Veterinary Medicinal Products Classification

Veterinary Medicinal Products Classification

• Two classes of veterinary medicinal products (VMPs) were previously recognized: immunological and non-immunological.
• The current regulatory framework (Regulation (EU) 2019/6), now clarifies biological VMPs, including immunological, and non-immunological VMPs.
• Novel therapy veterinary medicinal products are recognized.
• Specific data requirements for different VMP types (e.g., biological, immunological) are outlined.
• Allocation of a VMP to a category can be unclear, especially for biological products with potential ambiguity in immunological vs. biological classification.

Classification of VMPs

• Immunological VMP: An active substance that initiates or mediates an antigen-specific immune response in the target animal.
• Biological, non-immunological VMP: An active substance that interacts with the immune system but does not initiate a specific adaptive immune response; focuses on modifying general immune system functions.
• Antibody-based immunological VMP: An active substance, like an antibody, targeting a specific exogenous target.
• Biological, non-immunological VMP with endogenous target: A product acting on a specific endogenous target via an immunological mechanism (e.g., monoclonal antibodies for growth factors). Dossier requirements for such products differ from immunological VMPs.

Novel Therapy VMPs

• Novel therapy veterinary medicinal products have specific data requirements in addition to standard quality/safety/efficacy evaluations.
• The type-specific requirements are provided in Annex II of Regulation (EU) 2019/6.
• Gene therapy, regenerative medicine, tissue engineering, blood product therapy, phage therapy, and RNA antisense therapy are examples of novel therapy product types.