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BiotechGeneralHealthcareMedical Devices
Andy van Esdonk
Andy van Esdonk
CJEU AG opinion: pharmaceutical company has EU VAT refund rights following ex lege payments to state health insurance body
On June 6, 2024, the Advocate General (AG) at the Court of Justice of the European Union (CJEU) delivered an opinion in case C-248/23 involving Novo Nordisk AS. The case pertains to the ex lege contributions paid by the pharmaceutical company to Hungary's state health insurance body, which subsidizes the retail sale of medicinal products in the country. The AG concluded that these contributions are effectively price reductions, entitling the pharmaceutical company to VAT refund rights. Why...
June 18, 2024
2 min read
medical companies Healthcare
Hester Borgers
Hester Borgers
 Jephta Zantinge
Jephta Zantinge
Developments in the Netherlands on preventing unwanted...
On 8 April 2024, the Dutch Minister of Medical Care (the
April 30, 2024
6 min read
Healthcare
Phillipus Putter
Phillipus Putter
 Sarah Faircliffe
Sarah Faircliffe
What does the European Commission’s proposed reform...
This article is part of a series that covers the proposed...
July 26, 2023
4 min read
pharmaceutical legislation Healthcare
Sarah Faircliffe
Sarah Faircliffe
 Nour Saab
Nour Saab
 Johanna Harelimana
Johanna Harelimana
Reform of the EU pharmaceutical legislation: proposals...
This article is part of a series that covers the proposed...
July 10, 2023
4 min read
Psychedelics Healthcare
Josh Price
Josh Price
Increased interest in the use of psychedelics as mainstream therapies
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July 4, 2023
6 min read
Environmental Risk Healthcare
Emma Stok
Emma Stok
 Hester Borgers
Hester Borgers
 Sarah Faircliffe
Sarah Faircliffe
Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 23, 2023
3 min read
data protection Healthcare
Marc Martens
Marc Martens
 Sarah Faircliffe
Sarah Faircliffe
 Benedicte Mourisse
Benedicte Mourisse
European Commission proposes to change the rules on regulatory data protection for medicines
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 15, 2023
4 min read
Healthcare
Sophie Vo
Sophie Vo
AI as a Medical Device
To add to all the chatter about AI, let's talk about AI as a medical device. Last...
May 22, 2023
3 min read
clinical trials General
Phillipus Putter
Phillipus Putter
Single-arm clinical trials: EMA launches consultation
In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively...
April 26, 2023
2 min read
Biotech
Katrina Dang
Katrina Dang
 Johanna Harelimana
Johanna Harelimana
 Christian Lindenthal
Christian Lindenthal
 Hester Borgers
Hester Borgers
 Emma Stok
Emma Stok
 Pieter Erasmus
Pieter Erasmus
 Patrick Brown
Patrick Brown
 Enrique Rivas
Enrique Rivas
An international overview of the regulatory legislation concerning telemedicine
Telemedicine has been available to healthcare providers for several years. However, it was not until quite...
April 24, 2023
1 min read
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