Ivermectin - referral

Current status

European Commission final decision

Overview

Ivermectin belongs to the macrocyclic lactone class of endectocides with activity against a wide rage of internal and external parasites. Injectable veterinary medicinal products containing ivermectin, either as a single active substance or in combination with a second active substance are indicated for use in cattle for the treatment of endoparasitic and ectoparasitic infestations.

National Marketing Authorisations for injectable products containing ivermectin for use in cattle have been granted in all the Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases.

Due to concerns that the difference in withdrawal periods established across the European Union for injectable veterinary medicinal products containing ivermectin which are indicated for use in cattle and with a dose of 200μg ivermectin/kg bodyweight may present a potential serious risk to human health, the United Kingdom referred the matter to the EMEA on 14 December 2007, under Article 35 of Directive 2001/82/EC. The CVMP was requested to give its opinion on the matter.

The referral procedure started on 16 January 2008. The Committee appointed Dr G. J. Schefferlie as rapporteur and Dr J. G. Beechinor, Prof C. Friis, Prof R. Kroker and Dr B. Urbain as co-rapporteurs. Further to the resignation of Prof R. Kroker as CVMP member, Dr C. Ibrahim was appointed to replace him and took over the co-rapporteurship.

On 21 May 2008 the EMEA received a total of 19 written explanations from the Marketing Authorisation Holders (either as a group of or individual Marketing Authorisation Holders). The submitted information concerned 173 of the 293 Marketing Authorisations involved in this referral procedure.

On 4 June 2008 the National Competent Authorities of the Member States were requested to provide the missing information for the outstanding 120 Marketing Authorisations. Eighteen Member States responded and submitted information concerning 103 of the outstanding 120 Marketing Authorisations.

On 17 September 2008 the CVMP considered that there were still issues with regard to some products which needed further clarification and therefore the Committee requested the relevant Marketing Authorisation Holders to address the outstanding issues in writing. Written explanations were provided by the Marketing Authorisation Holders on 13 November 2008.

On 9 December 2008 and 14 January 2009 two Marketing Authorisation Holders provided oral explanations at their request.

Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that a single withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin. Therefore, the Committee adopted an opinion on 11 February 2009 recommending the variation of the existing Marketing Authorisations in accordance with the recommended amendments to the Summary of Product Characteristics.

On 25 February 2009, Norbrook Laboratories Ltd, notified the EMEA of its intention to request the re-examination of the CVMP opinion of 11 February 2009.
During its 10-12 March 2009 meeting, the CVMP, appointed Dr A. Holm as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur for the re-examination of the above mentioned opinion.

The detailed grounds for the re-examination were submitted by Norbrook Laboratories Ltd on 14 April 2009. The re-examination procedure started on 15 April 2009. Oral explanations were given on 12 May 2009.

Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that its opinion of 11 February 2009 should be revised. The Committee confirmed that a withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin as a single active substance. The withdrawal period of 49 days for cattle would also apply to all concerned injectable products containing ivermectin in combination with closantel as a second active substance. With regard to the products containing ivermectin in combination with clorsulon as a second active substance a withdrawal period of 66 days for cattle was recommended. Therefore, the Committee adopted by written procedure an opinion on 5 June 2009 recommending the variation the existing Marketing Authorisations in line with the proposed amendments of the Summary of Product Characteristics, labelling 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, package leaflet and label in the Annex III.

The final opinion was converted into a Decision by the European Commission on 1 October 2009.

Opinion following an Article 35 referral for Injectable veterinary medicinal products containing ivermectin that are indicated for use in cattle at dose of 200 ug ivermectin per kg bodyweight: International Non-Propriet...

AdoptedReference Number: EMEA/471056/2009

Key facts

About this medicine

• Approved name:
  Ivermectin
• International non-proprietary name (INN) or common name:
  ivermectin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/471056/2009
• 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:
  05/06/2009
• EC decision date:
  01/10/2009

All documents

Ivermectin - Article 35 Referral - Annex I, II, III

Adopted

Opinion following an Article 35 referral for Injectable veterinary medicinal products containing ivermectin that are indicated for use in cattle at dose of 200 ug ivermectin per kg bodyweight: International Non-Propriet...

AdoptedReference Number: EMEA/471056/2009

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)