Pharmaceutical Law
The pharmaceutical distribution chain is in motion, not only with regard to pharmacies, but also within other levels of trade. Apart from their traditional role in the supply chain, pharmaceutical wholesalers will have to engage in innovative distribution concepts. In addition, the drug pricing system is confusing and it entails numerous uncertainties caused by permanent health reforms. Last but not least, cross-border distribution of pharmaceuticals raises complex issues.
Our legal services to the pharmaceutical industry encompass the following key areas:
- distribution of pharmaceuticals, regulations on wholesale distribution
- drug pricing and discount schemes
- classification of medicinal products (Rx, OTC, unrestricted), demarcation from other health care products
- rules on advertising and labeling
- FSA-Codex, healthcare compliance
- importation and exportation of medicinal products and medical devices
- license- and distribution agreements, R&D agreements, clinical trial agreements
- contract manufacturing
- marketability of medical devices, demarcation from medicinal products, foodstuffs, cosmetics and biocides
- conformity assessment procedures for medical devices
- medicinal products for veterinary use
