CMDv report for release April / May 2015 published

10 July, 2015

The CMDv has published the report from its meetings of April and May 2015 (Link). Among the items reported:

  • There is to be a Presidency meeting from 20th-22nd September, at which the CMDv will review the EC draft proposal for legislative change of 2001/82/EC.
  • The first meeting of the CMDv-Industry Joint Task Force on Variations took place.  The main areas in which the task force plans to focus were identified.
  • The EGGVP/ IFAH-Europe initiative to combine industry’s feedback on additional national requirements will be prepared in time for the autumn interested parties meeting. CMDv members will review the new data provided by EGGVP and IFAH-Europe and give written feedback.
  • CMDv is drafting a recommendation paper on MA transfers for VMPs authorised via MRP/DCP, which will provide some guidance on the steps to be followed. A draft will be circulated to Interested Parties for comment.
  • A pilot begining in July seeks to trial a common Risk Assessment Template for use where products authorised by DCP/MRP are selected for testing. A Working Group on Product Testing will develop a risk-based approach to the selection of products to be tested.

The CMDv has also made available their validation checklists for renewals (Link) and applications through the MRP or DCP (Link).

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