Measures to help protect patients from falsified medicines

New regulation introduces ‘safety features’ on the packaging of medicines for human use

The European Medicines Agency (EMA) and the European Commission (EC) have prepared an implementation plan for centrally authorised medicines to guide applicants and marketing-authorisation holders in meeting the requirements of a new regulation of the Falsified Medicines Directive. The delegated regulation introduces two safety features, a unique identifier (a 2-dimension barcode) and an anti-tampering device, to be placed on the packaging of most medicines for human use.

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