Pharmaceutical Law and Regulation 

How we can help you:

• Legal support on issues related to the process of registration of medicinal products and classification of medical devices, as well as in the area of regulation of clinical assessment and manufacturing of medicinal products, including the set-up of related contractual relations with respect to legal impacts; 
• Setting up comprehensive distribution models taking into account the legal and regulatory aspects;  
• Legal assistance and representation in administrative procedures led by the state regulatory authorities, namely the State Institute for Drug Control and the Ministry of Health (e.g. in connection with registration, application for manufacturing or distribution licences, inspection findings and related administrative torts); 
• Assessment of individual discount and bonus schemes from the perspective of price regulation; 
• Advisory services in the area of compliance with the principles of pricing and reimbursement regulation, namely the maximum price of the producer and the maximum amount of mark-up; 
• Legal services in the area of regulation of advertising, namely the assessment of specific advertising messages from the perspective of their compliance with advertising law and regulations, consumer protection, unfair competition, intellectual property rights and other rights of third parties; and 
• Analysis of competition law implications of distribution models, implementation of related internal compliance processes, including advisory services in the area of dominant position, namely with respect to the assessment of its potential abuse, or assessment of activities of associations of medicinal product manufacturers or distributors.