Dear pharma members
Germany has recently published a court decision with major impact on the pharma supply chain (commercial and clinical) in the EU Member States:
The court decision in a nutshell
• German pharmaceutical wholesalers are only allowed to purchase drugs from companies holding an appropriate authorization granted in one of the EU Member States.
• An equivalent authorization (e.g. a wholesale distribution license “WDA”) from a third party country like e.g. Switzerland, US and as per 1 January 2022 the U.K.is not sufficient, in order to sell medicinal products in Germany and/or to the German market. Such a “non EU” WDA is not subject to EU law and therefore not recognized as a sufficient equivalent for the respective business operation in Germany.
• Several EU Member States have already implemented similar local rules, i.e. not only the German market is affected.
Let’s discuss this crucial topic in more details during our next Pharma Webinar from a tax, regulatory affairs and supply chain point of view.
Happy to welcome you to our upcoming webinar as foIIowing:
07 July 2021
Free of charge
I am looking forward to a fruitful discussion.
Best regards and see you soon.