Update on Europharma DK
Europharma DK can now legally sell parallel imported and parallel distributed medicines repacked and released by Abacus Medicine.
On 3 January 2017, the Danish Medicines Agency suspended Europharma DK’s authorisation for secondary repackaging and release of medicinal products. Any medicinal products repacked by Europharma DK before the suspension must still be held back during the suspension.
However, Europharma DK can still legally wholesale distribute medicinal products that they have not repacked themselves.
The Danish Medicines Agency has approved a variation approval whereby repackaging and release of Europharma DK’s non-repacked medicinal products can be made by Abacus Medicine that holds a valid manufacturing authorisation. Europharma DK can legally sell medicines repacked and released by Abacus Medicine.
The Danish Medicines Agency has an ongoing dialogue with Europharma DK about the restoration of an acceptable GMP level and correction of the illegal activities found at our inspection on 13 December 2016. The suspension is maintained until further notice.
In this connection, specific batches will be withdrawn from pharmacies, however, the Danish Medicines Agency still assesses that these medicinal products do not constitute a health risk to patients.