Delegated Acts describing the details of the system for the verification of medicinal products have been published


Delegated Acts describing the details of safety features of medicine packages have been published in the Official Journal of the European Union on 9 Feb 2016. There will be three years implementation time for the verification system. In practice this means that serialization numbers need to be in use in prescription medicines by 9 Feb 2019. In addition to the serialization number, e.g. expiry date and lot number need to be added both in human-readable format and as a two-dimensional barcode, data matrix, on the packages. The manufacturer needs to save the data to a repository system as well. By comparing the information in the data matrix to the information in the repository, the stakeholders of the delivery chain can authenticate the medicinal packages. Medfiles is happy to help and give advice to marketing authorisation holders with the implementation of the safety features.

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