Like many other countries in the EU, the Czech Republic has repeatedly experienced shortages in the supply of medicinal products for human use. In response to this unfavorable situation, the Government of the Czech Republic prepared and submitted for discussion to the Parliament of the Czech Republic a draft amendment to Act No. 378/2007 Sb. on Medicinal Products and on Changes to Some Related Acts, as amended.
Author
Milena Hoffmanová
BrowsingMilena Hoffmanová heads the Prague office Pharmaceuticals & Healthcare group. Her practice covers pharmaceuticals and healthcare matters, compliance, general commercial law, administrative law, as well as data protection and privacy law matters. She studied law at the University of Limerick in Ireland prior to graduating from the Law Faculty of Charles University in Prague in 2008. Ms. Hoffmanová’s practice focuses mainly on ensuring compliance with legal regulations as well as ethical standards relating to medicinal products and medical devices, including assisting with drafting of internal company guidelines and policies and labeling/packaging requirements. She also advises on anti-corruption compliance matters, including the extraterritorial application of US law, such as application of the Foreign Corrupt Practices Act and foreign bribery laws. She has experience in a broad range of compliance matters, including corporate and regulatory investigations, FCPA and global anti-corruption compliance, compliance program development and anti-corruption due diligence, including data privacy issues such as cross-border data flows, data security, whistle-blower hotlines, e-monitoring and other privacy-related issues. Admission Czech Republic (2008)