Closantel - referral

Current status

European Commission final decision

Overview

On 21 February 2019, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat and offal) for sheep for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection. The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to the withdrawal periods for sheep to provide assurance for consumer safety. Withdrawal period refers to the minimum period of time from administering the last dose of veterinary medicinal product and the production of meat or other animal-derived products for food.

What is closantel?

Closantel is intended for use in cattle and sheep for the treatment and control of adult and immature flukes, nematodes and larval stages of some arthropods and is administered subcutaneously by injection or as an oral solution. In addition, cattle may also be treated topically on their skin.

Why were solutions for injection containing 50 mg closantel per ml (as a single active substance) reviewed?

The United Kingdom noted that, for veterinary medicinal products containing closantel presented as solutions for injection, there are different approved withdrawal periods for sheep across the European Union e.g. sheep meat and offal, from 28 days to 107 days.

Consequently, on 5 February 2018, the United Kingdom initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products. The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for meat and offal derived from treated sheep.

Which data has the CVMP reviewed?

Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.

What are the conclusions of the CVMP?

Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefit-risk balance for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep, is positive and agreed that the withdrawal periods (meat and offal) for sheep should be harmonised and amended to provide assurance for consumer safety. The CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products are required in order to amend the product information accordingly.

The European Commission issued a decision on 20 May 2019.

Closantel Article-35 referral - Questions and answers on veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep

Reference Number: EMA/246018/2019

Key facts

About this medicine

• Approved name:
  Closantel
• International non-proprietary name (INN) or common name:
  closantel

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/126
• 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:
  21/02/2019
• EC decision date:
  20/05/2019

All documents

European Commission final decision

Closantel Article-35 referral - Annex I, II, III

Closantel Article-35 referral - Questions and answers on veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep

Reference Number: EMA/246018/2019

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)