Podcast
Questions and Answers
Which of the following classes of veterinary medicinal products (VMPs) was recognized in the obsolete Directive 2001/82/EC?
Which of the following classes of veterinary medicinal products (VMPs) was recognized in the obsolete Directive 2001/82/EC?
Regulation (EU) 2019/6 introduced the definition of a biological veterinary medicinal product (VMP).
Regulation (EU) 2019/6 introduced the definition of a biological veterinary medicinal product (VMP).
True
What new category of veterinary medicinal product has been introduced due to advancements in the field?
What new category of veterinary medicinal product has been introduced due to advancements in the field?
Novel therapy veterinary medicinal product
The obsolete Directive 2001/82/EC did not define a __________ VMP, as the field barely existed at the time.
The obsolete Directive 2001/82/EC did not define a __________ VMP, as the field barely existed at the time.
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Match the following VMP categories with their descriptions:
Match the following VMP categories with their descriptions:
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What is the primary basis for classifying a veterinary medicinal product (VMP)?
What is the primary basis for classifying a veterinary medicinal product (VMP)?
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An active substance that interacts with the immune system but does not initiate a specific response can be classified as an immunological VMP.
An active substance that interacts with the immune system but does not initiate a specific response can be classified as an immunological VMP.
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What type of VMP is classified if it initiates an antigen-specific immune response?
What type of VMP is classified if it initiates an antigen-specific immune response?
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An active substance that has a general modifying effect on the immune system is classified as a __________ non-immunological VMP.
An active substance that has a general modifying effect on the immune system is classified as a __________ non-immunological VMP.
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Match the following types of VMPs with their descriptions:
Match the following types of VMPs with their descriptions:
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Study Notes
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.
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Description
Explore the classification of veterinary medicinal products (VMPs) as outlined in the Regulation (EU) 2019/6. This quiz will cover the distinctions between immunological and non-immunological VMPs, as well as highlight the criteria for categorizing novel therapy VMPs. Test your knowledge on the specific data requirements and classifications of various VMP types.
