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Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
The Danish Medicines Agency (DMA) is entrusted with a wide range of powers to enforce the law governing medicinal products, including:
- conducting inspections;
- ordering corrections;
- withdrawing authorisations;
- penalising violations; and
- reporting certain actions to the police as criminal offences.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
The DMA supervises companies manufacturing and distributing medicinal products in the legal supply chain in Denmark. Further, the agency cooperates with drug regulatory authorities both in and outside the European Union and the European Economic Area to prevent the distribution of falsified medicines.
The authorities in the European Union and the European Economic Area must inform the authorities in other EU and EEA countries if a suspicion of falsified medicinal products arises.
Further, under the Medicines Act, the holder of a manufacutring authorisation for a medicinal product must immediately notify the DMA and the marketing authorisation holder if it obtains information that a medicinal product that it manufactures is or may have been falsified.
Likewise, a holder of a wholesale distribution authorisation for medicinal products must immediately notify the DMA and the marketing authorisation holder if it receives or is offered to buy medicinal products that are or may have been falsified.
With the ongoing implementation of EU Directive 2011/62/EU on falsified medicines, further initiatives against falsified medicinal products will be introduced in 2019, hereunder a requirement that all prescription medicinal products and certain over-the-counter medicinal products must be labelled with a unique code.
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