ITX pharma virtual round table 2023

Dear all

Thank you for your interest in our ITX pharma virtual round table. This event will be held online on Wednesday, 31 May 2023, from 15:00 to 16:00 CEST.

After the success of our global ITX health industry convention last year, we will once again be discussing current developments, innovations and challenges that could have a major impact on the pharmaceutical, healthcare and life science industries from an indirect tax perspective.

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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.

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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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The impact of Brexit on Pharma, Life Science and MedTech companies – A PwC Pharma & Life Sciences Webinar

Dear pharma & life sciences colleagues

Brexit is coming closer every day with many aspects still unclear which makes it hard for you to prepare for it.

We’re excited to take a closer look at the current status quo and the impact of Brexit on indirect taxes, movement of goods and trade for Pharma, Life Sciences and MedTech Companies.

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Pharma & Life Sciences: 4 cutting edge digital tax & regulatory solutions

Discover PwC’s four cutting edge digital tax & regulatory solutions and how they can add value to your business, help you complying with new laws, stay up to date with upcoming changes in legislation and regulatory.

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Event: “Tax Engineering” für MedTech – 19. März 2020, PwC Luzern

Innovation gilt als Kernwert des Wirtschaftsstandorts Schweiz – und der MedTech-Branche. Das Volks-Ja zur Steuerreform hat der innovativen Tätigkeit von Unternehmen wie Ihrem eine neue Bedeutung verliehen. Auch andere nationale und internationale Neuerungen der indirekten Steuern und Zölle sowie neue regulatorische Rahmenbedingungen wirken sich 2020 auf die aktuelle und zukünftige Situation Ihres Unternehmens aus.

Wie daraus ein echter Mehrwert generiert werden kann, möchten wir gerne an unserem speziell der MedTech Branche gewidmeten Event mit Ihnen diskutieren.

Continue reading Event: “Tax Engineering” für MedTech – 19. März 2020, PwC Luzern