Advice from CMDh
Information on nitrosamines for marketing authorisation holders
- Notice to marketing authorisation holders (26 September 2019)
- Questions and answers on “Information on nitrosamines for marketing authorisation holders” (November 2019) [Tracked]
- CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines(November 2019) [Tracked]
- Templates:
- Step 1: response - no risk identified;
- Step 1: response - risk identified (doc);
- Step 1: response - risk identified (xls);
- Step 2: response - no nitrosamine detected;
- Step 2: response - nitrosamine detected (doc);
- Step 2: response - nitrosamine detected (xls);
- End of pilot for splitting of MRP/DCPs (July 2019) [Tracked]
Deletion of interaction between broad spectrum antibiotics and combined oral contraceptives (COC)
- Cover note to Public Assessment Report (March 2015)
- Public Assessment Report (March 2015) corrected in March 2016 [Tracked]
- List of ATC codes for which the change applies (January 2016)
- Monitoring of medicines originating from Japan (September 2019) [Tracked]
Bioequivalence studies conducted at GVK Biosciences Private Limited (GVK Bio), Swarna Jayanthi commercial complex, Ameerpet, Hyderabad 500 038, India (new name since 15 July 2014: Clinogent)
Abbreviated core Risk Management Plan for bisphosphonates
EU Worksharing Procedure
Questions and Answers