However, exceptions to this general interpretation are described in the following two subsections. For example: In clinical studies, frequent side effectsobserved more often with Ingredient X than the placebo (sugar pill), were headache and diarrhea. Refer to the Health Canada policy document, Drug Identification Number: A Brand Name Product with Different Fragrances, Flavours or Colours, for more information. is the information in the list of ingredients displayed: on a panel other than the bottom? If the expiry date includes the year and month, the four digits of the year and two letters of the month (e.g., 2009 AL), If the expiry date includes the year, month and day, the four digits of the year, the two letters of the month and the two digits of the actual day of the month (e.g., 2009AL30). 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 mock-ups are not draft labels but should reflect the final label which, once approved, will be used to market these products. The postal code should be included in all cases. Definitions 2.1 Container 2.2 Dealer 2.3 Label 2.4 Prepackaged product 2.5 Principal display panel 2.6 Principal display surface Labelling 1. 11, May 26, 2010, SOR.2010-105, May 13, 2010. 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 (. Some indications for use may be evident in the trade name of the drug product, (e.g., "Brand X Sunscreen"). 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. For example, a combination cough/cold product containing acetaminophen, pseudoephedrine hydrochloride, and chlorpheniramine maleate should indicate at least one symptom treated by each of these ingredients. However, there are some drugs (e.g., new drugs) that require a product monograph if they have received market authorization through the issuance of a Notice of Compliance (e.g., Plan B). Claims such as sweetener-free, artificial sweetener-free, and artificial sweetener X-free may be acceptable if true. For small inner labels of these products, where space is limited, abbreviated statements such as "dilute before use" may be used. Labelling of Pharmaceutical Drugs for Human Use replaces the Health Canada guidance document Labelling of Drugs for Human Use. Guidance documents are meant to provide assistance to industry and healthcare professionals on how to comply with governing statutes and regulations. The substantiating data should include results derived from measurable, objective parameters, where feasible. Product Class: for the purpose of this guidance, a product class consists of drug products indicated for the same condition or range of symptoms, and sold under similar regulatory requirements. (1) (c) (iii)). 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. 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. Where the strength is expressed in terms of the salt, the same salt is used as the common name for the drug product. No person shall sell any food, drug, cosmetic or device. Guidance for Industry: Product Monograph. It may be misleading to build unwarranted expectations in the consumer's mind by the use of success stories. 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. 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. 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. 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. are ingredients in descending order of proportion by weight? Single-dose packs, such as: sachets, pouch-type packs, individual dose vials of liquid or pre-packaged syringes. Internal Use: "means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane" (Regulations, section C.01.001). mg/m2/day). Non-prescription Drug:a drug containing ingredients not listed on the Prescription Drug List and available without a prescription. 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. (except for single-serving containers), placed so that product will not leak or be damaged in order to view the, standard format: all foods and certain assortments, simplified format: 6 or more of calories and core nutrients =0, simplified format - single-serving prepackaged products, dual format: foods requiring preparation/different amounts, aggregate format: different kinds/different amounts, infants 6 months of age or older but less than 1 year of age. The manufacturer/sponsor is responsible for having data available on file to support these non-therapeutic claims. Any auxiliary labelling material that exceeds the limits of market authorization for the drug product, such as representing new claims or indications, should be submitted to Health Canada for review. 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). Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective. Refer to Section 5.4, "Prescribed and Parenteral Drugs," for further information. 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. Pursuant to sections C.01.004 and C.01.005 of the Regulations, the principal display panel of aninner and outer label must normally showFootnote 1the following information: Pursuant to section C.01.004 of the Regulations, the following information must normallyFootnote 2 be displayed on any panel of the inner and outer labels: The following information is to be displayed on any panel of the outer label: For prescription pharmaceutical products and those products administered or obtained through a health professional, section C.01.004.01(1) requires that. (except for alternate methods of presentation), not destroyed when product is opened? Co-packaged products should be appropriately labelled, as outlined in Section 3.6.1, "Co-packaged Products.". 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. Both these changes do not justify the use of the terms, where there is no proven therapeutic benefit for them. 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). Special benefits or advantages of the competitive product are generally omitted. Although the pharmacological classification may replace specific indications on the drug labels, in cases where indications are specified, the dosage directions applicable to each indication or a dosage range encompassing all the indications should appear where possible. Brand Name: "means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership, or individual, in English or French. The Labelling Manager is responsible to prepare and maintain English core SmPC . Pursuant to section C.01.010 of the Regulations, where mention of the condition is necessary to provide adequate directions for the safe use of a parenteral drug product or a drug containing an ingredient listed in the Prescription Drug List (i.e. For labels showing a claim, indication or reference for a Schedule A disease, see section 2.7 of this guidance. A prescribed standard is a standard prescribed by the Regulations. Final labels (in English and/or French) should accurately represent the marketed labels, including final complete text, text layout, font size, and text order as well as any other symbols, pictures, notations, diagrams, graphs, pictorials, logos , and visible marks which could be considered therapeutic label content (e.g., pictures of electroencephalography or [EEG] recordings). Refer to the Health Canada policy document Labelling of Professional Samples of Drugs. Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-001). This includes drugs that. (See section C.01.011 (4) of the Regulations.) However, some containers are too small to show all the information required by the Act and Regulations. 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. The use of "unique" would require justification and documentation to demonstrate the therapeutic advantage and would be evaluated on a case-by-case basis. 2004, Communication Research Institute of Australia (CRIA), . This use of "g" may be difficult to see in some print and size formats and might be misread as the prefix "mg.". The common name of a drug substance is a name chosen by a respected body responsible for drug nomenclature, often with international recognition (e.g., International Non-proprietary Name [INN], United States Adopted Name [USAN], and British Approved Name [BAN]). Where a package of a drug product has only one label, that label must carry all the information required on the inner and outer labels (section C.01.006). 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. There was substantial input from industry and industry associations representing innovator and generic companies as well as Health Canada employees. The following table show several examples. All stakeholder comments were considered in the finalization of this guidance document. is consistent with applicable Health Canada guidance documents and policies; is consistent with the terms of market authorization for the drug product ( e.g. Is it expressed using a household measure (HM) first, followed by the corresponding metric measure (MM) in parentheses, based on the food as sold? (for example. number of tablets); and. Part III of the Product Monograph, Consumer Information/ Patient Medication Information, is considered to be the complete and sufficient product information. The words "professed standard" should not be displayed on the labels. For exceptions to section 3(1) of the Act, please refer to section 2.7, "Schedule A Claims," of this guidance. provided these claims do not conflict with the therapeutic understanding of the product. Manufacturers/sponsors are encouraged to promote drug products on their own merits in a positive manner instead of by comparison with other products. 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." Manufacturers/sponsors should consider whether repeating the information would be useful in administration of the drug product. There are only a few drug products that can be considered "advanced" and labelled as such to the general public. 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. 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. Abbreviations used exclusively to describe routes of administration (e.g., "i.v." If the drug product received market authorization as a Division 1 drug1, a new application for a Drug Identification Number (DIN) should be submitted and prior approval is required before the new name can be used. For example, 500 mg, 650 mg, and 1000mg acetaminophen products could be progressively described as "extra strength," "super strength," and "ultra strength" to differentiate these products. If so, is it present with the sweetener content declared? A manufacturer/sponsor cannot claim to meet a previous version of the pharmacopoeial standard. cannot declare a pharmacopoeial standard). contrast media for magnetic resonance imaging (MRI) and other imaging agents; dental-use hemostat agents to stop bleeding in dental surgery; dental antiseptic solutions for administration by dental professionals; and. The declaration must be in both English and French. Health Canada recommends that positive statements should be used on labels to avoid ambiguity, wherever possible. 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." Teaspoon: "means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres" (Regulations, section C.01.001). 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. Where a pharmacopoeial standard has been updated and the manufacturer/sponsor has been declaring that standard for that drug product or ingredient, it is the manufacturer's/sponsor's responsibility to update the processes and specifications of that product or ingredient, and to submit the appropriate submission where required. in a manner so that characters do no touch each other? 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)). Therapeutic claims are those related only to the therapeutic aspects of the drug product (e.g., therapeutic actions, efficacy, speed of action, symptom relief). 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. The following checklist is a self-assessment tool to help industry understand labelling requirements set out in the Food and Drugs Act (FDA) and Regulations and the Safe Food for Canadians Act (SFCA) and Regulations. 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). Labels should generally state the route of drug administration. 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. Failure to disclose the lack of real therapeutic advantage is often deceptive. Consumer-available non-prescription drugs products, intended for self-treatment by the general public, must carry sufficient information on the labels for an individual to use the medication properly without consulting a healthcare professional. This text requires an ability to evaluate two different comparisons and assess their significance, which may be difficult for some consumers. The volume of liquid that can be withdrawn for administration after reconstitution should also be declared. (See Appendix B). (Administered by Measurement Canada, an agency of Industry Canada). Changes to Canadian natural health products labelling requirements Similarly, such terms may not be appropriate in the consumer labelling of prescription drugs, if considered to be unduly alarming or an exaggeration of the medical condition. Frequently Asked Questions - Guidance Document for Industry- Review of Drug Brand Names, Guidance Document: Questions and Answers: Plain Language Labelling Regulations. 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. For additional information see Section 4.2, "Absence of Ingredients," and Section 4.3, "Absence of Side Effects.". However, it is recognized that some negative statements in warnings are very effective and will continue to be used (e.g., "Do not take Drug Product B while taking Drug Product A"). Food Product Labelling - Retail Council of Canada The use of terminal (trailing) zeroes following a quantitative declaration of the medicinal ingredient should be avoided. Food Product Labelling Recent Updates Health Canada publishes updated guidance on front-of-package nutrition labelling May 10, 2023 Health Canada has published their updated Front-of-package nutrition symbol labelling guide for industry (Version 2) (Guidance). or, foreign name and principal place of business is identified? These regulatory amendments come came into force on June 13, 2015 for prescription products and products which are administered or obtained through a health professional. 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. 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. This reference may be acceptable in terms of Good Manufacturing Practices, if it is clearly explained. The sponsor is responsible for ensuring that the applicable non-therapeutic, comparative claims meet the requirements of Health Canada's policy. Seals of approval on the labelling of certain drug products issued by independent professional bodies (e.g., Canadian Dental Association) may be acceptable if the written material explaining the exact nature of the endorsement has been provided to TPD for review and the products in the product class meets the independent product recognition based on certain criteria. 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). Where more than one name appears on the label, each person mentioned may be held responsible for compliance with the requirements of the Act and Regulations. For example, "For subcutaneous use only" is preferred over a negative statement such as "Not for intravenous use." Examples include: a) Cathartics are not to be used by children under six years of age b) Antihistamines that are known to cause drowsiness should be labelled so they are not to be used by individuals while operating machinery. 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. The brand name must be consistent on all labelling. 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. 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. ", It is generally inappropriate to label any non-prescription drug product as "free." Refer to the Industry Labelling Tool for further information on date markings. Manufacturers/sponsors should exercise caution when presenting comparative statements to the public to avoid being in contravention of subsection 9(1) of the Act. The following subsections provide guidance for the use of endorsements, testimonials, and quotations from the media or medical literature. Guidance Document - Annex 13 to the Current Edition of the Good The word "new" may be used to describe a drug product that is marketed under its present brand name for the first time in Canada, or in a different version of an existing preparation (e.g., a new pharmaceutical form or strength). The labelling requirements checklist was last modified in July 2022. 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. This accompanying statement will reduce the risk of misleading consumers. It is the manufacturer's/sponsor's responsibility to ensure that any proposed brand name will not cause potential confusion with another brand name, common or proper name. Herbs used as Non-medicinal Ingredients in Non-prescription Drugs for Human Use. 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. For example, phenylpropanolamine as a non-prescription oral decongestant has been removed from drug products in Canada because of safety concerns. proper name) for this ingredient as outlined in section C.01.002 of the Regulations. 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). USP Nomenclature Policy: Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations.USP Pharmacopeial Conventionwww.usp.org/USPNF/notices.general Chapter1121.html. - For example. 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.". The term "Expiration" or its abbreviation "EXP." 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.". Where a manufacturer/sponsor of a prescription drug product chooses to list nonmedicinal ingredients on the label (optional), then the non-medicinal ingredients should be similarly and clearly identified by the common or proper name and identified as nonmedicinal or inactive ingredients. These factors should not impact the readability of the labels. Therefore, informative or qualifying statements regarding these ingredients may be acceptable. In cases where the improvement refers to some non-therapeutic aspect of the formulation (e.g., taste, colour, texture), this should be specified. [1] Plant-based proteins and cultivated cells are two promising alternatives that are quickly gaining popularity . Terms such as "amazing," "astounding," "fantastic," "remarkable," "wonderful,", and other superlativeterminology are considered inappropriate in drug product labelling. 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. 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. (. In other words, obtaining this critical information does not require the opening or destruction of any outer label, the opening of an accordion label, the opening of a panel, or the opening of the carton itself to gain access to information on the inside.
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