In europe, from 9th of February on, the presence of a unique identifier (a two-dimensional bar-code) is complimentary in medicinal products for human use, as well as a security system on the outer packaging, which indicates whether the packaging was opened or altered after leaving the manufacturer and guarantees the authenticity of the content. This measure is part of the falsified medicines directive and it will be applied in all member states, except for Greece and Italy, which have until 2025 to update their traceability systems.
For more information, please check the European Medicines Agency website here, and the INFARMED, I.P.’s communication .
At ELS Solutions, we have a rigorous and vigilant regulatory affairs team, watching for changes in legislation, no matter what your market is. We are here to help you comply with legal requisites, make the most of your time and become even more competitive!
