Colistin - referral

Current status

European Commission final decision

Overview

Colistin sulfate is a polypeptide antibiotic belonging to the polymyxins group of antibiotics. Veterinary medicinal formulations containing colistin sulfate at 2 000 000 IU per ml and intended for administration via drinking water to calves, pigs, lambs and poultry are used for the treatment of infections of the gastrointestinal tract caused by Escherichia coli and Salmonella spp susceptible to colistin.

Due to concerns that the differences in posology and withdrawal periods established across the European Union for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species may present a potential serious risk to public and animal health, the United Kingdom referred the matter to the Agency on 1 April 2009, under Article 35 of Directive 2001/82/EC.

The referral procedure started on 16 April 2009. The rapporteur and co-rapporteur appointed were: Prof. Christian Friis and Dr Karolina Törneke, respectively. Written explanations were provided by the applicants/marketing authorisation holders on 15 July 2009 and 13 January 2010.

Based on the rapporteurs' assessment of the currently available data, the CVMP, adopted, on 10 February 2010, an opinion recommending variations of the marketing authorisations for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species in order to amend the summary of the product characteristics (SPC), labelling and package leaflet to harmonise the posology and withdrawal periods (where applicable) for the concerned products.

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

The final opinion was converted into a Decision by the European Commission on 10 June 2010.

Opinion following an Article 35 referral for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species: Background informatio...

AdoptedReference Number: EMA/189829/2010

Key facts

About this medicine

• Approved name:
  Colistin
• International non-proprietary name (INN) or common name:
  colistin sulfate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA/189829/2010
• Type:
  Article 35

  Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Key dates and outcomes

• Opinion date:
  10/02/2010
• EC decision date:
  10/06/2010

All documents

Colistin - Article 35 referral - Annexes I, II, III

AdoptedReference Number: EMA/189829/2010

Opinion following an Article 35 referral for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species: Background informatio...

AdoptedReference Number: EMA/189829/2010

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)