Healthcare Committee on Changes related to Medicines’ Packaging
This week, AmCham Healthcare Committee addressed a letter to the Medicines and Medical Devices Agency, articulating the changes in the medicines’ packaging safety features, which will be operated by EU drug manufacturers according to new European Communitary regulation.
In particular, it was pointed out that the transition from unidimensional to new two-dimensional Data Matrix codes appearing on the pharmaceuticals’ packaging is qualified as minor change not affecting the products' characteristics, and hence should be notified to the Moldovan authorities without triggering a variation approval procedure.
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