Safety Features on Medicinal Packs in use at the beginning of 2019?


Detailed regulation on the safety features, which are described in the falsified medicines directive (2011/62/EU), are expected to be published as delegated acts at the end of 2015 by European Commission. Safety features need to be applied to the pack of the medicinal products three years after the publication of delegated acts in most of the European countries. Organisations involved in the pharmaceutical supply chain are preparing for the upcoming changes, which will greatly affect the manufacturing and the distribution of medicines. Medfiles follows the changes in legislative requirements and the development of the system related to safety features. Please contact Anu Gummerus for further information on Medfiles´ regulatory affairs services.

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