Blog Archive - Welcome

8. Schweizer MWST-Tagung 2023

Die Mehrwertsteuer ist im steten Wandel, wird immer transparenter und digitaler.

Für Sie als Entscheidungsträgerin und Entscheidungsträger wird es immer schwieriger, die gesetzlichen sowie behördlichen Vorgaben und Neuerungen sowohl effizient als auch kostengünstig einzuhalten. Dazu kommen die neue Geopolitik der Lieferketten, die Ukraine- und Energie-Krise sowie die wachsenden Spannungen des Westens mit China. All dies bringt umsatzsteuerliche Herausforderungen mit sich, die es zu meistern gilt. Gleichzeitig spielen künstliche Intelligenz sowie hoch entwickelte Chatbots wie ChatGPT eine immer wichtigere Rolle. Dieser absehbare Wandel birgt neue Chancen zur Prozessoptimierung.

Es gilt, alle diese Faktoren in Ihrem Unternehmen aufeinander abzustimmen, Chancen zu ergreifen und Hürden erfolgreich zu bewältigen.

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.

Switzerland has reached a Mutual Recognition Agreement with the US

Switzerland has reached a Mutual Recognition Agreement (MRA) with the United States for good manufacturing practice (GMP) inspections, which will facilitate and decrease administrative barriers in the exchange of pharmaceutical products between the two countries which will further strengthen the supply chain.

Thank you: Pharma & Life Sciences Get Together Ticino – novità regolatorie e fiscali (IT)

Last week we had the pleasure to host the first Pharma & Life Sciences get together in Ticino since 2017 in collaboration with Farma Industria Ticino.

During the event focusing mainly on regulatory and tax topics, we introduced the latest changes in the industry incl. our white paper on a game changing new pharma regulatory rules for non EU/EEA companies selling drugs in the EU, read more here.

Many thanks to all the participants who shared extremely valuable inputs and ideas.

New Italian Decree Impacts MedTech Companies: What You Need to Know about MedTech Payback

We update you on legislation being approved that could impact the companies operating in the MedTech sector in Italy.

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.

Pharma & Life Sciences Get Together Ticino – novità regolatorie e fiscali (IT)

Siamo lieti di invitarvi al nostro evento “Pharma & Life Science Get Together Ticino” nato dalla collaborazione tra PwC e Farma Industria Ticino (FIT) per presentarvi alcune novità in ambito regolatorio e fiscale di rilevanza per le società del settore farmaceutico.

In particolare durante questo evento che si terrà il 4 aprile a Villa Sassa, vi parleremo dei seguenti argomenti di attualità:

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 :

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.