The EMVO is not in a position to provide advice or other recommendations and guidelines regarding the consequences and penalties for failure to comply with the obligations laid down in the Delegated Regulation (EU) 2016/161 or Falsified Medicines Directive. For these and other similar questions, we recommend contacting the European Commission or the relevant National Competent Authority for further information. Contacting the European Commission is possible through their website, an overview of the National Competent Authorities is available here. Thank you for your understanding!