At Jalsovszky, we provide comprehensive legal services to international healthcare, pharmaceutical, and life sciences companies, including especially, but not limited to marketing authorization holders (MAHs), seeking to establish, expand, or optimize their operations in Hungary. Our deep understanding of Hungary's healthcare regulatory framework, combined with our extensive experience in cross-border life sciences transactions, positions us as the preferred legal partner for foreign enterprises across the entire healthcare value chain.
Our support provided in relation to distribution encompasses comprehensive legal services across distribution-related regulatory, commercial, and compliance matters, both for innovative pharmaceuticals as well as those operating in the field of generics and biosimilars. Jalsovszky assists clients in obtaining and maintaining wholesale distribution licenses and ensuring compliance with local health authority expectations. Contract drafting and negotiation is also key, covering distribution, supply, warehousing, and service agreements, as well as sale and delivery terms and schemes applied vis-á-vis wholesalers.
Our legal support extends to advising on parallel trade, import/export controls, and customs matters relevant to pharmaceutical products. We also guide clients on anti-bribery, transparency, and promotional rules affecting distributors. We offer support with internal policy drafting as well as assisting compliance audits. Our expertise includes establishing pharmacovigilance systems and adverse event reporting procedures required for pharmaceutical marketing authorization holders.
Jalsovszky provides comprehensive support not only to clients marketing medicinal products, but companies manufacturing and distributing medical devices or food and dietary supplements. These businesses operate in a highly regulated space, and legal guidance is essential to ensure compliance and protect the brand.
The medical device sector operates within the comprehensive EU Medical Device Regulation framework, requiring rigorous compliance with safety, performance, and quality requirements. Foreign medical device companies must navigate complex conformity assessment procedures and ongoing regulatory compliance requirements.
Regarding the industry of food and dietary supplements, regulatory compliance is at least as crucial. We help our clients in navigating these complex rules, particularly when it comes to permissible health-related claims and labelling rules. Our lawyers have vast experience in reviewing marketing materials, product labels, websites, and social media content to ensure that all such materials fully comply with local laws as well as EU requirements. Our expertise in this specific area of life sciences and consumer protection law is coupled with special insight into the operation of MLM companies – a distribution regime often applied within the dietary supplement industry.
Hungary's strong clinical research infrastructure and patient populations make it an attractive location for international clinical trials and pharmaceutical research activities. We provide comprehensive legal support for clinical research operations, including clinical trial authorization procedures, ethics committee approvals, and data protection compliance for clinical studies. Our services cover support both in the area of interventional, as well as non-interventional studies.
Our services encompass negotiation of clinical trial agreements with research sites and management of regulatory interactions with the competent Hungarian authorities. We advise on clinical trial insurance requirements, investigator agreements, and patient informed consent procedures.
The life sciences sector is driven by intellectual property and requires sophisticated strategies for data exclusivity, and trade secret management. Our services encompass negotiation of research collaboration agreements, licensing arrangements for pharmaceutical technologies, and IP dispute resolution in life sciences contexts. We also advise on compliance with competition law requirements in pharmaceutical licensing and technology transfer arrangements.
Health data protection represents a critical compliance area for life sciences companies. We provide specialized guidance on GDPR compliance for health data processing, clinical trial data management, and cross-border health data transfers. Our expertise includes structuring data sharing arrangements that balance research needs with privacy protection requirements. Our law firm has special expertise in assisting various forms of intra-industry cooperations as well, such as between pharmaceutical companies and local hospitals, universities and patient support groups, including experience in supporting the launch of joint university industry departments operated within the scope of collaboration between market players of the healthcare industry and prestigious Hungarian universities. These cooperations provide a unique opportunity for growth for all parties involved but simultaneously require accentuated attention to compliance with data privacy rules, as well as the protection of each parties’ intellectual property rights and other proprietary information.
Pharmaceutical promotion is a highly scrutinized and tightly regulated field that requires careful legal oversight. As a law firm experienced in this sector, we provide comprehensive support to pharmaceutical companies seeking to market their products responsibly while remaining compliant with national and international regulatory frameworks.
The promotion of over-the-counter (OTC) and especially prescription drugs is governed by a complex network of regulations, including not only conventional statutory provisions, but various ethical codes and the practice of competent authorities. These regulations cover all forms of promotional activity—ranging from direct-to-consumer advertising and healthcare service provider engagements to digital marketing, sponsored medical education, cooperation with patient support groups and special patient support programs often offered by pharmaceutical market players.
We assist pharmaceutical clients in ensuring that all promotional materials and campaigns adhere strictly to regulatory standards. This includes the pre-publication review of advertisements, digital content, sales representative marketing materials, and providing strategic advice in relation to patient support programs.
Our firm also provides advice on interactions with healthcare professionals (HCPs), ensuring compliance with anti-kickback statutes, and other transparency requirements, including specifically but not limited to compliance with the requirements of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Additionally, we advise on internal compliance programs and training for marketing and sales teams, helping clients build robust systems to avoid missteps that could lead to regulatory enforcement or litigation. In cases where issues arise, our firm represents clients in authority-initiated investigations, and handles disputes related to promotional conduct, including competitor challenges and whistleblower complaints.
Another key topic within the scope of pharmaceutical promotion is the question of fair market value (FMV), particularly in the context of relationships between pharmaceutical companies and healthcare HCPs, institutions, and other third-party stakeholders. At Jalsovszky, we support pharmaceutical and life sciences companies in navigating the legal and regulatory landscape surrounding FMV to mitigate risk and maintain compliance.
Whether a client is launching a new product, developing a multichannel marketing campaign, or expanding globally, our team ensures promotional strategies are built on a legally sound foundation. Our deep knowledge of pharmaceutical marketing law positions us as a trusted partner for companies operating in this high-stakes and rapidly evolving field.
Pharmaceutical and medical device market access in Hungary involves complex pricing and reimbursement procedures that determine commercial viability for healthcare products. We provide guidance on pricing negotiations with national health insurance authorities, and reimbursement application processes.
Our services include advising on pharmaceutical pricing regulations, including reference pricing systems and price volume agreements. We also advise on tender procedures and public procurement requirements for healthcare products.
Healthcare operations require specialized personnel with professional qualifications subject to stringent regulatory oversight, continuing education requirements and strict conflict of interest rules. The engagement of sales representatives is also subject to various special regulatory requirements, compliance with which requires specialized expertise. We provide comprehensive employment law support tailored to the unique requirements of healthcare sector operations.
Our services include structuring employment arrangements for healthcare professionals, including physicians, pharmacists, and research personnel. For clients utilizing foreign healthcare professionals, we provide guidance on professional qualification recognition procedures, work permit requirements for healthcare workers, and compliance with regulations governing the employment of healthcare professionals from non-EU countries within Hungary's healthcare system.
Hungary's healthcare, pharmaceutical, and life sciences sector offers exceptional opportunities for foreign businesses seeking to establish or expand their presence in one of Europe's most dynamic healthcare markets. At Jalsovszky, we combine deep local expertise with international perspective to deliver practical, effective legal solutions that enable our clients to achieve their healthcare business objectives in Hungary.
Our comprehensive approach ensures that foreign healthcare businesses receive the specialized legal support necessary to establish successful, compliant, and sustainable operations in Hungary's evolving healthcare landscape.
