The Pharma Gamechanger

Happy to share the following Article of Chemie Pharma Innovation with you (German only): https://www.chemiepharma-innovation.ch/pharmaindustrie/der-pharma-gamechanger

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Update: Mutual Recognition Agreement CH-EU

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.

Swiss Medtech companies have recently engaged national associations in order to take action against the so-called SQS ban by the EU Commission.

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Trade obstacles for MedTech companies due to the failed negotiations on the EU-Switzerland Institutional Agreement

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.

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WEBINAR – Pharma news: German court decision – Sale of drugs from a Swiss company and new EU requirements

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:

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