Veterinary products Subject

Any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state (adapted from GMP. ... 

For an assessment of environmental indicators, the biological or health-related aspects of animal welfare will be taken into consideration. Most indicators of animal welfare reflect relatively specific problems, measuring different components of welfare rather than welfare per se. Some of the parameters that may serve to describe the indicator animal welfare are immune problems, occurrence of disease, reduced productivity, mortality, physiological stress and behavioural deprivation. These parameters are influenced by animal husbandry issues such as housing conditions, breeding goals, and health measures, i.e. veterinary medicine. These factors are the subject of the following sections. 

Imports of biological products into the USA are restricted by the requirement to have the manufacturing facilities licenced and inspected by US inspectors or by local inspectors, if these are recognized by the USA. Furthermore, biological products are subject to a permit for each individual shipment, quarantine for the product and tests by the authorities before release. Veterinary biological product licences will not be issued for products from countries "...known to have exotic diseases, including but not limited to, foot and mouth disease, rinderpest, fowl pest (fowl plague), swine vesicular disease, Newcastle disease, and African swine fewer (9 CFR 104.2). 

In this chapter the subject of scale-up is reviewed, which is taking small laboratory cultures (e.g. 10 ml) to industrial-scale processes (e.g. 10 000 litre), i.e. a 1 000 000-fold scale-up The aim of such scale-up is to provide more cells, and more cell product, in as efficient and cost-effective a manner as possible. Cell cultures have been used since 1954 for the production of human (e.g. polio, measles, mumps, rabies, rubella) and then veterinary (e.g. FMDV) vaccines (Griffiths, 1990a). Interferon was the next most important product to be developed, followed by monoclonal antibodies and a range of recombinant proteins. 

The use of "herbal preparations" in the treatment of some human parasitic infections has been described in traditional systems of medicine like Ayurveda, Traditional Chinese Medicine and Unani, practiced since immemorial times. The drugs used in traditional systems thus provide useful leads for development of modem drugs. Consequently a variety of medicinal plants have been subjected to detailed chemical and biological investigations culminating in the discovery of novel anthelmintic natural products of medicinal and veterinary importance [1]. 

There are various reasons for the wide scattering of dairy articles. Principally, while the subject matter may be dealing with dairy products, the topic may have its greatest interest to workers in other fields, such as nutrition, pediatrics, geriatrics, biochemistry, or veterinary medicine. Also in smaller countries the population may be insufficient to support a scientific journal devoted to dairying, and hence articles of dairy interest will appear in journals of general agriculture or science. 

The Committee for Human Medicinal Products (CHMP), Committee for Veterinary Medicinal Products (CVMP) and Committee for Orphan Medicinal Products (COMP) are the major committees run by this agency to ensure the above objectives. Additional support comes from more than 90 Working Parties (e.g., on efficacy, safety, quality, biotechnology, pharmacovigilance, blood and plasma, etc.) as well as ad-hoc Expert Groups (on subjects like pediatric use, bioterrorism, oncology, anti-HIV drugs, etc.) and also approximately 2500 European experts from competent national authorities. 

In derogation from point 3.6, ectoparasiticides for external application to animals, which are veterinary medicinal products, and subject to marketing authorization, may be produced and filled on a campaign basis in pesticide specific areas. However, other categories of veterinary medicinal products should not be produced in such areas. 

NOTE This annex applies to all veterinary medicinal products falling within the scope of Directive 81/851/EEC other than immunological veterinary medicinal products, which are the subject of a separate annex... 

Veterinary medicinal products shall at least once a year be subjected to a detailed review, by which the records of preparations received and supplied shall be compared to the stocks held, and a report shall be drawn up of any discrepancies. This documentation shall be kept available to the National Board of Health for a period of 6 years. 

Pharmaceutical Product Any substance or mixture of substances, the manufacture of which is for use as a medication in a pharmaceutical form for human or veterinary use, and which is subject to health legislation. 

Article 14(7) of Regulation (EC) No. 470/2009 [49] states where it appears necessary for the protection of human health, the classificadmi shall include conditions and restrictions for the use or application of a pharmacologically active substance used in veterinary medicinal products which is subject to a MRL, or for which no MRL has been set (e.g., not for use in animals from which milk or eggs are produced for human consumption). 

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