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Pharmaceutical Serialisation
ProtectCode pharmaceutical serialisation meets DSCSA unit-level requirements for US market entry and EU Falsified Medicines Directive requirements for European markets. Every pharmaceutical unit carries a unique unique serialised QR code.
No implementation project. Live within 30 days of first print run.
Brands globally
Countries
Codeifai Limited. Publicly listed. Transparent. Accountable.
How it works
The Drug Supply Chain Security Act (DSCSA) requires every pharmaceutical product sold in the US to carry a unique product identifier. The EU Falsified Medicines Directive requires equivalent unit-level serialisation for EU market entry. ProtectCode meets both.
Beyond compliance, pharmaceutical serialisation also provides consumer authentication at the point of dispense, chain of custody documentation for regulatory audits, and rules-based monitoring for diversion and grey market activity in pharmaceutical distribution.
DSCSA-compliant unit-level serialisation for US market entry
EU FMD compliant for European pharmaceutical markets
Chain of custody documentation generated from scan data
Consumer and pharmacist authentication at point of dispense
Rules-based monitoring for pharmaceutical diversion
API integration with pharmacy ERP and wholesale systems
Every individual product tracked, not batches or shipments
Data updated live with no processing lag
Works across every market and distribution channel
Use cases
ProtectCode is deployed across FMCG, pharmaceutical, wine, cosmetics, and export-focused industries globally.
US DSCSA compliance
Unit-level product identifiers meeting DSCSA requirements for every pharmaceutical unit sold into the US market.
EU FMD compliance
Falsified Medicines Directive compliant serialisation for pharmaceutical manufacturers entering EU member state markets.
Patient authentication
Patients and pharmacists verify pharmaceutical authenticity at point of dispense using standard smartphone camera. No app required.
Recall and withdrawal
Unit-level serialisation enables pharmaceutical product withdrawals targeting specific production batches. Regulatory documentation generated automatically.
Diversion monitoring
Rules-based monitoring detects pharmaceutical products appearing in unexpected markets or distribution channels.
Pharmacy system integration
REST API connects ProtectCode pharmaceutical serialisation data with pharmacy management and wholesale distribution systems.
Yes. ProtectCode serialised QR codes meet DSCSA unit-level product identifier requirements for pharmaceutical manufacturers selling into the US market. The platform generates the chain of custody transaction data required under DSCSA automatically from scan records.
Yes. ProtectCode serialisation meets FMD unit-level serialisation requirements for pharmaceutical manufacturers selling into EU member state markets.
Unit-level pharmaceutical serialisation means a product recall or withdrawal can target specific production batches, specific distribution channels, or specific geographic regions. This limits the commercial impact while satisfying regulatory requirements for traceability documentation.
Yes. The same ProtectCode QR code that meets DSCSA or FMD serialisation requirements also functions as a consumer and pharmacist authentication interface. One scan via smartphone returns an instant authentication result.
Book a demo and see how ProtectCode pharmaceutical serialisation works for your product and target market.
Connected packaging.
First-party data.
Supply chain intelligence.