Reliable serialisation and labeling systems for the manufacturers of pharmaceutical products can put an end to the very serious global trade in illegal drugs once and for all. With 2011/62/EU Directive, the European Union has brought the initiative to combat the life threatening counterfeiting of medicinal products irrevocably closer to victory. Result: Mandatory serialisation is coming!
The prerequisite for protection against counterfeit medicines is the assignment of a unique serial number linked to the individual production data (product identification GTIN / NTIN / PPN, expiration date and lot number) in the form of a Matrix Code of data. The distinctive brand of the pharmaceutical industry along with sealed labels on the packaging ensure the authenticity and integrity of a drug unit and protection against manipulation. Traceability is an essential key for safe medicines and the basis of absolute consumer confidence in the pharmaceutical industry and its products.
Delegated Act to protect against falsified medicines as per EU-Directive 2011/62/EU
There is still no global standard for consumer protection with respect to prescription drugs. To date, several nations have launched separate drug safety initiatives. Turkey, for example, is considered a pioneer and, since 2010, has had legislated controls throughout the supply chain. Brazil, China, South Korea and EE. UU They have also enacted specific laws to make medicines evident in order to protect consumers more. Most countries in the rest of the world are currently working on more binding legal texts, announcing the start of the hot implementation phase until a fixed date.
There is still no global standard for consumer protection with respect to prescription drugs. To date, several nations have launched separate drug safety initiatives. Turkey, for example, is considered a pioneer and, since 2010, has had legislated controls throughout the supply chain. Brazil, China, South Korea and EE. UU They have also enacted specific laws to make medicines evident in order to protect consumers more. Most countries in the rest of the world are currently working on more binding legal texts, announcing the start of the hot implementation phase until a fixed date.......
In the autumn of 2015, in the context of such a declaration, the EU Commission issued the essential technical details for the design of safety features for pharmaceutical products. The delegated act is scheduled for publication in the Official Journal of the European Union in the first quarter of 2016.
Directive 2011/62 / EU strongly regulates that, in the future, all prescription drugs must have security labels that allow verification checks throughout the entire supply chain. In effect, all interested parties, from pharmaceutical companies and their contracted suppliers to market wholesalers and retail pharmacies, participate in this implementation. Counterfeit medications can be identified immediately and safely removed from the circulation.
Drug Supply Chain Security Act (DSCSA)
Members of the US drug supply chain UU They asked Congress to create a law that would govern the identification, administration and traceability of all prescription pharmaceutical products (Rx) within the United States in 2013. The Drug Supply Chain Safety Act 2013 (DSCSA) aims to facilitate the exchange of information at the individual package level on the legitimacy of a drug in the supply chain. This serialization process is oriented to verify and identify, not only at the unit level (for example, cardboard or bottle), but also at the level of packaging (for example, loader) of the medicine. DSCSA improves the detection and notification of illegitimate products in the drug supply chain, and facilitates more efficient withdrawals of pharmaceutical products.
The FDA forced compliance regulation for the US UU And all the others represent a significant challenge for each partner in the pharmaceutical supply chain, from the manufacturer to the pharmacist. It is through the creation and subsequent use of serialization data that manufacturers have the ability to gain real-time, end-to-end visibility, traceability and control of orders and shipments as they move along the supply chain .
November 2017, is the date manufacturers must serialize. This is required by the Drug Supply Chain Safety Act (DSCSA) that applies to the United States.
Pharmaceutical companies that produce for export and manufacturers of pharmaceutical contracts must comply with DSCSA regulations in order to continue selling their products in the world's largest market for pharmaceutical products.
Since June 30, 2017, an important change has been applied: the FDA will grant a transition period until 11/2018. In a draft directive issued by the FDA to manufacturers and other interested parties in the supply chain of prescription drugs, it is explained that the prosecution and sanction of non-compliance with the legal requirements, which should be effective as of The change date in November 2017 will be suspended for one year. The originally scheduled change date will be maintained, but the FDA will grant a transition period until 11/2018 during which no sanctions will be imposed. The stated reason for the change is that manufacturers will be given more time to implement the serialization requirements technically. Postponing the date also aims to avoid interruptions in the supply chain.
Download the playbook to learn how to prepare for federal US serialization legislation. UU For the traceability of health care products:
Statutory requirements for labeling and serialization in the pharmaceutical sector
The design of a solution that complies with the legal provisions regarding tamper-proof prescription drugs is, in any case, a complex project and presupposes the implementation of a reliable Tracking and Tracing system. In addition, packaging processes must be adapted for printing and additional labeling. As the serial numbers vary from one package to another, the boxes must be printed during the packaging process in the production lines. The unique serial numbers required for the assignment must be generated first and then combined with additional product data in a Data Matrix Code.
The guarantee of uniqueness is absolutely key because the verification necessarily requires that each serial number occurs only once. The accumulated volume of data must be stored centrally in databases between companies.
Also noteworthy are the economic challenges facing the affected businesses: budgets must be provided for new or replacement investments and the time and resources for implementation are planned efficiently. From the planning stage to the complete implementation of a Track & Trace system, a period of at least 2 years is considered appropriate.
Specifically, this means that: any drug manufacturer or contract provider that does not reach an intensive agreement on this issue now risks serious consequences in the future, from delivery delays to total inability to deliver. Do not let that happen!
Pharmaceutical serialization – End-to-end control system
Serialization encompasses the end-to-end application and data technology to generate and record serial numbers during the manufacturing process. When the pharmacist, as the last link in the value chain, sells a prescription drug to a patient, the package code is read at the pharmacy and sent to a central database for verification and verification.
Track & Trace systems for drug companies
The Track and Trace solution includes any additional information generated in each packaging step during the various levels of aggregation in the distribution chain and registers it in the corresponding code sent to the central database. The complete supply chain is traceable, transparent and secure.
Secure national system for the pharmaceutical industry
In order to make it easier for German drug manufacturers to implement a practical and realistic solution, various pharmaceutical associations, the wholesale association and the pharmacists' association came together to form securPharm. The objective of securPharm is to promote the development of a serialization system that can be owned and operated by manufacturers. The verification system developed subsequently in the context of securPharm complies with the requirements of the EU Directive and already allows companies to tag the selected medicines and submit the technical platforms to practical tests before the legal provisions come into force.
Given the global nature of the need for serialization solutions, and considering the fairly limited number of suitable suppliers in the market, the counterfeit drug project can be seen as a very special challenge in terms of achieving optimal consumer protection.
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