Section 8 establishes the complaint-handling framework. Internal oversight mechanisms alone cannot be guaranteed to capture all instances of inappropriate sales information activities. A complaints channel supplements the blind spots of internal monitoring by bringing in external voices. The requirement for a channel that is "recognisable from outside" is the condition that ensures this mechanism functions in practice rather than on paper alone.

Key point: Merely having a complaints channel is not enough—it must be established in a form that external parties (healthcare professionals, patients, etc.) can actually recognise and use. When a complaint is received, the oversight department must promptly investigate the facts and take necessary action.

01Establishing a Complaints Channel Recognisable from Outside

A channel must be established to receive complaints relating to sales information activities. The guideline's explicit requirement that it be "recognisable from outside" is significant. A channel whose existence is known only internally does not satisfy the requirement. Healthcare professionals, patients, and other stakeholders must be aware that the channel exists and be in a position to contact it. In practice, this means publishing it on the company website, including it in product information materials, or prominently displaying it in materials distributed to medical institutions.

So what: Even if the company has an internal arrangement such as "please consult the responsible department," this does not qualify as a guideline-compliant complaints channel if external parties cannot access it. Contact details and the method of submission must be publicly disclosed in a form that actually prompts contacts from outside.

So why: Internal monitoring alone may not capture all field-level problems. If there is no route by which a healthcare professional who has actually received inappropriate information provision can report it, the issue remains latent and unaddressed. Making the channel externally visible creates a genuine feedback loop that complements the internal oversight structure.

02Prompt Fact-Finding and Necessary Action by the Oversight Department After Receiving a Complaint

When a complaint is received, the oversight department must promptly investigate the facts and take necessary measures. The explicit designation of the oversight department as the entity responsible for handling complaints is meaningful. When the sales department or the MR involved handles the complaint as a first-line response, the impartiality of the fact-finding cannot be adequately guaranteed. Having the oversight department conduct the investigation from an independent position enables fact-gathering free from conflict-of-interest bias.

So what: Post-complaint processing is positioned as the oversight department's responsibility—delegating it wholesale to the sales side is not permissible. "Promptly" prohibits leaving a complaint unattended for an extended period before fact verification begins. If investigation confirms a problem, the response continues in line with Section 7.

So why: Healthcare professionals and patients who file complaints are attempting to report a problem while maintaining some degree of trust in the company. A slow, insincere, or party-driven response causes complainants to regret having come forward and suppresses future reports. Establishing a prompt and independent investigation process maintains the credibility of the complaints channel itself.