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Combining the knowledge of local laws and cultures with a global reach is just one of the ways Baker & McKenzie separates itself from other firms. Our genuinely global perspective allows us to operate without boundaries around the world, in every jurisdiction that is important to your business.

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Clinical trials and non-interventional trials – We advise clients on regulatory issues in all phases of clinical trials and non-interventional trials. We draft and localize clinical trial agreements, patient information and consent forms, indemnification letters and we assist clients in connection with the licensing of clinical trials at the National Institute of Pharmacy
Marketing authorization and licensing – We assist clients in obtaining of marketing authorizations and develop legal strategies for a marketing authorization portfolio. We have handled a number of complex operations related to mergers and acquisitions, company restructurings, transfers of regulatory approvals and product dossiers. We provide assistance in day-to day management of valid marketing authorizations which includes advice on variations and extensions, among others
Pricing and reimbursement matters – We advise several pharmaceutical industry clients in connection with price negotiations and other pricing and reimbursement issues before the National Health Insurance Fund Administration and on subsidy-volume agreements to be concluded with the National Health Insurance Fund Administration for our pharmaceutical industry clients
Promotional compliance – We advise multinational pharmaceutical and medical device companies on the interpretation of and compliance with Hungarian advertising laws and ethics rules as well as anti-bribery rules and the US Foreign Corrupt Practices Act in connection with their operations and promotional practices in Hungary. We conduct regulatory compliance audits, draft internal SOPs, template agreements, and represent clients before competent regulatory authorities
Regional coordination of regulatory work – We assist in regional coordination of regulatory work (particularly pharmaceutical promotion, regulation on interaction with healthcare professionals as well as pricing and reimbursement regulations) and the review of commercial agreements (distribution and agency agreements) covering the whole Europe, CIS, Middle East and Africa
Competition – We regularly advise major pharmaceutical companies on a wide range of antitrust issues; for instance, the competition law implications of cross-border pharmaceutical distribution, potential restrictions on parallel trade, the application of Hungarian and EC competition law on cartels and abuse of dominant position. We also regularly advise on competition law compliance with sector-specific vertical restraints included in commercial contracts with pharmaceutical wholesalers and pharmacies
Commercial agreements – We negotiate and draft complex commercial agreements with industry-specific regulatory aspects, such as joint product development, manufacturing, supply as well as distribution and agency agreements
Data privacy – We advise pharmaceutical companies with regard to the processing and transferring of patient information (sensitive data) and business secrets of medical doctors, prepare relevant consent forms and represent companies before the Hungarian data protection commissioner. We also regularly advise on all data privacy aspects of clinical trials and non-interventional trials
Disputes and product liability – We help anticipate and avoid, or litigate, mediate or otherwise resolve commercial disputes and product liability matters
Intellectual property – We advise on all aspects of portfolio management, technology transfer and licensing transactions. We also conduct IP audits, provide patent validity and infringement opinions and assist with litigation
Mergers & acquisitions – We help structure, conduct due diligence, negotiate, document and execute all types of transactions, strategic alliances and joint ventures in the pharmaceutical and medical device industry
Tax – We advise on special taxes imposed on pharmaceutical companies as well as on transfer pricing, tax planning strategies and structures, and other tax law-related issues. We also advise pharmaceutical companies on tax issues in clinical trial agreements, donations for charitable purposes and the provision of assets to hospitals


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