Do all medicines have a 2D Datamatrix code?

All Rx medicines sold in the EU after 9 February 2019, yes. OTC medicines and supplements are not mandatory under the FMD, although many manufacturers have voluntarily extended serialisation.

Can I scan the Datamatrix code myself with my phone?

Yes, with a QR/Datamatrix code app you will see the technical string — GTIN, batch, expiry, serial. But you don’t have access to the SNVM database to verify “decommissioned / genuine”. Only the pharmacist does.

The seal broke accidentally. Is the medicine still good?

If it’s a box from an authorised pharmacy, scanned correctly at dispensing, a seal broken at home is not a problem. The ATD’s role is to protect the distribution chain, not the patient after purchase. Use it normally, paying attention to the expiry date.

I buy supplements online — how do I check authenticity?

Food supplements do not fall under the FMD. You check: a site notified to ANSVSA (the National Sanitary Veterinary and Food Safety Authority) or approved by the Ministry of Health. For herbal products — the ANMDMR Register of medicinal plants.

I bought from a Facebook group. How do I check?

There is no valid post-purchase verification for unauthorised sources. Recommendation: stop buying. The counterfeiting risk is high, plus it is an offence (buying Rx medicines without authorisation). Return it to an authorised pharmacy if it is sealed — they will tell you whether it is known or not.

Does the pharmacist scan every box?

Yes, every Rx box dispensed. For OTC medicines or medical devices, scanning is not mandatory. You hear a “beep” at the Datamatrix reader — a sign the check has been done.

How to check a medicine's authenticity: serialisation, 2D scannin

Since February 2019, every box of Rx medicine sold in the EU carries a unique Datamatrix code — verified at every pharmacy through the National Medicines Verification System (SNVM, Sistemul Național de Verificare a Medicamentelor), part of the European EMVS network (European Medicines Verification System). Here is how it works and how you, at home, can check whether a box is genuine.

The legal framework — the FMD Directive 2011/62/EU

Directive 2011/62/EU (Falsified Medicines Directive — FMD) plus Delegated Regulation (EU) 2016/161 require all manufacturers of Rx medicines sold in the EU to print two safety features on the packaging:

Unique identifier (UI) — a 2D Datamatrix code that contains: the product code (GTIN), the unique serial number (SN), the batch and the expiry date. Stored in a European database (EMVO) and verified at every node of the distribution chain.
Anti-tampering device (ATD) — a physical seal (foil, perforable label) which, once broken, cannot be reset. It proves the box was not opened within the distribution chain.

In Romania, the national system is operated by the Medicines Serialisation Organisation (OSMR / NMVO Romania, the national medicines verification organisation), and public checks are carried out through mva.ro or dedicated apps.

What the pharmacist sees when scanning the box

At every dispensing to a patient, the pharmacist scans the Datamatrix code on the box with a 2D reader connected to the SNVM system. Within a few seconds, the system returns a response:

OK / Active — the code exists, has not yet been decommissioned and is genuine. The pharmacist confirms “dispensing” and the system marks the code as “decommissioned” — it can no longer be sold a second time.
Warning / Unknown code — the code does not exist in the European database or is misprinted. The pharmacist does not release the box; they send it back to the distributor and report it to ANMDMR (the Romanian Agency for Medicines and Medical Devices) and OSMR.
Alert / Code already decommissioned — the code has already been used. Suspected counterfeit. The box is blocked and reported to ANMDMR.

How to check authenticity at home

There is no official public app that checks an individual code on demand for patients (SNVM access is restricted to the pharmaceutical chain). But you can check visually:

The ATD seal — on most boxes there is a foil or a perforable label on the lid. If it is broken with no signs of opening, that is alarming. If it is intact — a good sign.
The Datamatrix code — a small square 2D code (not a barcode). If it is missing on an Rx medicine sold in the EU after February 2019, it is certainly counterfeit or expired.
The batch number and expiry date printed separately — check on the packaging and on the blister/vial. They must match.
The quality of the print and packaging — uniform colour, standard fonts, no spelling mistakes, a package leaflet included in Romanian.
The source you bought it from — exclusively from authorised pharmacies. Never from Facebook, OLX or unauthorised websites. The list of authorised pharmacies: anm.ro + cnas.ro.

Which products are most often counterfeited

According to ANMDMR and WHO reports, the top risk categories are:

erectile dysfunction medicines (sildenafil — Viagra, tadalafil — Cialis);
weight-loss medicines (orlistat, sibutramine — banned but still circulating);
anabolic steroids (sold illegally in fitness gyms);
expensive oncology medicines (when purchased online from outside the EU);
unregulated imported antibiotics.

These products circulate online — they are not sold in authorised Romanian pharmacies. Catena, Dona, Tei, Help, Dr.Max, Mattca, Springfarma, Minifarm, Dav are part of the regulated chain and are checked periodically by ANMDMR. The risk of counterfeiting is very small if you buy from them.

What to do if you suspect a fake medicine

Don’t take it.
Return it to the pharmacy where you bought it — a repeat scan can clarify things.
If the result is “alert”, the pharmacy keeps it and reports it to OSMR + ANMDMR.
You can report directly to ANMDMR via an online form (anm.ro → report quality defects).
For suspicious online purchases, notify the DGSU/IGPR (the Romanian police and emergency-response authorities) — under Emergency Ordinance 122/2020 (OUG 122/2020), the online sale of Rx medicines outside the authorised framework is a criminal offence.

How to visually recognise genuine packaging

Manufacturers of medicines authorised in the EU follow strict packaging standards. What to check on a new box:

The printing on the box — colours uniformly saturated, no stains, no smudges. The font is clearly legible; there is no grammatical mistake in Romanian (the official leaflet is professionally translated). The manufacturer’s name appears on the front, side and bottom of the box, with the official logo.
The batch number — printed with thermolithographic ink, not with a sticker. It appears in 2-3 places (box, blister/vial, internal leaflet). All must match perfectly.
The expiry date — in DD.MM.YYYY or MM/YYYY format (month and year). Never a sticker applied over the original date — that would be a clear sign of tampering.
The Datamatrix code and the ATD seal — on the packaging of any Rx sold in the EU after February 2019. Their absence on a new Rx is a warning signal. The ATD seal is a foil or a perforated label; broken within the chain it is suspect, broken by the patient after purchase it is normal.
The internal leaflet — in Romanian, titled “Package leaflet: Information for the user”, with the standard ANMDMR structure (What it is, Before you take it, How to take it, Side effects, How to store it, Contents of the pack, Manufacturer/Distributor). Standard fonts, correct formatting, ANMDMR-approved.
The declared quantity matches the physical quantity — a pack labelled “30 tablets” must contain exactly 30, distributed evenly in identical-format blisters.

Legal online purchasing in Romania — the framework

The online sale of medicines in Romania is strictly regulated by Emergency Ordinance 122/2020 (OUG 122/2020) (transposed from Directive 2011/62/EU). Only pharmacies with a CNAS authorisation (CNAS — the National Health Insurance House) and ANMDMR approval for online sale may deliver. Permitted categories:

OTC medicines — all of them, including paracetamol, ibuprofen, vitamins, supplements and medical devices.
Cosmetics and personal-care products — without restrictions.
Rx medicines — FORBIDDEN for direct online sale. The only exception: collection at the pharmacy after online payment, presenting the health card at pickup. Many chains (Catena, Dona, Tei, Dr.Max) offer this option, called “click & collect”.

The list of authorised online pharmacies is published on anm.ro. Every authorised online pharmacy must display on its site the common EU logo (a stylised green cross) plus a link to the official list. If that logo is missing, the site is not legal — the risk of counterfeiting is at its maximum.

Precautions with food supplements

Food supplements are not medicines — they do not go through ANMDMR but through ANSVSA (the National Sanitary Veterinary and Food Safety Authority) or through the Ministry of Health for notification. Quality standards are laxer than for medicines. A few signs that a supplement is legal on the Romanian market:

an ANSVSA / Ministry of Health notification number printed on the box;
a complete label in Romanian (composition, method of administration, contraindications);
the manufacturing and expiry date;
a manufacturer or distributor with an EU registered office.

Supplements imported without notification (sold on Facebook, OLX, “life coach” groups) are frequently contaminated or have a composition different from the label. There have been cases in Romania of weight-loss or muscle-building products with banned substances (sibutramine, anabolic hormones, unauthorised sildenafil).

The impact of EMVS — 2019-2025 data

According to EMVO’s 2024 reports, over 99.9% of EMVS scans return an “OK” result. Fewer than 0.01% trigger alerts, and most of them are false positives (printing errors at the manufacturer, a faulty scanner). But the system has allowed several thousand real cases to be intercepted in the EU, particularly on parallel-import oncology medicines.

In Romania, OSMR reports that 100% of the large chains and 95+% of the independents are connected to the SNVM in 2026. A pharmacy that does not scan can no longer dispense Rx.

Frequently asked questions

Do all medicines have a 2D Datamatrix code?: All Rx medicines sold in the EU after 9 February 2019, yes. OTC medicines and supplements are not mandatory under the FMD, although many manufacturers have voluntarily extended serialisation.
Can I scan the Datamatrix code myself with my phone?: Yes, with a QR/Datamatrix code app you will see the technical string — GTIN, batch, expiry, serial. But you don’t have access to the SNVM database to verify “decommissioned / genuine”. Only the pharmacist does.
The seal broke accidentally. Is the medicine still good?: If it’s a box from an authorised pharmacy, scanned correctly at dispensing, a seal broken at home is not a problem. The ATD’s role is to protect the distribution chain, not the patient after purchase. Use it normally, paying attention to the expiry date.
I buy supplements online — how do I check authenticity?: Food supplements do not fall under the FMD. You check: a site notified to ANSVSA (the National Sanitary Veterinary and Food Safety Authority) or approved by the Ministry of Health. For herbal products — the ANMDMR Register of medicinal plants.
I bought from a Facebook group. How do I check?: There is no valid post-purchase verification for unauthorised sources. Recommendation: stop buying. The counterfeiting risk is high, plus it is an offence (buying Rx medicines without authorisation). Return it to an authorised pharmacy if it is sealed — they will tell you whether it is known or not.
Does the pharmacist scan every box?: Yes, every Rx box dispensed. For OTC medicines or medical devices, scanning is not mandatory. You hear a “beep” at the Datamatrix reader — a sign the check has been done.