Quarter-based selective dry cow therapy - referral

Current status

Opinion provided by Committee for Veterinary Medicinal Products

Overview

CVMP concludes review on quarter-based selective antibiotic dry cow therapy

The European Medicines Agency (EMA) has concluded a scientific review of quarter-based selective antibiotic dry cow therapy.

In the context of prudent use of antibiotics, the EMA’s veterinary medicines committee (CVMP) received a request from Germany to assess whether it is scientifically justified to generally allow quarter-based selective dry cow therapy with antibiotic intramammary veterinary medicines (medicines applied into the udder). The request also sought clarity on whether the product information (summary of product characteristics, package leaflet and labelling) for these veterinary medicines should be updated to reflect this practice.

After evaluating the available scientific data, the CVMP concluded that routinely treating all cows and quarters with antibiotics at dry‑off does not offer signifcant efficacy or safety benefits compared with selective antibiotic dry cow therapy (SDCT). In contrast, selective approaches help reduce antimicrobial use and hence likely antimicrobial resistance. Both cow‑based and quarter‑based SDCT are suitable options if supported by good herd management, accurate diagnostics, and the use of teat sealants. The decision on which approach to use should be made case‑by‑case by the veterinarian together with the farmer, taking into account herd‑specific indicators and practical considerations.

As part of its scientific advice, the CVMP considered quarter-based SDCT to be consistent with the latest scientific knowledge aimed at reducing antibiotic use, without compromising animal health.

The CVMP also considered how this approach could be reflected in the product information of intramammary antibiotic dry cow veterinary medicines and made recommendations for possible amendments. Including such information would provide clear, evidence-based guidance which is expected to assist veterinarians and farmers in determining whether cow-based or quarter-based SDCT is more appropriate under specific herd conditions, while ensuring use remains within the terms of the marketing authorisation. 

More about the procedure

The review was initiated on 17 July 2025 at the request of Germany under Article 141(1)(i) of Regulation (EU) 2019/6.

The review was carried out by the Committee for Veterinary Medicinal Products (CVMP), responsible for questions concerning medicines for veterinary use, that has provided a scientific advice on this matter. 

Quarter-based selective dry cow therapy 141(1)(i) procedure - CVMP concludes review on quarter-based selective antibiotic dry cow therapy

Key facts

About this medicine

• Approved name:
  Quarter-based selective dry cow therapy

About this procedure

• Current status:
  CVMP opinion
• Reference number:
  EMA/REF/0000285673
• Type:
  Article 141(1)(i) procedures

  This type of procedure is initiated when there is a request to the Committee to provide scientific advice on the use of antimicrobials and antiparasitics in animals in order to minimise the occurrence of resistance in the Union.

• Authorisation model:
  Centrally and nationally authorised products (mixed)

Key dates and outcomes

• Procedure start date:
  16/07/2025
• Opinion date:
  12/03/2026

All documents

Procedure started

Quarter-based selective dry cow therapy 141(1)(i) procedure - Notification

Quarter-based selective dry cow therapy 141(1)(i) procedure - CVMP list of questions to be addressed by stakeholders

Reference Number: EMA/CVMP/231325/2025

Quarter-based selective dry cow therapy 141(1)(i) procedure - Timetable for the procedure

Reference Number: EMA/CVMP/224794/2025

Opinion provided by Committee for Medicinal Products for Veterinary Use

Quarter-based selective dry cow therapy 141(1)(i) procedure - CVMP scientific advice

Reference Number: EMA/CVMP/44250/2026

Quarter-based selective dry cow therapy 141(1)(i) procedure - CVMP assessment report

Adopted Reference Number: EMA/CVMP/44249/2026

Quarter-based selective dry cow therapy 141(1)(i) procedure - CVMP concludes review on quarter-based selective antibiotic dry cow therapy

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)