News updates from HMA during February and March 2018

15 March, 2018

Updated content posted on the CMDv website during February and March 2018 includes the following:

  • New Q & A: Art 13.a Bibliographic application, use of assessment reports (Link).
  • Minutes from the January CMDv-Interested Parties meeting (Link). Discussions included:
    • Brexit
    • National requirements and VMP database maintenance
    • Variations (supergrouping, umbrella variations, cost of DDPS changes)
    • Package leaflet combinations
    • SPOR and CESSP
    • Pictograms
    • Training
  • Updated: format and no. of copies for new MA applications (Link).
  • Updated: format and no. of copies post-authorisation procedures (Link).
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Regulatory Outsourcing Options

Cyton’s dedicated regulatory procedures team can support you with:
 - Dossier preparation, submission & regulatory procedures
 - Regulatory intelligence and strategic planning
 - Life cycle management
 - Key person cover
 - Pharmacovigilance
 - Brexit support services