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 :

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PwC Virtual Global ITX Health Industry Convention

Dear all,

Thank you for your interest in this year’s Global Virtual ITX Health Industry Convention. This event will be held online on Wednesday, 9 November 2022, from 15:00 to 17:00 CET.

Just like at last year’s successful event, we will be discussing current developments, innovations and challenges that are set to have a major impact on the pharmaceutical, healthcare and life science industries – with a heavy focus on indirect tax. Speakers from our various different territories will be on hand to share their expertise and country-specific views, while further sector specialists will be giving keynote speeches with further insights into strategic and industry developments.

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Event: ESG and its indirect tax journey – a hustle or an opportunity?

Do you know which global sustainability trends are relevant to your business? How does it align with your internal strategy? Do you even have an ESG strategy? Which of these new obligations will or should land on your table?

If you are interested in the above and you are dealing with trade and indirect taxes, we have an event for you!

Continue reading Event: ESG and its indirect tax journey – a hustle or an opportunity?

Your VAT payback opportunity: Further clarifications provided by the Italian tax authorities on the VAT deduction related to the pharmaceutical payback

With the Ruling reply no. 440/2022 dated 29th August 2022, the Italian tax authorities provided clarifications with reference to a case submitted by a taxpayer related to the the possibility of recovering the VAT included in payback amount[1], according to the Law Decree no. 78/2015, on the procedures related to the years 2015 and 2020, for which, as a matter of prudence, the relevant VAT had not been deducted by the taxpayer.

Continue reading Your VAT payback opportunity: Further clarifications provided by the Italian tax authorities on the VAT deduction related to the pharmaceutical payback

PwC’s 7. Schweizer MWST-Tagung

Die Mehrwertsteuer, insbesondere im Pharma Bereich für Konzerne, KMUs und Start-ups, ist im steten Wandel und immer transparenter.

Für Sie als Entscheidungsträger im Pharma & Life Sciences Bereich, wird es immer schwieriger all die gesetzlichen und behördlichen Vorgaben und Neuerungen effizient als auch kostengünstig einzuhalten. Dazu kommen die anhaltenden Auswirkungen der COVID-19-Pandemie sowie die Ukraine-Krise, welche umsatzsteuerliche Herausforderungen mit sich bringen und die es zu meistern gilt. Gleichzeitig spielt Industrie 4.0 und die umfassende Digitalisierung in der industriellen Produktion eine immer wichtigere Rolle. Dieser absehbare Wandel bringt neue Chancen zur Prozessoptimierung.

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Strategy&’s 2022 Global CDMO Study of Pharmaceutical Operations

How to gain a competitive advantage in a fast-changing pharmaceutical supply ecosystem.

The global Covid-19 pandemic as well as geopolitical tensions and trade restrictions have drawn attention to profound geographical, technical, and structural shifts in pharmaceutical supply chains. Treatments are increasingly produced by highly capable contract development and manufacturing organizations (CDMOs). As new, extraordinarily sophisticated, advanced therapies (ATx) emerge to complement traditional large and small molecule treatments, this trend looks set to deepen and accelerate. Today, CDMOs are targeting an increasingly attractive business segment, in which pure play CDMOs and other market participants are taking on a growing role.

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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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Indirect Tax virtual round table

24 November 2021 or 25 November 2021

Dear Pharma and Life Science Colleagues,

Thank you for your interest in our virtual round table on ESG, regulation and rebates in the health industry. This event will be held online on Wednesday 24 November 2021 from 15:00 to 16:00 CET, and again on Thursday 25 November 2021 from 09:00 to 10:00 CET.

Using environmental, social and governance (ESG) metrics to evaluate companies and countries on their progress towards sustainability has become a hot topic all around the world. Alongside these issues, the health sector is also facing major regulatory challenges. 

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PwC’s 6. Schweizer MWST-Tagung

Die Mehrwertsteuer, insbesondere im Pharma Bereich für Konzerne, KMUs und Start-ups, ist im steten Wandel und immer transparenter.

Für Sie als Entscheidungsträger im Pharma & Life Sciences Bereich, wird es immer schwieriger all die gesetzlichen und behördlichen Vorgaben / Neuerungen effizient und kostengünstig einzuhalten. Dazu kommt die anhaltende COVID-19-Situation, welche umsatzsteuerliche Herausforderungen mit sich bringt und die es zu meistern gilt. Gleichzeitig spielt Industrie 4.0 und die umfassende Digitalisierung in der industriellen Produktion eine immer wichtigere Rolle. Dieser absehbare Wandel bringt neue Chancen zur Prozessoptimierung.

Continue reading PwC’s 6. Schweizer MWST-Tagung