A sampleof a drug product given to a healthcare professional and intended for subsequent distribution to a patient, must be labelled with the same directions required for the safe and effective use as for regular package sizes of prescription and non-prescription drug products. Section C.01.004. 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. For most product classes, these standards do not exist; therefore, these terms are unacceptable. Canada Product Labeling Requirements: An Overview - Compliance Gate In Section A.01.010 of the Regulations, the outer label includes any label affixed to the drug product packaging, such as a pouch, card, accordion label, or other construct. The following subsections provide guidance for the use of endorsements, testimonials, and quotations from the media or medical literature. , telephone number, email address, website address, postal address or other information that allows communication) and. Osmolarity is usually expressed in terms of mOsmol/L, or for volumes less than 100 mL, in terms of mOsmol/100 mL. Labels for single-dose packs should include the same information as labels for multiple-dose packs (See A), but if there is insufficient space, the expiry date may be omitted. 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. An example would be Product Y containing dextromethorphan and other ingredients that are not in any Health Canada labelling standard or monograph for pharmaceutical drugs, or in Category I, United States Federal Register. 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. 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. 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June 13, 2015, the regulatory requirement in C.01.014.3 to submit final labels after the drug is available for sale, is repealed. 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. Differences of opinion between experts regarding the truth and impact of the compared qualities are often undisclosed. 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]. Although the Act and Regulationsdo not define a "sample." 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. However, it should be clearly indicated that the drug products being compared are the old and new formulations. A pharmacopoeial or manufacturer's standard cannot be used for these drug products. (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. 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 term "Expiration" or its abbreviation "EXP." In most cases this formulation change is limited to either the addition of an ingredient to a formulation or to an increase in concentration of an ingredient. 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. Health Canada suggests that drug product labels claiming one of the sugar alcohols specify the number of energy calories provided per dose. For example, drowsiness is a side effect perceived to be frequently associated with the use of non-prescription cough and cold products. If claims for the drug product exceed the authorized claims for the components, or new claims are made on the concomitant administration of the drug and non-drug product, then the manufacturer/sponsor must file a drug submission for the new combined use. There have been photographs added to drug product labelling following review, which have been found to be misleading and in violation of the Act. The labelling of co-packaged drug products must include only those claims and indications that have been authorized for the individual drugs. Section 3 of the Act prohibits the labelling and advertising of a drug product to the general public, as a treatment, preventative, or cure for the diseases, disorders, or abnormal physical states, including synonymous names, listed in Schedule A of the Act. 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 sponsor is responsible for ensuring that the applicable non-therapeutic, comparative claims meet the requirements of Health Canada's policy. Quantitative declaration of the medicinal ingredients; Delivery rate of the drug (e.g., X mg/hour). Refer to the Industry Labelling Tool for further information on name and principal place of business. More appropriate wording would be, "Frequent side effects were headache and diarrhea." (Subsection 10(1)). There is no objection to the use of additional languages in product labelling (e.g., inserts), at the discretion of the sponsor, provided this does not obscure the readability of the label in either or both official languages, English and French. 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. If Part III (consumer information/patient medication information) is not part of the package insert and is distributed separately, then the following two statements should appear on the label: "See package insert" and "Pharmacist: Dispense with consumer information/patient medication information (leaflet).". Non-prescription Drug:a drug containing ingredients not listed on the Prescription Drug List and available without a prescription. 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. is the appropriate manner (volume, weight, count) for the product used? You will not receive a reply. The following expressions are considered acceptable to describe a manufacturer's standard: Where a standard for a drug has not been prescribed and no standard for the drug is contained in any publication referred to in Schedule B, no person shall sell the drug, unless: This section refers to non-official drug products for which no standard prescribed in the Act or Regulations or pharmacopoeial standard exists. 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). Memorandum D11-3-1 - Marking of imported goods 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 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. It is Health Canada's expectation that the manufacturer/sponsor supply the consumer information/patient medication information document to the pharmacist or doctor who will distribute this information to the patient/consumer. For drug products containing multi-ingredients (e.g., cold product with four ingredients) where the blister package label may not accommodate the quantitative amount of each ingredient as required by the Regulations, the use of a brand name unique for a particular potency is acceptable. No undue emphasis on the statement about the absence of side effects is presented in labels or advertising. 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. To avoid violating subsection 9(1) of the Act, sponsors should describe such a product as a "new" or "improved" formulation. is the wording grouped with the date or does it clearly explain the date if located elsewhere on the label? The terms "high" and "low" generally imply unidentified comparisons and standards against which a drug product must be measured. In scope: Medicinal products (Generics) within Sandoz portfolio. Refer to the Industry Labelling Tool for further information on sweeteners. Lot No., Lot, L.), and must appear on any panel of the inner and outer labels (section C.01.004 (1) (c) (ii)). (1) (c) (iii)). Product-specific data showing that a product meets this seal of approval is not expected with a drug product submission submitted for review but must be available on request. However, regarding drug product labelling, Health Canada recommends that the abbreviation "mcg" be used. The checklist only covers core labelling requirements applicable to all foods. In addition to the general labelling requirements outlined in Sections 2 and 3, there is specific information that applies to parenteral drug products. Labels should generally state the route of drug administration. The following subsections describe different types of negative terminology. 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. Labelling material containing non-drug product information (e.g., general disease information), should be submitted to Health Canada for review. Changes were made to the document to reflect amendments to the Food and Drug Regulations: Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) which came into force on June 13, 2015 for prescription products and those administered or obtained through a health professional. Special labelling considerations are outlined below in the following section for these products. 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"). 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). in a manner so that characters do no touch each other? those that are sold directly to healthcare professionals and institutions and intended for professional use only (e.g., contrast media, some anesthetics). Canada Product Labeling Requirements: An Overview Posted on March 25, 2021 by Vincent Cheng Leave a comment Understanding labeling requirements is essential for Canadian importers and manufacturers. do the characters appear in upper case / lower case as required? If the caution or warning does not appear within quotation marks, the wording may be altered but the meaning must be retained. This guidance document reflects the new requirements set out in the above amendments as well as comments from stakeholders received during the consultation period for the Plain Language Labelling amendments, which took place from July to September 2014. There was substantial input from industry and industry associations representing innovator and generic companies as well as Health Canada employees. They should not be advertised, labelled, or recommended to the general public for self-medication (e.g., drugs where the dosage exceeds the limits of section C.01.021 and drugs intended for the treatment of diseases listed in Schedule A of the Act). Frequently Asked Questions - Guidance Document for Industry- Review of Drug Brand Names, Guidance Document: Questions and Answers: Plain Language Labelling Regulations. The labelling of small containers is exempt from many of these 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. This material may not reflect the entire data package supporting the drug product and may represent the isolated opinion of the author or a biased selection of data; therefore, sponsors should avoid using quotations on drug labels. Revised as of 1 April 2008, 21CFR201.66. February 2006. For example, if the proper name of the drug product is Chloramphenicol Palmitate Oral Suspension and the strength is expressed in terms of milligrams per millilitre of the chloramphenicol, then an acceptable quantitative declaration of the medicinal ingredient would be "Chloramphenicol 30 mg/mL as Chloramphenicol palmitate". These separate package labels generated by the manufacturer/sponsor may be included in the packaging or supplied to the consumer at the time of dispensing. Manufacturers/sponsors wishing to use the term "antioxidant" should use adequate wording to make a more specific, therapeutically meaningful claim and provide substantiating data to support the claim. 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. have the ingredients been declared using an appropriate common name? 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. The lot number may be any combination of letters, figures, or both (section A.01.010 of the Regulations) by which a drug product can be traced to the manufacturer/sponsor and, if applicable, to the distributor or importer. ", Proper Name: "means, with reference to a drug, the name in English or French. have evidence available to support the cosmetic claim. 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. In these instances, the dosage form should be clearly labelled to reflect the combination. For prescription products and those administered or obtained through a health professional, as of June 13, 2015 there are new regulatory requirements under C.01.014.1(2)(o) and C.08.002(2)(o) for submissions regarding product names. In these situations, the declared absence of one sweetener should be accompanied by the equally prominent declaration of the actual sweetener used. 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"). Marking and Labeling Imports: Canada's Rules | PCB However, many manufacturers/sponsors choose to voluntarily include a package insert or Part I of the PM with the drug product as a convenience to the healthcare professional, particularly if special directions are required to prepare the product for dispensing (e.g., an injectable product requiring reconstitution). 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. All stakeholder comments were considered in the finalization of this guidance document. 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. Inner Label: "means the label on or affixed to an immediate container of a food or drug" (Regulations, section A.01.010).
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