Newly released Guidelines
In September 2010, new ICH Step 4 Tripartite Harmonised Guidelines have been released for implementation...
Template for AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006 (July 2010)
Paediatric Regulation: Article 46 Template for AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006 (April 2025) [Track version]
Working Group on Active Substance…
Working Group on Active Substance Master File Procedures Working Party on Variation Regulation Working Party on Pharmacovigilance Procedures Work Sharing CTS Working Group Joint CMDh/GCP Inspectors Working Party Non-Prescription Medicinal Products Task Force
List of active substances and agreed SmPC wordings – EU work sharing procedure in the assessment of paediatric data (April 2010)
Worksharing project on paediatric data List of active substances and agreed SmPC wordings - EU work sharing procedure in the assessment of paediatric data (April 2010)
Variation Procedure
Guidance on the Application of the Amended Variations Regulation from 1 January 2025 In order to view some of the documents on this website you need Acrobat Reader (click here to download)
Applications for Marketing…
Applications for Marketing Authorisation QRD Assessment Reports Article 29 Referrals to CMDh PSUR Variations Renewals RMP MRP / RUP Applicant's response
Templates – Art. 61.3 Procedure – Notification form (July 2011)
Notification form