By distributor, we mean the business partners who support the commercialization of the company products in the concerned territories. We won’t discuss the non-compliance areas but provide considerations for the marketing authorization holder (MAH) for ensuring compliance.

Every MAH can’t have commercial operations in every country in which it holds licenses. This may even apply to large countries where the MAH has limited operations, e.g., an MAH operating in the US (which has 50 states in all) but having commercial operations in only 25 states. The MAH may consider having a commercial partner to distribute the products in the remaining 25 states.

The distributor may be involved in local activities besides the commercialization, impacting patient safety. The MAH must execute a safety data exchange agreement (SDEA) with the distributor that includes a reference to the activities that are not limited to the following:

1. Product labelling
2. Literature monitoring
3. Medical information
4. Risk Management
5. Website
6. Translation
7. Safety activities – that may include local safety database, QPPV (and back-up)
8. Patient Support
9. Market Research

Besides, the distributor is expected to have the following resources to fulfill the responsibilities of pharmacovigilance.

1. Infrastructure
2. Trained personnel
3. Written procedures

Tender Supplies

At times, the distributor may participate in a tender on behalf of the MAH in the same or different territory. The product may not be approved in the tender market. To further complicate this, the entire arrangement may not be associated with any agreement. At times, the product may get relabeled, further complicating the situation. The MAH still needs to figure out a process to ensure compliance.

Audits and Inspections

Eventually. the MAH is accountable for pharmacovigilance. If the distributor acts as the local MAH, then it is going to be a shared responsibility. The MAH also needs to qualify the distributor and undertake periodic risk assessments and audits. If the distributor undergoes a regulatory inspection, it is essential to notify the business partners. One should make sure to include this clause in the SDEA.

If non-compliance is identified in any of the above areas, efforts should be put to mutually sort out the issues. If things don’t improve, then one may consider escalation to the marketing team and even the management. If things still don’t work out then the only option will be to terminate supplies; else change the distributor, but continue reconciliation until the expiry of the last batch.