The PAAB only reviews the PI format. As such only changes in format require resubmission. Content updates should be provided as FYIs.
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The PAAB only reviews the PI format. As such only changes in format require resubmission. Content updates should be provided as FYIs.
No. Such linkage would suggest that the drug somehow addresses the issue of adherence. Linking product X to disease information about adherence would therefore require insertion of Product X adherence data. This would also require insertion of the product indication and fair balance.
Dear PAAB: We have both unbranded and branded APS approved by PAAB. What are suggested and appropriate mechanisms for unbranded (HCP:patient teaching tools) and branded APS to be distributed by sales representatives, so as to not create linkage between the pieces? Are separate calls (branded and unbranded) appropriate? Is distribution of the unbranded APS (i.e. by request form, business reply card etc.) with follow-up by the sales representative specifically to discuss the unbranded APS, an acceptable way to separate the pieces?
Yes and yes respectively. For more information see Q&A # 232.
Yes. BUT it is critical to restrict the content to disease information in a manner which neither refers to nor alludes to the unapproved product. Even indirect promotion of an unapproved product could contravene section C.08 002 of the Food and Drug Regulations.
Cosmetics are not in the scope of the PAAB code unless they are medicated or hypoallergenic. I assume that any medicated have a DIN or NPN.
Is this also true of products with a hypoallergenic claim? We have a Cosmetic (no DIN, no NPN)in our portfolio that the company wants to detail to HCP. As such, HCP specifc promotional material is being created. Despite the fact that cosmetics without a DIN or NHP are outside the scope of PAAB, does the fact that the promotional material is directed to HCP mean it should be reviewed by PAAB or would this still fall under ASC? Thank you for your assistance.
For the purpose of the PAAB Code, cosmetics (as defined in the Food and Drugs Act and Regulations) are excluded from the definition of "Healthcare Product" and therefore do not fall within the scope of PAAB preclearance.
See PAAB code section 11.3(a). Therapeutic claims cannot be made for such cosmetics AND all cosmetic claims should be aligned with the Health Canada guidance document " Guidelines for Cosmetic Advertising and Labelling Claims".
Note that therapeutic cosmetics, e.g. medicated and hypoallergenic preparations, are classed as pharmaceutical products. Advertising/Promotion Systems (APS) for such products must be submitted for PAAB review and clearance.
I can see why you'd be concerned. This activity would inherently brand the non-branded piece through linkage. If the non-branded piece contains content which would not be accepted in a branded context, this activity would contravene the regs.
Whenever linking separate materials/activities, always pause to examine whether the linkage would change the regulatory status of those materials.
Is it permissible to advertise for sale NHP's or OTC's to the general public via such media as The Home Shopping Network? Are there any restriction that a distributor should be aware of?
Advertising to the general public for NHP's and OTC's must meet the requirements outlined in the Health Canada policy document "Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products)". Here is a link for your convenience: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_consom_consum-eng.php
No, a disclaimer and a checkbox are not sufficient. Assuming that the content on the app exceeds that which is permissible within the consumer advertising regulations, you'll need a well-controlled entry system (i.e. some sort of gate which poses an effective barrier of entry for non-HCPs) .
For apps, this is often done through a password entry mechanism which is encountered once the user tries to open the app (after having downloaded it on his/her device). In such cases, it is critical to ensure that the combined content prior to successful password entry (e.g. app name, keywords that generate the app name as a search result, content on app store description, user generated comments...) do not exceed the consumer regulations. Another option is to place the app download in a gated part of the pharma manufacturer's website (such that consumer regulations do not need to be considered in creating any post-gate app descriptions). In this scenario, we've seen and approved barriers requiring some sort of hardware (such as USB sticks) distributed in a controlled manner by the manufacturer, a password distributed in a controlled manner by the manufacturer, the HCP's license number, or a URL sent to the HCP through a targeted email.
Our agency has always laid out Prescribing Information pages closely following the two-column format set out by PAAB a few years ago. I notice that some prescribing information pages now are in three columns (and otherwise seem to follow the font-size and headings guidelines set out).
Shifting to a three-column format could save considerable space (especially in adverse events tables) and might reduce by one page our clients' number of Prescribing Info pages required. So if we submit a three-column version for review, and follow all the other rules, we will be likely get it accepted?
The answer is "yes" as per the PI style on the PAAB website. It can be found at the following URL: http://www.paab.ca/resources/pdfs/Prescribing%20Information%20Style%20Guide.pdf.
In reference to PAAB code section 6.3 Detail Aids (2nd paragraph):
"Prescribing information should form an integral part of the presentation or be attached to it when the item is left with the health professional".
Is it acceptable, for a sales representative to offer the HCP with an electronic copy of the Product Monograph (PM) rather than the hard copy? The PM (pdf copy) would be sent as an attachment by email to the HCP within the same visit the material is left behind. If an electronic copy is acceptable, could we also refer the HCP to a link (usually the website of the company) where to obtain the Product Monograph?
Currently, the answers are "No" and "No" respectively. The PI must be accessible while the APS claims are being accessed. This is ensured by delivering the PI over the same type of media as the APS.
Requirements relating to the PI are in the process of changing. Stay tuned...
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising