Pharmaceutical Law and Medical Devices Law
Dr Wolińska-Umschaden specializes in the field of pharmaceutical and medical devices law, and has extensive experience in cooperation with companies manufacturing pharmaceutical products, medical devices, and cosmetics in terms of regulatory aspects. Her area of expertise encompasses, inter alia, launch of pharmaceutical products and medical devices in the market, and advertising and promotion of drugs. In these areas Dr Wolińska-Umschaden has an extraordinary practice under Polish, Austrian, and European regulations. She provides legal advice:
- in marketing and in misleading advertisement
- in pre-marketing (including sponsoring)
- in trade-marks at medical devices
- in pricing and reimbursements
- in withdrawing pharmaceutical products and medical devices from the market
- in registration and licences proceedings (the EU, Poland, and Austria)
- in merger and acquisitions, restructuring, and privatization in the pharmaceutical and medical sector
- in tenders concerning delivery of pharmaceutical products to pharmacies
- in online pharmacies and mail-ordered sales of pharmaceuticals
- in on-going matters like changes in registers and organizations of shareholders
- in GMP
- in off-label use
- in compassionate use programmes
- in advertisements in social media and on the Internet
- in clinical trials, including drafting agreements, applications, and correspondence with supervisory authorities
- represents before public administration authorities (e.g., main pharmaceutical inspector, main sanitary inspector, local sanitary inspection authorities, the National Health Fund, AGES, BASG and FDA)
- assists in drafting drugs distribution-/import agreements
- runs training sessions on legal regulations for medical representatives and pharmaceutical companies
Dr Wolińska-Umschaden is highly specialized in the field of pharmaceutical law and medical law. She has a perfect understanding of the pharmaceutical sector and of rules governing the market in which the clients operate. She has extensive experience in providing legal advice to international clients in different European and US legal systems.
Dr Wolińska-Umschaden advises on problems associated with pharmaceutical products, medical devices, food, dietary supplements, food for special nutritional purposes, cosmetics and mergers and acquisitions between entities operating in the pharmaceutical and food markets.
She is an author of numerous publications about pharmaceuticals and medical devices, such as: Czy Legal Highs można interpretować jako produkty lecznicze w oparciu o Dyrektywę 2001/83/WE?, MIDA (2015); Arzneimittel- und Medizinproduktewerbung, doctoral dissertation (2015); Promoting Medical Products in Europe & North America, Bilingual 3rd edition Baker & McKenzie (2012); Pricing and Reimbursement Handbook, Pharmaceuticals & Healthcare Europe, Bilingual 1st edition Baker & McKenzie (2011) and runs training sessions in Pre-Marketing; Promoting pharmaceutical products and medical devices; Liability of pharmaceutical products; Pharma Social Media; Compliance in Medical Law; etc.
We provide full-range advice to entities carrying out medical activities and to external firms directly or indirectly involved in this area.
Our advice covers:
- patients’ rights
- claiming medical damages,
- proceedings before administrative authorities and all kind of courts in Poland and in Austria
- compliance in healthcare
- arbitration proceedings