Colistin oral - referral

Current status

European Commission final decision

Overview

Colistin sulfate belongs to the polymyxin group of antibiotics. This group of antibiotics has a polypeptide structure, with mainly bactericidal activity and a medium antibacterial spectrum, which covers Gram-negative microorganisms only.

Veterinary medicinal products containing colistin as a sole active substance for oral administration in food producing animals are widely used in almost all EU Member States. Oral colistin formulations including powder, solution, premix, tablets and paste have been authorised, mainly for group and flock treatment for the treatment and prevention of different specified gastrointestinal diseases caused by sensitive Enterobacteriacea species (e.g. Salmonella and Escherichia coli), but marketing authorisations without more specific indications do also exist. The most common target species are pigs followed by chicken and cattle then other poultry species (e.g. turkeys), horses, rabbits, sheep and goats.

On 12 May 2014, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing colistin to be administered orally. The CVMP was requested to give its opinion on the measures that need to be taken in order to ensure the prudent use of colistin in food-producing animals across the EU and to minimise potential risks with the use of the identified products; inter alia whether there is a need to include adequate indications and warnings on prudent use in the product information and/or restrict indications for the identified products taking into account the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005).

The referral started on 4 June 2014. The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur. No written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders.

Based on the evaluation of the currently available data, the CVMP considered that the overall benefit-risk profile for these products remains positive subject to amendments in the product information. Therefore, on 11 December 2014 the Committeeadopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing colistin to be administered orally.

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

The final opinion was converted into a Decision by the European Commission on 16 March 2015.

Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally

Reference Number: EMA/160340/2015

Key facts

About this medicine

• Approved name:
  Colistin oral
• International non-proprietary name (INN) or common name:
  colistin
• Class:
  Polymyxins

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/106
• 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:
  11/12/2014
• EC decision date:
  16/03/2015

All documents

European Commission final decision

Colistin oral - Article 35 referral - Annex I, II, III

Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally

Reference Number: EMA/160340/2015

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)