EU Introduces New Regulation for Safety Features Against Falsified Medicines

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 02-10-2016 06:58


The European Medicines Agency (EMA) and the European Commission (EC) have prepared an implementation plan for centrally authorized medicines to guide applicants and marketing-authorization 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.

The regulation has been published in the Official Journal of the European Union. The safety features are designed to protect against falsified medicines, which may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage. "The unique identifier and the anti-tampering device placed on the packaging of the medicines will guarantee medicine authenticity for the benefit of patients and businesses, and will strengthen the security of the medicine supply chain from manufacturers to distributors to pharmacies and hospitals," said the EMA in a statement.

The EMA has revised the product information templates for human medicines to enable the implementation of the new rules. Details on the regulatory requirements and timelines are available in the implementation plan.

Falsified medicines are fake medicines that pass themselves off as real, authorized medicines. In July 2011, the European Union adopted a new directive on falsified medicines for human use. The directive not only aims to prevent falsified medicines entering the legal supply chain and reaching patients, but also to allow EU citizens to buy high quality medicines online through verified sources. It introduces harmonized safety and strengthened control measures across Europe by applying new safety measures.

Source: European Medicines Agency


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