Reg. (EU) n. 2019/6

Advertising veterinary medicinal products, strengthened principles from 28 January 2022

Marketing 29 July 2021 News

Antimicrobial resistance is a complex and growing health problem worldwide. It has already crossed the borders and its impact goes beyond the severe consequences for human and animal health.

The answer is a One-Health¹ approach to tackle its spread and development. Prudent use of veterinary medicinal products by final users also involves proper communication of the characteristics and usage instructions.

The European Union has already experienced the effects of the lack of sufficient emphasis on the distinction between veterinary medicinal products (VMPs), biocides and feed. This distinction is often misrepresented in advertising.

Advertising of VMPs (including those not subject to veterinary prescription) could have negative consequences for public and animal health, but also distorting competition on the market. Fort these two reasons, the new VMP Regulation will improve and strengthen criteria set out for advertisement.

Let’s have a look at the general principles.

In a Member state, advertisement will be allowed only for products authorised or registered in that Member state. It will be necessary to make clear that the advertising aims at promoting the supply, sale, prescription, distribution or use of the veterinary medicinal product, which should not be presented in such a way as to suggest that it could be a feed or a biocide.

Advertisement will have to be consistent with the summary of the product characteristics and will have not to be misleading or lead to incorrect use of product. On the contrary, it will have to encourage its responsible use by presenting the product objectively and without exaggerating its properties. Distribution of samples for promotional purposes will be restricted and they will be given directly to veterinarians or other persons allowed to supply such veterinary medicinal products during sponsored events or by sales representatives during their visits.

What will happen for antimicrobials, specifically?

As we discussed recently², antimicrobials will be available only by veterinary prescription in all the EU Member states. Only veterinarians and persons permitted to supply veterinary medicinal products in accordance with national law will be allowed to advertise VMP subject to veterinary prescription.

It will not be possible to distribute antimicrobials for promotional purposes as samples or in any other presentation.

One peculiar aspect of the renovated principles for advertisement of VMPs is set out in article 121 (Promotion of medicinal products used in animals). When VMPs in general are promoted to persons qualified to prescribe (veterinarians) or supply them, no gifts, pecuniary advantages or benefit in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of prescription or supply of medicinal products. At the same time, these qualified professionals must not to solicit or accept any prohibited inducement.

These principles will not affect hospitality offered directly or indirectly, at events for purely professional and scientific purposes. Also, they do not impact on existing measures or trade practice in Member States relating to prices, margins and discounts.

What is new with these rules?

The power of advertising to influence final users, thus affecting the prudent use, and the role of bribery and corruption of qualified professionals and suppliers has been recognised as factors able to affect the development of AMR with detrimental consequences. This is an extremely important signal from EU institutions.

¹The One Health approach against antimicrobial resistance.

https://www.ozolea.it/the-one-health-approach-against-antimicrobial-resistance/

² Veterinary prescriptions and antimicrobials: new rules from 28 January 2022.

https://www.ozolea.it/veterinary-prescriptions-and-antimicrobials-new-rules-from-28-january-2022/

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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 prescriptions and antimicrobials: new rules from 28 January 2022

Marketing 24 June 2021 News

The new rules for veterinary medicinal products (VMPs) are strategic restrictions and provisions also against the development of antimicrobial resistance (AMR).

In this fight, one key professional figure is and will be the veterinarian. With the new VMP Regulation¹, they will be further recognized as key qualified figures for an efficient One-Health approach² and also further protected from unfair practices, such as bribery.

The incorrect use of antimicrobials is a risk for public and animal health. Starting 28 January 2022, to prevent this risk, veterinary antimicrobials will only be available on veterinary prescription in all the EU Member states.

This harmonization is essential to ensure an EU profile against the development of AMR: currently, not all the EU Member states require veterinary prescriptions for antimicrobials, however they will with the application of Reg. (EU) n. 2019/6.

Veterinarians will be required to prescribe antimicrobials on the basis of their knowledge of AMR, their epidemiological and clinical knowledge and their understanding of the risk factors for the individual animal or group of animals.

Moreover, veterinarians are called to respect their professional code of conduct. Thus, they must ensure to avoid any conflict of interests when prescribing medicinal products, while recognising their legitimate activity of retail in compliance with national regulatory framework.

To the end of prudent use of antimicrobials, also the supply of VMPs by veterinarians will be restricted to that quantity needed to treat the animals under their care.

As set out by art. 34 of the VMP Regulation, competent authorities, when granting a marketing authorization, shall classify antimicrobial VMPs among the products classified as subject to veterinary prescription. By way of derogation, competent authorities may classify antimicrobials as not subject to veterinary prescriptions if they fulfill criteria set out in art. 34.3.

Prophylaxis and metaphylaxis are two different procedures that will be significantly restricted by the VMP Regulation. For example, we have already discussed³ the impact of the new rules on blanket dry cow therapy and the need of implementing the selective dry cow treatment.

Prophylaxis and metaphylaxis will be possible only by way of exception and only if there is a veterinary prescription (art. 105). The treatment will have to be justified by veterinarians after a clinical examination or any other proper assessment of the health status of the animal or group of animals. This assessment must occur before issuing the prescription.

Other relevant aspects concern quantities of antimicrobials supplied (limited to the amount required for the specific treatment or therapy) and the limited duration of the period of treatment prescribed.

Moreover, the new rules for supplying VMPs will strengthen the traceability system across the EU: we will spend a little time to go deeper into the issue. In Italy, since 2019 the supply of VMPs has been reinforced thanks to the electronic veterinary prescription system.

We already know many of the weapons we should use against AMR. The fact that the EU is making them mandatory is a good sign: it will make the EU harmonized and equivalent in all its member states, both from a health and economic perspective.

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 The One Health approach against antimicrobial resistance.

https://www.ozolea.it/the-one-health-approach-against-antimicrobial-resistance/

³ Blanket dry cow therapy, ban on prophylaxis from January 2022. Any alternative? Selective treatment.

https://www.ozolea.it/blanket-dry-cow-therapy-ban-on-prophylaxis-from-january-2022-any-alternative-selective-treatment/

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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

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VMP Regulation: restrictions on the use in animals of critically important antimicrobials for humans

Marketing 1 April 2021 News

Reg. (EU) n. 2019/6 (VMP Regulation) will be applicable from 28 January 2022 and will deeply change the use of antimicrobials in veterinary medicine. Thus, this is something concerning also the dairy industry.

We discussed the impact on prophylactic treatments in a recent article (read Blanket dry cow therapy, ban on prophylaxis from January 2022. Any alternative? Selective treatment).

Among the key measures, the VMP Regulation forms the basis for restrictions on those products used both in human and veterinary medicines. The aim is preserving the efficacy of antibiotics that are of critical importance for the treatment of infections in humans. Restrictions on these products are needed since antimicrobial resistant bacteria can stem from the use of antimicrobials in food animals and spread to humans through the food chain.

Article 37 of the VMP Regulation establishes the reasons for refusal of marketing authorasitation of veterinary medicinal products (VMPs). In particular, in paragraphs from 3 to 6 are defined the rules for refusal of antimicrobial VMPs when they are reserved for treatment of certain infections in humans. Moreover, the European Commission shall adopt delegated acts to supplement the VMP Regulation “by establishing the criteria for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials”. In doing this, it will consider the scientific advice of relevant Union agencies, namely EMA, EFSA and others.

Let’s step back a little and make an overview on current aspects related to critically important antibiotics (CIAs) for humans. They are the most important antimicrobial products for treating infections in humans. According to the World Health Organisation’s categorisation, CIAs can be Highest Priority (Category 1 – their use in prophylaxis in animals should be avoided) and High Priority (Category 2 – antibiotics that pose a threat to human health if used in animals).

In 2019, the WHO updated the CIA list. With it, WHO developed and implemented criteria to rank antimicrobial products on the basis of their relative importance in human health.

The aim of the list is to help preserve the effectiveness of antimicrobials available to humans today by promoting their prudent use both in human and veterinary medicine. It includes also the Highest Priority CIAs, namely: quinolones, 3rd and higher generation cephalosporins, macrolides and ketolides, glycopeptides, and polymyxins.

Being OZOLEA at the forefront in the fight against AMR in dairy cows, in particular studying and developing tools for supporting the udder tissue functionality, it is worth mentioning the reason why quinolones and cephalosporins, used in dairy cattle to treat clinical and sub-clinical mastitis caused by E. coli, are included in this Category.

Quinolones are one of the few available substances to treat serious Salmonella and E. coli infections in humans. Also, they are known for they ability to select for quinolone-resistant Salmonella and E. coli in animals. Same issue for 3-rd and higher generation cephalosporins: they are one of the few available therapies for serious Salmonella and E. coli infections in human medicine, particularly in children and are known to select for cephalosporin-resistant Salmonella and E. coli in animals. The incidence of human disease due to Salmonella and E. coli is substantially high: thus, they are needed as the last resort for treatment in human medicine.

At the EU level, last year the European Medicines Agency (EMA) updated its scientific advice, prepared by the AMEG (Antimicrobial Advice Ad Hoc Expert Group) on the categorisation of antibiotics. EMA encourages veterinarians to check and consider this update when prescribing antibiotics for animals. It does not replace general guidelines, and other aspects (Summary of Product Characteristics, restrictions around use in food-producing species, regional peculiarities of disease and AMR, national policies, etc.) should also be considered.

This document is in line with the One-Health approach (see OZOLEA’s article “The One Health approach against antimicrobial resistance”). The new classification introduced by the AMEG currently comprises four categories:

A) “Avoid”: it includes antibiotics currently not authorised in veterinary medicine in the EU. They may not be used in food-producing animals and may be used in individual companion animals only by way of exception;

B) “Restrict”: this category rank critically important antibiotics (quinolones, 3rd- and 4th-generation cephalosporins, polymyxins) in human medicine and their use in animals should be restricted to mitigate any risk related in public health;

C) “Caution”: this category refers to those antibiotics which alternatives in human medicine are generally available in the EU, but only few alternatives exist in specific veterinary indications. Their use should be made only when there are no clinically effective antimicrobials in Category D;

D) “Prudence”: it includes antibiotics intended to be used as first line treatments, whenever possible. These products can be used in animals prudently: therefore, users should avoid unnecessary use and long treatment periods, limiting group treatment to situations in which individual therapy is not feasible.

In EMA’s document, the route of administration was also considered to evaluate its impact on selection of AMR.

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The One Health approach against antimicrobial resistance

Marketing 18 March 2021 News

The fight against antimicrobial resistance deserves an urgent and coordinated approach, and many are the reasons why.

Humans coexist with animals in the same environment. The relationship is complex and interdependent. We deal with animals for food production and when they are wild and companion animals. This means that human health and animal health are strictly interconnected.

The environment where they live in also has a role in their relationship. All these connections can be a source for diseases which would impact public health, society and the economy. These diseases, commonly referred as zoonoses are transmissible from animals to humans and vice-versa through direct contact or with food, water, and environment.

This process involves resistant bacteria as well.

The principle that recognizes these interconnections between human and animal health is globally known by the term One Health, and the EU embraced this principle as a tool against antimicrobial resistance.

In June 2017, the European Commission adopted the EU One Health Action Plan against AMR. The aim was to call for effective action against this threat, which must be tackled in human and animal health and the environment. The prudent use of antimicrobials is vital to limit its spread. The action plan is built on 3 main pillars, which address its key objectives:

making the EU a best practice region;
boosting research, development and innovation;
shaping the global agenda.

From the implementation of this Action Plan forward, important updates aiming at strengthening EU’s response to AMR have been made. Among the key updates, it is worth citing the adoption of the Farm to Fork Strategy in May 2020, as we discussed previously (click here). This strategy is supported by the implementation of two new regulations [Reg. (EU) n. 2019/6 on Veterinary Medicinal Products (VMP Regulation) and Reg. (EU) n. 2019/4 on Medicated Feed (MF)], providing for a wide range of measures to tackle AMR and stimulate a more prudent use of antimicrobial products in animals.

At EU level, the AMR One-Health Network is chaired by the European Commission and involves government experts in human health and animal health, Commission experts, and the EU scientific agencies – namely ECDC, EMA, and EFSA. These agencies will provide scientific expertise on infection prevention, biosecurity measures and control practices in human healthcare and in animal husbandry for the reduction of infections and therefore the use of antimicrobials.

A One-Health approach is required to get better evidence, coordination, surveillance and control measures with a continuous and open dialogue between the European Commission, supported by all the experts above, and Member states.

The VMP Regulation is one of the tangible expressions of the efforts currently made by the EU against AMR. Its preamble n. 41 clearly defines the need of a One-Health approach to AMR: it is recognized as a complex issue, it has a cross-border dimension and implies a high economic burden for the society. Moreover, “its impact goes beyond its severe consequences for human and animal health and has become a global public health concern that affects the whole of society and requires urgent and coordinated intersectoral action in accordance with the ‘One Health’ approach.”

With the VMP Regulation, all the actors from the livestock sector are called to be part of this approach by proactively improving best practices throughout the production chain and building reciprocal and synchronized relationships. Let’s start getting ready for its application, there is lot of work to be done!

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

Marketing 4 March 2021 News

Although the world has rightly focused attention on the ongoing Covid-19 pandemic since the end of 2019, we have still one big challenge to face: antimicrobial resistance (AMR). Sadly, the scientific literature is stressing how Covid-9 may worsen the development of AMR. Institutions worldwide have already put on paper strategies to tackle AMR, and some are now clearly defined by specific regulatory frameworks.

In May 2020, the European Commission adopted the Farm to Fork Strategy, which aims to help address the EU’s path towards sustainable food systems. With respect to AMR, the objective of the strategy is to halve overall EU sales of antimicrobials for farmed animals and in aquaculture by 2030. Reg. (EU) n. 2019/6 on Veterinary Medicinal Products (VMP Regulation), repealing Directive 2001/82/EC, is one of the regulatory tools that will support all the players in this process. It will be applicable from 28 January 2022 and one question now arises: are we from the livestock sector ready with effective strategies to comply with these new rules?

The VMP Regulation sets out rules for the sale, manufacture, import, export, supply, distribution, control and use of VMPs. It aims to: modernization of the regulatory framework; boost innovation in veterinary medicines; increase their availability and strengthen the EU’s campaign against AMR. It is one of the laws of a package designed for the improvement of animal and human health which includes other two relevant Regulations for livestock farming [Reg. (EU) n. 2019/4 on medicated feed and Reg. (EU) n. 2019/5 on procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency].

In addition to clearly establishing the definition of veterinary medicinal products, among the key measures, the new law brings innovation into the legal framework since it specifies harmonized labelling requirements, adopts a simpler system for decisions on exceptions and a risk-based approach to pharmacovigilance. Important details are also defined for promoting availability of VMPs by stimulating innovation and competition.

Law harmonization usually makes changes to the way things are currently done, so will Reg. (EU) n. 2019/6: it will reinforce the EU’s strategy against AMR by introducing a ban on the preventive use of antibiotics in groups of animals (prophylaxis) and a ban on the preventive use of antimicrobials via medicated feed. It will bring restrictions on the use of antimicrobials as a control treatment (metaphylaxis) to prevent a further spread of infection, a reinforced ban on the use of antimicrobials for promoting growth and increasing yield in addition to the prohibition established in 2006. Moreover, it will reserve to humans only certain antimicrobials that are critical for them and the collection of data on sale and use of antimicrobials will be mandatory for EU countries. It will also establish several measures for the careful and responsible use of such products and science-based maximum limits for cross-contamination of feed with antimicrobials.

The international dimension of the development of AMR deserves attention: for this reason, for exports into the EU, non-EU countries will have to honor the ban on antimicrobials for promoting growth and increasing yield, as well as the restrictions on such products when specifically reserved for human use in the EU.

By setting such high standards of quality, safety, efficacy for VMPs, this Regulation intends to meet common concerns related to the protection of public and animal health and of the environment.

When it comes to changes such as those that will be introduced by Reg. (EU) n. 2016/9, less than 11 months is a pretty short range of time to get ready with solutions and tools that can contribute to reverse the pattern of the development of AMR. There is no doubt of the importance of joining our forces in a One-Health approach, helping livestock farmers to strengthen their ability to build the road towards the management of biosecurity in animals and farms.

At OZOLEA, we have been working hard for many years to be part of this big challenge and got experience from the field. Now, we are definitely ready to tackle AMR: are we in this together?