EMA
eSubmissions (eCTD)
- Questions and Answers document from the public webinar “DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live” held on 12th July 2022
The Q&A document from the public webinar is now available.
CMDh
- UPDATE - EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (Clean Version) (July 2022) [Track version]
- UPDATE - Chapter 7: CMDh BPG on Worksharing give this link clean and tracked EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (July 2022) (Clean Version / Tracked Version)
- UPDATE - Procedural advice on Validation of MR/Repeat-use/DC Procedures (July 2022) (Clean Version / Tracked Version)
- UPDATE - Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures (July 2022) (Clean Version / Tracked Version)
- UPDATE - Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure (July 2022) (Clean Version / Tracked Version)
Health Canada
- Notice: Revision to the Guidance Document Management of Drug Submissions and Applications (August 2022) [2022-08-02]
- Notice: Revisions to the performance standards for Post-authorization Division 1 Changes [2022-08-02]
