CMDv VMPs news for reg affairs May/Jun 18: pictograms, the ASMF and Type II variations

8 June, 2018

The latest CMDv Report for Release (RfR), giving an overview of the activities of the March and April 2018 meetings, is available to view and download (Link). The report includes, amongst other items, the following:

  • Reduction in administrative burden relating to variations (Link)
  • Questions from Applicants regarding consolidated dossier submission and approval of extension applications (see RfR)
  • Clarification on the acceptance of pictograms (see RfR)
  • ASMF worksharing procedure (Link)
  • Best practice guide for Type II variations, with its track changes version (Link)

In addition, the HMA has updated the "Recommendations for classification of unforeseen variations" for SPC changes to implement PSUR outcomes (Link).


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