Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
The Medicines Act and the more than 50 executive orders which supplement it grant the Medicines Agency significant powers and discretion in matters relating to medicinal products. The Medicines Agency is authorised to penalise violations of the legislation by means of, for example, enforcement orders and withdrawal of relevant authorisations. In addition, the agency collaborates with police and prosecutors in cases where it believes that fines or imprisonment are required. However, such cases are relatively rare.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
The Medicines Act includes provisions which implement, among other things, EU Directive 2011/62/EU relating to falsified medicinal products. The Medicines Agency cooperates with other regulatory authorities within and outside the European Union and the European Economic Area and the pharmaceutical companies in order to combat dishonest practices (eg, counterfeiting).
The legislation includes detailed rules on anti-bribery, fraud, collusion and similar activities. These rules are primarily found in the Criminal Code (Consolidated Act 1052, April 4 2016, as amended) and in certain other legislation, including the Competition Act (Consolidated Act 869, July 8 2015, as amended).
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