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

09/02/2016

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.

Marketing-authorisation holders are required to place the safety features on the packaging of most prescription medicines and certain non-prescription medicines no later than 9 February 2019.

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