Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions: Labelling and advertising
On this page
- Labelling of human and veterinary drugs
- Product monograph for human drugs
- Transparency measures for veterinary drugs
- Additional transparency measures for human drugs
- Advertising and pre-clearance of all promotional materials
Labelling of human and veterinary drugs
On a case-by-case basis, we will assess the labelling of drugs that may be granted market authorization based on promising evidence of clinical efficacy that meet the requirements of the Food and Drugs Act (FDA) and the regulations. This evaluation will help determine if enhanced labelling requirements are necessary. This assessment is based on:
- proposed conditions of use (for example, hospital setting, physician or veterinarian administered)
- indication (multiple or singular) and
- other potential considerations
For veterinary drugs, package inserts (PI) should include, at a minimum, the sections necessary to ensure veterinarians, producers, and animal owners are properly informed about the imposed T&Cs.
For human and veterinary drugs, manufacturers should refer to sections 3, 9 and 10 of the FDA, as well as related provisions of the Food and Drug Regulations, to ensure compliance with labelling requirements.
For more information on labelling requirements, refer to:
- Guidance on veterinary drug labelling
- Guidance document: Labelling of pharmaceutical drugs for human use
Product monograph for human drugs
The product monograph (PM) should contain the standard information as outlined in the product monograph guidance document. It should also include additional information in specific sections, clearly stating that the:
- DIN for the drug was assigned with imposed terms and conditions (T&C)s and
- information presented in the PM is based on promising evidence of clinical efficacy
It should also include an instruction for health care providers to notify the patient that the drug's market authorization was granted based on promising evidence of clinical effectiveness.
Each drug product authorized based on promising evidence of effectiveness should include a PI in its packaging. The PI should include, at a minimum, the sections necessary to ensure health care providers and patients are properly informed about the imposed T&Cs.
For additional information on labelling and PI, refer to:
Generic or biosimilar products that compare to a Canadian reference product (CRP) or Canadian reference biologic drug (CRBD) with T&Cs to confirm clinical benefit may have T&Cs imposed on their DINs. Manufacturers of generic or biosimilar products may be required to reflect the promising nature of efficacy in their product monograph. They may also be required to include a copy of the PI within the product packaging.
For specific wording for subsequent entry products, refer to:
Transparency measures for veterinary drugs
After issuing a T&C letter, we will post information related to the T&Cs on the Health Canada website as outlined in the Draft guidance on terms and conditions for human and veterinary drugs.
Additional transparency measures for human drugs
Once a T&C letter is issued, in addition to publishing relevant T&Cs information on our website, as outlined in the Draft guidance on terms and conditions for human and veterinary drugs. We will also include details about those issued a notice of compliance (NOC) based on promising evidence of effectiveness with T&Cs imposed on their DIN.
This will be done by posting a "Notice of market authorization based on promising evidence of effectiveness with imposed terms and conditions" on Health product InfoWatch. The notice will also be shared with key health care groups to highlight that the drug was authorized with imposed T&Cs supporting approval came from promising evidence of efficacy.
We will not include any confidential business information in the notice. However, we will provide relevant links to the PM and MAH contact information.
We will send a copy of the notice to the MAH 2 business days before posting the notice on the Health Product InfoWatch web page. During this time, the MAH will be able to verify that the information is accurate.
Since the Health product InfoWatch is a monthly publication, the notice of market authorization with imposed T&Cs will be published in the month following the assignment of the DIN and issuance of the NOC, or soon after.
Learn more:
Advertising requirements and pre-clearance of all promotional materials
Manufacturers of human and veterinary drugs must comply with all advertising requirements outlined in the FDA, the Controlled Drugs and Substances Act(CDSA) and the associated regulations regarding the advertising of drug products.
The term "advertising" includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device. It includes:
- brochures, booklets, detailing pieces, bulletins, calendars, videos and slides
- materials published in journals, magazines, other periodicals, and newspapers
- materials presented at healthcare professional conferences, continuing medical education activities and other learning activities (OLAs)
- advertisements broadcast through media such as radio, television, the internet, social media and telephone communication systems
Advertising material must abide by the restrictions or conditions specified on the labels for human and veterinary drugs and the PM for drugs intended for human use.
If T&Cs require confirmatory trials, advertising material must clearly state that the authorized indication(s) is based on promising evidence of efficacy and that additional studies are being conducted to confirm the clinical benefit.
If the approved labelling and PM include statements about promising evidence of efficacy, the display portion of all advertising material for these drugs must contain boxed text. This boxed text must disclose that the market authorization was granted based on promising evidence of clinical effectiveness. It must also state that T&Cs have been imposed to confirm the drug's clinical benefit.
For human drugs, manufacturers must submit all healthcare professional directed promotional material related to products authorized based on promising evidence of clinical effectiveness to an independent advertising preclearance agency (APA) recognized by Health Canada. Refer to: