Deltanil - referral

Current status

European Commission final decision

Overview

Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin as active ingredient and is intended for use in cattle and sheep as a topical application for the treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs.

The applicant, Virbac, submitted an application for a decentralised procedure for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle. These are 'hybrid' applications according to Art. 13(3) Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose registered in the United Kingdom. The reference Member State is the United Kingdom for both products. For the pour-on product 24 concerned Member States are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain. For the spot-on product Belgium, France, Germany and the Netherlands are involved as concerned Member States.

The decentralised procedure started on 19 December 2011. Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands 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 17 December 2012. Day 60 of the CMD(v) procedure was on 14 February 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.

On 26 February 2013, the reference Member State, the United Kingdom, notified the European Medicines 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 6 March 2013. The Committee appointed Dr C. Ibrahim as rapporteur and Ms H. Jukes as co-rapporteur. Written explanations were provided by the applicant on 22 May 2013.

Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle is positive. Therefore, the Committee adopted by majority a positive opinion on 17 July 2013 recommending the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.

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 24 September 2013.

Opinion following an Article 33(4) referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle

AdoptedReference Number: MA/539462/2013

Key facts

About this medicine

• Approved name:
  Deltanil
• International non-proprietary name (INN) or common name:
  deltamethrin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/093
• 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:
  24/09/2013
• EC decision date:
  24/09/2013

All documents

European Commission final decision

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

Divergent position on a CVMP opinion on an Article 33(4) referral of Directive 2001/82/EC for Deltanil 10 mg/ml pour-on solution for cattle and sheep and Deltanil 100 mg spot-on solution for cattle

Adopted

Opinion following an Article 33(4) referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle

AdoptedReference Number: MA/539462/2013

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)