EuropharmaDK regains its authorisation

13 March 2017

The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.

The precise reason for lifting the suspension of EuropharmaDK's authorisation is that the company has employed a new qualified person and appointed a new Managing Director as of 1 February 2017. The company has moreover undergone a cultural change, establishing a basis to rebuild trust in the company. With the help of advisers within good manufacturing practice for medicinal products (GMP), the company has worked professionally to correct all the deficiencies the Danish Medicines Agency identified at its last inspection in December 2016, and which led to the suspension of EuropharmaDK's manufacturing and importation authorisation. The company has subsequently answered a number of questions and submitted considerable material to inform the Danish Medicines Agency of the company's procedures.

At a follow-up inspection on 8 March 2017, the Danish Medicines Agency verified that the previous major deficiencies had been corrected sufficiently. Some new deficiencies were identified, but the company has already corrected several of them and presented a satisfactory plan for correction of the remaining deficiencies.

During the inspection on 8 March, the company's stock of medicinal products, which had been quarantined, was also subjected to thorough spot checking, and no deficiencies were found in this connection. It was also agreed that all of the batches held in the company's stock of quarantined medicinal products should be released by the new qualified person prior to delivery.

"The company has worked hard and professionally to regain its authorisation and has shown strong will to change its past culture. It is against this background that we have handed back their authorisation to manufacture medicinal products. But we will of course keep a close eye on the company," says Thomas Vestergaard Pedersen, Team Manager of the Danish Medicines Agency's inspection.