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Pharmaceutical companies’ reporting of discovery of counterfeit medicines

Pharmaceutical companies have a legal duty to report any discovery of counterfeit medicines to the Danish Health and Medicines Authority. Reporting is done using the e-form available in the box to the right (the e-form is in Danish only).

Legal basis

Companies holding an authorisation granted under section 7 and section 39(1) shall immediately report any discovery of counterfeit medicines in the company to the Danish Medicines Agency, now the Danish Health and Medicines Authority, (cf. section 43B(2) of the Danish Medicines Act).

For holders of an authorisation granted under section 7 and holders authorised to manufacture medicinal products, such reporting duty shall also apply to any findings outside their company that come to their awareness.

Updated 23 April 2012