Documents adopted in CVMP November meeting now published

17 November, 2016

The EMA has now published the following documents adopted in the November meeting of the CVMP:

Draft reflection paper released for consultation

  • QUALITY: Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances (Link).

Guidance adopted

  • QUALITY: revised guideline on process validation for finished products – information and data to be provided in regulatory submissions (Link).

In addition, the EMA has also released the following documents:

  • Type II variations Q & A: What pre-submission steps will apply to my Type II variation? (Link).

October monthly report on application procedures, guidelines and related documents for VMPs (Link), which includes the following:

  • Summary of procedures processed (MA applications, variations, MRL applications, Scientific Advice given, referrals etc)
  • List of all opinions to date in 2016
  • List of all MRLs established in 2016
  • List of guidelines and working documents, including drafts, adopted in 2016
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