Q（Question）

Is there a prescribed method for publicly communicating the contact point that receives complaints about promotional information activities?

A（MHLW answer）

There is no objection to publicizing the contact point by any method considered appropriate in light of each company's situation.

So what (meaning): The method of communication is left to each company's discretion, but the chosen means must be practically accessible to healthcare professionals and pharmacists who may wish to file a complaint.

So why (rationale): If complaints cannot be submitted in practice, the supervisory department will remain unaware of problematic activities, so a genuinely accessible channel is the prerequisite.

Commentary — background, application, practical notes

This Q&A confirming that no particular method for publicizing the complaints contact is prescribed shows that the Guidelines care about the substance—a system through which complaints actually arrive—rather than the form of the method. A contact point that is difficult to access serves no purpose; the goal of complaint collection the Guidelines intend cannot be achieved through an inaccessible channel.

Typical approaches include providing the complaints contact address on business cards or product introduction materials distributed by practitioners at initial visits, including it in product information summaries sent to medical institutions, and posting it on web portals for healthcare professionals. In each case, a clear operational flow specifying who classifies, records, and reports complaints to the supervisory department must accompany the publicization effort.

The common practical error is establishing publicization of the complaints contact without defining the processing flow for received complaints. For the contact point to function, the following chain of processes must be documented: (1) receipt and classification of complaints; (2) identification of complaints related to promotional information activities; (3) reporting to the supervisory department; (4) implementation of corrective actions; and (5) retention of complaint records. It is also a prerequisite for effective complaint handling that the contact point staff have received training to judge whether a given submission relates to promotional information activities.