It is common for pharmaceutical sales activities to be partially outsourced or conducted through partnership arrangements. Within these structures, a critical question arises: which party bears responsibility for reviewing and supervising promotional materials? Section 5 of Chapter 4 answers that question by defining a special exemption—and the conditions that must be met to invoke it.
The GL's baseline rule requires every company conducting sales information activities to establish its own Review and Supervisory Committee and pre-approve all materials used (Section 2.2). Section 4.5 carves out a conditional exemption for outsourcees and partners—but only when they are effectively absorbed into the principal's supervisory structure. The exemption is not a free pass; it is a transfer of accountability.
01The two conditions for the exemption
An outsourcee or partner may forgo its own committee only when two requirements are satisfied simultaneously.
First, every material used must have passed review and received approval from the principal's supervisory department. There is an additional requirement attached: the material must display the name of the company that created it. Anyone reading the material—an HCP, a regulator—must be able to identify who produced it without further inquiry.
Second, all activities must be carried out in accordance with the rules set by the principal. The scope of permissible materials, the methods of information provision, the prohibited conduct—all of these must be defined by the principal, and the outsourcee or partner must operate within that framework.
So what: An outsourcee may only use materials that the principal has reviewed and approved, and each material must name the creating company. Without both conditions met, the outsourcee must either establish its own committee or conduct its own review.
So why: Consolidating review authority in the principal eliminates the "no one is watching" gap that delegation creates. The authorship disclosure requirement preserves traceability—if a problem surfaces, regulators and the principal can identify who created the material and hold them accountable.
02Ongoing reporting obligations
The exemption does not dissolve the outsourcee's or partner's responsibilities. The responsible department, staff, and supervisory function must report implementation status to the principal's supervisory department on an ongoing basis.
When the principal conducts a compliance review or audit, the outsourcee or partner is obligated to cooperate. The arrangement is not a one-time delegation—it is a continuing relationship in which the principal retains real oversight capability.
So what: "No committee required" does not mean "no obligations." Reporting and audit cooperation remain mandatory. The exemption shifts the locus of oversight from the outsourcee to the principal—it does not eliminate oversight.
So why: A principal that approves materials but never learns how they are used in the field cannot correct problems. The reporting obligation is the mechanism that keeps the principal's oversight real rather than nominal.
03Guidance from industry bodies — prompt action required
When guidance or advice arrives from a relevant industry body (such as a fair competition code body), routed through the principal, the outsourcee or partner must take necessary corrective measures promptly.
"Promptly" signals immediacy. Waiting for the next quarterly review or the next committee meeting does not satisfy this standard. External guidance indicates that field activity has a problem; the appropriate response is immediate prioritization of correction.
So what: Guidance transmitted through the principal carries the same force as if received directly. The outsourcee or partner must treat it as an immediate corrective trigger, not a discussion item for a future meeting.
So why: A non-compliant activity continues to affect HCPs and patients until it is corrected. Delay amplifies harm. Requiring prompt action prevents the outsourcee from using the indirect transmission route as an excuse to slow-walk remediation.
Section 4.5's logic is consistent throughout: tolerating the absence of an independent committee at the outsourcee is acceptable only when the principal's supervision is substantively active. Creator attribution on materials, status reporting, audit cooperation, and immediate response to guidance are not the price of the exemption—they are the minimum evidence that real supervision is functioning.