BDK Advokati has contributed Serbia chapters to two related Getting the Deal Through publications: Life Sciences 2020 and Pharma & Medical Device Regulation 2020. Both chapters were authored by partner Bogdan Ivanišević and senior associate Bisera Andrijašević.
In the Life Sciences chapter, we examined the law and practice concerning organisation and financing of healthcare, advertising, collaboration of the pharmaceutical industry with healthcare professionals, infringements of competition law, compliance on the part of medicines and medical device manufacturers, pharmaceuticals, pricing and reimbursement of medicinal products, and access to information. We take notice of the adoption of the new Healthcare Act (2019) as a potential tool for improving the organisation and financing of healthcare services. At the same time, much room for refinement remains in the regulatory area, especially with respect to digitisation and provision of digital health services in Serbia.
In the Serbian chapter for Pharma & Medical Device Regulation 2020 we 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, clinical practice, marketing authorisation, advertising rules, pricing and reimbursement, off-label use and unlicensed products, and sale and supply. The special focus in this year’s chapter is on the newly applicable Medical Devices Act of 2017, which regulates all issues related to medical devices for human use and aligns quality and technical requirements for medical devices with those set in the relevant EU law.
The chapters can be downloaded here (Life Sciences) and here (Pharma & Medical Device Regulation). Reproduced with permission from Law Business Research Ltd. These articles were first published in Lexology Getting the Deal Through – Life Sciences 2020 (Published: January 2020) and Lexology Getting the Deal Through – Pharma & Medical Device Regulation 2020 (Published: December 2019). For further information please visit www.gettingthedealthrough.com.
