Posts Tagged ‘post-authorisation measures’

EMA implements new submission form for post-authorisation measures The European Medicines Agency (EMA) has launched a new form to help marketing authorisation holders submit data generated to satisfy post-authorisation measures(PAMs) for centrally authorised products. PAMs require marketing authorisation holders (MAHs) to provide additional data on the safety, efficacy or quality of the medicine once it is authorised. They fall into several categories, depending…