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Report suspected illegal activities with medicines

04 January 2011, Updated 25 June 2012

The Danish Health and Medicines Authority now makes it possible to anonymously report suspected illegal activities concerning medicines by means of an e-form in Danish, which is available on the website.

E-form

Indberetning af mistanke om ulovlige forhold vedrørende lægemidler (e-form in Danish only)

You can report a company or person to the Danish Health and Medicines Authority if you suspect that the person or company concerned manufactures, distributes, imports, exports or stores a medicinal product illegally.

Since the e-form is available in Danish only, we advise non-Danish readers to contact us directly with information about suspected illegal activities concerning medicines (please see contact details on the right-hand side).

The suspected activities must be described in such detail that we can investigate the matter further. It is therefore important that you fill in all the fields of the form, except for the contact details if you should wish to file the report anonymously.

When you submit the completed form, all data in the form will be encrypted. Unauthorised persons will therefore not be able to access the information.

When we have received the form, a case will be opened detailing the information that you have submitted.

The company or person that the report concerns has – like everyone else – the right to request access to the documents of the case. Any such request will be processed in accordance with the rules of the Danish Public Administration Act or the Danish Access to Public Administration Files Act. If you have filled in the fields with your contact details, and so deciding not to be anonymous, we remind you that others, including the company or person that your report concerns, can request to be informed of your identity.

As part of investigating the report, the Danish Health and Medicines Authority can carry out inspection(s) of companies authorised to handle medicines pursuant to section 39(1) of the Danish Medicines Act, and we may demand samples of medicines, intermediate products and raw materials from such companies.

If the information of the report leads us to conclude that the rules of the Danish Medicines Act have been violated, we have the legal authority to – depending on the circumstances – prohibit the distribution and dispensing of the medicinal product and to order the withdrawal of the product from the Danish market.