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Compliance and enforcement

Enforcement          

What measures are in place to enforce the laws governing medicinal products?

There are considerable differences among EU member states in their approach to the implementation and enforcement of the rules governing medicinal products and clinical trials.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

EU member states have adopted laws on bribery, fraud and anti-corruption which govern interactions between pharmaceutical industry and healthcare professionals.

The Falsified Medicines Directive (2011/62/EC) introduced harmonised safety measures to allow verification of the authenticity of medicinal products. These measures include:

  • a common, EU-wide logo to identify legal online pharmacies and retailers of medicinal products – the Implementing Regulation (699/2014) provides the technical, electronic and cryptographic requirements for ensuring the authenticity of the logo; and
  • two obligatory safety features – a unique identifier (a two-dimensional barcode) and an anti-tampering device. The Commission Delegated Regulation (2016/161) describes the characteristics of the safety features and the procedures that govern the verification of their authenticity. Marketing authorisation holders must place these safety features on the outer packaging of most prescription medicines and certain non-prescription medicines no later than February 9 2019.

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