Bart Jong focuses on European and Dutch regulatory matters concerning pharmaceuticals and biologicals. From the world’s leading pharmaceutical and biotechnology companies to more medium- and small-size operations, Mr. Jong advises clients on all aspects of medicinal product development, including marketing authorisation procedures, manufacturing (GMP) and distribution (including import and export), regulatory exclusivities and related enforcement, pharmacovigilance, inspections, and pricing and reimbursement. He also has extensive experience in administrative law pertaining to procedures against administrative authorities such as the Ministry of Health, the Dutch Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen) and the Dutch Healthcare Authority (Nederlandse Zorgautoriteit). Before joining private practice, Mr. Jong was a judge on the District Court of Amsterdam.
Experience
- Multiple pharmaceutical companies in cross-border litigation cases concerning the authorisation of medicinal products and/or enforcement of regulatory exclusivities through national or international (decentralised, mutual recognition or centralised) procedures.
- Pharmaceutical companies on issues regarding the administrative authorities and healthcare insurers’ pricing, reimbursement and substitution policies for biologicals and other expensive medicinal products.
- Clients in interactions with the EU regulators, the European Medicines Agency and the Commission, and national competent authorities, including inspections and investigations and, where necessary, representations before the EU and national courts.
Perspectives
Recognition
Credentials
Education
- LL.M., University of Amsterdam, 2003
Admissions
- Netherlands (Healthcare Law)
Languages
- Dutch
- English