Nuflor - referral

Current status

European Commission final decision

Overview

Nuflor 300-mg/ml solution for injection for cattle and sheep contains 300 mg florfenicol per ml.

Florfenicol is structurally related to thiamphenicol and has a similar pharmacological profile. The active substance is included in veterinary medicinal products currently authorised in several Member States in the European Union for use in cattle and pigs for the treatment of respiratory diseases.

The applicant, Intervet International BV, submitted an application for a decentralised procedure for Nuflor 300-mg/ml solution for injection for cattle and sheep. This application was an extension (Article 19 of Regulation 1234/2008/EC) to add sheep as new target species. The application was submitted to Ireland as reference Member State and Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain and the United Kingdom as concerned Member States.

The decentralised procedure (IE/V/0269/001/DC) started on 13 August 2010. Potential serious risks were identified during the decentralised procedure by two concerned Member States, by France regarding the proposed indications and by Denmark regarding the efficacy 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 (CMDv) was started on 22 July 2011. During the procedure, the applicant provided additional data and the issues raised by France regarding the proposed indications were resolved. Day 60 of the CMD(v) procedure was on 20 September 2011, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.

On 21 September 2011, the reference Member State, Ireland, notified the European Medicines Agency that the CMDv 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 12 October 2011. The Committee appointed Prof Christian Friis as rapporteur and Dr David Murphy as co-rapporteur.

Written explanations were provided by the applicant on 9 January 2012 and 23 April 2012. Oral explanations were given on 15 May 2012.

Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit-risk profile of Nuflor 300-mg/ml solution for injection for cattle and sheep is positive subject to changes in the product information in order to clarify that the recommended treatment dose and treatment interval for sheep is based on the time mean florfenicol concentrations are maintained above MIC90. Therefore, the Committee adopted a positive opinion on 12 June 2012 recommending the granting of a marketing authorisation for Nuflor 300 mg/ml solution for injection for cattle and sheep.

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

The final opinion was converted into a decision by the European Commission on 17 September 2012.

Opinion following an Article 33(4) referral for Nuflor-300 mg/ml solution for injection for cattle and sheep

AdoptedReference Number: EMA/556747/2012

Key facts

About this medicine

• Approved name:
  Nuflor
• International non-proprietary name (INN) or common name:
  florfenicol

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/078
• 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:
  12/06/2012
• EC decision date:
  17/09/2012

All documents

European Commission final decision

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

Adopted

Opinion following an Article 33(4) referral for Nuflor-300 mg/ml solution for injection for cattle and sheep

AdoptedReference Number: EMA/556747/2012

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)