are ingredients in descending order of proportion by weight? gaining access to these labels does not destroy or harm the integrity of the labelling (i.e. 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). There should be no direct or implied new therapeutic use for the cross-promoted products that may exceed the terms of market authorization for each of the individual products. See Section 3.4.3 of this guidance. In addition, special labelling may be required to show the total osmolar concentration of the final formulation. delayed-release or extended-release), the modified-release product should be considered a Professed Standard ( i.e. For example, "For subcutaneous use only" is preferred over a negative statement such as "Not for intravenous use." 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. 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 expressions "low salt," "low sodium," "suitable for low sodium diets," or "suitable for restricted sodium diets" are acceptable if the daily amount of sodium provided by the drug product is 25mg or less. 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 products that are not declaring the USP standard, sponsors should provide the qualitative declarations of the complete formulation of parenteral preparations in all cases. Some drug products require a qualification on repeat doses (e.g., "may be repeated in X hours if required"). Consistent with the use of "extra strength" (Section 4.9.6), the added ingredient or ingredients referred to or responsible for the use of the terms "complete" or "total" must be clearly identified as the medicinal ingredient(s) on the label to clearly differentiate this drug product from the reference product. Some consumers are concerned with the intake of certain non-medicinal ingredientsin drug formulations (e.g., salt and sugar). Lot No., Lot, L.), and must appear on any panel of the inner and outer labels (section C.01.004 (1) (c) (ii)). may be included on the label provided that the metric units are also present. 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 term "advanced" in a drug product name is acceptable in a therapeutic sense if the advanced product treats a wider range of symptoms or has an additional medicinal ingredient compared to a reference drug product in the same product line. Teaspoon: "means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres" (Regulations, section C.01.001). owns the DIN). The one exception to the above interpretation is when the narcoticpresent in the combination is codeine in an amount that does not require a prescription (e.g., 8 mg). . As noted in Section 4.9.6.1 of this guidance, a series of multiple ingredient products containing analgesics such as acetylsalicylic acid in 500 mg, 650 mg, and 1000mg strengths should use different brand namedescriptors such as "extra strength," "super strength," and "ultra strength" to differentiate the strengths in a multi-ingredient product line or product line extension (see Appendix A: Definitions). (vi) the name of the manufacturer/sponsor of the drug, (vii) the expiration date of the drug, and. Healthcare professionals (e.g., doctors) may distribute this auxiliary information (e.g., PAAB reviewed material) independently of the drug product package information, at their own discretion. A claim indicating the absence of this side effect for a drug product within this product class, would be acceptable provided all other conditions are met. The declaration of the medicinal ingredient should reflect how the strength of the drug product is expressed. 44, no. 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. For some prescription drug products there is no accurate consumer language to describe some conditions; therefore, the original technical language must be maintained, while attempting to explain the condition in a way the consumer would understand.
Labelling requirements - Canada.ca for which a standard is provided in these, for which no standard is provided in these. Information for the Patient) section, the same label information as above is expected. 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"). 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. Section 201.56 Requirements on Content and Format of Labelling for Human Prescription Drug and Biological Products. No person shall sell any food, drug, cosmetic or device. Proper or common name, and potency or quantitative list of the medicinal ingredients; Standard of manufacture where required by the. is the information on any label panel except solely on the bottom (except ornamental containers)? For further information on the type of contact information and language to be included, see section 2.1.2 of this Guidance. Drugs should be promoted in a positive fashion to provide the consumer with useful information. Statements regarding the absence of side effects should be submitted via the Post-NOC Changes process for new drugs and via the Post Drug Identification Number (DIN) Changes process for drugs that are Division 1 drugsFootnote 13. For example, ISED's regulations require that certain product related information such as fabric content of apparel be shown on a . These standards and monographs provide basic information on: acceptable indications, uses, medicinal ingredient identities, strengths, dosages, warnings,and precautions to help ensure the safe and effective use of products that fall within the standards. The route of administration (e.g., intravenous, subcutaneous); If no preservatives are present, wording such as "Single use. This document also reflects revisions made as a result of the Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations) which provided for the repeal of Schedule F and incorporation by reference of a list of prescription drugs. 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. have the correct units and %DV (percent Daily Value) been used, when permitted/required? Pharmacy bulk vials are large volume vials containing multiple doses and are intended for a pharmacy admixture program to create infusion mixtures or transfer to empty sterile syringes. The use of "unique" would require justification and documentation to demonstrate the therapeutic advantage and would be evaluated on a case-by-case basis. The following patterns to express the expiry date are optional; however, Health Canada recommends this format in drug product labelling: As provided in section B.01.007of the Regulations, the following two-letter abbreviations for the months are acceptable in both official languages: JA, FE, MR, AL, MA, JN, JL, AU, SE, OC, NO, DE. Quantitative declaration of the medicinal ingredients; Delivery rate of the drug (e.g., X mg/hour). Health Canada suggests that drug product labels claiming one of the sugar alcohols specify the number of energy calories provided per dose. The term "non-narcotic" on a drug product label may negatively imply that other drugs in the same class are narcotizing, or have a potential for abuse, when this may not be the case. The term must be examined in the total context of the labelling. Code of Federal Regulations, Title 21, Volume 4. The therapeutic benefit(s) should be specified in the labelling whenever this term is used. For any prescription drug product where substantial product preparation may be required by the healthcare professional before dispensing (e.g., reconstituting parenterals), sponsors/manufacturers should consider including the prescribing information as a package insert. all regulatory requirements concerning the label have been met and the bar code information does not change the terms of market authorization for the product; and. This text requires an ability to evaluate two different comparisons and assess their significance, which may be difficult for some consumers. Where a drug product is required to be sterile by the Regulations (section C.01.065), then the notation "sterile" "(strile)" must normallyFootnote 6 be shown on the principal display panel of the inner and outer label in accordance with section C.01.004 (1) (a) (v). proper name) for this ingredient as outlined in section C.01.002 of the Regulations. Cautions shown within quotation marks in the Regulations must be printed verbatim. Health Canada generally considers labels affixed by pharmacists to fall under the practice of pharmacy and therefore be regulated by the provinces and territories. 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. Pursuant to section C.01.004 (1) (c) (iii) of the Regulations, drugs must carry adequate directions for use on the labels. If an immediate-release drug product is listed in a Schedule B publication and there is not a Schedule B monograph for the modified-release form of the product (e.g. Common Name: "means, with reference to a drug, the name in English or French by which the drug is, Drug: "includes any substance or mixture of substances manufactured, sold or represented for use in, Dosage Form: A drug product that has been processed to the point where it is now in form which may be administered in individual doses.Footnote 15. However, claims for the absence of a particular artificial sweetener (e.g., "aspartame-free") may be misleading if it is not revealed to the consumer that the drug product may contain another artificial sweetener (e.g., acesulfame potassium). Using pictures, charts, graphs, statistics, and symbols in labelling can often be misleading as to the use, merit, and character of a drug product and should be avoided. 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). The term standard can be applied to a drug product or to an ingredient. 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. Failure to disclose the lack of real therapeutic advantage is often deceptive. Health Canada will issue two separate DINs to emphasize the difference in drug product identity. (iii) the net content of the drug if it is not in a discrete dosage form.
Canada - Labeling/Marking Requirements | Privacy Shield For all new drug products in the new format, the consumer information/patient medication information document (i.e. (1)(c)(v)). 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. Mandatory label information The use of the term "new" for more than one year of product sale is considered to be misleading. The use of the term "plus" in the brand name or as a label descriptor is acceptable in a drug product line that contains a reference product and where the "plus" product contains an additional amount of one or more ingredients or an added medicinal ingredient that provides an additional therapeutic benefit. Directions to examine the solution for drug product integrity before use such as "mixture (solution) should be inspected visually for clarity, particulate matter, precipitation, discolouration, and leakage prior to administration whenever solution and container permit." 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. The names of pharmacopoeiamay be abbreviated as indicated in Schedule B of the Act. Where a standard has not been prescribed for a drug, but a standard for the drug is contained in any publication referred to in Schedule B, no person shall package, label, sell or advertise any substance in such a manner that is likely to be mistaken for that drug, unless the substance complies with the standard. Child Resistant Package: "means a package that meets the requirements of subsection (2)" (Regulations, section C.01.001). Claims such as sweetener-free, artificial sweetener-free, and artificial sweetener X-free may be acceptable if true. (See Appendix B). The checklist only covers core labelling requirements applicable to all foods. professional information) for new drug products not conforming to the new Product Monograph format or for products not subject to Division 8 of the Regulations should contain at least the following: Manufacturers/sponsors can use the above format when updating old prescribing information documents, creating new prescribing information documents where none previously existed, or when this information does not have to be incorporated into the new Product Monograph format. ", For a new drug, subject to the requirements of Part C, Division 8, of the Regulations, the inner and outer labels should include a statement regarding the availability of the Product Monograph, such as, "Product Monograph available on request.". For more information on voluntary claims or statements and commodity specific labelling requirements, visit the Industry Labelling Tool. When a drug product contains a combination of ingredients from two or more of the schedules or ingredients listed in the Prescription Drug List, only the scheduling symbol corresponding to the more stringent control is required on the label. If dilution is required, the directions for performing the dilution. "For intravenous injection") or other product attributes are generally discouraged in consumer labelling and most product monographs, prescribing information documents and prescription labels. Sponsors can refer to their own standards as house, firm, or manufacturer's standard. Pursuant to section C.01.004 (1) (a) of the Regulations, when a drug producthas a proper or a common name, this name must appear on the main panel of the inner and outer labels. The following additional labelling is required for pharmacy bulk vials: To be shown prominently, preferably on the main panel of the label: In accordance with Federal Legislation, there are some unscheduled non-prescription drug products that do not require a prescription as a condition of sale but are generally prescribed by a medical practitioner. It is not applicableto disinfectants, drug products for veterinary use, drug products used in clinical trials, drug products regulated solely as natural health products subject to the provisions of the Natural Health Products Regulations, and radiopharmaceuticals and biological drug products as listed in Schedules C and D of the Food and Drugs Act. Drug products that contain salts for oral use (e.g., potassium chloride for oral solution) or combinations of salts for oral use (e.g., oral rehydration solutions, electrolyte replenishers) should include the quantitative declaration in terms of weight of each medicinal ingredient per container, and weight per final volume after dilution. In this case, the name in the Regulations takes precedence and if it meets USP requirements, the final product is labelled in Canada as Acetylsalicylic Acid Tablets USP. Drug Identification Number: A Brand Name Product with Different Fragrances, Flavours or Colours.
Global Labeling Manager | Novartis United States of America 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. Bar codes may be used on a drug product label for appropriate purposes (retail inventory, tracking, confirmation of identity, or potency) provided that: See Appendix C of this guidance for further information. New scientific evidence may increase or decrease acceptable dosages depending on circumstances, and each drug product is evaluated on its own merits and the specific conditions indicated.
Food Product Labelling - Retail Council of Canada However, regarding drug product labelling, Health Canada recommends that the abbreviation "mcg" be used. Part A is more general and refers to the labelling of food and drug products, whereas parts C, D, G, and J refer to drug products only. Pursuant to section A.01.065 of the Regulations, drug products intended for ingestion, inhalation, or insertion into the human body, mouthwashes, or drug products intended for ophthalmic use, must be contained in a security package if the drug product is available to the general public in an open selection area. Label statements such as "sugar-free" are acceptable only for those drug products that do not contain any of the chemical classes of sugar, including sugar alcohols. 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. In addition to the general labelling requirements outlined in Sections 2 and 3, there is specific information that applies to parenteral drug products. Guidance on appropriate storage conditions assists patients, consumers and healthcare professionals in maintaining product quality and safety. The name of the contact person does not need to be listed. 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. 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). The evidence would consist of data from well-designed clinical trials, including sufficient sample sizes and adequate control groups, such that a significance level of 0.05 is attained and the study meets the 80 to 90% power test for excluding Type I and Type II errors. The Labelling Manager is responsible to prepare and maintain English core SmPC . Numerous labelling standards and monographs for general drug product classeshave been developed for the common consumer-available non-prescription drug products and are available on the Health Canada website. Refer to the Industry Labelling Tool for further information on date markings.
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