Notice of Transition

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Contact:RARC-RPCR

December 8, 2006
06-127531-955

Re: New System for Consumer Advertising Preclearance Agencies

Further to the release of the Notice of Intent of August 9, 2006 announcing changes to the consumer advertising preclearance system and subsequent consultations on attestation criteria recommended by Health Canada on August 16, 2006, Health Canada has now finalized the attestation criteria and the change is in effect as of this date. The criteria are posted under the Regulatory Requirements for Advertising section on Health Canada's website.

Advertising preclearance agencies in Canada who wish to perform the function of preclearing advertising material directed to consumers for nonprescription drugs and natural health products should demonstrate to the public that they meet all these criteria. Health Canada is requesting that each agency post on its website, its Statement of Qualifications describing how it meets all the Health Canada criteria to assist industry in the selection of a competent agency. Health Canada will not be reviewing the agency's Statement of Qualifications. Industry is responsible to meet the federally legislated requirements for advertising of health products. Canadian advertising preclearance agencies should advise Health Canada that they have attested to the public that they meet all the Health Canada criteria by submitting their name and contact information to MHPD_DPSC@hc-sc.gc.ca. Upon the receipt of such a notification, the name of the agency will be included in Section 1 of the "List of Canadian Advertising Preclearance Agencies" posted on the Health Canada website. In the interim, to avoid a gap in service, Advertising Standards Canada, an advertising preclearance agency previously recognized by Health Canada since 1997, will be identified in Section 1 of this list pending receipt of notifications. This new system will allow industry the opportunity to choose an agency that has publicly self-attested to meeting Health Canada's recommended criteria for the preclearance of advertising material of nonprescription drugs and natural health products.

Health Canada will be updating several documents and policies relating to advertising that have been impacted by this change as follows:

• Fact Sheet - Overview of Drug Advertising
• The two policies - Pharmaceutical Advertising Advisory Board and Health Canada's Roles and Consultation Related to Advertising Review and the Advertising Standards Canada and Health Canada's Roles and Consultation Related to Advertising Review and Complaint Adjudication - will be combined into one generic document entitled the Advertising Preclearance Agencies and Health Canada's Roles and Consultation Related to Advertising Review and Complaint Adjudication.
• All other policies related to advertising of health products as deemed necessary to reflect current changes.

Current versions of these documents are available on the Regulatory Requirements for Advertising section of the Health Canada website and revisions to them are expected to be completed by the summer of 2007.

Health Canada will also be enhancing communication mechanisms between itself and all self-identified advertising preclearance agencies by promoting periodic meetings to discuss processes, policies, complaints and to facilitate the general exchange of information. As has been done in the past, Records of Decision from these meetings will be posted on the website.

Health Canada is confident that advertising preclearance agencies will work diligently towards providing the same high standards in advertising preclearance that have made the voluntary advertising preclearance system initiated in the late 1990's, as successful as it is.

Additional questions can be directed through e-mail to: MHPD_DPSC@hc-sc.gc.ca.