We provide end-to-end legal services for pharmaceutical companies, pharmacies, and healthcare providers – covering the full lifecycle of a medicinal product, from clinical trials and manufacturing to distribution, marketing, reimbursement and pharmacovigilance. Our support includes regulatory approvals, GMP/GDP inspections, contracts with CROs, wholesalers, pharmacies and suppliers. We represent clients before the Registration Office (URPL), the Chief Pharmaceutical Inspectorate (GIF), the Ministry of Health (MoH) and the National Health Fund (NHF). We also assist in market access strategies, compliant promotional activities, and implementation of quality and supervision systems. Our advice combines regulatory accuracy with deep industry insight and a practical, business-oriented approach.
Clinical Trials, Medical Experiments
- CTAs – preparation and negotiation of clinical and non-interventional trial contracts
- ICFs – review of Informed Consent Forms
- data protection and personal data processing in clinical trials
- secondary use of medical data
- structuring relationships between entities involved in clinical trials (including financing)
- manufacturing & labelling of investigational medicinal products / non-investigational medicinal products / auxiliary medicinal products
- representation of sponsors in litigation over liability in clinical trials
- proceedings before the president of the Registration Office (URPL) and ethics committees
- obligations of sponsors regarding financing and provision of non-investigational medicinal products / auxiliary medicinal products
- early Access Programmes / Access to treatment at the end of clinical trials
- negotiations with investigators, sites, and CROs
- personal data processing in clinical trials
- biobanking
Manufacturing and importing
- GMP inspections
- distribution models for manufactured and imported medicinal products
- contract manufacturing agreements
- quality agreements
- serialisation
Direct and intervention imports
Wholesale trade
- establishment of pharmaceutical wholesale warehouses
- development and verification of wholesale procedures
- amendments to wholesale distribution authorisations
- implementation of GDP quality systems
- distribution models
- GDP inspections
- proceedings before the Chief Pharmaceutical Inspectorate (GIF)
- agreements with logistics operators
- management of product shortages (out-of-stock situations)
- serialisation and reporting to the ZSMOPL system
- humanitarian aid
Pharmacies and retail trade of medicinal products
- establishment of pharmacies (obtaining, amending and transferring pharmacy licences)
- proceedings related to pharmacy licences (revocation, refusals)
- non-pharmacy retailing of medicinal products
- supplier agreements, distribution agreements, lease agreements
- pharmaceutical care and pharmacy services
- ban on advertising of pharmacies and pharmaceutical outlets
- strategic advisory on pharmacy development and models of delivery of medicines to patients
- pharmacy franchising and other models of cooperation
- telepharmacy and mail-order sales of medicinal products
- inspections by the pharmaceutical inspectorate
- proceedings before pharmaceutical and sanitary inspection authorities
- disputes with the National Health Fund (NHF)
Pharmacovigilance
Marketing
- review of advertising and promotional materials
- relations with Healthcare Organizations (HCOs) and Healthcare Professionals (HCPs)
- development of marketing procedures
- relations with wholesalers and pharmacies
- advisory on Codes of Good Practice
- umbrella branding
- agreements with service providers (e.g., marketing agencies)
- proceedings before the Chief Pharmaceutical Inspectorate (GIF), the Registration Office (URPL), and the Ministry of Health (MoH)
Reimbursement | Market Access
- strategic advice, preparation of market access strategies
- review of reimbursement applications and RSS
- support in negotiations with the Ministry of Health (MoH), the HTA agency (AOTMiT) and the Economic Commission
- participation in pricing negotiations
- participation in meetings with the MoH and other stakeholders
- preparation of position papers and analysis re. various aspects of reimbursement proceedings
- disputes with the National Health Fund (NHF) and MoH
- participation in legislative work regarding changes in the reimbursement law
- cooperation with stakeholders in reimbursement matters – pharmaceutical companies, scientific societies, patient organisations and industry associations
- training on legal issues regarding market access
Advisory services for industry organisations
- ongoing legal support (contracts, participation in working groups)
- development of internal procedures, including Codes of Good Practice
- legal support in the legislative process
- legislative reviews
- industry reports