Hello @kshulist

Enrolling a patient in a support program means that the decision to prescribe the product has already been made (i.e. patient is on the drug). Additionally, given the type of information on the form (e.g., including dosing or monitoring info), the form is not considered promotional but rather administrative in nature. Given these two reasons, indication/FB is typically not required. However, should promotional messaging be added (in the context of an HCP completed PSP enrolment form), indication and fair balance would indeed be required. For a patient completed enrolment form, no promotional messages would be acceptable and therefore the form would be administrative.

Good Morning @munitalp

As the recruitment piece is not target to HCPs, there should be no reference to the manufacturers product, generic name or brand name. Furthermore, the copy should not state the company name. It should be limited to something similar to “a Canadian manufacturer” and “investigating a product”. The trial name, study acronym or logo can be easily linked to the company and products and therefore would also not be acceptable for a clinical trial recruitment piece under the distinction document.

Inclusion criteria which restrict to patients which have had prior treatment with specific products can be referred in a non-promotional way.

Good Morning @tmcd

The PSP is a service offered by the sponsor and for the sponsors brand, it is therefore subject to the PAAB code and would not be deemed exempt.

Hey @NatBourre
We have not received a response at this time. We will reach out to Health Canada to see what the status of this question is. In the interim, we will continue to apply our understanding that this cannot been done as this would contravene consumer regulations.

Hey @Infoseeker, Section 3 of the Food and Drug Act, prohibits advertising to the general public of any drug (whether Rx or non-Rx) as a treatment for a disease listed in Schedule A. Promotion of drugs for prevention of Schedule A does not contravene this section of the Act. The Food and Drug Regulation C.01.004 also states that where a person advertises to the general public a prescription drug, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantify of the drug. If the brand falls into these categories, then yes, a gate would be required.