Drug serialization consists of marking each medicine box with a unique identifier. Through this approach, it is possible to guarantee the authenticity of each medicine. This is about effectively fighting fake products (counterfeit, contaminated or bearing a false label).
Governance of serialization at European and national level is an essential process to prevent falsification. To ensure implementation and management of the medicines verification system, several organizations are involved, such as:
- the European Medicines Verification Organisation (EMVO) at European level;
- the Inter-Pharmaceutical Club (CIP) in France.
Governance of Serialization at European Level
EMVO (European Medicines Verification Organisation) is a Belgian non-profit organization. It represents stakeholders united in securing the legal supply chain against falsified medicines, namely:
- manufacturers (Medicines for Europe; EFPIA; EAEPC);
- wholesalers (GIRP);
- community pharmacists (PGEU).
This structure bears responsibility for implementing the European Medicines Verification System (EMVS), to which manufacturers connect.
The European Medicines Verification System
EMVS is compliant with the European directive on falsified medicines (FMD) and the delegated regulation (DR). It guarantees implementation of a functional, secure and interoperable system throughout the European Union. Thus, it prevents counterfeit medicines from entering the legal supply chain.
This IT hub is connected to national systems. Therefore, it allows verifying unique identifiers placed on each medicine box during dispensing. In addition, the system is interconnected with national medicines verification systems (NMVS) within each member country. It is under the governance of the National Medicine Verification Organisation (NMVO), which takes the name of France MVO (for Medicines Verification Organisation) in France.
Governance of Serialization at National Level
To strengthen information protection, each country has created a national body. The objective is to avoid storing data from all countries within a single European system.
The Inter-Pharmaceutical Club (CIP) is a non-profit association. CIP federates all actors in the medicine supply chain, such as:
- manufacturers;
- operators;
- holders;
- wholesaler-distributors;
- professional organizations representing healthcare establishments and community pharmacists.
Different medicine actors have chosen CIP to ensure governance of serialization in France. Thus, it is France MVO that carries out this activity. The latter is responsible for implementing and managing the medicines verification system in French territory. France MVO is notably responsible for:
- making available texts and practical recommendations, validated by stakeholders, for all professionals;
- managing IT interoperability of the verification system for each medicine;
- ensuring implementation of the French database;
- operating its interconnection with EMVS to verify unique random codes placed on each medicine box.
Governance of serialization at European and national level is essential to effectively fight product falsification and guarantee patient safety.
Read also: “Pharmacy Compliance with Drug Serialization”
PharmaliZr Software
Drug serialization is an essential measure to ensure quality and safety of pharmaceutical products. Also, if you wish to simplify compliance of your pharmacy, do not hesitate to join PharmaliZr on the ELODI portal or by subscribing directly on our website.
We are listening to you and we accompany you in implementing serialization. Do not wait any longer and take action by contacting us right away!