We would like to share a very important news that you might anticipate. This time, not an indirect tax one but more a regulatory one.
This news will impact all the companies that are doing clinical trials in Europe.
In a nutshell :
Continue reading Clinical Trials Information System (CTIS): Mandatory submission of Information for researchers and companies conducting clinical trials in the EU and EEA
1) General background information
As a consequence of the failed MRA between CH and the EU, EU certificates (i.e., medicinal products with SQS certificate) which were issued by the respective Swiss body, shall no longer be recognized in the EU and an EU representative is required.
Continue reading Update: Mutual Recognition Agreement CH-EU
Swiss Medtech companies have recently engaged national associations in order to take action against the so-called SQS ban by the EU Commission.
Switzerland and the EU did not reach a consensus on the negotiations of the Institutional Framework Agreement. As a consequence, the Mutual Recognition Agreement (MRA) between the EU and Switzerland and related provisions for medical devices were not updated and, therefore, ceased to apply on 26 May 2021. With that, as of now Switzerland is considered as a ‘third country’ and Swiss MedTech companies lost their previously barrier-free access to the EU market and vice versa. The following article shows what companies selling medical devices need to consider when exporting to the EU or Switzerland.
Continue reading Trade obstacles for MedTech companies due to the failed negotiations on the EU-Switzerland Institutional Agreement
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:
Continue reading WEBINAR – Pharma news: German court decision – Sale of drugs from a Swiss company and new EU requirements