Anna Pothof

Anna Pothof advises and represents pharmaceutical and biotechnology companies on EU and national regulatory and market access matters. Her practice covers all stages of the product lifecycle, including marketing authorization procedures, regulatory data and marketing protection, orphan and pediatric incentives, and compliance with GMP, GDP, and pharmacovigilance requirements.

Anna has acted in several landmark regulatory cases before the General Court and Court of Justice of the EU concerning the interpretation and enforcement of EU rules on regulatory data protection, new active substance status, and orphan market exclusivity. She also assists clients in cross-border proceedings relating to the launch of generic and biosimilar products, including issues around carve-outs and patent–regulatory overlap.

In addition, Anna advises on market access and reimbursement matters in the Netherlands. She also frequently advises and litigates on compliance with the Dutch Code of Conduct for Pharmaceutical Advertising (CGR).