Borderline Veterinary Products: Medicine, Biocide or Cosmetics?
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January 2023 marked a year since the implementation of the new Veterinary Medicine Regulation (EU) 2019/6. Veterinary Medicines Regulation (VMR) EU 2019/6 came into force on 28 January 2022 and replaced Directive 2001/82/EC. Therefore, 2022 gave us good insight into the challenges companies might face when classifying their products in and out of the scope of this regulation.
Veterinary products can fall into the scope of several regulations depending on their composition and intended use, e.g. VMR or PT3 Veterinary Hygiene BPR. For animal cosmetics or care products, there is no specific regulation, other than general chemical regulations at the EU level (i.e. CLP and REACH). Member States can implement their national rules on veterinary medicines, and animal cosmetics (sometimes called animal hygiene) or non-medicinal animal care products (further referred to as animal care products).
As of January 2022, companies in the EU must comply with the new regulatory framework for veterinary medicines. The new regulation intends to harmonise the internal EU market for veterinary medicinal products, ease the administrative burden, increase the availability of veterinary medicinal products and ensure the highest level of safety of these products and lower the risks these products pose on the public, animal health and the environment. One main objective of the regulation is to prevent the overuse of antibiotics to fight antimicrobial resistance.
Several products still fall on the borderline between medicines, biocides and cosmetics due to the presence of antimicrobials in the products. Not only this, the broad definition of veterinary medicines in the new VMR, the strict approach to assessment (by presentation, function and intention) and national regulations make it more complex to determine how rules relate to specific products. In the case of borderline products, the decision on a product's classification must be taken on a case-by-case basis.
The three most important factors appear to dominate borderline cases:
Presence of a low concentration of an active substance with known pharmaceutical effect (listed in European Pharmacopoeia or other Pharmacopoeias, or already used in marketed medicinal products)
The product's intent is presented through claims (to heal, restore, eliminate, disinfect), any other claim directly targeting specific species or pest (to kill, destroy) or indicating change and improvement of animal immunity, metabolism or other functions.
Presence of indicative pictures, advertisements, promotional materials (e.g. leaflets) or packaging that resembles medicines
Active substances often can be used in products of different categories. In general, the presence of substances such as antibiotics, hormones and anaesthetics in products can lead to the classification of the products as medicinal and as such will require the VMR product marketing authorisations.
For veterinary medicines, the final classification depends on concentration, route of administration, efficacy, and other known pharmacological properties. The product's intent is equally as vital to understanding the active substances they incorporate. This intent is assessed via claims, described purpose and nature of the product.
In the case of VMR, even the package’s design can suggest the product is medicinal (e.g. a picture of a capsule, usage of terms such as dosage, similarity with other prescription or over-the-counter drugs) and impact the product classification as VMR. Similarly, routes of administration such as “for use in the eye (e.g. artificial tears)”, or intra-uterine use are considered as medicinal products by the nature of their route of administration and their potential risks.
Animal care products not classified as VMR or Biocides, as already mentioned, are not regulated at the EU level. Nevertheless, each Member State (MS) has the right to impose its national regulations and stricter rules which can still impact the product classification as VMR in a specific country. Classification and requirements can differ for animal care products in each country. Member States have the right to implement National regulation in parallel with the VMR and further impose requirements for animal care products. Further, except for the VMR products registered through a centralised procedure, to place products on the MS market companies must comply with national rules. The initial classification depends, the same as in the EU, on the presence and concentration of active ingredients known to be used in veterinary medicinal products already on the market.
Additional attention is on packaging, presentation and claims. This level of assessment varies from country to country and their interpretation. For example, Germany has no specific instructions on how an active ingredient's nature and intent will influence a classification as VMR or animal care product, but national authorities may assess the role of active ingredients even when in low concentrations. The UK published guidance on marketing non-medicinal products prescribing prohibited and permitted words and phrases to be used on the packaging and additional materials. Ireland published Guidelines on Borderline Veterinary Medicinal Products while finalising national legislation.
For biocidal products, the BPR focus is given to disinfectant or antimicrobial claims focused on the pest, whereas VMR focus is on the product effect on animals (e.g. restoring the physiological function). Notably, the VMR regulation has a prevalence over BPR classification.
It is of essence to look at the whole presentation of the product to determine whether it would be medicinal, biocide or animal care product.
The presence of antimicrobial active substances - even in low concentrations, can result in product classification as VMR. Thus, the crucial aspect in determining whether the product should comply with VMR, BPR (or neither) is the product's principal mode of action as well as having properties for treating or preventing disease in animals or in any other way acting against any harmful organisms other than mere physical or mechanical action.
It is also important to ensure companies understand any additional national law that is enforced in addition to VMR products or on specific animal care products. This can often lead to CA discussions on the classification and requirements for such borderline products.
If you need help defining regulatory requirements for your borderline products and ensuring compliance for marketing across the globe get in touch here. You can also sign up for our Veterinary Borderline Products - Challenges of Regulatory Compliance webinar for an in-depth look at the compliance challenges associated with borderline products. To learn about our other biocide-related services, visit our website.