European hospital pharmacies, compounding units and small manufacturers face the same operational problem as their US counterparts: batch records, quarantine and release, traceability, recall and a quality system, on a budget that rules out enterprise MES. Pharmacy Flow's core was built for that problem and is not tied to any US rule. Its edges, however, were built for US operations, and we would rather list them here than have you find them in week three.
What is jurisdiction-neutral
- ✓Formulations with a bill of materials, labour and QA minutes and a BUD rule; variants with SKUs
- ✓Batch creation in one transaction: finished lot in quarantine, batch In Process, first-expiry-first consumption with quantities, BUD floored by component expiry, QC tests pending
- ✓Lot and order state machines enforced by database triggers, with a status history per record
- ✓Receiving to quarantine with supplier lot, expiry, temperature check and certificate reference; permission-gated release; rule-suggested putaway
- ✓Unit serials with GS1 SGTIN, SSCC cartons and pallets, EPCIS-style events at every station
- ✓Recall by lot with per-unit disposition; deviations, CAPA, change control, environmental readings, document control
- ✓Electronic signatures bound to the session identity with password re-authentication
- ✓Demand forecast, material requirements, draft purchase orders, supplier invoices
- ✓Multi-facility routing and inter-site transfers; a partner portal and order API; a warehouse execution layer
Tenancy, facilities and data residency
Identifiers and events
GS1 identifiers, EPCIS-style events
A unit gets a serial at fill and an SGTIN formed from the product's GTIN; parcels aggregate into SSCC-18 cartons and pallets with a computed check digit; each station writes an event with business step, disposition, read point, facility, serial or SSCC and actor. These are the GS1 building blocks that both US DSCSA and EU FMD systems are built on.
What is not built: generation of the FMD unique identifier data set for the EU hub, verification and decommissioning against a national medicines verification system, and any connection to the EMVO hub. A compounding unit preparing patient-specific or in-house preparations is generally outside the FMD safety-feature obligation; a manufacturer placing packs on the market is not. Which applies to you is the first thing to establish.
Batch record and quality system
What is not built for the EU
| Area | Status today | What an EU deployment would need |
|---|---|---|
| Ship-to validation | Two-letter US state code required by the order API and portal | Country and region validation; the eligibility gate rewritten for national rules |
| Licence table | US nonresident-pharmacy licences by state with a controlled-allowed flag | Manufacturing and wholesale authorisations per member state; narcotics permits |
| FMD safety features | Not built | Unique identifier generation, EMVO hub upload, verification and decommissioning |
| Hosting region | Single region, no residency choice | EU-region deployment and processor terms |
| Language and units | English; dates ISO; currency USD in finance views | Localisation and multi-currency |
| Controlled substances | DEA schedule on materials; CII and CIII–V refill rules | National narcotic classification and record-keeping rules |
| Carriers | Carrier scans by webhook; labels for US parcel carriers | European carrier integrations |
If you are a European hospital pharmacy, compounding unit or small manufacturer, tell us your jurisdiction, your product types and whether you place packs on the market. We will tell you within a call whether a pilot makes sense now.
The EU rules that would apply
A realistic path for an EU pilot
- 1Scope the data
Decide whether the pilot stores patient identity or only partner and patient references. This determines whether hosting region is a blocker.
- 2Use the neutral core
Formulations, batches, lots, receiving, QA release, environmental readings, QMS, signatures, serials and recall work as they are. Configure facilities, roles and products.
- 3Work around the US edges
Ship-to validation and the licence gate can be bypassed for internal dispensing by running orders as staff entries against a configured state code; this is a workaround, not a feature, and we say so.
- 4Qualify for intended use
Run your Annex 11 assessment against the documented behaviours, with our support on evidence and access.
- 5Decide together what to build
Country validation, an authorisation table and EU hosting are the first three items on any EU roadmap; FMD connectivity is a larger, separate project only manufacturers need.
The Critical Medicines agenda
Frequently asked questions
Can a European pharmacy use Pharmacy Flow today?+
Does it handle FMD serialisation?+
Where is data hosted?+
Is the system validated for EU GMP Annex 11?+
Can ship-to countries other than the US be entered?+
Is the GDPR addressed?+
Multi-site production on one record.
The batch record and QMS in depth.
Tenancy, RLS, roles and signatures.
Environmental monitoring and QC release.
Much of it maps to Annex 11.
Every module on one page.