Marketing, Manufacturing, Packaging & Labeling, Advertising
The ins and outs of the marketing, manufacturing, packaging & labeling, and advertising in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products?
The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are mentioned in Regulatory, Pricing and Reimbursement Overview , Question 3.
2. What is the authorization process for the marketing of generic versions of these products?
Manufacturers of generic products can submit an abbreviated authorization submission (the ANDS) to Health Canada to receive a NOC. An ANDS must include evidence of pharmaceutical and biological equivalence and have the same route of administration and conditions of use as those of the Canadian Reference Product. See Regulatory, Pricing and Reimbursement Overview , Question 6.
3. What are the typical fees for marketing approval?
See Regulatory, Pricing and Reimbursement Overview, Question 4.
4. What is the period of authorization and the renewal process?
See Regulatory, Pricing and Reimbursement Overview, Question 5.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Drug manufacturers are required to report any serious adverse drug reactions that have occurred in Canada within a prescribed period of time as well as unexpected serious adverse reactions that occurred outside of Canada.
Similarly, medical device manufacturers and importers are required to each report any incident that occurred within Canada involving a device that relates to a failure of the efficacy of the device in whole or in part, any inadequacies related to labelling, and any incidents which led to the death or deterioration of the health of a patient, user or other person (or could do so were it to recur). Manufacturers and importers are also required to report incidents which occurred outside of Canada if they resulted in corrective actions.
6. Are foreign marketing authorizations recognized?
Foreign marketing authorizations are not recognized in Canada with respect to marketing authorization of drugs and biologics.
Foreign market authorizations of medical devices are recognized as long as the applicant is governed by a regulatory authority that is recognized by the Minister, and the application is accompanied by a certificate of compliance and a supporting summary report, issued by a conformity assessment body of the recognized country, which certifies that the medical device meets the applicable safety and efficacy requirements of the Medical Devices Regulations.
7. Are parallel imports of medicines or devices allowed?
The Food and Drugs Act and its regulations do not provide for parallel imports. Nonetheless, because the regulations require that both the inner and outer label of a drug display the imported product’s identification number (i.e. the DIN) assigned by Health Canada, parallel importation is not legally possible.
The parallel importation regime for trademarks in Canada follows the international exhaustion model.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
The acceptance of gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners is governed in Canada by both domestic and foreign bribery and fraud laws, healthcare professionals’ codes of ethics, and industry standards such as the Innovative Medicines Canada Code of Ethical Practices.
Programs, services, and activities provided by industry must not be offered nor provided to health care professionals, medical practices, their agents or healthcare facilities as an incentive to gain access to a medical practice to hospital formulary listing. They cannot be offered as an obligation, as undue inducement to prescribe particular prescription medicines in exchange for recommending for use, or in a manner that could be construed as a gift.
Moreover, any payment made must not be intended to cover acts or tasks that are part of the health care professional’s standard of care or which are covered as part of the healthcare system’s reimbursement process.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The manufacturing of medicines and devices is regulated through the issuance of Establishment Licences (i.e., DELs) for drugs and biologics and medical devices by Health Canada. Establishments must comply with GMPs.
See Regulatory, Pricing and Reimbursement Overview, Question 3.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
Yes, there is a requirement to comply with GMPs in the Food and Drugs Regulations.
11. What is the inspection regime for manufacturing facilities?
Part of the Health Canada Inspectorate program is to conduct inspections of establishments that are involved in activities covered by the Establishment Licencing framework. These inspections are conducted to verify the compliance with, among others, GMPs, good pharmacovigilance practices, and labelling standards.
See Regulatory, Pricing and Reimbursement Overview Question 8.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Yes. There is a cooperation agreement between Health Canada and the FDA that allows the respective regulatory agencies to inspect establishments in the other’s country. These inspections are conducted together with inspectors from both government agencies.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The quality management requirements for storage, packaging, and handling of medicines and devices and their constituent components in Canada are part of GMPs and thus are regulated through the Establishment Licencing framework.
14. What information must be included in medicine and device labeling?
In general and where applicable, medicine, medical device, and natural health product labels must include:
- The distinctive brand name;
- The common or proper name;
- The name and address of the manufacturer/distributor/licensee;
- The expiration date;
- Adequate instructions for use of the product;
- The product identification number;
- The lot number;
- Any special storage conditions;
- The standard for the drug if necessary;
- The dose per unit of any medicinal ingredient;
- The net amount of the drug product (e.g., number of tablets);
- Any precautions or warnings; and,
- A quantitative list of all non-medicinal ingredients
All mandatory label information must be present in both French and English. However, bilingual labelling is not required for prescription drug products, drug products available in hospitals and clinics only, or drug products for professional use.
15. What additional information may be included in labeling and packaging?
Any information that is not false or misleading or is not otherwise expressly excluded (see Question 16 below) may be included in the labeling or packaging.
Information on the label can be additionally stated in any other language presuming it does obscure the information present in French or English.
16. What items may not be included in labeling and packaging?
The following items may not be included in the labelling and packaging of medicines and medical devices:
- References to the Food and Drugs Act or the Food and Drugs Regulations, except where required explicitly by the legislation;
- The phrases “Registered by Health Canada,” or “endorsed,” “promoted,” “acceptable,” or “recommended by Health Canada” or any acronym commonly associated with Health Canada;
- The Health Canada logo; or,
- Abbreviations for proper or common drug names.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
In general, the Food and Drugs Act prohibits health product advertising which is false, misleading or deceptive, or which is likely to create an erroneous impression related to its character, value, quantity, composition, merit or safety. This prohibition also captures any off-label advertising. Promotion of a drug or device prior to market authorization is considered false and misleading because the terms of such authorization have not been established and proposed indications for use have not been verified.
The Food and Drugs Act also prohibits consumer-directed ads for health products that make claims to treat, prevent, or cure any of the serious diseases listed in Schedule A of the Act (i.e. disease for which self-care is not appropriate, such as cancer, dysentery, or diabetes, etc.). Schedule A prevention claims are permitted by regulation for non-prescription drugs and natural health products.
The Food and Drugs Regulations prohibits direct to consumer advertising of prescription drug advertising beyond a drug’s name, price and quantity. As a result, two types of ads are permitted:
- Reminder Ads, in which the name of the drug is mentioned but no reference to the disease state appears in the ad; and,
- Help-Seeking Messages, in which a disease state is discussed, but no reference is made to a specific prescription drug product.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
For most provinces, restrictions on the conditions of sale of drug products are based on recommendations made by the National Association of Pharmacy Regulatory Authorities (“NAPRA”). NAPRA recommends that each drug product be placed into one of four categories (i.e., Schedule I, Schedule II, Schedule III, or Unscheduled). The categories each reflect a different level of restriction, such as prescription, non-prescription, etc.
Schedule I drugs require a prescription for sale and are dispensed to the public by a pharmacist following the diagnosis and professional intervention of a medical practitioner. The sale is controlled in a regulated environment (i.e. a pharmacy) as defined by applicable provincial pharmacy legislation.
Schedule II drugs, while less strictly regulated, do require professional intervention from a pharmacist at the point of sale and possibly referral to a medical practitioner. While a prescription is not required, Schedule II drugs are available only from a pharmacist and must be retained within an area of a pharmacy where there is no public access and no opportunity for patient self-selection.
Schedule III drugs are available without a prescription. These drugs are to be sold from the self-selection area of a pharmacy which is operated under the direct supervision of a pharmacist, subject to any local professional discretionary requirements which may increase the degree of control. Such an environment is accessible to a patient and clearly identified as a “professional services area” of the pharmacy. The pharmacist must be available, accessible, and approachable to assist the patient in making an appropriate self-medication selection.
Unscheduled drugs can be sold without professional supervision as adequate information is available for the patient to make a safe and effective choice and labeling is deemed sufficient to ensure the appropriate use of the drug. Unscheduled drugs may be sold from any retail outlet.
Provided that these rules are followed, medications can be sold and delivered by mail.
Devices which are not used or implanted by a physician or other healthcare professional may be sold direct to consumers via retail locations or delivery.
19. What are the restrictions and requirements for electronic marketing and advertising via email, via the Internet, social media, and other channels?
The restrictions and requirements for electronic marketing and advertising via email, internet, social media, and other channels are the same as the restrictions placed on any other form of advertisement.
In addition, in order to send advertisements via e-mail in Canada, companies must comply with Canada’s anti-spam legislation which applies to commercial electronic messages.
20. May medicines and devices be advertised or sold directly to consumers?
Regarding advertising, see Preclinical and Clinical Trial Requirements, Question 2.
Regarding sale, see Preclinical and Clinical Trial Requirements, Question 3.
21. How is compliance monitored?
Health Canada is the national regulatory authority for health product advertisements and is responsible for administering and directing compliance with the Food and Drugs Act and its regulations.
Canadian Advertising Preclearance Agencies (“APAs”) provide advertising material review services to advertisers and advertising agencies. APAs use Health Canada’s guidance documents and their own codes of advertising to ensure that advertising material submitted to them, in all media, is in compliance with the law. APAs also review advertising for consistency with the health product’s terms of marketing authorization and verify that the advertising is accurate, balanced and evidence-based.
The first route for advertising complaints adjudication of all Health Canada authorized health products is through the APAs, except as specified below. APAs will process complaints pursuant to the provisions and time frames expressed in their internal complaint resolution procedures.
The following types of advertising complaints should be reported directly to Health Canada, bypassing the APAs:
- Complaints related to direct-to-consumer advertising of prescription drugs and Schedule D drugs (biologics, including vaccines);
- Complaints related to advertising of unauthorized health products.
22. What are the potential penalties for noncompliance?
For the potential penalties related to non-compliance with advertising complaints reviewed by Health Canada, see Regulatory, Pricing and Reimbursement Overview, Question 9.
If an APA finds that an ad is non-compliant, the penalties are restricted to non-monetary penalties that range from immediate withdrawal of offending advertising, to notices in annual reports or newsletters, to public letters of apology. When material has been disseminated that is substantially misleading, or where the information may cause inappropriate product use or constitutes an imminent and/or significant health hazard, remedial measures contained in letters of correction or published notices may be required.