Articles for the ‘Life Sciences’ Category

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.

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.