An agency of the European Union Consultation on draft VICH guidelines in the EU 2nd VICH Outreach Forum meeting, 19-20 February 2013 Presented by: Kornelia.

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Presentation transcript:

An agency of the European Union Consultation on draft VICH guidelines in the EU 2nd VICH Outreach Forum meeting, February 2013 Presented by: Kornelia Grein Head of Veterinary Medicines

Consultation on VICH guidelines in the EU Responsibility for guidelines regarding data requirements and assessment of veterinary medicinal products in the EU: Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) Following sign-off of a VICH guideline by the VICH SC at step 3 (for release for consultation), the CVMP adopts the draft guideline at its next meeting (i.e. within 1 month) for public consultation. Consultation period as per VICH, i.e. normally 6 months 1 Consultation VICH guidelines in the EU: 2 nd Outreach Forum meeting, Feb 2013

Consultation on VICH guidelines in the EU Publication of draft VICH guideline on EMA website, indicating –Deadline for comments, –Format for comments – address for sending comments. Announcement of adoption for consultation in CVMP press release Pro-active dissemination of draft guideline to interested parties 2 Consultation VICH guidelines in the EU: 2 nd Outreach Forum meeting, Feb 2013

Consultation on VICH guidelines in the EU Collation of comments received after end of consultation period Comments are sent to the responsible VICH EWG for review and consideration Consideration of all comments received in VICH regions and via OIE and VICH secretariat. 3 Consultation VICH guidelines in the EU: 2 nd Outreach Forum meeting, Feb 2013