Avinew - referral

Current status

European Commission final decision

Overview

Avinew is a freeze-dried live vaccine intended for use in chickens from the age of 1 day for the active immunisation against Newcastle disease to reduce mortality and clinical signs associated with the disease.

The marketing authorisation holder, Merial, submitted an application via mutual recognition for Avinew, on the basis of the marketing authorisation granted by France. The reference Member State is France. The concerned Member States are Austria, Belgium, Germany, Finland, Greece, Ireland, Luxembourg, the Netherlands, Portugal and Spain.

The mutual recognition procedure started on 1 February 2001. Potential serious risk to human health was identified during the mutual recognition procedure by the Netherlands regarding the withdrawal period of zero days.
On 2 May 2001, in view of the unsolved issues, the Netherlands submitted a referral notification under Article 18 of Council Directive 81/851/EEC to the CVMP.

The referral procedure started on 16 May 2001. The Committee appointed R. Breathnach as rapporteur and O. Papadopoulos as co-rapporteur. Written explanations were provided by the marketing authorisation holder on 13 July 2001.
Based on the evaluation of the available data, the CVMP considered that the objections raised by the Netherlands during the mutual recognition procedure should not prevent the granting of a marketing authorisation for Avinew. Therefore, the Committee adopted a positive opinion on 12 September 2001, recommending the granting of the marketing authorisation the above-mentioned product.

The scientific conclusions are provided in Annex I. The list of product names concerned is given in Annex II, together with the Summaries of Product Characteristics in Annex III.

The opinion was converted into a Decision by the European Commission on 4 February 2002.

Opinion following an Article-33 referral for Avinew

Reference Number: EMA/310365/2014Summary:

Avinew is a freeze-dried live vaccine intended for use in chickens from the age of 1 day for the active immunisation against Newcastle disease to reduce mortality and clinical signs associated with the disease.

Key facts

About this medicine

• Approved name:
  Avinew
• International non-proprietary name (INN) or common name:
  Newcastle disease virus, VG/GA strain, live

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/001
• 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:
  12/09/2001
• EC decision date:
  04/02/2002

All documents

European Commission final decision

Avinew Article-33 referral - Annex I, II, III

Opinion following an Article-33 referral for Avinew

Reference Number: EMA/310365/2014Summary:

Avinew is a freeze-dried live vaccine intended for use in chickens from the age of 1 day for the active immunisation against Newcastle disease to reduce mortality and clinical signs associated with the disease.

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)