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Get to know the Falsified Medicines Directive

 

Falsified medicines – which are fake products intended to pass as authentic – pose a serious threat to health and wellbeing. They may contain the wrong dosage of key ingredients or even poor-quality or dangerous substances, like mercury and arsenic. These products are not subject to the same quality control standards as authentic medicines, either. 

The Falsified Medicines Directive works to keep these products from entering the legal supply chain, where they may be given to patients.

Where it applies

The Falsified Medicines Directive applies throughout the European Union.

Falsified Medicines Directive - Avery Dennison

Objectives

  • Making the manufacture and delivery of medicines across Europe more secure

  • Protecting patients by preventing falsified medicines from entering the supply chain

Actions

  • Requires the use of safety features on most prescription and some over-the-counter medicines in the form of a two-dimensional barcode and an anti-tampering device

  • Requires that all active substances manufactured outside of and imported into the EU include a written confirmation from the regulatory authority of the exporting country

  • Requires the websites of legally-operating online pharmacies and approved retailers in the EU to use a logo identifying them as approved sources of authentic medicines 

  • Establishes the good distribution practice, which outlines the minimum standards that wholesale distributors must meet to ensure that the integrity and quality of medicines are maintained across the supply chain

What this means for you

If you work in the pharmaceuticals industry, you may have to update your packaging and make other changes in order to align with the Falsified Medicines Directive.

Falsified Medicines Directive - Avery Dennison

How we can help

Our team of compliance experts can help you select solutions that meet the requirements of the Falsified Medicines Directive and other products that address the safety concerns of the pharmaceutical industry. We also have a portfolio of products specially designed to comply with this directive, including anti-tamper labels and RFID tags.