Advice from CMDh

Extension of pilot for splitting of MRP/DCPs (January 2017)

CMDh Working Document on Merging and Splitting of MRP/DCPs (December 2015)

Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh (October 2015)

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)

Harmonised traceability of gadolinium-containing contrast agents - update of Product Information wording regarding electronic patient records (February 2014)

Monitoring of medicines originating from Japan (April 2016) [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)

• Letter to Marketing Authorisation Holders (MAHs) / Applicants 
• Template for information to be submitted

Abbreviated core Risk Management Plan for bisphosphonates

• Guidance on the submission/updating of Risk Management Plans to reflect ‘atypical femoral fractures’
• Abbreviated core bisphosphonate RMP for atypical femoral fracture

EU Worksharing Procedure

• Public Assessment Report - Change in qualitative and quantitative composition of rubber stoppers of West Pharmaceutical Services (July 2008)
  

Questions and Answers

• Q & A on Requests for Advice from CMDh