Simplified renewal application for marketing authorisations
The regulatory procedures for renewal applications for Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP) have been simplified with the publication of the CMDh update of the Best Practice Guide for renewals in February 2023.
OMS and EudraGMPD - a responsibility of your organisation
As of 28 January 2022 organisations must verify that their relevant locations (company name and location address details) are correctly recorded in OMS.
Good news on search tips for EMA’s website
We have included the link to use for PRAC recommendations and PI translations, listed in chronological order including the option of choosing languages other than English.