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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VAT refund due to taxpayer on pharmaceutical rebates

The Dutch Court of First Instance has found in favour of the taxpayer in a case involving indirect rebates paid to pharmaceutical companies. In essence, the court granted a refund of VAT to a pharmaceutical company based on the CJEU Boehringer case (C-462/16), although the pharmaceutical company was not obliged to grant the rebates under national law. Although the case was concerned with price arrangements with the Minister of Health, Welfare and Sport, it is possible that the same rationale could be applied to other rebate schemes, such as rebate arrangements between pharmaceutical companies and insurance companies.

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EU Commission welcomes agreement on crucial VAT relief for COVID-19 vaccines and testing kits

The EU Commission has adopted a proposal, allowing the EU Member States to apply a zero rate VAT rate on Covid-19 vaccines and testing products. Currently, Member States can apply reduced VAT rates on sales of vaccines, but cannot apply a zero rate, while testing kits cannot benefit from reduced rates. As a consequence, different EU Member States might be adopting such a zero/reduced rate in the next coming months for these products (they are not obliged to).

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OFAC fined US subsidiary of Austrian ERBER Group after misinterpreting US Sanctions

Animal nutrition company BIOMIN America was fined by more than $250’000 for coordinating sales of agricultural commodities to a company in Cuba without authorization from OFAC (US Office of Foreign Assets Controls).

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Will you change your supply chain to benefit from a VAT and duty free importation into Belgium?

As an effort to limit the impact of COVID-19, the Belgian government has introduced a temporary relief measure whereby certain goods imported into Belgium can benefit from a VAT and duty exemption. 

A key condition to benefit from said exemption entails the importation by a so-called recognized healthcare institution (almost all Belgian hospitals qualify as such an institution). 

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Swiss Medtech companies – action required for the sale of products in the EU as per May 2020 – Is your business ready for the upcoming changes?

1. The background in a nutshell

  • Until 25th May 2020 all Medtech products that are admitted in Switzerland for the sale can be distributed also in the EU.
  • However, currently a new treaty is negotiated by Switzerland and the EU Joint Committee in that regard.
  • In case the treaty is not going to be concluded between Switzerland and the EU, all Medtech companies based in Switzerland are considered as not being anymore part of the EU. Indeed this treaty hangs by a hair.

Following the latest developments of the Swiss-EU negotiations concerning the Institutional Agreement and the Mutual Recognition Agreement (MRA), Swiss Medtech companies should be preparing for the case in which MRA would no longer apply to the medical devices after 26th May 2020.

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Cutting Edge Digital Solution – Pharma & Life Sciences Regulatory Radar

Dear all

I hope you had a relaxing summer time.

Do you face troubles in order to be up to date with all the required legislation changes in various countries in the Regulatory Pharma & Life Sciences field AND combine it with your supply chain and tax strategy?

I am happy to inform you that we have recently launched our Pharma & Life Sciences Regulatory Radar, to strive to assist you in that regard.

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