15. In what form should the safety features appear on the packaging of a parallelly imported medicinal product?

In case a parallel import is approved for a medicinal product the packaging of which bears safety features, pursuant to Section 45(f) of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, the repackaging of the medicinal product for human use has to include a removal of the existing unique identifier and its replacement with a new unique identifier following the procedure outlined in the Safety Feature Regulation.

Repackaging shall mean the replacement of the outer packaging or relabelling with a sticker.

If the medicinal product is repackaged in a new outer packaging, in accordance with Article 5 and Article 7 of Commission delegated regulation (EU) 2016/161, manufacturers shall print the 2D code on a smooth, uniform, low-reflecting surface of the packaging and further shall print data elements of the unique identifier (the product code and serial number) on the packaging in human-readable format.