EU: Strengthening the EMA

EU: Strengthening the EMA

Europe A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123 “on a reinforced role for the European Medicines...
Regulation on the mutual recognition of goods

Regulation on the mutual recognition of goods

Europe An updated regulation (2019/515) on the mutual recognition of goods lawfully marketed in another Member State is applied as of 19 April 2020. The mutual recognition principle ensures market access for goods that are not, or are only partly subject to EU...

New EMA regulations 2019/5 and 2019/6

European Union On January 7th, 2019 regulation 2019/5 was published in the Official Journal of the European Union “amending Regulation 726/2004, known as the Regulation on the Centralized Procedure. The new Regulation will apply from 28 January 2019. Regulation 2019/5...