Tagged with Serbia

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.…

Pharma Market Poland is by far the largest pharma market in the Central and Eastern Europe (CEE) region, with a total value of EUR 6.352 billion for 2017. The Czech Republic is in second place, followed by Romania and Hungary Made with Visme Infographic Maker     The CEE countries that exported…

Serbia Serbia macroeconomic factsheet including data on population, GDP, education and life expectancy. Serbia has risen 50 places in the World Bank’s ‘Doing Business’ rankings from 93rd in 2014 to 43rd in 2018. Serbia’s GDP per capita between 2008 and 2016. International comparison of healthcare spending growth and GDP growth between…

Serbia In a market environment that, up until recently, has been severely difficult for producers of chemical pharmaceutical products to operate in, three enterprising Serbian companies – Pharmanova, INNventa and Esensa – have found success by stepping up their offering in dietary and other health supplements, as well as cosmetics and…

Serbia Between 2010 and 2012 just one of the 139 new medicines to receive market authorisations globally was approved for reimbursement in Serbia, compared with 44 in Bulgaria and 27 in Croatia; meaning a severe lack of patient access to much-needed treatments as well as an extremely challenging environment for innovative…