Veterinary Medicines Directives

Table 1.1 Comparison of the content headings of the Human and Veterinary Medicines Directives.

Veterinary Medicines Directive 2001/82/EC (96 Articles) Human Medicines Directive 2001 /83/EC (130 Articles)... 

Consolidated Veterinary Medicines Directive 2001/82/EC, Title III Regulation (EC) No. 726/2004, Title III, Chapter 1... 

The authorisation of generic medicinal products is covered by Article 10 of the Human Medicines Directive 2001/83/EC and Article 13 of the Veterinary Medicines Directive 2001/82/EC. A generic drug is defined as a medicinal product that has ... 

European Regulations Veterinary Medicines Directive 2001/82/EC o Title IV Manufacture and imports o Title VII Pharmacovigilance o Title VIII Supervision and sanctions. 

Tetracyclines are produced by various Streptomyces strains and are extensively applied in human and veterinary medicine. They display a broad spectrum of antimicrobial activity in combination with low toxicity and can be applied orally. The most commonly prescribed tetracycline drugs are tetracycline itself and oxytetracycline, an oxygenated derivative, which are directly isolated from fermentation liquors, and doxycycline whose partial synthesis from oxy-... 

Health and Safety Factors. The LD q of anhydrous sodium thiosulfate for mice is 7.5 0.752 g/kg (40). Because of low toxicity, it can be safely used iu veterinary medicine. Sodium thiosulfate pentahydrate is affirmed as a GRAS indirect and direct human food ingredient under the Federal Food, Dmg, and Cosmetic Act (41) (see Food additives). 

EC Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. 

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products... 

According to Article 40 of Directive 2001/83/EG (human medicinal products) and Article 44 of Directive 2001/82/EG (veterinary medicinal products), pharmaceutical... 

Carmen Socaciu was bom in Cluj-Napoca, Romania and earned a BSc in chemistry in 1976, an MSc in 1977, and a PhD in 1986 from the University Babes-Bolyai in Cluj-Napoca, an important academic centre located in the Transylvania region. Dr. Socaciu worked as a researcher in medical and cellular biochemistry for more than 10 years, and became a lecturer in 1990 and full professor in 1998 in the Department of Chemistry and Biochemistry of the University of Agricultural Sciences and Veterinary Medicine (USAMV) in Cluj-Napoca. She extended her academic background in pure chemistry (synthesis and instrumental analysis) to the life sciences (agrifood chemistry and cellular biochemistry). Her fields of competence are directed especially toward natural bioactive phytochemicals (carotenoids, phenolics, flavonoids), looking to advanced methods of extraction and analysis and to their in vitro actions on cellular metabolism, their effects as functional food ingredients, and their impacts on health. 

In addition to plaguing humans directly, flies spread pathogens that infect a significant number of plants and animals. Veterinary medicine must deal with horse flies and black flies, as well as pests with such curious names as warble flies and bot flies. There are ubiquitous stable flies that look like everyday house flies but deliver a painful bite, and a multitude of less familiar species that prey on sheep, rodents, and rabbits. Flies that are crop pests typically feed on their plant hosts as larvae. Seedcorn maggots, for... 

The EU Directive 92/18/EEC [122] introduced for the first time the requirement for an ERA, as a prerequisite to obtain marketing authorization for veterinary pharmaceuticals. For this purpose, the European Agency for the Evaluation of Medicinal Products (EMEA) published a Note for Guidance where guidelines to assess the environmental risk of veterinary medicinal products are established [123]. 

Directive 92/18/EEC (1992) Modifying the annex to council directive 81/852/EEC on the approximation of the laws of member states relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products... 

GnRH is also used (in both human and veterinary medicine) to improve conception rates by enhancing basal hypothalamic-pituitary function. The preparations utilized clinically are manufactured by direct chemical synthesis and are usually administered by s.c. injection or, sometimes, by i.v. injection. Occasionally it has also been administered intranasally. Frequent injection is often required, particularly if administration is via the i.v. route, as the peptide s plasma half-life is of the order of a few minutes (it is hydrolysed in the plasma and excreted in the urine). 

Tylosin is widely and exclusively used in veterinary medicine and is primarily directed against the chronic respiratory disease complex in chickens and infectious sinusitus in turkeys, although it is also effective for bovine respiratory and... 

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