Minutes of CVMP Meeting 6 – 8 September 2016 published

9 September, 2016

The EMA has posted the press release with details of the CVMP's meeting of 6 – 8 September 2016 (Link). General news relating to regulatory affairs includes:

Community referrals

  • France initiated an Article 35 referral for Zanil (oxyclozanide) and generic products thereof due to concerns related to the withdrawal periods in cattle, sheep and goats.

Draft Immunologicals guidance released for consultation:

  • Concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot and-Mouth disease (FMD)
  • Concept paper for the revision of the note for guidance on the use of adjuvanted immunological VMPs

Immunologicals guidance adopted

  • Reflection paper on the risks that should be considered prior to the use of unauthorised vaccines in emergency situations

The adopted documents will be published on the EMA website in the coming weeks.

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