Injectable veterinary medicinal products containing vitamin A for use in food producing species - referral

Current status

European Commission final decision

Overview

On 12 May 2021, the European Medicines Agency (the Agency) completed a review of the safety of injectable veterinary medicines containing vitamin A for use in food producing species. The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that regulatory measures and risk mitigation measures should be taken to assure consumer and user safety, including the amendment of withdrawal periods for milk, meat and offal for food producing species. The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered so that its meat or other animal derived products may be used for human consumption.

What is vitamin A?

Vitamin A is a fat-soluble vitamin which is essential for most mammalian species.

Injectable veterinary medicines containing vitamin A (retinol and its esters) as sole active substance or in combination with other active substances are used, for example, for the treatment and prevention of vitamin A deficiencies, decreased fertility, growth-related abnormalities such as rickets, maintenance therapy for stressful situations, diarrhoea and infectious diseases, during pregnancy and lactation as well as for stimulation of growth and productivity.

Why were injectable veterinary medicines containing vitamin A reviewed?

On 25 June 2020, the German veterinary medicines authority requested that the CVMP review all available data and recommend withdrawal periods for milk, meat and offal for food producing animals treated with injectable veterinary medicines containing vitamin A. The Committee was also requested to consider whether other risk management measures are feasible for these veterinary medicines as well as to assess the extent of user exposure due to accidental self-injection and the resulting risk, with a view to recommending appropriate user safety warnings.

The German authority considered that the withdrawal periods in the European Union (EU) might not be adequate to ensure consumer safety, noting that withdrawal periods differed across the EU: from 0 to 60 days for meat and offal and from 0 to 5 days for milk. There were also significant inconsistencies in user safety warnings, ranging from none applied to very detailed user warnings.

Consequently, the German authority asked the CVMP to carry out an assessment of the benefit-risk balance of injectable veterinary medicines containing vitamin A for use in food producing species and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.
 

Which data has the CVMP reviewed?

No proprietary residue depletion data or kinetic parameters were provided by the concerned companies. The CVMP reviewed residue depletion data from published literature, data from National Competent Authorities as well as proposals for risk mitigation measures provided by the concerned marketing authorisation holders.

What are the conclusions of the CVMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the withdrawal periods for milk, meat and offal for food producing animals should be amended and certain warnings should be included in the product information [summary of product characteristics (SPC), labelling and package leaflet]. The Committee recommended regulatory and risk mitigation measures in order to provide assurance for consumer and user safety.

The full changes made to the product information are detailed in Annex III of the CVMP opinion under 'All documents'. 

The European Commission issued a decision on 18 August 2021.

Injectable veterinary medicinal products containing vitamin A for use in food producing species Article-35 referral - Questions and answers on the review of injectable veterinary medicines containing vitamin A for use in food producing species

Reference Number: EMA/279146/2021

Key facts

About this medicine

• Approved name:
  Injectable veterinary medicinal products containing vitamin A for use in food producing species
• International non-proprietary name (INN) or common name:
  Vitamin A (retinol and its esters)

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/141
• 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.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• Opinion date:
  12/05/2021
• EC decision date:
  18/08/2021

All documents

European Commission final decision

Injectable veterinary medicinal products containing vitamin A for use in food producing species Article-35 referral - Annex I, II, III, IV

Injectable veterinary medicinal products containing vitamin A for use in food producing species Article-35 referral - Questions and answers on the review of injectable veterinary medicines containing vitamin A for use in food producing species

Reference Number: EMA/279146/2021

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)