Articles for the ‘General’ Category

BIOLEGIS webinar presents the comparative legal overview “Overview of the Laws on Drug Advertising & SmPC Compliance for 17 Countries”, jointly prepared by 17 BIOLEGIS member firms. The publication provides a structured cross-border analysis of the key legal frameworks governing medicinal product advertising and compliance with the Summary of Product Characteristics (SmPC) across Europe.

Key updates in Russian data security & healthcare CII: New rules for personal data consent (effective Sept 2025), healthcare CII categorization, and penalties for non-compliance. Essential for pharma & medical retailers

Misleading claims (so-called “denigration”) about competitors’ medicinal products or devices may be illegal, as several recent cases from the European Commission and national competition authorities illustrate. Even if the allegations are not incorrect in themselves, their totality and framing (“what is not said”) can still cross the line. Companies must be very careful with this type of “information campaigns”.

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.