EU Directive 2011/62/EU
Protection against counterfeit medicines
Human health is a top priority. To protect health and prevent counterfeit medicines, the European Commission (EC) adopted the Falsified Medicines Directive (2011/62/EU) on June 8, 2011. Since 2019, the directive has applied to all prescription medicines and certain over-the-counter medicines in the European Union.
One of the most important measures in this context is the "authentication" of medicinal products, which is to be carried out based on two safety features:
Firstly, a "Unique Identifier" that enables the verification of authenticity and the identification of an individual medicinal product pack. For this purpose, BRAINORITY offers a sophisticated solution with the SecIdent Pharma Coding System, which includes the four required data elements:
A product code: In Germany, this is the Pharmazentralnummer (PZN); in other countries, the product code may contain a reimbursement number, for example – PPN/NTIN (01 GTIN).
A serial number: A random sequence of up to 20 numerical or alphanumeric characters. A two-dimensional Data Matrix code serves as the data carrier for the unique identifier, allowing for machine reading (scanning) of the data (21 SN).
The batch number (10 LOT).
The expiry date (17 EXP).
Secondly, an "Anti-Tampering Device" (tamper-evident, first-opening protection, tamper-evident closure) that makes it possible to identify whether the outer packaging of a medicinal product has already been opened or tampered with.
What is a White List?
The white list contains prescription drugs and drug categories that may not be marked with security features.
What is a Black List?
The Black List contains those medicines that are not prescription-only but must be verified.
Practical Implementation of the Falsified Medicines Directive
As described above, a unique and tamper-proof serial number is generated for every pack of medicine. This data is uploaded by the pharmaceutical company (MAH – Marketing Authorization Holder) to the respective National Medicines Verification Systems (NMVS). A Europe-wide distribution system, the so-called EU Hub of the pharmaceutical industry, serves as the 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 only needs to be verified once.
By scanning the Data Matrix code and the unique serial code it contains, the information is cross-referenced with the respective national database. This process verifies whether the combination of safety features is valid and, consequently, whether the medication is authentic. This step takes place directly in the pharmacies before the product is dispensed to the patient. Upon verification of a valid serial number in the pharmacy, it is "decommissioned" in the system; any subsequent request will then result in an "invalid" status. Invalid serial numbers indicate a potential counterfeit and must be removed from distribution immediately. To ensure data protection, the verification request from the pharmacy is performed anonymously via a separate pharmacy system. In Germany, this is operated by the NGDA (Netzgesellschaft Deutscher Apotheker).
To provide technical and organizational support for the Falsified Medicines Directive in Germany and to continuously improve the authentication system for medicinal products, the associations of pharmaceutical companies, wholesalers, and pharmacists joined together to form the non-profit stakeholder organization securPharm e.V. In parallel, ACS PharmaProtect GmbH was established as the operating company for the pharmaceutical industry's database system in Germany and is part of the securPharm-Initiative.
Further useful information
We offer customized solutions in the area of global anti-counterfeiting guidelines for the following countries – we would be happy to advise you:
Russia
Korea
Saudi Arabia
Turkey
