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What does the sticker on the medicinal product from parallel import mean?

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What does the sticker on the medicinal product from parallel import mean?

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

Origin

  • Parallel import drugs are original, high quality and safe, at a lower price, imported from countries of the European Economic Area.
  • Each parallel imported medicine is of guaranteed origin proven and verified not only by one but by two executive drug agencies - one in the country from which it is purchased and by BDA in Bulgaria which is issuing permission for this medicine after very strict verification procedure.

Safety

  • The presence of a sticker shows that very strict internal control of the supply chain has been applied, according to the requirements of Good Distribution Practice (GDP)
  • The sticker is a sign that the medicine is from a batch that is certified for Bulgaria by a GMP-licensed manufacturing company (GMP)
  • The label on the primary packaging of the product is a mandatory attribute according to the regulations in Bulgaria. It not only does not break the primary packaging but also prevents the medicine from mechanical damage to the integrity of the packaging