Pharmaceutical companies’ reporting of discovery of counterfeit medicines

Updated 15 September 2017

Pharmaceutical companies have a legal duty to report any discovery of counterfeit medicines to the Danish Medicines Agency. Reporting is done using the e-form available below.

Form

Reporting any discovery of counterfeit medicines (in Danish, opens in a new window)

Note: You have 20 minutes to complete and submit the form after you have opened it. If you spend more time, we will not receive your form.

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 Medicines Agency, (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.

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