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192 - Is it necessary, whenever a letter pertaining to your product is sent to a government official (either elected or part of the public service, at all levels of government) to include a copy of the Product Monograph if you refer in passing to an issue you may be having as it relates to your drug. For example, if we were bringing to the attention of Minister XYZ about Product A not being approved fast enough by internal bodies to meet the demands of physicians/patients, would we then have to include the PM simply because we mentioned the name of the product? Also, is it necessary, in private correspondence to government officials that is exempt from PAAB pre-clearance and non-promotional, to include both the generic name of said product, the dosing information, etc?
Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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The advertising regulations apply to advertising. A letter sent to a government official is a one-on-one correspondance (i.e. the advertising regulations would not apply). The letter should be non-promotional. It is therefore advisable that this activity not to be overseen by the marketing department. Although the activity we've described is likely not subject to the provisions of advertising, it would appear to be a good idea to include the PM or PI as a comprehensive resource for product information.
