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Effective and safe veterinary drugs – healthy animals

Veterinary medicinal products are substances presented as having properties to allay, treat, prevent or diagnose diseases in animals. The BVL is responsible for the national and European authorisation of veterinary drugs in Germany. It also monitors the development of resistance to antibiotics and when authorising veterinary drugs, takes into consideration the results of antibiotic resistance monitoring. If undesirable side effects occur from authorised veterinary drugs, the veterinarians and pharmaceutical companies are obliged to notify the BVL of this.

Effective and Safe Veterinary Drugs – Healthy Animals

Veterinary drugs are such substances as are made to treat, prevent or diagnose diseases in animals. The definition of the term Pharmaceuticals thus also encompasses the areas of prevention and diagnosis of diseases in addition to the classical medication-based therapy. The definition is derived from the Medicines Act (Arzneimittelgesetz), which serves as a uniform basis for the proper supply of medicinal products for humans and animals. Particularly the guaranty of the quality, efficacy and safety of veterinary drugs is paramount to this law.

National Licensing of Veterinary Drugs

In Germany, the Federal Office of Consumer Protection and Food Safety (BVL) is the authority responsible for the licensing of veterinary drugs. The BVL assesses the documents furnished by an applicant, which contain evidence of the properties of the new product within the framework of authorising a new animal drug: the information on pharmaceutical quality covers the manufacturing process and the structure (identity, content, purity) of the veterinary pharmaceuticals or the starting substances. The stability thereof is also documented, i.e. the period for which the structure and effectiveness of the product can be guaranteed. Furthermore, specific field of use, recommended dosage and the target animal species must be specified in the documents submitted. Evidence must be furnished of the efficacy and compatibility. The risk of the drug therapy to the animal itself, the user of the product, the consumer of food of animal origin and the environment is described on the basis of specifications on safety.

Authorization at European Level

Major and extensive duties in the authorisation of veterinary drugs are assumed by the BVL on behalf of the European Medicines Agency (EMA). The BVL works with its experts in the Committee for Medicinal Products for Veterinary Use (CVMP) of the EMA and its working groups. The EMA located in London coordinates the assessment and monitoring of medicinal products in the European Union and merges the scientific resources of the 28 EU Member States into a single network with 42 national agencies. If a centralized authorization is sought, the application is processed by the CVMP of the EMA. A member is appointed as Rapporteur within the scope of the centralized procedure, which then prepares an Assessment Report that is reviewed and commented upon by one further member, the Co-rapporteur. Should the CVMP finally issue a positive statement, the European Commission usually issues a license for the product that is valid throughout the EU, after Member States have agreed on the decision in the Standing Committee. The number of decentralized authorization procedures has grown in the past years. The authorisation of a veterinary drug in a Member State of the EU is applied for in this procedure. Should the responsible national authority approve of it, other Member States are obligated to recognize this authorization within 90 days if there are no serious risks which speak against it. The short deadline poses a great challenge to all government agencies in the process. The BVL participates in a working group, in which the competent authorities jointly discuss the proceedings of decentralized procedures.

If a company in the EU aspires to gain the authorisation of a veterinary drug for food-producing animals, the CVMP of the EMA suggests the maximum level of residues for each of the pharmacologically active substances contained in the drug in the food gained from the animal treated. It is verified in this process, on the basis of scientific studies, if and which residue of a substance will occur in the food gained from the animal and which maximum concentration of such residues can be tolerated with regard to consumer safety. These maximum residue levels apply as binding values after their publication by the EU Commission in the European Official Journal.

International Activities

To balance the standards required in the licensing of veterinary drugs´s between the EU, Japan and the USA, the VICH program (International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products) was founded in 1996. Guidelines have already been adopted for the pharmacological-toxicological, pharmaceutical and clinical areas and implemented in the countries involved and in the EU. BVL experts are intensively involved in these activities. The BVL is represented in various working groups at the level of the EU Commission and the Council of the EU, particularly in the area of the General Directorate Internal Market. The BVL also works in the Codex-Alimentarius Committee concerning residues from veterinary drugs in food.

At present this English content is the only available in the field veterinary drugs. More English content will be provided soon. If you have any questions in the meantime, please let us know by using the contact form.

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