Articles for the ‘Life Sciences’ Category

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

Belgian Medicines Agency announces stricter monitoring of negative formulations on medicines packaging

Published 14 June 2023 by Kirian Claeyé ALTIUS Lawyers, Belgium

On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings”. Apart from limited exceptions, MAHs will therefore need to remove such negative formulations from their current future packaging by 17 May 2026, and non-compliant formulations will be rejected.

... Read more