On the regulation of animal semen preservation media in the EU.
Animal semen preservation media are liquid solutions employed to dilute ejaculates, thereby augmenting ejaculate volume to achieve the appropriate sperm cell concentration for artificial insemination. Furthermore, these media serve to uphold the functionality of sperm cells for fertilization. Comprising salts and sugars, semen preservation media regulate pH and osmolarity, while also incorporating antibiotics to mitigate the proliferation of microorganisms. Moreover, various other substances can be included in these media.
Unlike veterinary medical products, there is currently no regulation specifically governing animal semen preservation media. For instance, sperm preservation media may include antibiotics, which are intended to sustain the viability of sperm cells rather than exerting a physiological effect on the animal undergoing insemination. It is possible that certain components found in specific semen preservation media, whether commercially available or otherwise, could be categorized as veterinary medicines. If these ingredients are indeed veterinary medicines, they would likely necessitate compliance with relevant regulatory requirements.
The classification of certain ingredients in sperm preservation media can be ambiguous, creating uncertainty about whether the medium should be classified as a veterinary medicine or if the ingredient can be considered a non-medical substance. Some ingredients may not act as preservatives but still play a role in fertilization. For example, substances added to diluted semen to enhance its miscibility with vaginal mucus can potentially increase the chances of conception, as demonstrated in species such as pigs and rabbits. Or substances added to the medium to assist in the process of natural ovulation, such as in the case of the rabbit semen preservation medium Lepex-Novum.
When faced with the dilemma of classifying ingredients as veterinary medicinal products or non-medicinal sperm preservation additives, one can request a classification from the Borderline Working Group (BWG) established by the Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv) of the European Medicines Agency (EMA). The CMDv, formed under revised pharmaceutical legislation, addresses queries related to marketing authorization of veterinary medicinal products in multiple Member States through mutual recognition or decentralized procedure.
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The CMDv has given the BWG the following mandate.
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1. To make an inventory of relevant personnel, working groups, and teams within National Competent Authorities to create a European ‘borderline’ network. To identify the relevant legislation, the Commission implementing acts as referred to in Article 3(2) and the European jurisprudence related to the issue and the European jurisprudence related to the issue.
2. To identify the different areas of borderline products.
3. To agree on common understandings between Member States about borderline definitions and to different areas of borderline products identified, to minimize any differences in interpretation between Member States.
4. To provide recommendations for the classification of a product or group of products.
5. To communicate with the European Commission when required on a specific recommendation.
6. Classification is based on the evaluation of function and presentation of the product case-by-case.
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With this mandate, the BWG can issue recommendations concerning ingredients of animal semen preservation media for which a request has been submitted.
Recommendation of the European Medicines Evaluation Board - Agency
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 Novum was forwarded to the Veterinary Medicines Agency for the classification of the supplement Novum. The submission included details about all ingredients 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.
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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.
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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, 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.
Barex Biochemical Products
The art of semen preservation
