by In2Pharma | Aug 26, 2024 | News
Europe We would like to inform you of a significant new EU regulation—the Ecodesign for Sustainable Products Regulation (ESPR)—which came into force on July 18th, 2024, replacing the previous 2009 legislation. This regulation is designed to make products more...
by In2Pharma | Jul 10, 2024 | News
Europe Extension of the IVD Regulation Transitional Periods Brussels, 30 May 2024 – The EU co-legislators have adopted an amendment to the In Vitro Diagnostics and Medical Devices Regulations (IVDR and MDR), extending the IVDR transitional provisions and adding a...
by In2Pharma | Jul 2, 2024 | News
Europe On 9/04/2024 CBG published three new implementing acts regarding the new legislation on packaging for veterinary medicines in Europe. The following implementing acts (IAs) have been published: Implementing regulation (EU) 2024/875: This regulation establishes a...
by In2Pharma | Jul 2, 2024 | News
Europe When a pharmaceutical company has developed a new therapy and the European Medicines Agency (EMA) advises positively on its market authorization, a Health Technology Assessment (HTA) follows. To date, member states conduct this HTA separately. By January 2025,...
by In2Pharma | Jun 25, 2024 | News
Europe On the 21st of May, a new revision of the guidance on medical devices for applicants, marketing authorisation holders and notified bodies has been published. This document provides regulatory and procedural guidance on the implementation of the medical devices...
