Pharmaceutical wholesalers sit between manufacturers and healthcare institutions, moving products and passing along information. Their promotional role is largely one of transmission—delivering materials that manufacturers have already created and reviewed—rather than generation. Section 4.6 is built on that operational reality, calibrating compliance obligations to match the wholesaler's actual risk profile.

The GL requires manufacturers to establish a Review and Supervisory Committee and pre-approve all materials (Section 2.2). For wholesalers, a committee is recommended but not mandatory—provided certain conditions are met. Where the wholesaler creates its own materials, however, a supervisory review obligation applies with its own exception framework.

01Why the committee requirement is relaxed for wholesalers

Two structural facts drive the relaxation.

First, wholesaler activities are ordinarily conducted in line with the manufacturer's own activities. The manufacturer creates promotional materials; the wholesaler delivers them to HCPs. The content originates upstream.

Second, wholesalers are not generally expected to generate independent information for provision. Independently collecting clinical data, creating materials from that data, and proactively presenting it to physicians falls outside the normal wholesaler business model.

So what: A wholesaler that confines itself to delivering manufacturer-approved materials as-is may operate without its own committee. This is a rational response to a genuinely lower risk profile.

So why: Regulation must fit reality to function. If a wholesaler only circulates materials that the manufacturer's committee has already cleared, a second committee review adds little safety benefit while increasing distribution cost. The GL avoids performative compliance by matching the obligation to the actual source of information risk.

02Using manufacturer materials unchanged — no wholesaler review needed

When a wholesaler uses a manufacturer's material without modification, no wholesaler-level review is required. This applies to activities that do not fall under the Section 4.5 outsourcee exemption.

The word "unchanged" matters. If the wholesaler adds a sentence, removes a section, or adjusts any content, the result is no longer the manufacturer's material—it is the wholesaler's material. Once modification occurs, the wholesaler's supervisory department must review the entire document, including unchanged portions.

So what: No edits, no review obligation. A single added sentence transforms the material into one the wholesaler has created, triggering supervisory review of the whole document.

So why: The manufacturer's quality control extends to the exact document that was reviewed and approved. The moment the wholesaler alters the content, the manufacturer's approval no longer covers the altered version. Drawing the line at modification preserves a clear chain of accountability.

03Wholesaler-created materials — pre-review is the rule, with one narrow exception

Any material the wholesaler creates independently must be reviewed by its supervisory department before use. There is one exception: comparison materials that meet all three of the following conditions may receive post-use review instead of pre-use review, provided that review occurs promptly after use.

Three conditions for the post-review exception

Condition 1: The material was created in direct response to an HCP's specific request to compare particular items. Materials prepared on the wholesaler's own initiative do not qualify.

Condition 2: The material was created in accordance with internally circulated standards that the supervisory department has pre-approved. Ad-hoc creation without a standing standard is not permitted.

Condition 3: The items being compared are accurately transcribed from the package insert, official notifications, or ministry notices—with no changes to that source content since the material was created. Independent interpretation or summarization is not permitted.

So what: An HCP says, "Can you compare Drug A and Drug B on dosage?" The wholesaler creates a side-by-side drawn verbatim from the package inserts, following a pre-approved in-house template. In that scenario only, the material may be handed over first and reviewed afterward. Miss any one of the three conditions and pre-review is required.

So why: An HCP's real-time information need cannot always wait for a committee to convene. The three conditions—request-triggered, pre-approved standard, accurate transcription—collectively ensure the content is objective and traceable, which is what pre-review would otherwise verify. Post-review is the minimum viable substitute, not a blanket waiver.

Summary

Section 4.6 applies a proportionality principle: the manufacturer is the information originator and bears full committee obligations; the wholesaler that stays within that information chain inherits the manufacturer's quality controls without duplicating them. The moment the wholesaler steps outside the chain—by modifying a material or creating a new one—its own review obligation activates. The post-review exception for comparison materials is the narrowest possible allowance for serving HCPs in real time, bounded by three conditions that preserve objectivity and accountability.