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Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
In general, the National Organisation for Medicines (EOF), as the supervising authority, enjoys extensive powers, both preventive and suppressive, for the purpose of enforcing the pertinent legislation. Indicatively, it can perform inspections, revoke licences, ban exports and order corrective actions and recalls. Articles 162 to 178 of Ministerial Decision YA DYG3a/GP 32221 also provides for serious penalties where the applicable law is violated, from recalls to fines.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
Apart from internal corporate responsibility and systems of shelf control that almost every pharmaceutical company employs, the EOF, in cooperation with the European Medicines Agency, also plays a significant role in combating bribery, fraud, collusion, counterfeiting and other dishonest practices, by ensuring the adherence to the relevant rules by all parties involved in the pharmaceutical industry. In that respect, the EOF has the discretion to cooperate with all relevant national authorities such as tax authorities, the public prosecutor and other competent state departments.
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