Veterinary public health in the Federal Republic of Germany.
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The measures of execution as laid down in section 16 a of the animal protection law (TierSchG) are of great importance in the daily work of the state offices for veterinary affairs to put an end to conditions of animal treatment offending against the law. Compared to the other available legal means 1. the administrative offences (fines) and 2. the penal law (fines or imprisonment) they offer the advantage that the guilt of the animal holder (intent or negligence) need not be proved. A thorough documentation of the controls made at the respective controlled place which offers evidence even in a trial is the main condition for carrying through effective measures of execution. To issue an administrative order requires in particular 1. to observe the principle of precision, 2. to fulfill the obligation to exercise discretion and 3. to provide well-founded reasons to support the decision of immediate execution. To be successful in court, certain basic requirements must also be fulfilled when a fine is imposed or a complaint is made by the state offices of veterinary affairs.
For the veterinarian, drug sale is generally permitted by his licence of drug dispensing. According to the law on animal feed, feedstuffs are not regarded as drugs and thus they are not licensed to be sold by veterinarians. Drugs, however, may only be released for the treatment of individual animals, which are previously examined by the vet. The sale of animal feed is not regarded as part of veterinary practice. Only in case of a registered additional business, a veterinarian is allowed to sale feedstuffs. Dietetic animal feedstuffs are also regulated by the Animal Feed Act. Dietetic drugs, however, are regulated by the Drug Act and are strongly to be delineated from dietetic feed. Thus, the term "dietetic" alone does not automatically give any legitimatization for a sale of feedstuffs in veterinary practice.
A number of features of the Veterinary Medicinal Products Act, which are of importance to veterinarians, are reviewed. These features result in a number of consequences connected with obtaining and handling veterinary drugs. These consequences are discussed.
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Pharmacovigilance is a growing discipline and nowhere is this more true than in the context of the legislative requirements for veterinary pharmacovigilance within the European Union (EU), or more specifically, within the European Economic Area. Since 1995, the legislation governing the authorization of veterinary medicinal products in the EU has resulted in the older national procedures being replaced by the mutual recognition procedure and the centralized procedure. Also since 1995, the regulatory requirements for pharmacovigilance have developed and grown, as have the associated guidelines. The recent review of European veterinary medicines legislation, which concluded with the publication of an amending directive and a new regulation in March 2004, has introduced refinements to the pharmacovigilance system. This paper examines the EU legislation governing the authorization of veterinary medicinal products, including the elaboration of maximum residue limits, and the way in which this relates to the requirements of pharmacovigilance.