Danish Medicines Agency Revokes Scanpharm’s Authorization to Manufacture Drugs

Regulatory NewsRegulatory News | 07 November 2019 |  By 

Following an inspection that uncovered GMP deficiencies, the Danish Medicines Agency said Thursday that it has revoked Danish pharmaceutical company Scanpharm A/S’s authorization to manufacture medicinal products and intermediate products.

A three-day inspection in September showed the company lacked the necessary knowledge regarding its responsibilities related to qualified persons, as well as other issues with reporting of out-of-specification (OOS) results, OOS and missing data for stability studies and inconsistencies between registration files and specifications.

The Danish Medicines Agency also found the company used non-validated analytical methods and did not perform its self-inspection sufficiently.

“As a result of this, the quality of the products manufactured at the site is not ensured,” the agency said.
Batch recalls from wholesalers are recommended depending on each national competent authority’s assessment on the criticality of each product, the agency added.

The company has been removed from the Danish Medicines Agency’s list of companies holding a valid manufacturing authorization, and the authorization is also highlighted as suspended in the European database on compliance with GMP, known as EudraGMDP.

But the Danish Medicines Agency said it expects the suspension to be temporary.

“Scanpharm A/S is also not permitted to carry out the tasks in question under contract for other pharmaceutical companies. However, it may still store medicinal products and manufacture medicinal products for other companies which effect batch release of the medicinal products themselves,” the agency said.

Scanpharm CEO Andreas Bjørn Jensen, who was appointed in March at the age of 31, did not respond to a request for comment.

Danish Medicines Agency


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