Please find below some recent news of relevance for the life sciences sector as well as press releases and publications published by us.
The article discusses new requirements for pharmaceutical companies related to reporting obligations for post-market surveillance studies in Germany…
Focuses on the impact of the orphan designation for national HTA-procedures…
Discussion of the judgement of the Regional Court Frankenthal regarding the liability of the Notifed Body in connection with the so called PIP-scandal (breast implants)…
The article focuses on the reimbursement of innovative medical devices in the out-patient and in-patient sector vis-à-vis patients, if the statutory health insurances does not bear the costs for these products…
The article discusses the scope and limitations of the information claim according to Section 84a subsection 2 German Drug Act…
Discussion of the judgement of the Federal Court of Justice (BGH, 26.03.2013 – VI ZR 109/12) regarding liability for medicinal products according to Section 84 German Drug Act…