Drug verification system, what does it consist of?

The Spanish drug verification system «SEVeM» is the Spanish response to the European directive aimed at combating the increasingly frequent counterfeit of medicines. In this article we will explain what it is.

Risks of counterfeit medicines

The falsification of medicines constitutes an economic crime that goes against the pharmaceutical industry and the state itself, by not paying taxes. But also, it becomes a risk to health.

Users may be consuming not only counterfeit medicines that do not contain the active ingredients for the treatment of their disease, but also they may be ingesting toxic products or with side effects of different severity.

As in other directives, the European Union sets the general guidelines for its fulfillment and each state designs the start-up strategy.

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Objectives of the drug verification system

Your ultimate goal is define guidelines, safety framework and technical precepts that allow the identification and verification of the authenticity of drugs that are dispensed through the pharmacy channel. In addition, it aims to fight against the sale online of counterfeit drugs.

The security measures introduced aim at the easy identification of medicines by printing security codes and devices in the outer packaging thereof.

This increases and toughens controls to pharmacies that dispense medications online, and increases the requirements for the registration of wholesalers. These security measures will have a register of entry and exit of pharmacies, of those that operate online and those of hospitals, both public and private.

What does the medication verification system provide?

  • Coding and unique identification for each medicine.
  • Consolidated and unified database for all industry, commerce and administration.
  • Verification of each and every medication at the point of dispensation.
  • Facilitate patient safety and, at the same time, protect your privacy.
  • Take advantage of the global benefits of universal signaling of all medicines.
  • Have a unique serial code for each medication.
  • Simplify security measures and, at the same time, make them reliable and robust.
  • Encourage participation and involve all actors in the pharmaceutical system.

Security measures

The security measures to guarantee the authenticity of the medicines through the Spanish system of verification of medicines, «SEVeM», They consist of a logo designed by the European Community. It is common to all member countries and serves to identify pharmacies that sell drugs without recipes so online

Further, strict controls and rules are applied about the composition of medicines, active ingredients and wholesale manufacturers and marketers.

The containers will carry security devices called "Datamatrix" that must be incorporated into the assembly lines of the pharmaceutical industry. Its objective is to verify its authenticity and prevent its manipulation.

Read also: What is the process that a drug passes before going to market?

Entry into force

In the development and implementation of European regulations have worked, in addition to the Spanish authorities:

  • FARMAINDUSTRIA (National Association of the Pharmaceutical Industry).
  • FEDIAR (Federation of Pharmaceutical Distributors).
  • AESEG (Spanish Association of Generic Drugs).
  • CGCOF (General Council of Official Associations of Pharmacists).

This verification system came into effect on February 9, 2019 in all the countries of the European Union, after three years of work. Although at this moment, in Spain, some developments are still pending, tending to its full compliance.

The pharmaceutical industry has invested more than 200 million euros to adapt its production lines to the new requirements posed by the start-up of the new Spanish drug verification system «SEVeM».

The incidence of counterfeit medicines in the Spanish market is very low and is always related to the sale of medicines online However, experts believe that is a good safety measure that will benefit consumers, industry and the state.

The Spanish drug verification system «SEVeM» will be the key mechanism for the effective traceability of medicines.