Quarter-based selective dry cow therapy - referral

Current status

Procedure started

Overview

Start of review concerning quarter-based selective dry cow therapy

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

In the context of prudent use of antibiotics, the national veterinary medicines regulatory authority of Germany considers it necessary to review whether it is scientifically justifiable to generally allow quarter-based selective dry cow therapy with antibiotic intramammary veterinary medicines (medicines applied into the udder). This approach would allow veterinarians and farmers to practice quarter-based selective dry cow therapy in accordance with the terms of the marketing authorisation, thereby reducing antibiotic use and lowering the risk of resistance development.

The EMA’s veterinary medicines committee (CVMP) has received a request from the national veterinary medicines regulatory authority of Germany to assess this matter. The request relates to whether the product information (summary of product characteristics, package leaflet and labelling) of intramammary antibiotic veterinary medicines used at drying off should be amended to allow for selective treatment at quarter level, without contradicting national policies.

EMA will now review all available scientific data to determine if quarter-based selective dry cow antibiotic therapy could be considered consistent with the latest scientific knowledge aimed at reducing antibiotic use, without compromising animal health. 

In the interest of transparency, the Agency invites stakeholders (e.g., marketing authorisation holders (MAHs), veterinary healthcare professionals, farmers, academia) to submit any relevant information or data that may assist the CVMP in reaching its scientific advice. Relevant data should be submitted to [e-mail] by 9 October 2025. For MAHs, the Agency would greatly appreciate if data were submitted using the eSubmission Gateway and Web Client.

The data received will be published on the Agency website and will be considered by the CVMP when preparing the scientific advice.

More about the procedure

The review has been initiated at the request of the veterinary medicines regulatory agency of Germany under Article 141(1)(i) of Regulation (EU) 2019/6. The review is being carried out by the Committee for Veterinary Medicinal Products (CVMP), responsible for questions concerning medicines for veterinary use, which will provide a scientific advice. 

Quarter-based selective dry cow therapy 141(1)(i) procedure - Start of review

Reference Number: EMA/235687/2025

Key facts

About this medicine

• Approved name:
  Quarter-based selective dry cow therapy

About this procedure

• Current status:
  Procedure started
• 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

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

Quarter-based selective dry cow therapy 141(1)(i) procedure - Start of review

Reference Number: EMA/235687/2025

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)