Danish regulators ban Europharma DK ApS and suggest firm needs new CEO

09-Jan-2017 - Last updated on 10-Jan-2017 at 08:38 GMT

iStock/Fredex8

Danish regulators have banned Europharma DK ApS from making or importing medicines and drug intermediates after identifying serious breaches of GMP at its plant in Esbjerg.

According to a document on EudraGMDP, Danish Medicines Agency (DKMA) inspectors who visited the site on December 13 found evidence that the expiry dates of repackaged medicinal products had been falsified.

A DKMA spokesman explained that the team identified "incorrect labelling" and raised concerns about the "use of a contract acceptor without audit of the site."

He added that: "In our decision to suspend Europharma's authorisation, we have required that Europharma employ a new CEO before we can regain our trust in the company."

The spokesman also confirmed the inspection was prompted by a whistleblower.

He added that: "At this time we cannot provide further details, as the information provided by the whistleblower are subject to a pending criminal investigation."

Manufacturing ban

The DKMA has partly suspended Europharma’s manufacturing authorisation (no. 30308) and withdrawn its good manufacturing practices (GMP) certification (no. DK H 00073116).

The agency stressed that none of the compliance breaches are related to product quality and advised patients to keep using meds provided by Europharma.

According to its website, Europharma imports drugs from EU countries which it repackages and sells in Denmark, Germany and Sweden.

The firm – which employs 44 people – claims to have a portfolio of “500 active products” and to generate annual revenue of €100m ($105m).