Pharmaceutical Serialization in Europe: Ensuring Safety in the Supply Chain
Pharmaceutical serialization in Europe combats counterfeit drugs by assigning unique codes to each product, ensuring traceability throughout the supply chain. Under the Falsified Medicines Directive (FMD), serialization boosts patient safety, transparency, and recall efficiency, despite high costs. Future tech like blockchain may enhance security further.
Introduction:
Over the past few years, however, Europe’s pharmaceutical companies have faced a rather challenging role of fighting counterfeiting of medicines and therefore their patients. Serialization, a system that uses a special code assigned to every product, has become one of the salient solutions to tackle counterfeit drugs. While serialization in terms of the Falsified Medicines Directive (FMD) is practically a measure that has been carried out in the European Union (EU), it certainly has a central position in the current structural approach to guaranteeing and enhancing the overall identification processes of the industry. This article is devoted to Pharmaceutical serialization, its characteristics of how it works and the analysis of its benefits and drawbacks to the European pharmaceuticals list of networks or supply chains.
1. What is Pharmaceutical Serialization?
Pharmaceutical serialization means that a single, identifiable number is assigned to each pack of a specific drug. Such codes, commonly a 2D data matrix barcode, afford an exact tracking of each package of the medicine right from the manufacturing company through distribution to the final consumer. For serialization to be effective, it has to entail some essential information: the Global Trade Item Number (GTIN), a serial number, expiry date of the product, batch or lot number, etc.
Today, due to the EUR-D requirements, all drugs need to be serialized, making Europe one of the most progressive markets in regard to combating counterfeit products. Serialization also contributes to protection of the population against counterfeit medicines circulation as well as increasing safety of patients and, respectively, public trust to pharmaceutical business.
All medicines have to be serialized in the EU, which is why Europe is one of the most highly developed markets in the fight against counterfeit products. Serialization contributes a lot of value by protecting the market from the spread of counterfeit medicine, making a patient’s experience safer and strengthening the public’s confidence in the industry.
2. Why is Serialization Necessary?
Serialization is now required because counterfeit drugs have become a major threat in the market. The World Health Organization (WHO) revealed that up to 10 per cent of drugs sold in lower income nations are counterfeit. Indeed, fakes can easily penetrate the different channels of supply in even the European countries with utmost dangers to the lives of patients. Counterfeit drugs may have wrong strength, toxic components, or no ingredients at all, leading to treatment failure, adverse health effects and deaths.
Counterfeit drugs also jeopardize the public’s confidence in the healthcare systems because citizens have confidence in medications they use, especially those that are used to treat critical illnesses. By defining each product, serialization plays a factor in countering supply chain legitimacy and eliminating counterfeit products.
3. The Role of the Falsified Medicines Directive (FMD)
With FMD that was enacted in 2011, EU has applied a legal tool to scrutinize counterfeit drugs in the supply chain. Another paramount concern under the FMD is serialization together with tamper proof packaging. The FMD requires that all prescription drugs sold in Europe must be accompanied by a serial number in a 2D bar code and an anti-tampering device on the package.
The system generates a package level and then registers every unique code in a centralized electronic database that is referred to as the European Medicines Verification System (EMVS). Technically, the pharmacist or the healthcare provider, before dispensation of the drug, can simply scan the code in the EMVS, and his system can verify the genuineness or otherwise of the code. In the case that a package has been marked as suspicious or fake, it can be looked into, possibly tracked, and then disposed of as appropriate.
Comments