Serialisation

Serialization, creating the system in Spain

Directive 2011/62, repositories systems and the Blueprint solution become important in the current vocabulary of the pharmaceutical sector. Directive 62 and its consequences are approaching, and strategies, investments and measures to adapt to a new regulation in just three years, need to be accelerated during the coming years. If a pharmaceutical company doesn’t comply with its provisions and Regulation 2016/161, it will not be able to market its products in Europe as of 2019.

As usual in any market and sector there will likely be a natural selection of companies, and in the market will remain those that know how to effectively adapt to the regulation changes. Either because their financial strength enabled it or they were cautious enough to initiate projects with sufficient time to reach a deadline (even though delayed, will surely finish), or a combination of both, the important issue is to be ready to launch into the market safe drugs in February 2019.

Although there has been a significant increase recently of information within the sector on serialization and tamper evidence, both public entities (Farmaindustria, GS2 Healthcare, AEMPS, EMVO) as well as private entities (companies directly involved in any part of the industry supply chain), the fact is there are still some deficiencies. The characteristics of the unique identifier and usefulness of an opening evidence system are clearer every day. The focus of the debates is now centered on the structure and functioning of the national repository systems, that will allow the management of all the unique codes that will be in the European market in three years.

To say good-by after the second half of the year, we would like to summarize the most relevant vocabulary that have marked the industry activity during the last year.

Vocabulary

  • EMVO: European Medicines Verification Organization
  • National Medicines Verification Organization.
  • EMVS: European Medicines Verification System. The system that EMVO proposes for the management of repositories.
  • NMVS: National Medicines Verification System.
  • Delegate Regulation (UE) 2016/161: Regulation that complements Directive 2011/83/CE, and by extension, Directive 2011/62/UE that modifies the first. This regulation establishes an “end to end” system that guarantees the identification and authentication of the drugs that contain safety features.
  • Directive 2001/83/CE. A community identifier is established for human consumption drugs. Its article 54 concerns guaranteeing the safety of the drugs and adaptability to pharmacovigilance systems and to technological and scientific advances.
  • Directive 2011/62/UE. Directive of June 2011 establishes a community identifier for human consumption drugs that reinforces the protection of the patient with measures against counterfeit drugs.
    • End to end verification system: it’s not a complete traceability system. It establishes what to do from the manufacturer, going through distributors and ending in the pharmacy.
    • Blueprint Solution: EMVO proposal to implement the national verification systems for medicines. Advantages:
      • Low adaptation and development cost, since they can take advantage of what has been developed at European level.
      • Minimize maintenance given they can benefit from synergies.
      • Minimize project implementation by learning already achieved by the European system.

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