Long-acting formulations for injection containing barium selenate for all food producing species - referral

Current status

European Commission final decision

Overview

Selenium is an essential micronutrient for both animals and man. Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep.

On 14 September 2011, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all long-acting formulations for injection containing barium selenate for all food producing species. Germany referred the matter to the CVMP due to serious human health concerns related to exposure to injection site residues from the use of long-acting barium selenate- containing injectable veterinary medicinal products.

The referral started on 15 September 2011. The Committee appointed C. Ibrahim as rapporteur and
H. Jukes as co-rapporteur. Written explanations were provided by the applicants and marketing authorisation holders on 14 November 2011 and on 30 November 2012. An oral explanation was given by the applicant/marketing authorisation holders on 6 March 2013.

Based on the evaluation of the available data, the CVMP considered that the benefit-risk balance for the concerned veterinary medicinal products was negative as, following treatment at recommended doses, barium selenate remains at injection sites for long time periods after treatment and, consequently, consumption of injection-site residues could pose a significant risk to human health. The Committee therefore adopted by majority a negative opinion on 10 April 2013, recommending suspension of the marketing authorisations for all concerned products.

On 26 April 2013, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products – BVP) notified the Agency of their intention to request a re-examination of the CVMP opinion of 10 April 2013.

During its meeting of 14-16 May 2013 the CVMP appointed K. Törneke as rapporteur and K. Baptiste as co-rapporteur for the re-examination procedure.

The consolidated detailed grounds for the re-examination were submitted by Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products – BVP) on
10 June 2013. The re-examination procedure started on 11 June 2013.

On 17 July 2013, the CVMP adopted by majority an opinion confirming the recommendation for suspension of the marketing authorisations for the concerned veterinary medicinal products.

On 23 August 2013, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to consumer risk assessment.

On 6 November 2013, the CVMP adopted by majority a revised opinion confirming the recommendation included in its opinion of 17 July 2013, that the benefit-risk balance for the concerned veterinary medicinal products was negative and therefore the CVMP recommended the refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisations for the products concerned.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisations in Annex III.

The revised opinion was converted into a Decision by the European Commission on 28 March 2014.

Opinion following an Article 35 referral for long-acting formulations for injection containing barium selenate for all food producing species

Reference Number: EMA/197955/2014

Key facts

About this medicine

• Approved name:
  Long-acting formulations for injection containing barium selenate for all food producing species
• International non-proprietary name (INN) or common name:
  barium selenate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/077
• 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:
  06/11/2013
• EC decision date:
  28/03/2014

All documents

European Commission final decision

Long-acting formulations for injection containing barium selenate for all food producing species - Article 35 referral - Annexes I, II, III

Divergent position on a revised CVMP opinion on an Article 35 referral of Directive 2001/82/EC for All long acting formulations for injection containing barium selenate for all food producing species

Opinion following an Article 35 referral for long-acting formulations for injection containing barium selenate for all food producing species

Reference Number: EMA/197955/2014

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)