Articles

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.

... Read more

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.

... Read more

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.

... Read more

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

... Read more

The Court of Justice’s New Ruling – Finnish Strict Liability Regime regarding Unfounded Preliminary Injunctions Compatible with the EU Enforcement Directive

Published 01 February 2024 by Ben Rapinoja. Borenius Attorneys Ltd, Finland

The Court of Justice of the European Union (the “Court of Justice”) handed down its judgment in case C‑473/22 (Mylan v. Gilead and Others) at the beginning of January 2024. The case concerned the Finnish compensation regime that can be invoked when a preliminary injunction is found to have been unfounded. This compensation regime is based on the concept of strict liability.

Although the judgment primarily concerns compensation claims subject to the Finnish law, the judgment has implications in all EU jurisdictions where a similar strict liability regime exists. The Court of Justice’s judgment provides clarity for cases where an intellectual property right is first used to justify a preliminary injunction and then subsequently found invalid.

... Read more
1 2 3 7