Danish Regulator Suspends Parallel Importer's GMP Certificate

Regulatory NewsRegulatory News | 06 January 2017 |  By 

The Danish Medicines Agency has suspended Danish parallel importer Europharma DK's manufacturing authorisation and good manufacturing practice (GMP) certificate over "serious breaches of compliance" uncovered during an inspection of the company's Esbjerg, Denmark site last month.

According to Europharma DK's website, the company specializes in parallel import of drugs from other EU countries that it repackages and distributes in Denmark, Germany and Sweden.

However, the agency says it found Europharma DK's packaging operations to be out of compliance and that the company attempted to hide information from inspectors.

"Serious breaches of compliance with GMP, for example, [include] deliberately hidden information, deliberate action to avoid our control, falsification of the expiry date on medical product, use of a contract acceptor without audit of the site," the Danish Medicines Agency writes.

As a result of the inspection, the Danish Medicines Agency says it has suspended Europharma DK's manufacturing authorisation and withdrawn its GMP certificate.

"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," the Danish Medicines Agency said in a press release on Tuesday, noting that the company will be prohibited from distributing or releasing any of their stored products.

However, the Danish Medicines Agency says it consulted with Europharma DK before issuing the suspension and says it expects the suspension will be temporary until the company is able to demonstrate compliance during a future inspection.

According to the Danish Medicines Agency, the issues cited during the inspection "do not generally affect the quality of [Europharma DK's] products," though some specific unnamed drugs "have been withdrawn from pharmacies."

Focus has reached out to the Danish Medicines Agency for clarification on what products have been subject to withdrawal.

EudraGMDP, Danish Medicines Agency


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy