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New public Clinical Trials database leads to increased tax & regulatory transparency – risk of supply chain disruption / recall

Dears

Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact:

1. Management Summary:

• Starting 31 January 2023, all EU clinical trial applications must be submitted via the clinical trial data base CTIS, the single-entry point for submitting and assessing clinical trial data.

• Previously, sponsors had to submit applications separately to national competent authorities and ethics committees in each country. CTIS streamlines the process, allowing sponsors to apply for authorizations in up to 30 countries at once. The Clinical Trial Regulation (“CTR”) foresees a transition period from 2022 to 2025, during which all ongoing trials approved under the Clinical Trials Directive will be transitioned to CTIS.

• The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing.

• Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

Fantastic News – EU initiative: Extension of the transition period for medical devices

A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR)¹ and (EU) 2017/746 (IVDR)².

Amendments to these regulations have been prompted by factors which include the insufficient operating capacity of conforming assessment bodies as well as the unpreparedness of many manufacturers to meet the strengthened requirements of the MDR by the end of the transition periods. Taken together, there is the risk of shortages of medical devices on the EU market.

Clinical Trials Information System (CTIS): Mandatory submission of Information for researchers and companies conducting clinical trials in the EU and EEA

Dears,

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 :

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

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.

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.

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:

Swiss established Medtech companies – action required for the sale of products in the EU. Is your business ready for the possible changes as per 26 May 2021?

Continue reading Swiss established Medtech companies – action required for the sale of products in the EU. Is your business ready for the possible changes as per 26 May 2021?