Pharmaceutical Manufacturer Use Cases
TraceLink Roles
TraceLink API Guides group messages by application. Each API Guide contains all messages available within that application. Your company's business type (e.g. CMO, Wholesale Distributor, 3PL) and role in the TraceLink Network (Owner or Partner1) determine which of these messages to develop (i.e. not all messages within this guide may fulfill your business or compliance needs).
See below to confirm which messages you should develop based on your role in the supply chain and/or the TraceLink Network.
Configure and exchange (send or receive) each message separately as a best practice.
Serialized Operations Manager ESM Owners
These messages are specifically intended for Pharmaceutical Manufacturers that use TraceLink for regulatory reporting and Track & Trace data exchange, but do not use the full TraceLink serialization platform as the system of record for serialization management. The Pharmaceutical Manufacturer uses an Enterprise Serialization Management (ESM) system as the system of record.

Pharmaceutical Manufacturers send the ESM Commission message to TraceLink, which associates a serial number to a particular object, product, or container.

Pharmaceutical Manufacturers send the ESM Commission message to TraceLink, which associates a serial number to a particular object, product, or container.

Pharmaceutical Manufacturers send the ESM Decommission message to TraceLink, which terminates the use of an associated serial number from a product or container. Pharmaceutical Manufacturers are able to recommission a decommissioned serial number at a later time with updated information.

Pharmaceutical Manufacturers send the ESM Decommission message to TraceLink, which terminates the use of an associated serial number from a product or container. Pharmaceutical Manufacturers are able to recommission a decommissioned serial number at a later time with updated information.

Pharmaceutical Manufacturers send the ESM Destroy message to TraceLink, which permanently terminates a serial number when a product is damaged or expired and the product or case is physically eliminated. A destroyed serial number cannot be recommissioned or re-used.

Pharmaceutical Manufacturers send the ESM Destroy message to TraceLink, which permanently terminates a serial number when a product is damaged or expired and the product or case is physically eliminated. A destroyed serial number cannot be recommissioned or re-used.

Pharmaceutical Manufacturers send the ESM Aggregation message to TraceLink, which details parent-child relationships when child products are added to a parent container during an aggregation event.

Pharmaceutical Manufacturers send the ESM Aggregation message to TraceLink, which details parent-child relationships when child products are added to a parent container during an aggregation event.

Pharmaceutical Manufacturers send the ESM Disaggregate message to TraceLink, which notifies upstream partners of any unpacking events. This message maintains the parent-child relationship between serialized items or cases, and their containers.

Pharmaceutical Manufacturers send the ESM Disaggregate message to TraceLink, which notifies upstream partners of any unpacking events. This message maintains the parent-child relationship between serialized items or cases, and their containers.

Pharmaceutical Manufacturers send the ESM Shipment message to TraceLink, which indicates a sale, transfer, or return-movement of goods. The EPCIS v1.0 message does not support the combination of the Commission and Aggregation messages into one Shipment message.

Pharmaceutical Manufacturers send the ESM Shipment message to TraceLink, which indicates a sale, transfer, or return-movement of goods. The EPCIS v1.2 message supports the combination of the Commission and Aggregation messages into one Shipment message, instead of sending the information separately for each event. The Shipment message requires the shipment information and supports the following use cases:
- Shipment only: Pharmaceutical Manufacturers only send the Shipment information because the Commission and Aggregation events have already been processed.
- Shipment + Commission + Aggregation: Pharmaceutical Manufacturers report all three events at the same time from their external system to TraceLink.
- Shipment + Commission: Pharmaceutical Manufacturers omit the Aggregation message because the product does not require aggregation.
- Shipment + Aggregation: Pharmaceutical Manufacturers omit the Commission message because the information has already been processed.

Pharmaceutical Manufacturers send the ESM Shipment message to TraceLink, which indicates a sale, transfer, or return-movement of goods. The XML message supports the combination of the Commission and Aggregation messages into one Shipment message, instead of sending the information separately for each event. The Shipment message requires the shipment information and supports the following use cases:
- Shipment only: Pharmaceutical Manufacturers only send the Shipment information because the Commission and Aggregation events have already been processed.
- Shipment + Commission + Aggregation: Pharmaceutical Manufacturers report all three events at the same time from their external system to TraceLink.
- Shipment + Commission: Pharmaceutical Manufacturers omit the Aggregation message because the product does not require aggregation.
- Shipment + Aggregation: Pharmaceutical Manufacturers omit the Commission message because the information has already been processed.

Pharmaceutical Manufacturers send the ESM Receive message to TraceLink, which communicates the transfer of product. The message conveys the receipt of a transfer, return, or purchase between customers and trade partners from an internal enterprise serialization system of record to TraceLink's Serialized Operations Manager.

Pharmaceutical Manufacturers send the ESM Receive message to TraceLink, which communicates the transfer of product. The message conveys the receipt of a transfer, return, or purchase between customers and trade partners from an internal enterprise serialization system of record to TraceLink's Serialized Operations Manager.

Pharmaceutical Manufacturers send the ESM Receive message to TraceLink, which communicates the transfer of product. The message conveys the receipt of a transfer, return, or purchase between customers and trade partners from an internal enterprise serialization system of record to TraceLink's Serialized Operations Manager.

Pharmaceutical Manufacturers use the Take Product Sample message to update item status to "Sampled" when quality personnel remove serialized product for sampling purposes. This enables a Serialized Operations Manager Owner to:
- Disaggregate items from the container if already packed.
- Trigger government reporting for the sampling of serial numbers.

Pharmaceutical Manufacturers send the ESM Void Shipment message to TraceLink, which informs TraceLink that a completed delivery has been voided. This message can only be sent for a shipment that has been marked as a sale, not a transfer. Pharmaceutical Manufacturers use the Void Shipment message for the following use cases:
- The shipment is damaged or the customer completely cancels the order.
- The customer accepts the delivery, but the delivery contains incorrect information. The customer voids the delivery and creates a new one to correct and replace the inaccurate information.

Pharmaceutical Manufacturers use the ESM Update Serial Number Status message to synchronize serial number status update data from their enterprise serialization system of record. This can be used to correct mistakes or indicate certain state changes for compliance reporting purposes.

Pharmaceutical Manufacturers use the ESM Set Recall Status message for the following use cases:
- A recall state change for an EU FMD Target Market – Pharmaceutical Manufacturers set the recall status for an entire lot, and all serial numbers in the lot, in all Target Markets specified in Product Master Data.
- A recall state change for a non-EU FMD Target Market – Pharmaceutical Manufacturers set the recall status for an entire lot, and all serial numbers in the lot, in selected Target Markets specified in Product Master Data.
- A recall state change for a non-EU FMD Target Market – Pharmaceutical Manufacturers set the partial recall status for a lot, and assign the recall attribute to the subset of serial numbers in the lot, in selected Target Markets specified in Product Master Data. Multiple partial recalls are possible on the same lot. Each partial recall for the same lot must have a unique effective date and serial numbers.

TraceLink maintains multiple Partial Recall events for when an ESM Serialized Operations Manager Owner requires an additional Partial Recall for the same lot. The Partial Recall events include values for Recall Target Market List, Recall Effective Date, Recall Description, and the list of associated serial numbers. The Recall Effective Date value and serial numbers must be unique within these instances of Partial Recall.

Pharmaceutical Manufacturers use the ESM Set Market Withdrawal Status message to set the status of all lots associated with a product, and all corresponding serial numbers, to the withdrawal state to indicate the product is entirely withdrawn from one or more specified markets. Owners are also able to unset the withdrawal state of a product previously reported to be in a withdrawn state, which removes the market withdrawal state from the products and the corresponding serial numbers.

Pharmaceutical Manufacturers send the ESM Update Lot Information message to TraceLink, which synchronizes updated lot information data from their enterprise serialization system of record. This message enables Pharmaceutical Manufacturers to correct a lot number or lot expiration date associated with all serial numbers in a previously commissioned lot for the following use cases:
- Updating an existing lot, previously reported with an incorrect expiration date, with a new expiration date. This updates all serial numbers associated with the item code and lot number with a new expiration date.
- Updating an existing lot, previously reported with an incorrect lot number, with a new lot number. This updates all serial numbers associated with the item code and lot number with the new lot number. This in turn creates a new lot identity.
- Updating an incorrectly reported lot with an existing, correct lot number. This updates all serial numbers associated with the item code and lot number with the new lot number, but does not create a new lot identity.

Pharmaceutical Manufacturers send the ESM Country Clearance message to TraceLink, which informs TraceLink that product is being imported into, or exported from, countries and provides supporting documentation.