The manufacturer/sponsor can label these drug products in the customer's choice of language. those that may be sold freely to the general public without the intervention of a healthcare professional (e.g., consumer-available non-prescription drug products); those that may not be sold to the general public without the intervention of a healthcare professional (e.g., nitroglycerin) in accordance with the provincial and territorial regulations; and. The names of pharmacopoeiamay be abbreviated as indicated in Schedule B of the Act. Special benefits or advantages of the competitive product are generally omitted. Quantitative declaration of the medicinal ingredients; Delivery rate of the drug (e.g., X mg/hour). In some specific drug product areas, such as sunscreens, where a measurable standard of comparative performance is available (e.g., SPF, sun protection factor), these terms may be accepted in a product line to assist the consumer in product choice, in addition to the principle measure of effectiveness, the SPF, which is outlined in the appropriate Health Canada labelling standards and monographs (see Section 5.2.1). Proper or common name, and potency or quantitative list of the medicinal ingredients; Standard of manufacture where required by the. 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). The user is encouraged to consult the official version of the applicable legislation in the FDA and in the SFCA for the purposes of interpreting and applying the law. Descriptive wording and phrases to describe the activity, effects, attributes, formulation, or development of drug products should be chosen to ensure that the consumer can appreciate the actual situation.
Canada Product Labeling Requirements: An Overview - Compliance Gate To avoid violating subsection 9(1) of the Act, sponsors should describe such a product as a "new" or "improved" formulation. Refer to Section 5.4, "Prescribed and Parenteral Drugs," for further information.
Alternative Proteins: Navigating the Maze of U.S. Federal and State Food labelling Tools and guidance on how to properly label your food products. (See Appendix B). Only the names listed in the Regulations may be used (section C.01.040) in drug product labelling. See also Section 4.8, "Cosmetic Claims.". Any special directions for the preparation, reconstitution, administration, volume, rate and timing of infusion, mixing and incompatibilities with other medications, period of use after reconstitution, storage, special handling, and disposal. 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. HC Pub: 4285, Cat H128-1/06-453, ISBN 0-662-49001-0 Available on the Advertising Standards Canada Website at:
. 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). 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). 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. Proper name of ingredient: Acetaminophen; Proper name of drug product in final dosage form:Acetaminophen Capsules; Proper name of a drug product combination: Acetaminophen and Pseudoephedrine Hydrochloride Tablets. If so, is it present with the sweetener content declared? However, when a standard exists for the entire combination, then this standard must normallyFootnote 10 be declared on the main panel of the label. The Global Labelling Manager is responsible to detect/evaluate external safety signals (HA and originator updates) and to prepare/maintain CDSs, including supportive relevant documentation as needed. 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. In the case of children's dosage units, 160mg acetaminophen products may be described as "extra strength" even in the absence of an 80mg formulation in the product line. Recognized abbreviations for microgram are "g" and "mcg." 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. You will not receive a reply. However, subsection 14(2) allows the "distribution, under prescribed conditions, of a sample to physicians, dentists, veterinary surgeons, or pharmacists." Health Canada approved, Health Products and Food Branch (HPFB) approved, Therapeutic Products Directorate (TPD) approved; Registered (endorsed, promoted, acceptable or recommended) by Health Canada, (HPFB, TPD, or any other acronym commonly associated with Health Canada); or. Most prepackaged foods sold in Canada require that a label be applied or attached to it [B.01.003, Food and Drug Regulations (FDR); 214, 217, Safe Food for Canadians Regulations (SFCR)]. 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). Endorsements of drug products (e.g., "doctor recommended") by healthcare professionals, celebrities, and others are acceptable in labelling provided the endorsements are consistent with the expected actions and terms of market authorization and supporting data is available (where necessary), and there is no violation of the Act and Regulations. For prescription drug products, a doctor may decide a patient needs a particular drug product to treat a serious condition and wording in this context may be appropriate in the consumer information section of a prescription drug monograph (e.g., "Your doctor has determined that you need Product X to treat your blood infection Y"). In these instances, the NarcoticControl Regulations are the most stringent, followed by the Controlled Drug and Substances Regulations, the Benzodiazepines and Targeted Substances Regulations, and the Prescription Drug List. The address should be sufficiently complete so that Canada Post could deliver a letter mailed to that address. Lifestyle advice in support of a drug therapy (e.g., auxiliary methods to cope with a smoking cessation regimen). This type of claim requires prior review and approval as part of the market authorization for the product. 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. Both these documents are intended for use by a healthcare professional. However, it should be clearly indicated that the drug products being compared are the old and new formulations. "Clinically proven" can be used on labelling for an ingredient when a drug product contains more than one medicinal ingredient, including one or more whose efficacy in a given dosage form and indication is well recognized and documented in the literature. The overall context of the use of such qualified statements would be evaluated on a case-by-case basis. Labels for multiple-dose packs should include, at a minimum, the following information: The above information should be presented in a way that ensures that the package information is maintained and can be read after units have been removed. This may encourage the consumer to believe that only a higher dose of medication can provide adequate relief of the symptoms, when often the regular strength product will provide sufficient relief. Labelling Code of Practice: Designing Usable Non-prescription Medicine Labels for Consumers. 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. However, in a combination offer, such as a co-packaged non-prescription drug and non-drug product, the term "free" is acceptable with appropriate labelling (e.g., "Product Y free with the purchase of Product X"). Additional information is provided in the Health Canada policy document, The Distinction between Advertising and Other Activities listed in Appendix B. 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. Drug in Dosage Form: "means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing" (Regulations, subsection C.01.005 (3)). Labels should generally state the route of drug administration. However, in the consumer informationdocuments for drugs containing an ingredient listed in the Prescription Drug List that treat serious conditions (e.g., cancer), the realities of the condition must be explained to fully inform the patient of the risks and benefits and this text may well be disturbing. provided these claims do not conflict with the therapeutic understanding of the product. It is the manufacturer's/sponsor's responsibility to periodically update product labels to be consistent with current scientific information and medical treatment. Cautions shown within quotation marks in the Regulations must be printed verbatim. 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. Changes to Canadian natural health products labelling requirements See Section 3.4.3 of this guidance. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met. Manufacturers/sponsors are responsible for ensuring that final labels are clearly written, legible and consistent with the approved market authorization. Pharmacopoeial standards are for those drug products contained in the publications listed in Schedule B to the Act and for which no standardhas been prescribed in the Regulations. For further information, refer to the Regulations, section G.02.019 (c) for controlled drugs and section J.01.030 for restricted drugs. 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. Usually, only the advantages of the advertised drug product and the disadvantages of the competitive product are mentioned. The examples provided in this guidance are for illustrative purposes only and do not represent actual drug products. Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUIDE-0069). Testimonials or quotations from individuals on drug product labels frequently constitute an unfair and biased advantage. Canadian Standards Association, . The term may also be used in a non-therapeutic sense if adequately explained (e.g., antiseptic mouthwash with a cooling sensation flavour such as menthol). Labelling should clearly indicate that the product is a drug. The labelling requirements checklist was last modified in July 2022. Health Canada recommends that prior approval be obtained concerning the use of these statements for all drug products. The consumer, while competent to evaluate comparisons of taste, flavour, colour, and appearance, generally lacks the expertise and access to the supporting data required to evaluate the implications of comparisons about the therapeutic properties of drug products. The amount of information provided should not exceed that required to arrive at a proper conclusion. Drug products packaged in unpressurized containers operated by a manual pump spray device or any other containers that contain flammable ingredients should show a cautionary warning indicating flammable contents and appropriate directions for use (e.g., "Do not use near an open flame"). 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. It is also inappropriate to create fear of social embarrassment that may result from the consequences of a condition that may occur without the use of the medication (e.g., anti-diarrheal medications). In scope: Medicinal products (Generics) within Sandoz portfolio. This variation in the label statement will alert the pharmacist dispensingthe drug to provide the consumer information/patient medication information to the patient. The term "cooling" may be used in a therapeutic sense, if the drug product contains a medicinal ingredient for a therapeutic purpose such as "for cooling relief of sunburn" (e.g., topical anaesthetic with menthol or camphor). This accompanying statement will reduce the risk of misleading consumers. The Regulations require several cautionary statements, such as those for acetylsalicylic acid and salicylic acid. Summary of the new requirements The amendments will implement the following four key labelling requirements: Product Facts Table Certain important product information will need to be contained within a table in a standardized format, including: medicinal and non-medicinal ingredients, uses, warnings, directions for use, storage conditions, and or, foreign name and principal place of business is identified? Differences of opinion between experts regarding the truth and impact of the compared qualities are often undisclosed. This section refers to the standard to which a drug product is manufactured and represented. Consistent with the extra strength policy (Section 4.9.6), the list of medicinal ingredients on the product label should clearly identify the additional ingredients responsible for use of the term "advanced.". in a manner so that characters do no touch each other? 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. 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. in the correct width, height and use the correct leading? Global Labeling Manager | Novartis United States of America 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. Health Canada does not endorse the following documents and does not necessarily agree with their entire contents. In cases where the improvement refers to some non-therapeutic aspect of the formulation (e.g., taste, colour, texture), this should be specified. For enquiries,contact us. 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. Consumers and patients may be concerned about the health implications of certain medicinal and non-medicinal ingredients in drug product formulations (e.g., sugars, salts, sulfites). The expiration date should be expressed in full or in any manner that the general public or end user will clearly understand. are priority allergens, gluten and added sulphites declared using the prescribed source name or common names, as required? Refer to the Industry Labelling Tool for further information on date markings. Lot Number: "means any combination of letters, figures, or both, by which any food or drug can be traced in manufacture and identified in distribution" (Regulations, section A.01.010). In addition to the regulatory requirements for the labelling of injectable products which includes the declaration of preservatives, labelling should also state the following information: For all parenteral electrolyte salts, or salt/sugar combinations, the quantitative declaration for each ingredient in terms of weight (per volume or per container) and final concentration after dilution, must be shown on the labels. These products are available to and intended for use by a healthcare professional and are distributed to hospitals, clinics or directly to physicians, dentists, and other healthcare professionals. They are presented as sources of additional, useful information should the sponsor wish to further improve labelling, providing these improvements do not conflict with the Regulations and related guidance documents. Pursuant to provincial or territorial regulations, these drugs are kept behind the counter in pharmacies and must be distributed by a pharmacy healthcare professional (e.g., pharmacist). As the co-packaging of certain drugs products may imply certain unapproved claims, pose a safety concern, or require the filing of a New Drug Submission (NDS), manufacturers/sponsors should consult with Health Canada prior to marketing co-packaged products. In addition, the quantity should also be expressed in milliequivalents per unit of final volume for each element (ion). The Labelling Manager is responsible to prepare and maintain English core SmPC . one ingredient in a multi-ingredient drug product; one indication in a drug product treating several symptoms; a secondary attribute (e.g., non-drowsy); and. 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. additional commodity-specific requirements may apply to the product. The Charter of the French Language requires the use of French on product labeling, warranty certificates, product manuals and . Negations such as "non-toxic," "non-poisonous," or "non-allergenic" create an erroneous impression regarding the safety of a drug product. Assignment of Drug Identification Numbers (DIN) According to Product Name. The labels on these products must draw attention to the security feature of the package. it can be read after opening); consumers and patients are alerted to the location of the labelling information; and, placement of information does not otherwise contravene the, a telephone number, email address, website address, postal address or any other information that enables communication with a contact person in Canada; and. Except as otherwise provided in the Regulations, pursuant to section C.01.004(1)(c)(iv), the quantities of all medicinal ingredients must normally be declaredFootnote 9 on the inner and outer labels with the ingredients listed by their proper names or, if there are no proper names, by their common names. For further information, concerning the consumer information/patient medication information format, content and readability refer to the Guidance to Industry: Product Monograph. 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 Consumer Packaging and Labelling Regulations (CPLR) state: The alternate term, main panel has the same meaning as "principal display panel". When required use the country of origin declaration "Product of [Name the country of origin]". A manufacturer's/sponsor's use of a house standard on a label indicates that the drug product may differ in some respect from the pharmacopoeial standard. More appropriate wording would be, "Frequent side effects were headache and diarrhea." The adequate directions for use required to be shown on the inner and outer labels of a drug pursuant to section C.01.004 (1) (c) (iii) shall be in both the French and English languages if the drug is available for sale without a prescription in an open self-selection area. Qualifying statements, such as "external use only," may be required if there is a possibility that the pharmaceutical formcould indicate an alternate route of administration or cause confusion with other drug products (e.g., camphorated oil). The manufacturer/sponsor generated label should include a statement regarding the availability of this document, such as, "See consumer information [leaflet]" or "Pharmacist (or DoctorFootnote 8): Dispense with consumer information [leaflet]. Claims such as sweetener-free, artificial sweetener-free, and artificial sweetener X-free may be acceptable if true. Most non-prescription products treat symptoms of self-limiting conditions, not the condition itself. 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. Note: As of June 13, 2015, there are new regulatory requirements for prescription products and those administered or obtained through a health professional. Prescribing information that includes the indication must therefore be made available for physicians and pharmacists, and the label should state the availability of this document. (Regulations, section A.01.010) (CPLR). These terms may imply that the drug product is therapeutically better because it contains more of a certain ingredient, whereas the formulation remains within an effective therapeutic range to accomplish the same effect and data is not available to show any differentiation in effect based on different strengths. The use of such terms to describe novel or modified products is acceptable for one year. In addition to the general labelling requirements outlined in Sections 2 and 3, there is specific information that applies to parenteral drug products. If the caution or warning does not appear within quotation marks, the wording may be altered but the meaning must be retained. Labelling of Professional Samples of Drugs. Frequently Asked Questions - Guidance Document for Industry- Review of Drug Brand Names, Guidance Document: Questions and Answers: Plain Language Labelling Regulations. It is not mandatory to declare a standard for the drug product's ingredients. Health Canada's policy Non-medicinal Ingredients Nomenclature outlines the accepted nomenclature used in naming the non-medicinal ingredients in drug product formulations. Drug Identification Number: A Brand Name Product with Different Fragrances, Flavours or Colours. All labelling that is normally distributed with the regular package sizes should be distributed with samples, including the consumer informationdocument for all new drugsin the new Product Monograph format. Often these additions to labelling may imply some therapeutic benefit that is unauthorized for that drug product (e.g., a picture of a heart on a package of acetylsalicylic acid tablets may imply some vague, undefined therapeutic benefit for the heart). ", 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.". Certain drug product information, such as advertising, promotional material and general disease information are generally not considered to be drug product labelling and should not appear in the labelling and packaging material. 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)? Adequate directions for use should include the following information: In some cases, a pharmacological classification could suffice as an indication for use. (vi) the name of the manufacturer/sponsor of the drug, (vii) the expiration date of the drug, and. Highlighting a non-medicinal ingredient is also acceptable if the non-therapeutic purpose is clearly identified (e.g., Brand X first aid cream with moisturizing aloe).