CattleMarker IBR Inactivated - referral

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.

What is CattleMarker IBR Inactivated?

CattleMarker IBR Inactivated is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains inactivated glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac. The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection. Active immunisation of female cattle from 6 months of age is also indicated to reduce the clinical signs (pyrexia and duration of dyspnoea) of IBR and virus shedding caused by BoHV-1 infection and to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.

Why was CattleMarker IBR Inactivated reviewed?

Zoetis Belgium SA submitted an application for CattleMarker IBR Inactivated for mutual recognition on the basis of the initial authorisation granted by Belgium. The company requested the authorisation to be recognised in Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom (the 'concerned Member States').

However, the Member States could not reach an agreement and the Belgian Federal Agency for Medicines and Health Products referred the matter to the CVMP for arbitration on 29 September 2015.

The grounds for the referral were concerns raised by Germany regarding the immunological safety of CattleMarker IBR Inactivated, as the composition and manufacture of this product are similar to PregSure BVD, a vaccine from Zoetis which has been shown to induce a long-lasting allogeneic antibody response that has been associated with Bovine Neonatal Pancytopenia, a neonatal alloimmune disease, in the progeny of vaccinated dams. CattleMarker IBR Inactivated is produced on the same bovine cell line and is adjuvanted with the same highly potent adjuvant as PregSure BVD.

The potential risk of recurrence of Bovine Neonatal Pancytopenia linked to the use of this vaccine in pregnant cows had been addressed by Zoetis; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by Zoetis.

What are the conclusions of the CVMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that subject to the conduct of additional studies and the implementation of further measures specified in a Risk Management Plan the marketing authorisation for CattleMarker IBR Inactivated should be granted in all concerned Member States.

The European Commission issued a decision on 10 June 2016.

CattleMarker IBR Inactivated Article-33(4) referral - Questions and answers

Reference Number: EMA/290855/2016Summary:

Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac): outcome of a procedure under Article 33(4) of Directive 2001/82/EC, as amended

Key facts

About this medicine

• Approved name:
  CattleMarker IBR Inactivated
• International non-proprietary name (INN) or common name:
  Infectious bovine rhinotracheitis vaccine (inactivated)

About this procedure

• 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.

Key dates and outcomes

• Opinion date:
  17/03/2016
• EC decision date:
  10/06/2016

All documents

European Commission final decision

CattleMarker IBR Inactivated Article-33(4) referral - Annex I, II, III, IV

Reference Number: EMEA/V/A/115

CattleMarker IBR Inactivated Article-33(4) referral - Divergent position

Reference Number: EMEA/V/A/115

CattleMarker IBR Inactivated Article-33(4) referral - Questions and answers

Reference Number: EMA/290855/2016Summary:

Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac): outcome of a procedure under Article 33(4) of Directive 2001/82/EC, as amended

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)