Suspension of Scanpharm A/S's authorisation to manufacture medicines

07 November 2019

The Danish Medicines Agency has suspended parts of Scanpharm A/S’s authorisation to analyse medicines before these are made available to patients.

The Danish Medicines Agency has revoked Scanpharm A/S’s authorisation to manufacture medicinal products and intermediate products (GMP authorisation). The company's authorisation number is 37632.

The Danish Medicines Agency suspends the authorisation following infringements found at an inspection of the company showing that the company does not adequately fulfil the rules of good manufacturing practice (GMP).

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 company has been removed from the list on the Danish Medicines Agency’s website of companies holding a valid manufacturing authorisation, and their authorisation is also highlighted as suspended in the European database, EudraGMDP.

The Danish Medicines Agency expects the suspension to be temporary until the company has restored compliance with the GMP rules.

Until the suspension of the authorisation has been lifted, there may be disruptions in the supply of Scanpharm's medicines. Patients who are treated with medicinal products from Scanpharm A/S can, however, continue taking their medication as usual.