IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages

Member states contact points for review of national versions of the content of mobile scanning and other technologies

Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products

Chapter 3.II: XEVPRM user guidance of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA

Human medicines European public assessment report (EPAR): Nemdatine, memantine, Date of authorisation: 22/04/2013, Date of refusal: 22/02/2013, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Tegsedi, inotersen, Date of authorisation: 06/07/2018, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Prasugrel Viatris (previously Prasugrel Mylan), prasugrel, Date of authorisation: 15/05/2018, Revision: 10, Status: Authorised

List of centrally authorised products requiring a notification of a change for update of annexes

Membership list: HMA-EMA joint Big Data Steering Group