EMA
- Regulatory and procedural guideline:Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products (updated)
PSUR Repository (NCA UI) Go-live 3rd July 2023
We are pleased to inform you that an updated version of the PSUR Repository NCA UI is going live on the 3rd of July 2023.
The new version of the PSUR Repository NCA User Interface provides a technical update only. Following the update, the PSUR Repository NCA UI will have slightly different look and feel, however, there are no changes to the features and functionality of the system.
For the completion of the deployment, the PSUR Repository NCA User Interface will be unavailable on Monday evening 3rd of July 2023 between 18:30 and 19:30 (CET).
And
Updated regulatory practical guidance
The European Medicines Agency practical guidance on the application form for centralised type IA and IB variations (europa.eu) has been updated and can also be found under the section “Regulatory”.
CMDh
- UPDATE - Template - request for RMS in a decentralised procedure for medicinal products for human use
- CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity[Track version]
- Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure[Track version]
- Paediatric Regulation[Track version] Further Q&As have been published on the EMA website
MHRA
