Press release

30.08.2023 To the attention of interested persons Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5 download document […]

Press release

16.08.2023 To the attention of interested persons EMA review of data on paternal exposure to valproate download document …

Important notification

27.07.2023 To the attention of all interested stakeholders Please be informed that the most recent update of the EU common […]

Important notification

24.07.2023 To the attention of manufacturers, authorised representatives, economic operators and all interested stakeholders Please be informed that on 18 […]

Press release

21.07.2023 To the attention of interested persons Start of a review concerning the conduct of studies at Synapse Labs Pvt. […]

Important notification

20.07.2023 To the attention of interested persons List of training providers with the topic of legislation in the field of […]

Press release

19.07.2023 To the attention of interested persons Reflection paper on the use of artificial intelligence in the lifecycle of medicines […]

Press release

11.07.2023 To the attention of interested persons EMA statement on ongoing review of GLP-1 receptor agonists download document …

Press release

27.06.2023 To the attention of interested persons Withdrawal of application for the marketing authorisation of Lagevrio (molnupiravir) download document …

Press release

23.06.2023 To the attention of interested persons Refusal of the marketing authorisation for Albrioza (sodium phenylbutyrate / ursodoxicoltaurine) download document […]