A veterinary medicinal product means any substance or combination of substances to be used in, or administered to, animals for the purpose of treating or preventing disease in animals. The term "veterinary medicinal product" also includes substances used in, or administered to, animals to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis, or for euthanasia of animals. This definition originates from Regulation (EU) 2019/6 (Article 4), which lays down rules for the placing on the market, manufacturing, import and export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products as a uniform legal basis throughout the European Union. 

As part of the authorisation process, the BVL assesses clinical efficacy and target animal safety of the veterinary medicinal product concerned based on the documents submitted by the applicant. The term “efficacy” refers to the indication specified by the applicant in the respective target animal species, which must be demonstrated by appropriate data taking into account the proposed dosage and duration of treatment as well as the proposed route of administration. In addition, the term “safety” refers to the safety of the veterinary medicinal product in the respective target animal species.

The requirements for the demonstration of clinical efficacy and target animal safety are legally enshrined in Annex II of the Veterinary Medicinal Products Regulation 2019/6/EU and therefore apply uniformly for European Member States. They are supplemented by European and international scientific guidelines that contain general and specific information on the preclinical and clinical testing of certain substance- or indication groups (e.g. for antibiotics or antiparasitics). This is intended to ensure that pharmaceutical companies carry out studies in accordance with the applicable scientific standard and that these are assessed and recognised by the respective competent national regulatory authorities according to the same standards.

Evidence of efficacy and safety includes pre-clinical documentation on pharmacology, target animal safety, dose determination and -confirmation and, where appropriate, data on resistance as well as the conduct of clinical trials. Clinical trials are controlled studies conducted under field conditions with the aim of investigating the safety and efficacy of a veterinary medicinal product in the target animal species under normal conditions of animal husbandry and/or in the context of normal veterinary practice. They serve primarily to confirm the efficacy and target animal safety of the veterinary medicinal product to be tested for the claimed therapeutic indication at the recommended dosage in a larger target animal population under practical conditions of use. The documentation submitted by the applicant on efficacy and target animal safety must be summarised and evaluated by an expert in a critical expert report in accordance with Annex I of Regulation 2019/6/EU as amended.

For veterinary medicinal products for which a marketing authorisation is sought and which contain an active substance for which an well-established veterinary use in the Union for at least 10 years in accordance with Article 22 of Regulation 2019/6/EU has been proven and for which efficacy is established and target animal safety is acceptable, the necessary evidence of efficacy and target animal safety may be provided by a detailed scientific bibliography together with information adequately demonstrating the link between bibliographical references and the veterinary medicinal product. The bibliographic data submitted may need to be supplemented by product-specific documentation, e.g. user safety assessments and environmental safety studies or residue test data, to justify the proposed withdrawal period(s).

In the case of applications for generic veterinary medicinal products with reference to a reference product for which the period of protection for the technical documentation specified in Articles 39 and 40 of Regulation 2019/6/EU has expired or will expire in less than two years, the above-mentioned requirements for preclinical and clinical evidence may be waived if the generic veterinary medicinal product has the same qualitative and quantitative composition of active substances, the same pharmaceutical form as the reference veterinary medicinal product and bioequivalence with the reference veterinary medicinal product is demonstrated. As a rule, a period of 10 years after authorisation of the reference veterinary medicinal product must be observed before marketing the generic product. This period is extended to 14 years if the reference veterinary medicinal product is a veterinary medicinal product containing an antimicrobial active substance that was not included as an active substance in a veterinary medicinal product authorised in the Union at the time of authorisation. In addition, the period is extended to 14 years for reference veterinary medicinal products authorised for target animal species other than cattle, sheep (for meat production), pigs, chickens, dogs or cats. The period of protection for new veterinary medicinal products intended for the use in the target species bee is 18 years.

In the case of applications for hybrid veterinary medicinal products, the results of suitable preclinical studies or clinical trials are required if not all the characteristics of a generic veterinary medicinal product are fulfilled; for example, if the active substance, strength, pharmaceutical form or route of administration are changed compared to the reference veterinary medicinal product or if bioavailability studies cannot be used to demonstrate bioequivalence.

A marketing authorisation may even be granted for a limited market in the absence of comprehensive data on target animal safety and/or efficacy if the applicant demonstrates, in accordance with Article 23 of Regulation 2019/6/EU, that the veterinary medicinal product is intended for use in a limited market and that the benefit of the availability of the veterinary medicinal product outweighs the risk associated with the absence of required data on target animal safety or efficacy. The marketing authorisation for a limited market is valid for five years. It is then re-examined and re-evaluated by the competent authority.

The evidence of efficacy and target animal safety for the veterinary medicinal product to be authorised results in an overall assessment in the form of a benefit-risk assessment. A marketing authorisation is granted if the benefits outweigh the potential risks associated with use in terms of target animal safety, human health (as users and as consumers of foodstuffs derived from treated animals) and the environment. In addition, the summary of product characteristics and package leaflet contain all the necessary information that contribute to the safe and effective use of the veterinary medicinal product.

Homeopathic veterinary medicinal products (including those for food-producing animals) can be registered using a simplified procedure, provided they fulfil the criteria set out in Article 86 of Regulation 2019/6/EU.

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