Insights on Classification of Variation Assessments Required by Article 62 of Regulation (EU) 2019/6 for Veterinary Medicines and Documentation Submission Guidelines

Insights on Classification of Variation Assessments Required by Article 62 of Regulation (EU) 2019/6 for Veterinary Medicines and Documentation Submission Guidelines

Insights on Classification of Variation Assessments Required by Article 62 of Regulation (EU) 2019/6 for Veterinary Medicines and Documentation Submission Guidelines


Guidance on Variations Assessment for Veterinary Medicinal Products

Guidance on the Classification of Variations for Veterinary Medicinal Products

This article provides clarity on the types of variations related to veterinary medicinal products that necessitate assessment in line with Article 62 of Regulation (EU) 2019/6. The document also outlines the required documentation associated with these variations.

Classification of Variations

Variations in veterinary medicinal products can significantly influence their safety, efficacy, and quality. Consequently, it is critical to assess the implications of any proposed change. Variations are categorized into three distinct types:

  • Type I: These involve changes that do not affect the product’s quality or efficacy, warranting a simplified notification process.
  • Type II: This category includes modifications that might impact quality, efficacy, or safety, necessitating a thorough assessment.
  • Type III: Variations under this classification cover changes requiring substantial data to support the proposed amendments.

Documentation Requirements

To facilitate the evaluation of variations, specific documentation must be submitted. The requirements differ based on the variation type:

For Type I Variations:

Documents needed include basic notification details, the nature of the change, and assurance that the alteration does not correspondingly affect quality, safety, or efficacy.

For Type II Variations:

Applicants must provide a comprehensive rationale detailing the proposed change and its potential impact on the product. Additionally, relevant data supporting the variation must be included.

For Type III Variations:

The documentation for these variations is the most extensive, encompassing detailed evidence regarding the change’s implications on product performance and safety. A complete set of experimental data must accompany the submission.

Conclusion

Understanding the classification and documentation needed for variations in veterinary medicinal products is essential for compliance with Article 62 of Regulation (EU) 2019/6. Stakeholders must ensure accurate submissions to facilitate a smooth approval process, safeguarding public and animal health.