Bovimectin Injection and its associated names - referral

Current status

European Commission final decision

Overview

Bovimectin Injection and its associated names are solutions for injection and contain ivermectin as active substance. They are intended for use in cattle as a subcutaneous injection for the treatment and prevention of infestations by gastro-intestinal roundworms, lungworms, eyeworms, warbles, mange mites and sucking lice.

The marketing authorisation holder, Cross Vetpharm Group Ltd, submitted an application via mutual recognition for Bovimectin Injection, on the basis of the marketing authorisation granted by Ireland. This is a generic application referring to the reference product Panomec. The reference Member State is Ireland and Belgium is concerned Member State.

The mutual recognition procedure started on 23 November 2001. Potential serious risks were identified during the mutual recognition procedure by Belgium regarding the demonstrated bioequivalence with the reference product.

On 21 February 2002, in view of the remaining unsolved issues Belgium submitted a referral notification under Article 33 of Directive 2001/82/EC to the CVMP.

The referral procedure started on 12 March 2002. The Committee appointed C. Friis as rapporteur and M. Arboix as co-rapporteur. Written explanations were provided by the marketing authorisation holder on 11 April 2002.

Based on the evaluation of the available data, the CVMP considered that the objections raised by Belgium during the mutual recognition procedure should not prevent the granting of a marketing authorisation for Bovimectin Injection and its associated names. Therefore, the Committee adopted by majority a positive opinion on 12 June 2002 recommending the granting of the marketing authorisation the above-mentioned product.

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 in Annex III.

The opinion was converted into a Decision by the European Commission on 12 September 2002.

Opinion following an article 33 referral for Bovimectin Injection and its associated names

Reference Number: EMA/76071/2014

Key facts

About this medicine

• Approved name:
  Bovimectin Injection and its associated names
• International non-proprietary name (INN) or common name:
  ivermectin
• Associated names:
  Bovimec B

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/002
• 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:
  12/06/2002
• EC decision date:
  19/09/2002

All documents

European Commission final decision

Bovimectin Injection Article-33 referral - Annex I, II, III

Divergent position regarding the referral for arbitration under Article 33 of Directive 2001/82/EC submitted for Bovimec B and Porcimec P

Reference Number: EMA/76071/2014

Opinion following an article 33 referral for Bovimectin Injection and its associated names

Reference Number: EMA/76071/2014

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)