Assessment of applications for marketing authorisation

Prior to authorisation, the BVL evaluates the quality, efficacy and safety of a new veterinary medicinal product. For this purpose, the BVL assesses the documents submitted by the applicant describing the properties of the new product: The information on pharmaceutical quality covers the pharmaceutical development, production and control (analytical testing) of a veterinary medicinal product or its starting materials (active substances, excipients, packaging materials). Stability is also evaluated and a shelf life is specified. Assessment of efficacy is based on submitted documents that justify a recommended dose and duration of treatment for an indication in the respective target animal species. Based on the information concerning safety, target animal safety as well as possible risks for users of the veterinary medicinal product, for consumers of food of animal origin and for the environment is described. The documents submitted form the basis for the benefit-risk assessment by the BVL. The veterinary medicinal product is only authorised if the assessment is positive.

Efficacy and target animal safety

Efficacy and target animal safety need to be demonstrated for each veterinary medicinal product. For the intended target species, the indication is examined using the recommended treatment dose and -duration. Possible risks, e.g. adverse events, as well as precautions for safe and effective use shall be indicated in the product literature (Summary of Product Characteristics and Package Leaflet). For each target species, the expected benefit of the veterinary medicinal product is weighed against its risks. If the risk-benefit balance of the product is positive, a marketing authorisation can be granted.

Information on efficacy and target animal safety can be found here.

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Pharmaceutical quality

According to §8 of the Medicinal Products Act (AMG), medicinal products and active ingredients of inadequate quality may neither be manufactured nor placed on the market. The assurance of a consistent and good pharmaceutical quality of veterinary medicinal products is to be guaranteed on the one hand by the manufacturer and on the other hand by the licensing and supervisory authorities. Thus, within the framework of the authorisation procedure, we check whether the documents submitted by the pharmaceutical entrepreneur on the veterinary medicinal product comply with the national and European quality requirements. The documents are checked in accordance with the requirements of the Veterinary Medicinal Products Control Directive Regulation on the basis of the corresponding EU Directive (Directive 2001/82/EC in the current version).

You can find more information on pharmaceutical quality here.

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User safety

As part of the marketing authorisation procedure, the health risk to users from exposure to a veterinary medicinal product is assessed in order to establish warnings for the application of the veterinary medicinal product, which are included in the summary of product characteristics and package leaflet.

For more information on user risk assessment, click here.

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Environmental safety (ecotoxicology)

Veterinary medicinal products can have specific effects on organisms and harmful effects on the environment even in low concentrations. The environmental risk assessment is carried out in cooperation with the German Environment Agency (UBA).

Further information on environmental risk assessment can be found here.

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Setting of withdrawal periods

The use of veterinary medicinal products in animals kept for the production of meat, milk, eggs or honey may result in residues of pharmacologically active substances or their metabolites in these foodstuffs. Consumption of food containing these residues must not pose a risk to the health of consumers. Therefore, withdrawal periods are set for veterinary medicinal products which must be observed after the last administration of a medicinal product to an animal until the time when food is obtained from that animal.

You can find more information on setting withdrawal periods here.

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