Tagged with BIA

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? As outlined in the answer to question 3 in Chapter 1, marketing authorisation of medicinal products (including new drugs and biologics, regardless of the manner of reimbursement) may be…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are subject to a marketing authorization issued by ALIMS. Marketing authorization is not required for traditional herbal medicines or homoeopathic medicines which fulfil conditions prescribed in the Medicines Act. Instead, they are registered…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? In Serbia, there are two parallel regimes of product of liability applicable to medicinal products. The first one is established by the Obligations Act of 1978 (as amended), while the second type is prescribed by the Consumer Protection Act of…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Under the Patent Act (Official Gazette of the Republic of Serbia, nos. 99/2011, 113/2017 – other act, 95/2018, 66/2019 and 123/2021), in order to obtain patent protection for an invention, the invention must satisfy the basic requirements of…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? There is an overall tendency by the Government to improve the healthcare system in Serbia, especially through digitalization and investments into creating conditions for biotechnology and innovative therapies. Regarding legislative changes, a new medicines act has been…

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes, cannabinoid-based medicines may be authorised, under the requirements prescribed by the relevant legislation. Cannabinoid-based substances are classified as the psychoactive controlled substances that are regulated by the Psychoactive Controlled Substances Act (“Official Gazette of the Republic of Serbia”, no.…

Saudi Arabia As Managing Director for Healthcare at Accenture Middle East, Samar Nassar oversees the global consultancy’s healthcare practice in the region, focusing on end-to-end management of large clients in both public and private sectors. Nassar highlights some of the key healthcare trends and challenges in the region, including workforce shortages, mental…

Saudi Arabia Mostafa Nagib outlines Lundbeck’s strategy and growth in Saudi Arabia, emphasizing their dedication to neuroscience and expanded access to innovative treatments. He discusses the challenges in mental health awareness and stigma as well as the journey of transforming Lundbeck Saudi to adapt to the Kingdom’s rapid development, fostering an environment…

Saudi Arabia CEO of King Saud University Medical City (KSUMC), Dr Ahmad Hersi, provides an overview of the prominent hospital group and Saudi Arabia’s oldest and largest academic medical centre, offers insights into KSUMC’s collaborations with international organizations, its focus on prevention and pre-hospital care, and establishing itself as one of the…

Saudi Arabia Over the past three years, Sanofi has significantly expanded its presence in the GCC region, launching 40-50 new products, including treatments for rare diseases and advancements in immunology, diabetes management, and vaccines. As Jean-Paul Scheuer explains, this expansion aligns with Sanofi’s goal to become a leading immunology company globally and…

Saudi Arabia Fadi Ghanayem, Managing Director for Saudi Arabia and Caucasus, Central Asia, Iran and Mongolia (CCAIM) at French diagnostics firm BioMérieux discusses the remarkable growth he has witnessed in Saudi Arabia thanks to the government’s push to improve healthcare and prevention in recent years.  In addition, he outlines the opportunities that…

Saudi Arabia Prof. Ayman Abdo, SVP of Saudi private healthcare cornerstone Fakeeh Care Group, outlines the group’s large range of activities, encompassing a network of hospitals, home care services, ambulance systems, and an IT company, as well as its own medical, nursing and pharmacy schools. He shares his current focus on Public-Private…