Articles for the ‘General’ Category

The Court of Justice of the European Union’s judgment of 29 February 2024 sheds light on the question of whether Member States may prohibit the activities of e-commerce platforms operating in the field of medicinal products not subject to medical prescription.

The case involved the www.doctipharma.fr website which was edited and operated by the French company Doctipharma SAS (“Doctipharma”). The website connected pharmacists with customers and allowed the latter to buy medicinal products not subject to compulsory medical prescription from pharmacies websites.

On 9 July 2024, the State Duma passed Bill in first reading, which focuses on changes in the regulatory regime for the circulation of dietary supplements in Russia.

The proposed amendments would introduce significant changes affecting the circulation of dietary supplements and, to a certain extent, bringing it closer to the regime established for pharmaceuticals and medical devices.

The regulation of public advertising medicines in Spain aims to ensure that promotional practices are transparent, accurate, and responsible. This includes adhering to authorized technical details, presenting dosage information clearly, and avoiding misleading claims about efficacy. Advertising should be informative and comprehensible, avoiding exaggeration and ensuring that all claims are substantiated by technical data. This article explains in more detail what needs to be considered if you intend to advertise medicines in the Spanish market.

In the dynamic world of medical technology, it is essential to always be aware of the latest regulatory requirements. The introduction of the AI Act poses new legal challenges for medtech companies when using AI.

In addition, the requirements of the MDR and data protection must still be complied with, particularly with regard to the handling of sensitive health data. But how exactly does the “magic triangle” of MDR, AI Act and data protection work in medical technology?

Using practical examples we will answer this question and would like to invite you to our free webinar (in German language):

“The interplay of the Medical Device Regulation, AI and data protection in medical technology”
on Thursday, June 13, 2024
from 12:30 – 13:30
via MS Teams

Register for free today and benefit from our in-depth knowledge and expertise in the field of digital health: to the registration

As with many healthcare systems worldwide, the Czech Republic faces challenges regarding sustainable funding and escalating healthcare costs, particularly concerning chronic and rare diseases.

Aiming to address emerging needs in public healthcare, on 12 April 2024, the Ministry of Health of the Czech Republic introduced a draft amendment to the Act on Public Health Insurance and other related laws, which is proposed to take effect on 1 January 2026. In this article, we provide an overview of the key areas affected by the legislative proposal, namely (i) price and reimbursement regulation of medicinal products and medical devices, (ii) preventive care support, (iii) reimbursement of cross-border healthcare services, and (iv) dental care reimbursement.