CMDv report for release for January and February

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

• Initiatives on reduction of administrative burden relating to variations (Link)

• Updated document detailing requirements for the initial MAA dossier (Link)
• Clarification on acceptability of CTD format and Quality Overall Summaries (QOS)

• Document detailing number and format of dossiers for post-authorisation applications (Link)

• The current requirements relating to packaging in the Member States (so-called ‘Blue-box’ requirements) are summarised in an updated guidance document (Link)

• A new Q&A on the use of assessment reports in Art. 13a bibliographic applications was published (Link)