veterinary medicinal products

Traditional herbal products used to treat animals, what prospects?

Marketing 15 July 2021 News

Scientific literature highlights the potential of traditional herbal products to treat animals. For example, Bullitta and colleagues (2018)¹ reported 42 plant taxa traditionally used to treat animals among different traditional veterinary treatments.

The traditional approach to animal health care is based on the knowledge, methods, practices, skills acquired by members of communities, with differences among communities, as well as across regions. It also includes a large number of herbal remedies for diseases. This traditional knowledge has been disseminated across generations orally.

Since it has been developed by deliberate experimentation through the years, it is less systematic and less standardized than the current conventional approach to veterinary treatments.

Scientific research is exploring the literature to find evidence about traditional herbal products and treatments used in animal health care, aiming at further investigating their potential as medicinal products.

As per the Organic Production regulatory framework, phytotherapeutic, homeopathic and other products must be preferred to chemically synthesized allopathic veterinary medicinal products, including antibiotics, to treat animals. When herbal, homeopathic or other products are inappropriate for treatment, conventional medicines can be used under certain specific restrictions (e.g., longer withdrawal periods).

Thus, there is room for the application of traditional herbal products, but greater certainty is needed.

We have got few months left to get ready for the application of the New veterinary medicinal products law[Reg. (EU) n. 2019/6].

Since there is insufficient information to date on traditional herbal products used to treat animals, the Commission is called to examine the possibility of introducing a simplified system on the base of information provided by the Member States on the use of such products on their territory.

To create its legislative proposal (if appropriate), the Commission will report to the European Parliament and to the Council by 29 January 2027 on the EU use of traditional herbal products used to treat animals.

As per the legal definition of veterinary medicinal product, any product containing vegetable substances and fulfilling the conditions established in the definition² must follow the market authorization procedure and rules set up in the regulation.

Traditional herbal products for treating animals fall within this definition. Until a specific legislative framework is defined for these products, operators have to follow the procedure set up for other VMPs.

The assessment for traditional herbal products is needed since any product used to treat or cure animals must ensure an overall benefit-risk balance. Antimicrobial resistance development is one of the current biggest threats to human society and we cannot afford to misjudge risks.

For this reason, final users of VMPs should be careful at checking any product before using it on animals. As already discussed³, safe and prudent use on dairy farms is possible if products are clearly presented and if the final user is able to exclude misleading product from farm routine.

¹ Bullitta et al. Journal of Ethnobiology and Ethnomedicine (2018) 14:50.

DOI: https://doi.org/10.1186/s13002-018-0250-7

² Veterinary medicine product or not? OZOLEA’s innovative approach within the new regulatory framework.

https://www.ozolea.it/veterinary-medicine-product-or-not-ozoleas-innovative-approach-within-the-new-regulatory-framework/

³ Veterinary products clearly presented, safe use on dairy farms.

https://www.ozolea.it/veterinary-products-clearly-presented-safe-use-on-dairy-farms/

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Veterinary products clearly presented, safe use on dairy farms

Marketing 10 June 2021 News

There is increasing attention to antimicrobial resistance (AMR). The European Union is a few months away from the application of the new regulation on veterinary medicinal products (VMPs), which will involve manufacturers, distributors, veterinarians, and final users.

The new principles for advertising and communication of VMPs will certainly help in gaining greater clarity within the single market. Furthermore, they will allow a more conscious use by pet owners and breeders, who will be better informed.

All that concerns the Reg. (EU) n. 2019/6¹ is an important, gradual and clear revolution in the world of VMPs. The ultimate goal is something higher, namely safeguarding animal and human health and the protection of the environment.

Experience has taught EU Member States that it is necessary to clearly distinguish the various veterinary products on the market from veterinary medicines.

How can we understand today what kind of product retailers, salesmen and other professionals are offering us? Let’s try, in a simple way, to find the essential aspects to avoid buying products that have particular properties and/or activities, though are not legal.

First, we need to see whether or not the product is proposed as having pharmacological, immunological or metabolic action. Let’s consider a product that shows, in the description, the word “antimastitic”.

Mastitis is a disease, more precisely the inflammation of the mammary gland caused mainly by bacterial infections.

The term “antimastitic” is generally used in the description of the pharmacotherapeutic group of veterinary drugs such as antibiotics for the treatment of udder infections with intra-mammary application.

Therefore, if we find “antimastitic” on a product, or in any case terms that suggest that the product performs a pharmacological action, we are in front of something that is configured as a veterinary medicinal product.

How do we check that it really is a medicine? The product must show the marketing authorization number (AIC in Italy) on the package. For instance, when a new drug is authorized, in Italy the Ministry of Health issues a document relating to the AIC and its specific characteristics. The document is public, thus a web check is the easiest thing to do.

In general, when veterinary medicinal products can be used only under veterinary prescription, this information must appear on the package. Some veterinary medicines do not require a veterinary prescription; however, this is not the case of intra-mammary products.

Thus, seek veterinary advice and exclude from your dairy farm routine those products that declare pharmacological action for intra-mammary use but which do not require a veterinary prescription.

Another relevant aspect concerns the route of administration, which must be consistent with the proposed commercial format: if the package indicates “external use” and actually contains an intra-mammary applicator, it is not a product to be trusted as there is risk of incurring reports for unauthorized use of the product.

Veterinary medicines are always accompanied by the package insert, which provides important information on marketing authorization number, active substances, dosage and animal species, withdrawal periods, therapeutic indications, contraindications and negative side effects, and much more.

When read carefully, this element also helps us to discriminate between a veterinary medicinal product and an illegal product.

Be careful also with products containing vegetable substances (plants) presented as having pharmacological properties (antimicrobial, antibacterial, anti-inflammatory, anti-edema, stimulator of the immune response, etc.): as already mentioned¹, these products fall within the old and new VMP legislation, therefore they need a marketing authorisation.

As we have already seen¹, the new Regulation on veterinary medicinal products will be revolutionary.

For this reason, OZOLEA chose, even before the definition of the new EU regulatory framework, to manufacture products that do not contain active substances, without the obligation of a veterinary prescription, legal in the European Union and in the USA.

OZOLEA-MAST is a veterinary device designed precisely to allow the milker to intervene when something is going wrong in the udder, without the need of waiting for signs of a full-blown mastitis, which instead would require the use of antibiotics and veterinary support. OZOLEA-MAST can be used in lactation and at dry-off.

¹ Veterinary medicine product or not? OZOLEA’s innovative approach within the new regulatory framework.

https://www.ozolea.it/veterinary-medicine-product-or-not-ozoleas-innovative-approach-within-the-new-regulatory-framework/

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Veterinary medicine product or not? OZOLEA’s innovative approach within the new regulatory framework

Marketing 6 May 2021 News

Since the very beginning, OZOLEA has always had two clear goals.

The first is finding solutions to help the farmer improve health management at herd level, by addressing udder issues that could lead to milk loss, and those relating to the uterus, which are generally followed by reduced fertility in dairy cows.

The second, as important as the first, is to put the dairy farmer at the forefront of the prudent use of antimicrobials for tackling antimicrobial resistance (AMR).

The starting point was precisely the concept of resistance to active substances. Today we are aware of the fact that it is a problem for human and animal health, food safety and the environment.

In animal husbandry, the sustainable and rational way of using medicines should include the application of biosecurity strategies and a disease management plan, defined along with veterinary advice.

The dairy farmer’s ability and the availability of products such as those proposed by OZOLEA allow to avoid the use of unnecessary antibiotics and other drugs.

OZOLEA has therefore designed products capable of creating an environment, in the udder and uterus, hostile to microorganisms without acting directly against them. They belong to the product category of veterinary devices.

Let’s take a step back to the definition of a veterinary medicinal product as per Reg. (EU) n. 2019/6¹. Knowing it will help us recognize the products available on the market.

Veterinary medicinal product means any substance (of human, animal, vegetable or chemical origin) or combination of substances which fulfils at least one of the following conditions: (a) it is presented as having properties for treating or preventing disease in animals; (b) its purpose is to be used in, or administered to, animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; (c) its purpose is to be used in animals with a view to making a medical diagnosis; (d) its purpose is to be used for euthanasia of animals;

OZOLEA products consist of bioengineered food grade vegetable oils. They do not contain substances capable of carrying out pharmacological, immunological, metabolic actions. They cannot be used for disease treatment or prevention. They do not restore, correct or modify physiological functions. They are not designed to establish a medical diagnosis and, without a doubt, are not suitable for euthanasia.

OZOLEA tested them according to ISO standards, proving that they are non-cytotoxic products.

Furthermore, we have already focused on what antimicrobials² and biocides³ mean. The concept of “direct action on microorganisms” completely excludes OZOLEA products from the markets for these two types of products.

This is why OZOLEA products are veterinary devices, the definition of which is currently derived on the basis of the legislation in force for medical devices for human use.

To date, both in Italy and at EU level, there is no specific legislation that legally defines veterinary devices. However, Italy⁴ and other EU countries recognize this type of products on the market, with or without registration specifications for marketing.

The innovative and clear OZOLEA approach is not to fall into the definitions of veterinary medicinal product, antimicrobial and biocide, with the ultimate goal of fighting AMR.

Therefore, OZOLEA products are and will continue to be legal in the EU, but also in the United States⁵. The effort will have to be towards a harmonized EU standard for veterinary devices.

Insights

¹ Reg. (EU) 2019/6 on veterinary medicines applicable from 28 January 2022: are we ready?

https://www.ozolea.it/reg-eu-20196-on-veterinary-medicines-applicable-from-28-january-2022-are-we-ready/

² Why the enemy is resistance to antimicrobials and not only to antibiotics

https://www.ozolea.it/why-the-enemy-is-resistance-to-antimicrobials-and-not-only-to-antibiotics/

³ The fight against AMR also involves the correct presentation and proper use of biocides

https://www.ozolea.it/the-fight-against-amr-also-involves-the-correct-presentation-and-proper-use-of-biocides/

⁴ The Italian Ministry of Health has given indications about what veterinary devices are: http://www.salute.gov.it/portale/temi/p2_4.jsp?lingua=italiano&tema=Animali&area=veterinari

⁵ The Food & Drug Administration (FDA) clarified the definition of “Animal Medical Device”: https://www.fda.gov/animal-veterinary/products/animal-medical-devices