Veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep - referral

Current status

European Commission final decision

Overview

Questions and answers on withdrawal periods for injectable veterinary medicines containing tylosin when given to sheep

Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/130)

On 20 June 2019, the European Medicines Agency completed a review of the withdrawal periods for injectable veterinary medicines containing tylosin when used in sheep. The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered and its meat or other animal derived products may be used for human consumption.

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that for some of these medicines, the maximum injection volume per site and the withdrawal periods for sheep meat, offal and milk should be changed. However, for one medicine, Tilocen, the Committee concluded that there were insufficient data to determine the withdrawal period and that it should therefore no longer be used in sheep.

What is tylosin?

Tylosin is a macrolide antibiotic used mainly to treat infections caused by bacteria known as Gram-positive bacteria. Veterinary medicines containing tylosin are used in adult cattle, calves, pigs, sheep and goats and are given by injection into the muscle. In addition, cattle may also be treated by injection given slowly into a vein.

Why were veterinary medicines containing tylosin reviewed?

On 28 September 2018, the Dutch medicines authority requested that the CVMP review all available data and recommend withdrawal periods for milk, meat and offal from sheep treated with injectable veterinary medicines containing tylosin.

The Dutch authority considered that the withdrawal periods for sheep in the EU might not be adequate to ensure consumer safety, noting that withdrawal periods differed across the EU: from 8 to 42 days for sheep meat and offal and from 4 to 7 days for sheep milk.

Which data has the CVMP reviewed?

The CVMP reviewed available data on residue depletion, which indicates how long a medicine takes to fall below maximum residue limits (MRLs) in the animal’s body. These included data from companies and from the published literature.

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, for 49 out of 50 products, those containing benzyl alcohol and propylene glycol as a non-active ingredient, the withdrawal periods for meat and offal from treated sheep should be 42 days, while the withdrawal periods for milk from treated sheep should be 108 hours. The Committee concluded that the injection should be divided over two injection sites (maximum 2.5 ml injection volume per injection site). The CVMP recommended the variation of the marketing authorisations for these veterinary medicines.

For one medicine, Tilocen, which contains the non-active ingredient polyethylene glycol 400, there were no data available that could be used to set adequate withdrawal periods in sheep. Therefore, the CVMP concluded that the benefit-risk balance for the veterinary medicine Tilocen is not favourable for sheep and recommended a change to its marketing authorisation to remove any reference to use in sheep.

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 20 September 2019.

Tylosin injectable for sheep Article-35 referral - Questions and answers on withdrawal periods for injectable veterinary medicines containing tylosin when given to sheep

Reference Number: EMA/510184/2019

Key facts

About this medicine

• Approved name:
  Veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep
• International non-proprietary name (INN) or common name:
  tylosin
• Associated names:
  See annex I

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/130
• Type:
  Article 35 referrals (prior to January 2022)

  This type of referral is 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:
  Centrally authorised product(s)

Key dates and outcomes

• Opinion date:
  20/06/2019
• EC decision date:
  20/09/2019

All documents

European Commission final decision

Tylosin injectable for sheep Article-35 referral - Annex I, II, III

Tylosin injectable for sheep Article-35 referral - Questions and answers on withdrawal periods for injectable veterinary medicines containing tylosin when given to sheep

Reference Number: EMA/510184/2019

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)