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Guidelines on the Falsified Medicines Directive

FAMHP

Recently, FAMHP has published guidelines as well as Q&A documents related to the Falsified Medicines Directive.

No later than 9 February 2019, safety features as imposed by the Falsified Medicines Directive 2011/62/EU of the European Parliament and of the Council should be placed on the packaging of most medicinal products for human use. Safety features include a unique identifier (a 2-dimension barcode) and an anti-tampering device.

These guidelines are not applicable to medicinal products that are included in Research & Development trials and did not yet obtain marketing authorization. They do also not apply to veterinarian medicines.

By implementing these safety features, falsified medicines can be prevented from entering the legal supply chain. In this way, medicine authenticity should be guaranteed for patients, manufacturers, distributors, pharmacies and hospitals.

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