Q（Question）

If the company already has external inquiry channels such as a company website or a customer service center, is it acceptable to use those channels while ensuring that complaints related to promotional information activities are properly reported to the supervisory department?

A（MHLW answer）

There is no objection. However, care must be taken to clearly distinguish complaints related to promotional information activities from other complaints and to handle them appropriately.

So what (meaning): Reusing existing customer contact channels is acceptable, but complaints about promotional activities must be categorized separately, logged distinctly, and escalated to the supervisory department through a documented workflow.

So why (rationale): If promotional-activity complaints are mixed with general complaints, the supervisory department will not be alerted, and recurring problematic conduct will go unaddressed.

Commentary — background, application, practical notes

This Q&A permitting the repurposing of existing customer inquiry channels concedes practical convenience while imposing the substantive condition of 'handling complaints related to promotional activities distinctly from other complaints.' The purpose is to prevent the risk that complaints about promotional conduct, mixed with general product claims or adverse event reports, will fail to trigger proper escalation to the supervisory department.

A typical scenario is using an existing Medical Information (MI) department as the contact point, while designing an operational flow that identifies and records complaints about promotional activities from among received inquiries and reports them periodically to the supervisory department. The information flow between the MI department and the supervisory department must be clearly defined, with a reporting structure that enables the supervisory department to regularly receive information on the number of complaints, their content, and the status of responses.

A boundary case that commonly becomes problematic is field-level ambiguity in distinguishing 'complaints' from 'general product information inquiries.' For example, a submission stating 'the practitioner gave me incorrect information about the dosage of Drug X' should be identified as a complaint about promotional activities, not as a product information inquiry. To sharpen this identification accuracy, training for contact-point staff and a mechanism for referring doubtful cases to the supervisory department are essential. Building a double-check mechanism to prevent missed identifications into the SOPs is advisable.