This year’s edition of Lexology Getting the Deal Through publication Pharma & Medical Device Regulation includes a contribution by BDK Advokati. Partner Bogdan Ivanišević and senior associate Bisera Andrijašević authored the chapter on Serbia.
Bogdan and Bisera provide a comprehensive overview of the legislative and regulatory landscape in Serbia for this dynamic and innovative industry. The reader may find detailed information about the topics such as health services framework and competent authorities, conduct of clinical practice, issuing of marketing authorisation, advertising rules, medicine pricing and reimbursement of medicines, off-label use and unlicensed products, and sale and supply. The special focus in this year’s chapter is on the temporary emergency measures concerning medicines and medical devices, which the state authorities adopted in response to the coronavirus outbreak.
The Serbia chapter in Pharma & Medical Device Regulation 2021 can be downloaded here. Reproduced with permission from Law Business Research Ltd. This content was first published in Lexology GTDT: Pharma & Medical Device Regulation 2021, October 2020. For further information please visit https://www.lexology.com/gtdt/tool/workareas/report/pharma-and-medical-device-regulation.