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Helen Jukes, of the Veterinary Medicines Directorate, outlines some of the steps pharmaceutical companies must take to gain a marketing authorisation for a new veterinary medicinal product. In particular, she looks at the safety and efficacy data required, and how this relates to the therapeutic indications and warnings that are included in the Summary of Product Characteristics to help ensure safe use
THE European Veterinary Medicinal Products Directive 2001/82/EC (as amended) came into effect in 2001. This is the legislation that sets out the data requirements and procedures to be followed in order for a product to gain the marketing authorisation (MA) that allows it to be placed on the market in the EU. It also outlines the procedures for pharmacovigilance (surveillance after authorisation).
The data required to support an application for a MA are submitted to the regulator for assessment in the product's dossier. In summary, these data relate to:
■ The product's manufacture and pharmaceutical quality;
■ Its safety for the animal to be treated (the target species), the person administering the product, consumers of produce from treated animals, and the environment;
■ Its efficacy in the target species.
This article discusses the data required to support a MA for a product containing a novel drug substance. The requirements for MAs for generic products are more limited and usually rely on demonstration of bioequivalence to a product that is already authorised.
The preclinical part of a product's dossier contains studies that have been conducted in experimental animals, usually of the same species as that in which the product is intended for use. These include pharmacodynamic, pharmacokinetic and dose-finding studies, which provide information about the pharmacology of the drug and help to optimise the dose rate and dosing regimen. In addition, the safety of the substance in the target …