EU Falsified Medicines Directive (FMD)

Directive 2011/62/EU

Since February 2019, the Falsified Medicines Directive (2011/62/EU) has been in force for many medicines in the European Union. This is intended to protect patients from counterfeit medicines in the legal distribution chain.

Protection against counterfeit drugs

The health of a human being has the highest priority. In order to protect this health and prevent counterfeit medicines, the European Commission (EC) adopted the Falsified Medicines Directive (2011/62/EU of 8 June 2011) in July 2011. Since 2019, the Directive applies to all prescription and certain over-the-counter medicines in the European Union. One of the most important measures is the "authentication" of drugs, which is to be carried out on the basis of two safety features:

On the one hand, an individual recognition features ("Unique Identifier"), which enables the verification of authenticity and the identification of a single drug package. For this purpose, Brainority offers the SecIdent® Pharma Coding System, a professional solution which includes four required data elements:

  • a product code: in Germany, among other things, the pharma central number (PZN) in other countries, the product code may contain, e. g. a cost reimbursement number - PPN/NTIN (01 GTIN)
  • a serial number: max. 20-digit sequence of numeric or alphanumeric characters, generated randomly. A two-dimensional data matrix code is used as the data carrier for the individual recognition feature, which allows the data to be read (scanned) by machine (21 SN)
  • batch designation (10 LOT)
  • expiry date (17 EXP)

On the other hand, an anti-tampering device ("Anti-Tampering Device", Temper-Evident, tamper-evident, first-opening protection, tamper-evident closure), which can be used to detect whether the outer packaging of a drug has already been opened or manipulated.

"White List"

The "White List" contains the prescription drugs and drug categories that may not be labeled with safety features.

"Black List"

The "Black List" contains those drugs that are not subject to prescription but need to be verified.

Further information to the delegated regulation (EU) No. 2016/161

End-to-end verification

For each drug package an individual and tamper-proof serial number is generated as described above. These data are registered by the pharmaceutical company (pU) in the respective national systems (NMVS). A Europe-wide distribution system, the so-called EU-Hub of the pharmaceutical industry, serves as a central interface. The EU-Hub is operated by the European Medicines Verification Organisation (EMVO) and ensures, among other things, that the legitimacy of the pharmaceutical company has to be proven only once.

By scanning the Data Matrix Code and the individual serial code it contains, it is compared with the respective national database. This checks whether the combination of security features to be verified is valid and the drug is therefore genuine. This step takes place directly in the pharmacies before dispensing to the patient. Once a valid serial number has been verified in the pharmacy, it is booked out of the system and results in the status "invalid" when requested again. Invalid serial numbers indicate a counterfeit and must be removed from distribution immediately. For compliance with data protection, the verification request of the pharmacies is made anonymously via a separate pharmacy system. In Germany this is operated by the NGDA.

In order to provide technical and organizational support for the anti-counterfeiting guideline in Germany and to continuously improve the system for verifying the authenticity of drugs, the associations of pharmaceutical companies, wholesalers and pharmacists have joined forces to form the non-profit stakeholder organization securPharm e. V. . At the same time the ACS PharmaProtect GmbH was founded as the operating company of the database system of the pharmaceutical industry in Germany and is part of the securPharm initiative.

Further useful information

Falsified Medicines Directive 2011/62/EU

Delegated Regulation (EU) 2016/161

For the following countries we offer individual solutions in the area of global Falsified Medicines Directive - we will be happy to advise you:

  • Russia
  • South Korea
  • Saudi Arabia
  • Turkey