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Saudi Arabia PwC veteran of 20 years and partner in the consulting firm’s strategy arm, Strategy&, Dr Walid Tohme has been directly involved in Saudi Arabia’s healthcare transformation journey since 2016. He discusses the significant progress that has been made since then, including the institutional restructuring to separate regulatory functions from healthcare…

Italy Some of the biggest pharma and healthcare stories coming out of Italy, including Italy’s antitrust investigation of Novartis and Genentech; Johnson & Johnson’s EUR 125 million investment in its Italian manufacturing site; Chiesi Farmaceutici’s licensing agreement with Gossamer Bio for a pulmonary hypertension drug, and Menarini and Insilico’s oncology partnership.…

Saudi Arabia Faisal Al Tlasi introduces Axantia’s strategic goals, the transformation of Saudi Arabia’s healthcare system, and the company’s role in supporting Vision 2030. He discusses the importance of expanding the company’s product portfolio, entering new markets, and enhancing employee capabilities. Emphasizing partnerships and regulatory advancements, Al Tlasi underscores Axantia’s commitment to…

Saudi Arabia Dr Eid Mansour, general manager of Gilead’s new Saudi affiliate, shares the strategic goals behind the creation of a strong direct presence in a region previously managed almost entirely through distributors and how these goals align with the kingdom’s Vision 2030 and the National Transformation Programme. He also outlines the…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Competences for implementation and enforcement of pharmaceutical and medical devices legislation are shared between three governmental bodies: the Agency for Medicines and Medical Devices (ALIMS), which is an independent regulatory body entrusted with…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no requirements for clinical trials to be conducted locally as a condition for marketing approval.   2. How are clinical trials funded? Clinical trials are funded by the sponsors.…

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.…