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Recommendation of the European Medicines Evaluation Board - Agency

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In July 2023, two requests for classification were submitted to the Borderline Working Group (BWG), a body established by the Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv) of the European Medicines Agency (EMA), concerning Pronexcell and Matrixcell, two prime ingredients of Lepex-Novum.

Additionally, in November 2023, the complete recipe of Lepex-Novum was forwarded to the Veterinary Medicines Agency for the classification of the rabbit sperm diluent Lepex-Novum. The submission included details about all 11 ingredients of Lepex-Novum, along with an explanation of the mechanism based on the presence of the NGF protein, consistent with the information available on the current website.

The written response from the Regulatory Project Leader/Dutch Representative – a member of the CMDv of the Veterinary Medicinal Products Unit of the Medicines Evaluation Board-Agency was as follows.

In accordance with EU Regulation 2019/6, the term "Veterinary medicinal product" encompasses any substance or combination of substances meeting at least one of the following conditions:

a) presented as having therapeutic or prophylactic properties for diseases in animals;

b) intended for use in or administration to animals to restore, improve, or modify physiological functions through a pharmacological, immunological, or metabolic effect.

Based on the provided information, Lepex-Novum does not meet the definition of a veterinary medicinal product as outlined in Article 4(1a) or 4(1b) of EU Regulation 2019/6.


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