CattleMarker IBR Inactivated

Table of contents

Current status
European Commission final decision

Overview

On 17 March 2016, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated). The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, subject to conditions relating to risk mitigation and surveillance measures, the marketing authorisation granted in Belgium for CattleMarker IBR Inactivated can be recognised in other Member States of the EU.

Key facts

Approved name
CattleMarker IBR Inactivated
International non-proprietary name (INN) or common name
Infectious bovine rhinotracheitis vaccine (inactivated)
Current status
European Commission final decision
Reference number
EMEA/V/A/115
Type
Article 33

Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.
Opinion date
17/03/2016
EC decision date
10/06/2016

All documents

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of CVMP
  • Divergent positions – divergent positions of the CVMP members (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)

How useful was this page?

Add your rating