How to verify a medicine is genuine
Verify a medicine by checking its track-and-trace serial number (İTS app in Türkiye, EU 2D barcode scan, or the manufacturer's confirmed complaint line), inspecting the anti-tampering seal, matching batch and expiry across carton, label and documents, and requesting a signed Certificate of Analysis. No single check is sufficient alone; combine several.
Counterfeit and substandard medicines reach patients through gaps in supply chains, not through sophisticated forgery alone. This guide walks through the official systems, the manufacturer-side reality, and the physical and documentary checks that together let a buyer or clinician build genuine confidence in a shipment.
What is Türkiye's İTS track-and-trace system?
İlaç Takip Sistemi (İTS), run by Türkiye's Ministry of Health, was the world's first fully deployed national medicine track-and-trace system. A karekod (GS1 DataMatrix) became mandatory on all human medicinal products from 1 January 2010, with the full track-and-trace phase — notifying every movement of every pack through the supply chain — live from March 2012, overseen by TİTCK.
Unlike the EU's end-to-end verification model, which checks a pack only at the point of dispensing, İTS requires notification at every single handover: manufacturer, wholesaler, pharmacy, hospital. The GS1 DataMatrix on the pack encodes four fields: AI 01 the GTIN (product code), AI 21 the unique serial number, AI 17 the expiry date (YYMMDD), and AI 10 the batch or lot number.
Citizens verify a pack through the Ministry of Health's "İTS Mobil" app (iOS and Android) — by camera scan or manual code entry — which returns one of four verdicts: registered, expired, not registered (report it), or recalled. There is no public web-based İTS query endpoint; the app is the only citizen-facing route. For a foreign buyer, the practical proof of authenticity is the supplier producing İTS notification records that match the exact serial numbers in the actual shipment.
How does the EU's FMD / EMVS verification system work?
The EU Falsified Medicines Directive (Directive 2011/62/EU) and its Delegated Regulation (EU) 2016/161 have been fully live since 9 February 2019, coordinated through the European Medicines Verification Organisation (EMVO).
Every pack carries two safety features: a unique identifier (a 2D barcode encoding product, batch, expiry and serial number) and a mandatory anti-tampering device on the carton. Unlike İTS, the EU model verifies and then decommissions the pack at the single point of dispensing — the pharmacy or hospital — rather than at every handover.
What is the US DSCSA and when does it fully apply?
Under the Drug Supply Chain Security Act (DSCSA), the United States ran a stabilisation period from 27 November 2023 to 27 November 2024 as the industry moved to full electronic, interoperable traceability. Staggered exemptions have applied to specific trading-partner categories since, and the final exemption — covering small dispensers — is due to expire on 27 November 2026, after which unit-level electronic verification is expected industry-wide.
How widespread are falsified and substandard medicines globally?
According to the WHO fact sheet on substandard and falsified medical products (updated 3 December 2024), an estimated 10.5% — roughly 1 in 10 — of medical products circulating in low- and middle-income countries are substandard or falsified.
WHO's Global Surveillance and Monitoring System launched in 2013 to collect and analyse such reports. Of around 1,500 reports received between 2013 and 2017, the regional distribution was heavily skewed:
| Region | Share of ~1,500 reports (2013–2017) |
|---|---|
| Africa | 42% |
| Americas | 21% |
| Europe | 21% |
| Western Pacific | 8% |
| Eastern Mediterranean | 6% |
| South-East Asia | 2% |
Do oncology manufacturers offer a public batch-checker?
No major oncology manufacturer offers a public serial- or batch-number lookup tool. Merck, Roche, Johnson & Johnson and Bristol Myers Squibb all route authenticity concerns to a complaint line or a local affiliate's quality-assurance team — not to a self-serve website. This means any website that markets itself as a 'manufacturer batch checker' or an independent lookup portal for these products is itself a red flag, not a legitimate verification tool.
The real routes for raising a concern are:
- Merck National Service Center — 1-800-444-2080
- Genentech (Roche group, US) Product Quality Assurance — 1-800-334-0290
- Roche outside the US — contact the local affiliate's Product Quality Assurance team and the national health authority
- FDA Office of Criminal Investigations — 1-800-551-3989 (see FDA BeSafeRx)
- WHO — rapidalert@who.int
What is the physical checklist for a suspect pack?
- Confirm the DataMatrix is present, undamaged, and scans to decode a valid GTIN, serial number, batch number and expiry date.
- Check that the serialisation label has not been overlabelled, peeled and reapplied, or shows any adhesive residue inconsistent with a factory-applied label.
- Confirm the anti-tampering device on the outer carton is fully intact, with no signs of resealing.
- Cross-check that the batch number and expiry date match exactly across the outer carton, the vial label and the accompanying shipping documents.
- Confirm the physical contents match the expected pharmaceutical form — for example, liquid found in a vial that should contain lyophilised powder is a documented falsification signal.
- Inspect the vial seal for deformation or signs of re-crimping.
- Check the solution or reconstituted product for any visible particulate matter.
- Verify the printed artwork is correct: DataMatrix position, colour blocks and any legally required local-language text.
- Confirm the batch was released for the destination market, or is accompanied by lawful parallel-import or named-patient supply documentation.
What must a genuine Certificate of Analysis contain?
Per the WHO Model Certificate of Analysis (TRS 1010, Annex 4, 2018), a genuine Certificate of Analysis (CoA) carries all of the following: the issuing laboratory's name and address; a unique CoA identification number with "page x of y" printed on every page; the sample registration number and its date of receipt; the product name, dosage form, strength and pack size; the batch number; the manufacture date; the expiry or retest date; the original manufacturer's name and address; a reference to the test procedures and specification applied; the results measured against their limits; a clear conclusion on conformity; and the date and signature of the head of laboratory or another authorised person.
An unsigned image with no batch number and no named laboratory is not a Certificate of Analysis, regardless of how official it looks.
Why does cold-chain integrity matter for monoclonal antibodies?
Monoclonal antibody medicines — including Keytruda, Opdivo, Herceptin, Avastin, Perjeta, Tecentriq, Darzalex, Imfinzi and Enhertu — must be stored at 2–8°C, protected from light, never frozen and never shaken. Heat exposure and freeze–thaw cycles drive protein aggregation and denaturation: the vial can look completely normal on visual inspection while the drug's potency is degraded and the risk of immunogenic reactions rises. Freezing damage is generally not recoverable once it has occurred.
Under EU Good Distribution Practice guidelines (2013/C 343/01), a legitimate cold-chain shipment is evidenced by qualified thermal packaging, temperature-mapped vehicles or containers, monitoring devices calibrated at least annually, a continuous temperature record for the actual shipment showing the logger's serial number and minimum/maximum readings, and delivery documentation stating the batch number, quantity, consignee, and the applicable transport and storage conditions.
When should a consignment be refused outright?
- No batch number is provided, or the manufacturer cannot confirm the one given.
- There is no scannable DataMatrix code on the pack.
- The anti-tamper seal is broken, missing, or shows signs of having been re-applied.
- The batch number or expiry date on the pack does not match the accompanying documents.
- The price is implausibly below the reference market — EU GDP guidance explicitly names unusual pricing and unsolicited bulk offers of normally scarce product as due-diligence red flags.
- No Certificate of Analysis is provided, or the one provided is deficient against the WHO model.
- There is no temperature log for the shipment, or the log shows an unexplained excursion.
- The seller cannot name its licensed legal entity, its wholesale distribution authorisation number, or its responsible pharmacist.
- The batch was released for a different market and is not accompanied by lawful parallel-import or named-patient documentation.
What do regulators say about buying medicine online?
FDA's BeSafeRx programme lists concrete warning signs of an illegitimate online pharmacy: it does not require a doctor's prescription; it is not licensed; it has no licensed pharmacist on staff; the medicine looks different from what was expected or arrives damaged, labelled in a foreign language, with no expiry date or already expired; and — in FDA's own words — it "offers deep discounts or prices that seem too good to be true."
By contrast, a safe pharmacy always requires a valid prescription, provides a real physical address and telephone number, employs a licensed pharmacist, and is licensed with its pharmacy board.
Frequently asked questions
Sources
- İlaç Takip Sistemi (İTS) — retrieved: 2026-07-28
- TİTCK — retrieved: 2026-07-28
- Delegated Regulation (EU) 2016/161 — retrieved: 2026-07-28
- Directive 2011/62/EU — retrieved: 2026-07-28
- EMVO — retrieved: 2026-07-28
- FDA — DSCSA — retrieved: 2026-07-28
- FDA — BeSafeRx — retrieved: 2026-07-28
- WHO — Substandard and falsified medical products — retrieved: 2026-07-28
- WHO TRS 1010 — retrieved: 2026-07-28
- EU GDP 2013/C 343/01 — retrieved: 2026-07-28
- GS1 DataMatrix Guideline — retrieved: 2026-07-28
Related pages
This page is editorial information about pricing systems, regulation and product authenticity. It is not medical advice and not an offer of sale. All prescription medicines require a valid prescription and, where applicable, an import permit issued by your own national authority.
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