Heilmittelgesetz

The Basel Commentary on Medicinal Products Law

Questions in medicinal products law are of utmost practical relevance – now more than ever. This commentary addresses issues and systematically, comprehensively, and practically presents practice, case law, and scholarly opinions. Additionally, numerous further proposals for solutions de lege ferenda are provided. In the context of the second edition, all partial revisions are comprehensively commented on for the first time, alongside necessary updates.

It concerns changes particularly in the following areas, some of which are profound: supply security regarding medicines in hospitals; framework conditions for child-friendly medicines (market approval, accompanying measures for the pharmaceutical industry); harmonization of international regulations on market surveillance (pharmacovigilance plan, good vigilance practice, reporting obligations); marketing of medical products to pharmacists and doctors; monitoring of antibiotic distribution and consumption as well as the resistance situation in veterinary medicine; simplified approval procedures for medicines (especially in complementary medicine and herbal medicine); simplification of self-medication (adjustment of dispensing categories and requirements); revision of the provisions concerning Swissmedic; implementation of the Medicrime Convention; adoption of European medical device regulation.

This Basel commentary is a must for anyone dealing with Swiss medicinal products law.

• The most up-to-date commentary on medicinal products law considering all partial revisions of the HMG since 2002
• Scientifically grounded with practical solution proposals
• Further legal comparisons.