Pharmaceutical Law 2200-1PS013

thematic blocks:
1. Introduction to pharmaceutical law – concept, sources of law, relation to other branches of law.
2. Constitutional foundations – right to health, proportionality principle, economic freedom. EU and international dimensions of pharmaceutical law.
3. The concept of medicinal product and medical device – definitions, classification, borderline issues.
4. Institutions and authorities responsible for regulation – URPL (Office for Registration of Medicinal Products), GIF (Chief Pharmaceutical Inspector), Ministry of Health, EMA (European Medicines Agency).
5. Marketing authorisation procedures – national, decentralised, mutual recognition (MRP), and EU central procedure.
6. Wholesale and retail distribution of medicinal products – principles, licences, professional liability.
7. Advertising of medicinal products – legal boundaries, public vs. professional audience.
8. Reimbursement of medicinal products – reimbursement policy, reimbursement lists, decisions, criteria.
9. Availability of medicinal products and drug shortages – distribution duties, export bans.
10. Innovation in the pharmaceutical market – regulatory and financial incentives, data protection, clinical trials.
11. Pharmacopoeia and medicinal product quality – quality requirements, market supervision.
12. Drug safety and post-marketing surveillance (PhV – Pharmacovigilance).
13. Legal liability in pharmaceutical law – civil, criminal, administrative.
14. Current challenges and developments in pharmaceutical law – legislative changes, pandemic-related issues.