Articles

European Commission proposes new PPP labelling requirements

Published 05 February 2025 by Philippe de Jong. ALTIUS Lawyers, Belgium

On 6 January 2025, the European Commission published a draft proposal aimed at further harmonising labelling requirements for plant protection products (PPPs) in the European Union (EU). The proposal intends to repeal the existing labelling rules and introduce certain new requirements, including mandatory digital labelling. Since the draft proposal has not yet been formally adopted, some changes to the final version remain possible.

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Significant Turnaround in Russian Antitrust Practice of Protecting the Exclusivity of Drugs

Published 01 November 2024 by Boris Malakhov. Lidings, Russia

Despite the fact that the issue of intellectual property rights turnover is included in the perimeter of antimonopoly regulation, until recently the Russian Antitrust Agency took rather an observant position.

The regulator’s position was that the issue of patent infringement is a private legal dispute between original and generic manufacturers, which should not affect the turnover of drugs, particularly the execution of contracts based on the results of public procurement. Only in isolated cases the Russian Antitrust Agency has established the fact of patent infringement and issued a corresponding order on the inadmissibility of anti-competitive practices.

Now the reverse trend has clearly emerged.

More in our update.

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Online platform and the prohibition of sale of medicinal product not subject to medical prescription: the CJEU rules that a factual analysis of the role of the platform must be conducted

Published 23 September 2024 by Fabrice Perbost. Harlay Avocats, France

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.

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Changes In Regulatory Framework for Dietary Supplements in Russia: What Is to Be Expected?

Published 11 September 2024 Lidings, Russia

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.

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Advertisement of Medicines Directed to the Public

Published 13 August 2024 by Cristina Hernández Lería. Lener, Spain

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.

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