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.

China Compliance Reporting Owners

Pharmaceutical Manufacturers use the China Ali Health Government Reporting Sales Warehouse message to communicate the sale of goods to the China Food and Drug Administration (CFDA).

EU Compliance Reporting Owners

Pharmaceutical Manufacturers use the EU Hub Government Report Response message to receive information from the EU Hub or NMVS which allows Pharmaceutical Manufacturers to take their own action.
Pharmaceutical Manufacturers use the Serial Number Verification Request message to request verification information for a product's serial numbers. The inbound message is sent to TraceLink, which then sends the request to the European Hub.
Pharmaceutical Manufacturers use the Serial Number Verification Response message to receive verification information for a product's serial numbers. The appropriate regulatory agency (e.g. EMVS) sends the Serial Number Verification Response message to TraceLink. TraceLink then sends the response to the Pharmaceutical Manufacturer, which contains verification information about the requested status of serial numbers.

India Compliance Reporting Owners

Pharmaceutical Manufacturers use the Exempt Production Notification message to report product that is exempt from India serialization and aggregation requirements. The India Government requires the reporting of exempt products through the DAVA Portal to indicate the tertiary serial numbers and sub-item counts of product produced for exportation.
Use of this message requires that the corresponding “Generate India Production Report” workflow has been enabled in the Company Admin App. Once the file has been processed, TraceLink sends the report information to the DAVA Portal, which causes the generation of the India GR Commission-Production Report.

SA Compliance Reporting Owners

Pharmaceutical Manufacturers can upload serialization data to the PTS when selling product within Saudi Arabia. They upload serialization data to the PTS after sending a SOM Sales Shipment message containing products with a target market of Saudi Arabia with a ship to country of Saudi Arabia. Saudi Arabia Compliance generates a PTS Upload (In-Country Sale) or PTS Upload (Export Sale) report as a record of the upload.

Pharmaceutical Manufacturers can also download serialization data from the PTS when receiving a shipment of purchased or returned items in Saudi Arabia.

Pharmaceutical Manufacturers can upload serialization data to the PTS when selling product within Saudi Arabia. They upload serialization data to the PTS after sending a SOM Sales Shipment message containing products with a target market of Saudi Arabia with a ship to country of Saudi Arabia. Saudi Arabia Compliance generates a PTS Upload (In-Country Sale) or PTS Upload (Export Sale) report as a record of the upload.

Pharmaceutical Manufacturers can also download serialization data from the PTS when receiving a shipment of purchased or returned items in Saudi Arabia.