Articles

Named Patient Program in Turkey

Published 18 March 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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Guidelines on Medical Device Meetings Has Been Updated

Published 06 February 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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Conditions for Pharmaceutical Exporters Other than Pharmaceutical Warehouses is Published

Published 06 February 2024 by Dicle Doğan. Gün + Partners, Turkey

The Turkish Medicines and Medical Devices Agency published Guidelines on 29 December 2023 to regulate pharmaceutical exports by entities other than pharmaceutical warehouses, aiming to ensure compliance with national and international standards and safeguard public health. These Guidelines require that only authorized companies can export pharmaceutical products and dietary foods for special medical purposes, necessitating a valid export permit. They outline the process for obtaining export permits, the responsibilities of exporting companies, including their obligation to report any issues with exported products, and the joint liability of the license holder and exporter for the export operations.

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Changes in the law on marketing of veterinary medicines: what you need to know

Published 06 February 2024 by Christophe Ronse. ALTIUS Lawyers, Belgium

Belgium is welcoming a significant development in the field of veterinary medicine law. The Act of 11 July 2023 containing various provisions on health, which entered into force on 8 September 2023, introduces changes across a wide spectrum of healthcare domains, which are encompassed in approximately 20 chapters. In this blog post, we provide an overview of the key changes related to the marketing of veterinary medicines set out in Chapters 4 and 14 of the new Law.

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The advertising of medical devices in Austria

Published 05 February 2024 by Francine Brogyányi. DORDA Rechtsanwälte GmbH, Austria

In every jurisdiction the advertising of medical devices comes with certain national peculiarities. The following article explains in more detail what needs to be considered if you intend to market medical devices to the Austrian market

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