List of medicines currently in PRIME scheme

Awareness session for SMEs on the reform of the EU pharmaceutical legislation, Online, 10:00 – 12:00 (Amsterdam time CET), from 24/11/2023 to 24/11/2023

Human medicines European public assessment report (EPAR): Herwenda, trastuzumab, Breast Neoplasms;Stomach Neoplasms, Date of authorisation: 15/11/2023, Status: Authorised

Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline

Letter to members of parliament

Overview of comments received on 'Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers' (EMA/CHMP/83033/2023)

Questions and answers on data requirements when replacing hydrofluorocarbons as propellants in oral pressurised metered dose inhalers - Scientific guideline

Pazenir (paclitaxel) supply shortage

Chemical-unlike biological substances considered as not requiring an MRL evaluation as per Regulation (EU) No. 2018/782, with regard to residues of veterinary medicinal products in foodstuffs of animal origin

Varroa destructor calmodulin gene-specific... RNA EP15 : summary of assessment undertaken to determine whether the substance may be entered into the list of chemical-unlike biological substances considered as not requiring an MRL evaluation