Medicines imported into Bulgaria undergo a repackaging process to adapt the accompanying information to patients in the local language. In the case of repackaging, the secondary packaging (box) and the package leaflet of the imported medicinal product shall be replaced by such in Bulgarian approved BDA. In addition to changing the secondary packaging and the package leaflet, a sticker is placed on the primary packaging (blister, sachet, bottle, etc.) in accordance with the national requirements envisaged in the national legislation. The contents of each packaging material shall be approved by the BDA.
The repackaging process is carried out by companies licensed to produce medicinal products issued by BDA and adhering to Good Manufacturing Practice (GMP).
The sticker on the primary pack (blister, bottle, vial, ampoule, syringe or sachet) means an additional guarantee of origin, quality and safety of the medicine.
Drugs and medical devices from parallel import have an additional guarantee of origin, quality and safety of the medicinal product