The EU has set a directive to protect medicinal products from falsification. These regulations came into effect on 9th February 2019 under the delegated Act, EU 2016/161, which supplements the directive 2001/83/EC, the Falsified Medicines Directive (FMD).
Spotting the Fakes: Understanding Falsified Medicines and Their Dangers
Falsified medicines are a dangerous scam. They masquerade as the real product, but they are actually of substandard quality. These fraudulent products may contain incorrect dosages or inferior-quality ingredients that can put your health at risk. To make matters worse, they haven’t undergone the rigorous safety, efficacy, and quality testing required by EU law. In contrast, counterfeit medicines are those that violate intellectual property rights.
Falsification of pharmaceuticals is an issue that affects us all because it risks public health and safety. Medicinal falsification threatens global health: as the level of sophistication of these products increases every year so does the risk of falsified medicines reaching the public. The importance of developing comprehensive prevention strategies in Europe and the rest of the world cannot be stressed enough.
The Scary Reality of Illegal Medicine Distribution
Falsified medicines can reach the public through illegal distributors, such as fake online pharmacies. Somewhat more disconcerting is the fact that falsified medicines can also reach the final consumer through the legal supply chain. This not only puts public health and safety at risk but can also result in a loss of trust in the pharmaceutical industry and well-known medicinal brands.
The need for robust intergovernmental policy and solid infrastructure to prevent falsified medicines from entering the market and reaching the public is clear.
Revolutionizing Medicinal Packaging to Protect Public Health
The illegal distribution of falsified medicines is a growing concern, which can put public health and safety at risk. To prevent this, the EU has introduced new regulations requiring serialization of medicinal packaging under EU 2016/161. This unique identifier will include a product code, batch number, expiry date, and national reimbursement number, allowing for the identification of individual packages throughout the supply chain. Additionally, tamper-evident seals will be included to provide physical evidence of tampering.
The end-to-end system is complemented by risk-based verification, with high-risk medicines undergoing additional checks. Verification will take place at the point of public supply, such as pharmacies. If a wholesaler identifies a false medicinal product, they will inform relevant authorities immediately, and supply or export of the product will be prohibited. These safety procedures will apply only to prescription-based medicinal products, as the risk to public health from taking falsified prescription-based medicinal products is greater than non-prescription products.
These new regulations provide a comprehensive and robust strategy to protect public health and safety by preventing the illegal distribution of falsified medicines.
Ensuring the Safety of Medicinal Products Across Europe
The participation of countries in the Falsified Medicines Directive (FMD) is critical in establishing a safe and secure supply chain for medicinal products across Europe. EU member states, Iceland, Lichtenstein, Norway, members of the European Economic Area, as well as Switzerland, have all agreed to take part in the FMD as set out in EU 2016/161. Each country will establish their own nationwide system to administer the program within their own borders.
These efforts ensure that all medicinal products reaching the European market are verified and safe for public use. The FMD and its intergovernmental policy and infrastructure are crucial to preventing the distribution of falsified medicines, maintaining public health and safety, and promoting trust in the pharmaceutical industry.
Protect Your Products with Authenticity Labels
At 3D AG, we specialize in creating authenticity labels that are designed to protect your products and ensure their authenticity throughout the supply chain. Our holographic labels use the latest technology to provide a unique identifier, including product codes, batch numbers, expiry dates, and identification numbers. We also offer additional security features to ensure that your products are protected against counterfeiters and falsifiers.
Don’t take any chances with your products. Contact us today to learn more about our services and how we can help protect your products from the risk of falsification and counterfeit.
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