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” (December 2019)
• CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines (December 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);

• Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (September 2019) [Tracked]

• Harmonised warning for ferrous sulfate-containing medicinal products on dysphagia and related bronchostenosis due to risk of aspiration (May 2018) [Tracked]

• Concomitant use of benzodiazepines/benzodiazepine like products and opioids (February 2018)

• End of pilot for splitting of MRP/DCPs (July 2019) [Tracked]

• Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh (August 2018)

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 (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)

• 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