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Țuca Zbârcea & Asociații
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Pharmaceutical Law

Pharmaceutical Law is a niche practice area of Romanian law in which few Romanian attorneys have consistent expertise, given its complexity and close connection with other practice areas such as intellectual property, competition, litigation, labelling and packaging, advertising, data protection, consumer protection, restructuring and insolvency, employment, work-out.  

Țuca Zbârcea & Asociații has a multidisciplinary team of experienced lawyers who have gained a solid and wide expertise in all relevant pharma issues. This continuity and consistency give Țuca Zbârcea & Asociații the necessary edge and comfort for the clients to entrust us with new challenges. Our clients are top international players in the pharmaceutical industry or major local companies acting on the medicines market.

Scope of Practice
EU Compliance
surveys of EU and national regulatory issues; interpretation of the Romanian pharmaceutical concepts within the context of EU directives and regulations.
Regulatory
providing legal assistance in relation to various matters, such as the establishment of new businesses in the industry (medicine distributors, affiliates of internationals companies, etc.), authorisation and sale of new medicines, pricing policies and reimbursement issues, clawback tax, promotional campaigns and advertising, disputes with the Ministry of Health and the National Health Insurance House, public procurement procedures, reimbursement/risk sharing protocols, protecting legal rights on innovative products, clinical studies, sponsorship agreements or specialized services agreements with healthcare professional or healthcare organizations, anti-corruption matters and ethical standards, medical devices and food supplements related legal regime, etc.


Ciprian Dragomir
Iulian Maier
Dominic Morega
Andreea Oprișan


Țuca Zbârcea & Asociații and Țuca Zbârcea & Asociații Tax are collaborating with Andersen Global in Romania
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