With and without safety feature in the transition period

Since 9 February, the new EU Directive on pharmaceuticals has been in force. In the start-up phase packages with and without safety features may be in circulation.

In the EU, prescription-only medicines must now carry a barcode on the packaging which can be used to scan the authenticity of the product at the pharmacy.  Securpharm e.V., an association of pharmaceutical, wholesale and pharmacy associations, has set up the authenticity check in Germany. Each package bears an individual serial number, which is fed into the system. On scanning the codes, it is possible to check in the Europe-wide database whether the number was assigned by a manufacturer, or whether perhaps a package with the same number has already been sold over the counter. According to Securpharm, 19,345 pharmacies, 346 pharmaceutical companies, 887 wholesalers and 406 hospital pharmacies in Germany are connected with the system. The German Pharmaceutical Industry Association (BPI) estimates that the companies alone are investing more than EUR one billion in the system.

As the packages with the new protection system are only being brought onto the market gradually from 9 February onwards, for a transitional period there will be packs with and packs without new security features in pharmacies. The industry stresses the fact that packs already on the market can be sold and used up to their expiry date. Both existing stocks and pharmaceuticals subject to verification will mix on the market for several years. Securpharm has now issued a detailed option for action for pharmaceutical wholesalers for the current start-up phase. For example – if packages from stocks, i.e. without the new security features, are verified via the new system, they trigger a „system feedback“, which is referred to as a „red lamp“. The system therefore detects a conflict. The Association recommends that pharmaceutical wholesalers can accept these stock goods if they are convinced of their authenticity and intactness.

Martin Bergen, Managing Director of Securpharm e. V., explains: „Patient protection is a valuable commodity and indispensable for partners in the pharmaceutical supply industry. We will increase the safety of medicines further with the new protection system“.  Initially, the safety systems will go into operation in 26 EU Member States, as well as in Norway, Iceland and Liechtenstein. By 2025, the systems in Italy and Greece will be added. Graphic source verification system: Securpharm e.V.