the quantitative declaration of preservatives used in parenteral preparations, the term "preservatives" refers only to antimicrobial agents. is the international symbol on the principal display panel? With respect to filing these drug submissions, manufacturers/sponsors may wish to consult the various Health Canada documents mentioned in Appendix B, such as: The labelling requirements for drug products generally apply to all container sizes. a drug in respect of which a drug identification number has been assigned, a radiopharmaceutical, as defined in sectionC.03.201, in respect of which a notice of compliance has been issued under sectionC.08.004 or C.08.004.01, and. The potency of medicinal ingredients may be declared in terms of the total compound or the active moiety, provided that the whole compound is identified by name. Canada - Labeling/Marking Requirements | Privacy Shield If the above material mentions the brand name, product name, or several products to be used together (e.g., statin and a diuretic), then it is considered labelling and subject to a Health Canada review. In some cases, qualified claims concerning advanced non-therapeutic aspects (e.g., cosmetic aspects) may be acceptable if the non-therapeutic benefit is clearly explained. If so, is there a written statement such as "irradiated" or "treated with radiation" or "treated by irradiation" and the international symbol? Canada - Labeling/Marking Requirements Canada - Labeling . The Regulations are flexible regarding type size. Nevertheless, regulatory provisions exist in the Food and Drug Regulations that are directed at pharmacy labels (e.g. Use 2 g rather than 2.0 g and 2.5 g instead of 2.50 g to avoid confusion. When an ingredient has been removed from drug products in Canada because of safety concerns, it is acceptable to include a statement to the effect that a drug has been reformulated to omit that ingredient or that the drug product does not contain that ingredient. For enquiries,contact us. Published by authority of the Minister of Health, Date Adopted: 2013/11/01 Date Revised: 2015/06/13 Effective Date: 2015/06/13. Close Proximity: "means, with reference to the common name, immediately adjacent to the common name without any intervening printed, written or graphic matter" (Regulations, section B.01.001). Only once a label is required do other labelling requirements apply, such as a . The format of the label including the manner in which all of its text and any graphics are displayed on it, shall not impede comprehension of the information referred to in (a) above. Alternative Proteins: Navigating the Maze of U.S. Federal and State Meat Labeling Requirements. There are 3 basic sub-categories of non-prescription drugs: For those in category a) consumer-available non-prescription drugs where there is no requirement for professional intervention, the wording of the product labelling is especially important to ensure safe and effective use. If so, check the food-specific labelling requirements, as for some imported prepackaged products it is mandatory to state the country of origin. is consistent with applicable Health Canada guidance documents and policies; is consistent with the terms of market authorization for the drug product ( e.g. Unlike the labelling conventions for consumer-available non-prescription drug preparations, the dosage directions for prescription and parenteral preparations may often be expressed in terms of units of weight of drug per unit of body weight (e.g., mg/kg/day) or weight of drug per body surface area ( e.g. 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. Guidance for Industry: Product Monographs of Non-Contraceptive Estrogen/Progestin-Containing Products. This accompanying statement will reduce the risk of misleading consumers. Manufacturers/sponsors should clearly explain the therapeutic advantage. For labels showing a claim, indication or reference for a Schedule A disease, see section 2.7 of this guidance. A balance between fully informing the patient, and avoiding any unnecessary fear-inducing copy should be maintained for these products. The following table show several examples. A pharmacopoeial or manufacturer's standard cannot be used for these drug products. All product monographs submitted in a new drugsubmissions filed in the new Product Monograph (PM) format, as outlined in the Guidance for Industry: Product Monograph, must include a consumer information/patient medication information section regardless of the type of product (e.g., prescription, non-prescription, or professional use only) and location of sale (e.g., for hospital use or professional use only). With the new requirement to include a Part III, Consumer Information document for all new drugs in the new Product Monograph format (see the Guidance for Industry: Product Monograph), there is an increase in technical information that has to be explained to consumers. the information that is required by these Regulations to appear on the label shall be, readily discernible to the purchaser or consumer under the customary conditions of purchase and use, and, the format of the label, including the manner in which its text and any graphics are displayed on it, shall not impede comprehension of the information referred to in paragraph (. Textile labelling These provisions ensure that the product identity is clear and prevents inappropriate substitutions of one salt for another, where differences in the pharmaceutical or pharmacological properties may cause adverse effects. The concept of absolute maximum limits for a drug product is difficult to maintain due to the variation of patient circumstance, product use, and the constantly changing scientific environment. 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). The following subsections describe potentially misleading promotional terms that should not be used on drug product labels unless specific data, rationale or circumstances support such a claim, or the addition of appropriate qualifying statements justify the wording. 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). 3. Standard: a monograph for a drug substance (as the medicinal ingredient) or the drug product (as the finished dosage form) that lists specifications relating to nomenclature, identity, purity, potency, quality, physical properties, tests, assays, packaging, labelling, and storage requirements. The statement "Dextromethorphan provides a clinically proven cough relief" would be acceptable, whereas, the statement "Product Y is clinically proven" would not be acceptable. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Scientific evidence to support the statement should be available to the manufacturer/sponsor and submitted to the Health Canada upon request. This is especially important when there is not enough space on the label for more detailed drug information that may be required by the healthcare professional for the safe and effective use of the drug product. Health Canada considers that the term "extra strength" as useful information to the purchaser during product selection. The Health Canada approved brand name must be presented in a continuous, uninterrupted fashion on the label, and be clearly evident to consumers and healthcare professionals. Is it expressed using a household measure (HM) first, followed by the corresponding metric measure (MM) in parentheses, based on the food as sold? While the regulations are not retroactive in application, sponsors are expected to bring their labels into compliance with the new regulations at the first submission after June 13, 2015 which requires a label change. If the incidence of a particular side effect exceeds that for the placebo, the statement regarding the absence of side effects should not be used. European Commission, Directorate-General III Industry. Canada Product Labeling Requirements: An Overview - Compliance Gate are priority allergens, gluten and added sulphites declared using the prescribed source name or common names, as required? Drugs should be promoted in a positive fashion to provide the consumer with useful information. For Division 1 drugsFootnote 4, the brand name is the name appearing on the Drug Notification Form issued for the drug product and signed by the manufacturer/sponsor. in the case of a container that is mounted on a display card, that part of the label applied to all or part of the principal display surface of the container or to all or part of the side of the display card that is displayed or visible under normal or customary conditions of sale or use or to both such parts of the container and the display card, in the case of an ornamental container, that part of the label applied to all or part of the bottom of the container or to all or part of the principal display surface or to all or part of a tag that is attached to the container, and, in the case of all other containers, that part of the label applied to all or part of the principal display surface.". (See section C.01.011 (4) of the Regulations.) Labelling of Pharmaceutical Drugs for Human Use replaces the Health Canada guidance document Labelling of Drugs for Human Use. For further information, refer to the Regulations, section G.02.019 (c) for controlled drugs and section J.01.030 for restricted drugs. Prescription Products and Products Administered or Obtained Through a Health Professional As of June 13, 2015, and pursuant to C.01.014.1(2)(m.1) and C.08.002(2)(j.1), bilingual mock-ups of the final labels (including mock-ups of the inner and outer label and package), the package insert and the Product Monograph are required at the time of submission. The words "professed standard" should not be displayed on the labels. 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. 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. Refer to Section 5.4, "Prescribed and Parenteral Drugs," for further information. The manufacturer/sponsor should perform an analysis and risk assessment for any proposed product name to support its use. Guidance for Industry: Post Drug Identification Number (DIN) Changes, Guidance for Industry : Post Notice of Compliance (NOC) Changes, Guidance for Industry: Review of Drug Brand Names. Refer to the Health Canada policy document, Drug Identification Number: A Brand Name Product with Different Fragrances, Flavours or Colours, for more information. Health Canada suggests that drug product labels claiming one of the sugar alcohols specify the number of energy calories provided per dose. In addition to federal regulatory limits on the strength of some non-prescription drug products the provinces and territories may have further regulatory limits on the distribution of some drug products in their jurisdiction that may vary for each province and territory. These vials are not meant for direct injection. Is it in bold face type? Products Other than Prescription and Those Administered or Obtained Through a Health Professional The written text of proposed labels or in the case of a new drug, drafts of every label, are required at the time of submission in accordance with sections C.01.014.1 (2)(m) and C.08.002(2)(j). Some illustrative examples of proper names for ingredients versus products in final dosage form include the following: The standard of manufacture (e.g., United States Pharmacopoeia [USP], British Pharmacopoeia (BP), European Pharmacopoeia [Ph.Eur. 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. All graphics that are considered to be therapeutically content-related, directly or indirectly implying any therapeutic attribute must be shown on the draft label included in the original drug submission (see Section 2.10, "Final Labels"). Information for the Patient) section, the same label information as above is expected. The label may also require the declaration of the number of milliequivalents per total volume (mEq/volume) for each salt/electrolyte. Claims such as sweetener-free, artificial sweetener-free, and artificial sweetener X-free may be acceptable if true. Packaging and labelling requirements - ic Refer to the Industry Labelling Tool for further information on common name. Many of the drug products in the categories covered by this section which are not new drugs require that the directions for use be detailed in a document called "prescribing information" (see Section 5.4.5 of this Guidance Document). Prescribed: "means prescribed by the Regulations" (Section 2 of the Act). Meal plans (e.g., an aid for those taking cholesterol-lowering drug products); Patient diaries to record diet, exercise, weight loss; and. (except for alternate methods of presentation), not destroyed when product is opened? The label should also include a statement indicating that the drug product is to be used only on a physician's advice. To provide consistency, the use of the pattern: year, month and day established in the foods section of the Food and Drug Regulations is suggested. Since dosage units for some analgesics are standardized by regulation, the use of the term "extra strength" to describe higher strength per dosage unit products is permitted. The Distinction between Advertising and Other Activities. Reference to a therapeutic action as "complete" or "total" (e.g., complete relief) implies 100% efficacy, which is generally considered misleading for a drug product. Canadian name and principal place of business, grouped with the geographic origin, or preceded by the expressions "Imported by /. This can be achieved by printing in a repetitive manner or by embossing on the edge of each card. The amount of information provided should not exceed that required to arrive at a proper conclusion. This measure is to aid sponsors and the industry to create labelling and advertising in compliance with the Act and Regulations, particularly subsection 9(1) of the Act.
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