Mușat & Asociații is one of the first law firms established in Romania. For more than 29 years, the firm provides legal advisory services in all areas of business law, being an acknowledged market leader in Healthcare & Pharma, Mergers & Acquisitions, Corporate & Commercial, Competition & Antitrust, Intellectual Property, Public Procurement, Labor & Employee Benefits, Litigation & Arbitration, Criminal Law and Taxation.
Mușat & Asociații is recognized as one of the country’s most knowledgeable law firms in the life sciences sector, having advised an impressive portfolio of international clients over the years, including 9 of the top 12 innovative pharmaceutical companies worldwide, leading medical devices companies, private healthcare providers, contract research organizations and industry associations.
Leading pharmaceutical companies rely on Mușat & Asociații for complex projects and day-to-day issues, including without limitation to the marketing authorisation, distribution and promotion of medicinal products, the pricing and the reimbursement of medicines, the supply of medicines and medical devices under public procurement proceedings, cost-volume agreements, the clawback tax, the EFPIA/ARPIM guidelines, competition, IP, corporate, employment, data protection, tax issues, FCPA and various other compliance matters.
In a unique position to provide expert advice in all legal matters concerning these highly regulated sectors, the firm has achie- ved constant success due to the strength and depth of its legal team, which encompasses regulatory, corporate, antitrust and intellectual property attorneys, as well as extensive litigation resources. This array of talent enables the firm to consolidate its undisputed top-tier position while developing further expertise in the most sensitive issues and conducting landmark cases.
The ins and outs of biosimilars and biologics in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? The biosimilar medicinal products are not considered the same as generic medicinal products, since the Romanian legislation regulates in a different manner biosimilars and generics. As per the local…
The ins and outs of localization in Romanian pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Romania has a favourable tax regime for companies, which encourages many businesses to set up and to…
All legal aspects surrounding the orphan drugs and rare diseases in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation no. 141/2000”), which is directly applicable in Romania, specifies that a medicinal product could be designated by the European…