Suspension of Europharma DK ApS’ authorisation to manufacture and distribute parallel imported medicinal products
Today, 3 January 2017, the Danish Medicines Agency suspended Europharma DK ApS’ authorisation number 30308 issued on 23 March 2015 for the manufacturing and import of medicinal products and intermediate products (GMP authorisation).
This means that as from today, Europharma DK ApS must no longer perform manufacturing activities, including the purchase of medicinal products from other markets with the purpose of repackaging. Europharma DK ApS must not release or distribute their stored medicinal products.
Europharma DK ApS no longer appears from the list of companies holding a valid Manufacturing and Importation Authorisation on the website of the Danish Medicines Agency. In addition, Europharma DK ApS’s authorisation has been classified as suspended in the European database EudraGMDP.
The reason for the suspension is that on its inspection on 13 December 2016 the Danish Medicines Agency found a number of non-compliance issues, which show that the company does not comply with the GMP rules on the manufacturing of medicinal products to an adequate extent. The company was consulted before the suspension was imposed from 21 December 2016 to 2 January 2017, and today the Danish Medicines Agency decided to suspend the company’s authorisation.
The Danish Medicines Agency expects that the suspension is temporary until the company is able to demonstrate compliance with the rules.
Europharma DK ApS’ medicinal products are not withdrawn from the market
In our opinion, the non-compliance issues found at Europharma DK ApS do not generally affect the quality of the products. However, in relation to individual medicinal products we assess that errors made by the company may have affected specific medicinal products. Consequently, these medicinal products have been withdrawn from pharmacies.
Patients in treatment with medicinal products from Europharma DK ApS can continue taking the medicine.