Published on 23/12/2025

Understanding Centralised vs National Veterinary Submissions in the EU

The regulation of veterinary medicines within the European Union (EU) is complex, involving multiple regulatory pathways tailored for varying needs based on the scope of the product and its intended use. Whether you are navigating the regulatory landscape for the first time or are a seasoned professional in veterinary regulatory affairs, understanding the differences between centralised and national submissions is crucial. This guide provides a structured, step-by-step approach to facilitate a clear understanding of these two pathways as part of EU veterinary medicines regulation consulting services.

1. Introduction to EU Veterinary Medicines Regulation

The EU has established a robust framework for the regulation of veterinary medicines, primarily governed by the Veterinary Medicines Regulation (Regulation (EU) 2019/6). This regulation stipulates the need for ensuring the quality, safety, and efficacy of veterinary products while also promoting public health and animal welfare.

Regulatory oversights are divided mainly into two submission pathways: centralised and national. The choice between these pathways will depend on the product scope, its risk profile, the target market, and other regulatory considerations which we will explore in the subsequent sections.

2. Overview of Centralised Veterinary Submissions

Centralised submissions are defined by the processes set forth by the European Medicines Agency (EMA) and are ideal for veterinary medicines intended for use across multiple EU member states.

2.1 Advantages of Centralised Submissions

• Single Application Process: A centralised submission requires only one application to the EMA, which simplifies the process for products intended for multiple markets.
• Uniformity in Decision-Making: Since the assessment is conducted centrally, it ensures a uniform evaluation process and consistency in the granting of marketing authorisations across member states.
• Broader Market Access: Products with a centralized authorisation can be marketed in all EU member states, enhancing access and sales opportunities.

2.2 Eligibility Criteria for Centralised Submissions

Not all veterinary products qualify for centralised submissions. For a product to be eligible, it must fall within specific categories outlined by the EMA:

• Innovative medicinal products: New active substances that offer substantial therapeutic benefit over existing treatments.
• Products intended for the treatment of serious conditions: Those addressing unmet medical needs.
• Antimicrobial products: Particularly antibiotics which are crucial given the global emphasis on antibiotic resistance.

3. Step-by-Step Process of Centralised Submissions

3.1 Preliminary Considerations

Before initiating a centralised submission, consider the following aspects:

1. Conduct a thorough market analysis to define target regions and competition.
2. Evaluate the scientific and technical documentation needed for effective submissions.
3. Consult with regulatory experts to understand the EMA guidelines and requirements thoroughly.

3.2 Preparing the Dossier

The application dossier is a compilation of documents that includes:

• Quality Data: This includes detailed information about the product’s composition, manufacturing processes, and quality control measures.
• Preclinical and Clinical Data: Comprehensive studies demonstrating safety and efficacy are paramount. The efficacy studies must be designed in adherence to ICH guidelines.

3.3 Submission to the EMA

Submit your dossier via the EMA’s electronic submission system. The submission fees vary based on the product category, and further guidance can be obtained from the official EMA website.

3.4 Evaluation and Decision

The EMA will conduct a thorough evaluation of your submission. The evaluation process is divided into two phases:

• Science and Risk Assessment: A scientific committee reviews the data for quality, safety, and efficacy.
• Final Decision and Post-Authorisation: Once approved, the product is granted a marketing authorisation valid across the EU.

4. Overview of National Veterinary Submissions

National submissions entail applying for marketing authorisation in individual EU member states instead of through the EMS. This pathway is favoured for products intended for local markets or those with lower risk profiles.

4.1 Advantages of National Submissions

• Localized Response: National authorities often possess intimate knowledge of local market needs and regulatory nuances.
• Faster Approval Times: Depending on jurisdiction, national submissions can lead to quicker approval compared to centralised submissions.
• Cost Efficiency: These submissions often incur lower fees as compared to centralised pathways.

4.2 Eligibility Criteria for National Submissions

National submissions are recommended for the following scenarios:

• Generic Products: Products for which the safety and efficacy have already been established by similar approved products.
• Established Veterinary Products: Those that do not introduce new active substances but represent an existing formulation.

5. Step-by-Step Process of National Submissions

5.1 Preliminary Assessment

The first step in the national submission process involves:

1. Identifying the specific veterinary regulatory authority in the target member state (e.g., UK’s Veterinary Medicines Directorate).
2. Reviewing specific national guidelines and requirements for the submission process.

5.2 Documentation Preparation

The appropriate documentation is also critical in national submissions and typically includes:

• Limitative Quality Information: Details of the manufacturing process and quality controls specific to the national framework.
• Simplified Safety and Efficacy Data: For established products, extensive preclinical and clinical data may not be required, focusing instead on comparative studies.

5.3 Submitting the Application

Once the dossier is prepared, submit your application directly to the relevant member state’s regulatory authority. Submission guidelines and fees will vary and must adhere to local requirements.

5.4 Evaluation and Approval

After submission, the national authority will initiate its evaluation process, which generally involves:

• Review by Appropriate Committees: Assessment should cover safety, efficacy, and quality data sufficient based on the product type.
• Granting of a Marketing Authorisation: If successful, a marketing authorisation will be issued which permits the product’s sale within the respective member state.

6. Centralised vs National: Key Differences and Considerations

Understanding the key differences between centralised and national submissions can impact your strategic planning. Below are important distinctions to consider:

• Scope of Market: Centralised submissions provide a pathway to enter multiple EU markets at once, while national submissions are limited to specific member states.
• Complexity and Cost: Centralised submissions often entail a more complex and cost-intensive process compared to their national counterparts.
• Timeness of Approval: Approval times can vary significantly; national submissions may be quicker but centralised submissions are less burdensome in multiple regulatory requirements.

7. Conclusion

The choice between centralised and national veterinary submissions requires careful consideration of both the product and the strategy of market entry across the EU. Engaging in EU veterinary medicines regulation consulting services can also provide additional insights into the best pathway suited to your specific needs, ensuring compliance with veterinary regulations. Professionals involved in regulatory affairs, quality assurance, and pharmacovigilance should be well-versed in these two distinct pathways to ensure successful submissions and marketing of veterinary products in the EU.

For further information and detailed guidance, consider consulting the regulatory authorities or resources such as the European Medicines Agency and the FDA Center for Veterinary Medicine (CVM), as they offer extensive information on veterinary medicines policy and submission guidelines.