Norbonex 5 mg/ml pour-on solution for beef and dairy cattle - referral

Current status

European Commission final decision

Overview

Norbonex 5 mg/ml pour-on solution for beef and dairy cattle contains eprinomectin as an active substance and is intended for use in cattle as a topical application for the treatment and control of infections from gastrointestinal roundworms (adults and fourth stage larvae), lungworms (adults and fourth stage larvae), warbles (parasitic stages), mange mites, lice and horn flies.

The applicant, Norbrook Laboratories Ltd, submitted an application for a decentralised procedure for Norbonex 5 mg/ml Pour-on solution for beef and dairy cattle. This is a 'hybrid' application according to Article 13(3) of Directive 2001/82/EC, as amended, referring to the reference product Eprinex pour-on solution for beef and dairy cattle. The United Kingdom is the reference Member State and Germany and the Netherlands are concerned Member States.

The decentralised procedure started on 21 February 2012. Potential serious risks were identified during the decentralised procedure by Germany regarding the environmental safety of the product.

On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 18 February 2013. Day 60 of the CMD(v) procedure was on 18 April 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.

On 26 April 2013, the reference Member State, the United Kingdom, notified the Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.

The referral procedure started on 15 May 2013. The Committee appointed C. Ibrahim as rapporteur and H. Jukes as co-rapporteur. Written explanations were provided by the applicant on 19 November 2013.

Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Norbonex 5 mg/ml Pour-on solution for beef and dairy cattle is positive. Therefore, the Committee adopted by consensus a positive opinion on 15 January 2014 recommending the granting of the marketing authorisations for Norbonex 5 mg/ml pour-on solution for beef and dairy cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the summary of product characteristics and package leaflet in Annex III.

The opinion was converted into a Decision by the European Commission on 21 March 2014.

Opinion following an Article 33(4) referral for Norbonex 5 mg/ml pour-on solution for beef and dairy cattle

AdoptedReference Number: EMA/128538/2014

Key facts

About this medicine

• Approved name:
  Norbonex 5 mg/ml pour-on solution for beef and dairy cattle
• International non-proprietary name (INN) or common name:
  eprinomectin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/098
• 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:
  15/01/2014
• EC decision date:
  21/03/2014

All documents

European Commission final decision

Norbonex Article-33(4) referral - Annex I, II, III

Opinion following an Article 33(4) referral for Norbonex 5 mg/ml pour-on solution for beef and dairy cattle

AdoptedReference Number: EMA/128538/2014

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)