The Check Mark
Learn more about our updated Clearance Services Check Mark.
Health Product Submission Requirements and Considerations
- Every submission must include a script (i.e., a written transcript) of the ad or information message.
- Each ad/message must be submitted individually, except for SEMs, where multiple ads/messages can be submitted together.
- Social media submissions are platform-specific and must therefore be submitted and reviewed individually. For example, while Instagram and Facebook are owned by Meta, they have unique user interfaces.
- For videos, radio/streaming audio, articles/brochures, and websites, the length of the message (e.g., number of pages or duration) must be included.
- Ensure that the correct media type is selected for each submission.
- Multiple media types cannot be combined in a single submission.
- Bilingual messages do not fall into the “Other” category; “Other” is reserved for languages such as Cantonese, Mandarin, Punjabi, etc. English and French must always be sent as separate submissions, even if the final ad/message features both languages together.
- Every submission must include the name of the specific advertised health product. In the case of information messages, i.e. DTCI submissions, the product behind the campaign must be identified. Non-specific product names such as “Unbranded”, “Not Applicable”, “Rare Diseases”, “Biosimilars”, etc. are not acceptable. In the case of corporate messages, the name of the product is the name of the company.
What services does Ad Standards provide?
Nonprescription Drugs and Natural Health Products
- Review of advertising copy for radio, television, print and digital.
Direct to Consumer Advertising and Information (DTCA/I)
- Provide advisory opinions on consumer-directed messages for prescription drugs (DTCA)
- Provide advisory opinions on consumer-directed messages/materials discussing a medical condition or disease (DTCI)
Provide advisory opinions on consumer-directed messages for the recruitment of clinical trial patients(DTCI)
Do I need clearance by any other bodies?
Ad Standards Clearance Services reviews advertising in six regulated areas to ensure compliance with specific sectoral legislation, regulations, codes and guidelines. For television advertising, in addition to obtaining an Ad Standards Clearance number, prior to airing, commercials must be approved by thinktv to ensure their standards are met. Contact thinktv for complete details.
thinktv clearance provides commercial review services for its broadcaster members.
Health Product Categories
Over-the-counter drugs that can be purchased without a doctor's prescription.
Once authorized for sale, a nonprescription drug is assigned a Drug Identification Number (DIN).
Ad Standards submission must include:
- DIN
- Product label (or pack shot of the product as it will appear in the ad – not required for radio.)
Over-the-counter health products that contain/are derived from naturally occurring substances. NHPs, often called "complementary" or "alternative" medicines, include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines, probiotics, other products like amino acids and essential fatty acids. Certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are also classified as NHPs.
Once authorized for sale by Health Canada, an NHP is assigned either a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM).
Ad Standards submission must include:
- NPN or DIN-HM
- Product Licence (PL)
- Product label (or pack shot of the product as it will appear in the ad - Not required for radio.)
In Canada, there are four different classes of medical devices:
- Class I medical devices are not precleared.
- Class II, e.g. contact lenses, tampons, power toothbrushes
- Class III, e.g. dermal fillers, blood glucose meters, condoms
- Class IV, e.g. breast implants
Ad Standards submission must include:
- Medical Device Licence (MDL)
- Product Insert / Instructions for Use
- Product label (or pack shot of the product as it will appear in the ad - Not required for radio.)
Note: There are additional submission requirements for Class II Medical Devices. Please follow the procedure.
Ad Standards submission must include:
- Product Monograph or DIN
An announcement used to recruit patients for a clinical trial or investigational test concerning a health product.
Branded drug product ads, where the name of the drug is included in the message. Most often, the ad will be for a prescription drug; however, the DTCA category also includes drugs such as insulin and products listed on Health Canada’s “ethical” schedule.
Ad Standards submission must include:
- Product Monograph or DIN
Unbranded information messages about a disease state/condition or a drug company and its corporate philosophy. While they may include the drug manufacturer’s name, the message focuses on a disease/condition or the company. The name of the drug itself does not appear in the message.
Ad Standards submission must include:
- Reference Documents – URL links are not acceptable.
- Product Monographs for all authorized drug products (if message includes any references or discussion of treatment/management)
Submissions Types
Submission requesting review of an advertising message/commercial.
A compliant message is assigned an Ad Standards number.
Submission for review of a Clinical Trial Recruitment or DTCI message.
A compliant message is assigned a “DTC Reviewed” status and assigned an Ad Standards number.
General, one-time, top-line advisory opinion about a concept, usually before developing final creative.
Not issued an Ad Standards number.
Preliminary review of an advertisement before a health product has received its authorization by Health Canada, e.g. pre-Notice of Compliance (pre-NOC).
Review is solely based on the draft Product Monograph, recommended uses included in the Product Licence Application, or indications for use submitted for Health Canada review.
Not issued an Ad Standards number.
Once a health product is authorized, i.e. is issued a DIN, NPN or DIN-HM, the advertisement must be sent in as a new submission, along with all applicable final product documentation, for full review. Feedback is subject to change, based on the final Terms of Market Authorization (TMA). Ad Standards may have additional comments and/or may identify issues not noted in the preliminary pre-HC authorization review.
Media Types
Some examples:
- Linear TV
- Lower thirds
- Advanced TV
- Addressable TV
- OTT (over-the-top) video
- Connected TV (CTV)
- Online Videos (OLV)
- Digital Out-of-Home (DOOH) videos
- Social media short-form videos such as Reels, Stories and Shorts
- In-stream videos (skippable and non-skippable)
- Long-form videos
- Mobile videos
- Cinema/Theatre videos
Videos are reviewed individually. Multiple videos or videos of different lengths cannot be sent in together in one script.
Each submission must include a script (i.e. written transcript) that contains the audio, a detailed description of exactly what is happening in the visuals along with all supers, disclaimers and links that will be part of the message delivered to consumers.
Some examples:
- Traditional radio
- Ads on streaming platforms such as Spotify, SoundCloud, Pandora, and SiriusXM
- Podcasts
Only one ad/message per submission.
Some examples:
- Newspaper
- Magazine
- Poster
- Billboard
- Point-of-Sale, Endcap, Shelf Talker, etc.
- Digital Screen
Only one ad/message per submission. If the print message is a longer piece such as a brochure, pamphlet or article, please choose the “Article/Brochure” media type.
Longer “print” messages disseminated either online, via traditional media such as newspapers & magazines, at point-of-sale, or in a doctor’s waiting room.
Upon submission, the total number of copy deck pages must be included.
Submissions must contain a copy deck of the complete website. All consumer-accessible content must be included, along with legal copy such as Terms of Use, Privacy Policy, etc.
Page count is based on the number of pages in the copy deck, not the number of webpages. Ad Standards does not review MetaData/Meta Information or keywords. Any Search Engine Optimization (SEO) message, which directs the consumer to the website must be sent as a separate SEO submission for review.
Only one ad/message per submission.
All platform-specific overlays, captions, headlines, hashtags and sponsor identification must be included.
Only one ad/message per submission.
All platform-specific overlays, captions, headlines, hashtags and sponsor identification must be included.
Only one ad/message per submission.
Only one ad/message per submission.
Submit complete messages only. Batches/lists of individual headlines, descriptions and/or site link extensions are not acceptable. The various elements in each message, as seen by the consumer, must be combined together at time of submission (even if the elements will only be combined real-time through AI).
Do not submit Excel spreadsheets. SEMs can be sent as a Word document or PDF; however, the text must be in a size that can be easily read. The document should not require more than 100% zoom to be legible.
Keywords are not reviewed.
The Ad Standards number issued to a previously “Approved” or “DTC Reviewed” message may be transferred (at no charge) to an updated version as long as the changes are minor in nature and do not alter the claims and/or content of the main message.
For example, the following changes would not require a new submission:
- Spelling/Grammar corrections
- Legal updates such as copyright dates, version code changes, trademark changes, etc.
Number Transfer submissions are an option up to one year after the date of the original file completion.
Note: A message with significant copy changes, including the addition or removal of content, is not a Number Transfer and requires a new submission.