Applicators, veterinary

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

The Rules Governing Medicinal Products in the European Union, Volume 6 -Notice to Applicants, Veterinary Medicinal Products... 

Use Fungicide and bactericide, textile preservative, some dermatological and cosmetic applications, veterinary medicine. 

European Commission Notice to Applicants, Veterinary Medicinal Products. Presentation and Contents of the Dossier, 2004 (available at http //ec.europa.eu/ health/files/eudralex/vol-6/b/vol6b 04 2004 final en.pdf accessed 12/06/10). 

This section includes veterinary applications. The antiviral, bactericidal, and antimicrobial applications of 2-aminothiazoles and 2-imino-4-thiazolines are summarized in Table VI-7. They show a marked anti-trichonomicidal activity, which has even been quantitatively measured by the Hansch approach (797). The antiparasitic action of these compounds has been investigated for some compounds and is summarized in Table VI-8 interesting results were obtained with aminotrozal (1348). 

Other pharmaceutical applications have been proposed they are grouped in Table VI-11, which includes applications in both human and veterinary medicine. 

Veterinary Applications. Another use for antibiotics is for veterinary appHcations and for animal feed supplements to promote growth in Hvestock (see Feeds and feed additives). Feed antibiotics used in the United States far surpass all other agricultural appHcations in terms of kilogram quantities used and approach quantities used in human medicines (25). In 1980 the USA feed antibiotic usage was estimated to be between five and six million kg. The U.S. Council of Agricultural Science and Technology estimates that feed additives save the U.S. consumer approximately 3500 million per year in meat prices, and antibiotic use accounts for most of this. 

Condensation of 0,0-diethyl chlorothiophosphate with 2-isopropyl-6-methylpyrimidin-4(3//)-one gives the powerful insecticide dimpylate (1045) (57HCA1562). It is used in veterinary medicine (58MI21301), in particular for topical application, with or without added DDT, in cases of blowfly strike in sheep. 

NMR, 4, 575 Erythritol, 1,4-anhydro-structure, 4, 546 Erythromycin antibacterial veterinary use, 1, 206 as pharmaceutical, 1, 153 synthesis, 1, 480 Erythropterin biosynthesis, 3, 321 occurence, 3, 323 structure, 3, 276 synthesis, 3, 289 Erythropterin, 3,5-dimethyl-methyl ester synthesis, 3, 303 Erythrosine application, 3, 879 Esculetin... 

Nucleoside antibiotics biosynthesis, 1, 88-90 Nucleosides oxa analogues, 3, 1085 as pharmaceuticals, 1, 153 protected, 5, 316 Nucleosidin occurrence, 5, 603 Nupharolutine synthesis, 2, 393 Nybomycin applications, 6, 667 Nybomycin, deoxy-applications, 6, 667 Nystatin antifungal agent veterinary use, 1, 211... 

The Veterinary Drug Manufacturing Encyclopedia. The present volume deals only in "people drugs" as did its pradecessor volume but some drugs find application In both areas. 

The authorisation of veterinary medicines containing a new chemical entity for use in food-producing animals involves a two-stage application process (i) an application to establish MRLs and (ii) an application for a marketing authorisation. 

Applications to establish MRLs for new pharmacologically active substances must be submitted to the European Medicines Agency (EMEA) at least 6 months in advance of an application for a marketing authorisation. In order to avoid delays, manufacturers are advised to submit an application once all the necessary data are available, as a product authorisation carmot be granted unless established MRLs are in place. The EMEA should be notified of the intent to submit an application 3 to 4 months in advance of the anticipated date, so that a Rapporteur and Co-Rapporteur can be appointed from among the members of the Committee for Veterinary Medicinal Products (CVMP). 

APPLICATION FOR THE ESTABLISHMENT OF MRL(s) FOR AN ACTIVE SUBSTANCE TO BE USED IN VETERINARY MEDICINAL PRODUCTS IN ACCORDANCE WITH COUNCIL REGULATION (EEC)... 

The substance concerned should be identified in accordance with point A.1. However, where the application relates to one or more veterinary medicinal products, the product itself should be identified in detail. 

Figure 7.6 Outline of the dossier structure for a marketing application for a veterinary product.

Depending on whether it is classified as a drug or a biologic, the applicant must submit either a New Animal Drug Application (NADA) to the FDA CVM or veterinary biologies licence applications to the USDA CVB. 

Health, Environmental, Quarantine and Other Regulations Many countries have strict regulations designed to protect the ecosystem and agrochemical business. For example any matrix material derived from pork, beef, sheep or horse tissue has to be accompanied with a Veterinary Certificate confirming that the matrix material is free of certain specified diseases before it can be imported into the EU. The Australian import restrictions are even tougher and require the importer to obtain prior permission to import plant and animal materials and products derived from biological materials. To get an import license it is necessary to complete an application, which includes information from the producer about the actual production process used to prepare the matrix ... 

S. Porter and N. Johnston, The application of narrow-bore HPLC columns to the analysis of veterinary drugs, in Proceedings of the EuroResidue II Conference, pp. 538-542 (1993). 

In the following discussion, the detection of pesticides and veterinary dmgs in food animals by immunoassay will be described. Discussion will be organized by compound class, the specific analyte, and, finally, the tissues examined. The general principles described in the first part of this review provide the rationale in the applications described in the following pages. 

The use of immunoassays for the determination of pesticides and veterinary medicines in food animals has increased since the early 1990s. The advantages of simple analysis, quick results, and high throughput make immunoassays a powerful technique for problematic matrices commonly encountered in animal agriculture. Careful development and validation are required to obtain accurate results, however. This review has demonstrated that most immunochemical techniques have been designed for use with milk samples, but a number of applications have also been developed for liver and muscle samples. The development of immunoassay techniques for residue analysis in eggs has clearly not been pursued to the extent of other edible tissues. 

Activities include the areas of agriculture (except pesticides), household, food hygiene and other industrial, commercial, medical and veterinary applications. 

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