Articles

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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Guideline on Medicine Priority Assessment Has Been Updated

Published 24 June 2024 by Dicle Doğan. Gün + Partners, Turkey

The Turkish Medicines and Medical Devices Agency updated its Guidelines on Scientific Meetings and Educational Events for medical devices on 4 January 2024, introducing a notable change of imposing a fee for event applications, set at TRY 1,114.02, effective immediately. This update eliminates the need to upload a commitment letter for event notifications and aims to streamline processes and enhance transparency in industry activities. However, the decision to charge fees has sparked criticism for potentially reducing the number of notifications by imposing additional financial burdens on companies. Further, similar fees will apply to pharmaceutical companies, although guidelines for pharmaceutical products have not been updated yet.

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Guideline on Co-Marketing of Medicines has been Updated

Published 24 June 2024 by Dicle Doğan. Gün + Partners, Turkey

The Turkish Medicines and Medical Devices Agency updated its Guidelines on Scientific Meetings and Educational Events for medical devices on 4 January 2024, introducing a notable change of imposing a fee for event applications, set at TRY 1,114.02, effective immediately. This update eliminates the need to upload a commitment letter for event notifications and aims to streamline processes and enhance transparency in industry activities. However, the decision to charge fees has sparked criticism for potentially reducing the number of notifications by imposing additional financial burdens on companies. Further, similar fees will apply to pharmaceutical companies, although guidelines for pharmaceutical products have not been updated yet.

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AI in Health Care

Published 04 June 2024 by Maarten Schut. Kennedy Van der Laan, The Netherlands

We cannot imagine life without AI anymore. The health care world too makes increasing use of AI. In this fact sheet we will describe in broad outline what care providers should pay attention to when purchasing and using AI from a health care law perspective. We will also give tips and recommendations for good use.

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