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 […]

Important notification

22.06.2023 To the attention of manufacturers, authorised representatives, economic operators and all stakeholders Please be informed that Commission Implementing Regulation […]

Press release

26.05.2023 To the attention of interested persons EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo download document […]

Important notification

19.05.2023 To the attention of manufacturers, authorised representatives, economic operators and all stakeholders Please be advised that on 12 May […]