Poulvac Bursa Plus - referral

Current status

European Commission final decision

Overview

Poulvac Bursa Plus is a live vaccine against Infectious Bursal Disease Virus (IBDV), also known as Gumboro disease. Given its residual pathogenicity, the vaccine strain, V877, is classified as “intermediate plus” and also known as a “hot” strain.

The Marketing Authorisation Holder (Fort Dodge Animal Health Ltd) submitted an application for Mutual Recognition Procedure of Poulvac Bursa Plus (lyophilisate for suspension in drinking water, 102.2–103.4 EID50/dose), indicated for chickens from 10 days of age for oral administration via the drinking water. The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Spain, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovakia and Slovenia. The Mutual Recognition Procedure UK/V/0335/001/MR started on 29 January 2009.

On 13 July 2009 the United Kingdom, referred the matter to the Agency under Article 33 (4) of Directive 2001/82/EC due to concerns raised by Belgium regarding an unfavourable benefit and risk balance of the vaccine.

The referral procedure started on 14 July 2009. The Rapporteur and Co-Rapporteur appointed were Dr. F. Descamps (Belgium) and Dr. A.-M. Brady (the United Kingdom) respectively. Written explanations were provided by the Marketing Authorisation Holder on 17 August 2009.

On the basis of the grounds for referral, the points considered by the CVMP were whether the studies carried out by the Marketing Authorisation Holder were sufficient to address the risks associated with immunosuppression in a comprehensive way and whether the benefit/risk balance was favourable for the vaccine Poulvac Bursa Plus.

During its 13–15 October 2009 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by a majority of 25 out of 27 votes an opinion concluding that objections raised by Belgium should not prevent the granting of a Marketing Authorisation.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.

The final opinion was converted into a Decision by the European Commission on 25 January 2010.

Opinion following an Article 33 (4) referral for Poulvac Bursa Plus and associated names: Background information

Reference Number: EMA/698942/2009

Key facts

About this medicine

• Approved name:
  Poulvac Bursa Plus
• International non-proprietary name (INN) or common name:
  live infectious bursal disease virus, strain V877

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA/698942/2009
• 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:
  25/01/2010
• EC decision date:
  25/01/2010

All documents

Poulvac Bursa Plus - Article 33 (4) referral - Annexes I, II, III

Reference Number: EMA/698942/2009

Opinion following an Article 33 (4) referral for Poulvac Bursa Plus and associated names: Background information

Reference Number: EMA/698942/2009

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)