Global security in the pharmaceutical industry
The topic of drug safety is increasingly becoming an area of focus in politics. EU Directive 2011/62/EU (anti-forgery guidelines) and the further technical refinement provided by Delegated Regulation 2016/161/EU of the European Commission lay the foundations for combating counterfeit drugs in the legal supply chain.
Big changes starting 09 February 2019: The EU Falsified Medicines Directive states that from this date forward prescription drugs may only be put into circulation if their packaging carries an individual serial number. Using this serial number, the identity and authenticity of a drug can be checked, thus preventing counterfeit drugs from entering the legal supply chain.
In conjunction with securPharm, an initiative comprised of pharmaceutical manufacturers, pharmaceutical wholesalers and pharmacists, a pharmaceuticals authenticity checking system has already been developed for Germany.
Our solution – EMVO-certified blueprint provider
Proven system ready for international rollout
Arvato Systems has been officially named as National Blueprint Service Provider by the European Medicines Verification Organization (EMVO).
In addition, as part of its comprehensive supplier evaluation, the EMVO has confirmed Arvato Systems' quality standards. All member states of the European Union are obliged to provide a nationwide IT system that allows for an end-to-end handling and tracking process within the pharmaceutical distribution and supply chain.
securPharm: Protection against counterfeiting in Germany
Starting on 09 February 2019, the pharmaceutical industry must ensure that all prescription drugs are equipped with a data matrix code. The code, which will be printed on the packaging, will contain mandatory information such as
- the product code,
- the individual serial number,
- the batch number,
- the expiration date as well as
- additional information.
Before the product reaches the market, the manufacturer reports the information to the pharmaceutical companies' (PC) database.
Every package of medicine is then scanned by the pharmacist in the pharmacy before it is dispensed to the customer. Using the data matrix code and the item's individual identifier, the authenticity of the product can be instantly verified. Only once the status of the medicine has been verified is the pharmacist allowed to give the item to the customer. The status of the individual serial number is changed on the securPharm platform as soon as it is dispensed; it is then listed as "used" and cannot be dispensed again. The pharmaceutical wholesaler is also required to carry out risk-based audits.
Why Arvato Systems?
High data volumes, short reaction times and demanding safety regulations present securPharm with organizational and technical challenges. This is why participating trade associations in the industry turned to us early on for support and assistance. From its first hour of operation, we have run the securPharm platform from our own data center, supported ongoing test phases, and taken the lead in further developing and expanding the system – and that includes anticipating upcoming legal requirements.
Our roots are in Europe and this is also where we feel most at home: At some 150 locations in 22 countries, we support local projects with local resources so that we can be there, right by the customer's side.
With Arvato Systems we have an experienced and reliable partner at our side, who used the expertise for the successful implementation of our project from the outset. Arvato Systems does a great job: in time, in quality, in budget.Tobias Beer, ACS PharmaProtect GmbH