Florfenicol is a synthetic broad spectrum antibiotic with a range of activity, including many Gramnegative and Gram-positive organisms.
The Marketing Authorisation Holder, Virbac S.A., submitted an application via mutual recognition for Shotaflor 300 mg/ml solution for injection for cattle, on the basis of the marketing authorisation granted by the United Kingdom. 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 Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, The Netherlands, Portugal and Spain. The Mutual Recognition Procedure started on 28 February 2008.
Due to concerns raised by Germany and The Netherlands during the Mutual Recognition Procedure that Shotaflor 300 mg/ml solution for injection for cattle could present a potential serious risk to the environment, the United Kingdom referred the matter to the EMEA on 31 July 2008 under Article 33(4) of Directive 2001/82/EC.
The referral procedure started on 16 September 2008. The rapporteur and co-rapporteur appointed were: Dr Bruno Urbain and Dr Michael Holzhauser-Alberti, respectively. Written explanations were provided by the Marketing Authorisation Holder on 15 January 2009. Oral explanations were given on 16 April 2009.
Based on the evaluation of the rapporteurs' assessment of the currently available data, the CVMP considered that the use of the product as recommended for therapeutic use only does not constitute a risk for the environment. However, the CVMP also considered that the wording of the therapeutic indication as authorised in the Reference Member State should be amended to clearly state the limitations of the approved use and avoid incorrect interpretation. Therefore the Committee adopted an opinion on 14 May 2009 recommending the variation of the Marketing Authorisation in line with the proposed amendments to the Summary of Product Characteristics and package leaflet.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics and package leaflet in the Annex III.
The final opinion was converted into a Decision by the European Commission on 3 August 2009.
|International non-proprietary name (INN) or common name||
European Commission final decision
Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.
|EC decision date||
Opinion following an Article 33 referral for Shotaflor 300 mg/ml solution for injection for cattle International Non-Proprietary Name (INN): Florfenicol: Background information (PDF/22.77 KB)Adopted
First published: 04/08/2009
Last updated: 04/08/2009
Shotaflor - Article 33 Referral - Annex I, II, III (PDF/115.57 KB)Adopted
First published: 03/10/2009
Last updated: 03/10/2009
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)