securPharm is designed to protect the German pharmaceutical distribution system from counterfeit medicines. The initiative was established in 2012 as a not-for-profit registered association (e.V.).
Counterfeit medicines – a global problem
Counterfeit medicines are now popping up all over the world – including in Europe. The European Union therefore took the decision in 2011 to minimise the risk of counterfeit medicines entering the legal supply chain. The German legislator transposed the catalogue of measures prescribed by the EU into national law by amending the German Medicines Act (AMG) in 2012.
The EU Commission added the technical details regarding the design of security features in 2016. Since February 2019, only prescription medicines carrying the new safety features may be placed on the market. The legally required verification of the pharmaceutical products is carried out using a special security system.
The verification system for pharmaceutical products
Participants in the securPharm initiative have developed a verification system for pharmaceutical products. This system enables the authenticity of each pack of medicine to be checked by authorised users. Pharmacies have an important role to play in all this. If they suspect a counterfeit product, they can take the medicine concerned out of circulation before it reaches the patient.
The verification system consists of various subsystems, one of which is the pharmaceutical industry database system. ACS PharmaProtect GmbH operates this database and is continuously developing it.
How the ACS MAH System works
Every single pharmaceutical pack is given a unique serial number during production. It is printed on the packaging as a data matrix code and, in addition to the serial number, contains various information that can also be found in plain text on every pharmaceutical pack:
- central pharmaceutical number (PZN), coded as pharmacy product number (PPN) or national trade item number (NTIN);
- the batch number and
- the expiry date of the pharmaceutical product.
The pharmaceutical companies transmit the above information and the status of the pack to the ACS MAH System either via the EU Hub of the European Medicines Verification Organisation (EMVO) or via a national interface.
To verify the pack before dispensing, the responsible persons – for example, staff in the pharmacy – scan the data matrix code on the pack. In order to ensure that the data retrieval is anonymous, the database system used by pharmacies in Germany acts as an intermediate system in order to verify the serial number and product code. The dispensing pharmacy is sent the status of the pack as recorded in the ACS MAH System. If this is correct, the pack can be handed over. At the same time, the system changes the status of the pack in the database, which is now entered in the system as "dispensed". This means that it is no longer possible to verify a second pack with identical serial number and product code.