In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
The European Medicines Agency (“EMA”) has released a Practical Guidance concerning the steps that centralised Market Authorisation Holders (“MAH”) will be required to take should the United Kingdom (“UK”) become a third...more