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Environmental Assessment of Veterinary Medicinal Products in Denmark 10. Appendix B - Danish legislationThe following laws and regulations regulates the therapeutic and non-therapeutic application of veterinary medical substances in Denmark 1) The medicinal law, "Lægemiddelloven"1, regulates all aspects concerning the application of medicine including veterinary medicine and medicinal feed additives. This includes the V-marked substances such as antiparacetic agents, e.g. ivermectin, iron and vitamins used in livestock production and that can be purchased without a prescription or requisition. The consumption of V-marked substances are not quantified in any official register. Antiparacetic agents also differs from other veterinary medicines in the way that they may be sold from other sources than from pharmacies even though they are registered as a medical substance. Veterinary vaccines are primarily sold as indicated in "lægemiddelloven" through the Danish Veterinary Laboratory. The import of feed administered drugs2 applicable to animals and fish are regulated by the Danish Medicines Agency. Information concerning the production and sales of medicinal substances on single product level may be purchased by the Ministry of Health from companies or trade organisations, if necessary. 2)"Bekendtgørelsen om foderlægemidler til dyr"3, regulates the import, export, production, control and sale of feed administered drugs for livestock. The term medical feed additive is applied to all mixtures of medicinal compounds (pre-mixtures) with one or more feed ingredients. The product is pre-mixtured before sale with the intention to either have actual treatment of diseases (therapeutic use) or help in precautions treatment (non-therapeutic use). Feed administered drugs may only be prepared with registered medicinal compounds. These preparations of medical substances used in feed named "premix" may be sold under the supervision of the Danish Medicines Agency by both specially authorised feed companies and pharmacies. Data have to be collected, on a daily basis, by the company producing feed administered drugs, on the amount sold of active substance, the name and address of the livestock owner and the prescribing veterinarian. The Danish Plant Directorate issues a list of the applied amounts of feed administred drugs to livestock on a yearly basis. Only companies registered by the Danish Medicines Agency may produce medicinal feed additives. The permission is given in co-operation with the Danish Plant Directorate. These companies are mutually supervised by the Danish Medicines Agency and Danish Plant Directorate. 3) "Bekendtgørelsen om foderlægemidler til fisk"4, regulates the use of feed administred drugs to fish. This regulation is similar as the one for animals2 on main issues and is Also issued annually by the Danish Plant Directorate. 4) "Bekendgørelse om tilsætningsstoffer"5 regulates the preparation, sales and application of feed additives used non-therapeutic such as antibiotics, cocciostatics and growth promoters. For each single feed additives including medicinal products the Danish Medicines Agency issues detailed regulations, for individual types of livestock, regarding withdrawal times, maximum applicable quantities for certain livestocks and maximum concentration of drug in the feed. Also here the Danish Plant Directorate supervises that issued regulations are kept and inspects from time to time the companies that are licensed allowed to prepare feed additives. 5) "Apotekerloven"6, is the law regulating pharmacies. This law regulates all sales of medical products and determents all practise in pharmacies. The Danish Medicines Agency guides and controls the pharmacies. The Ministry of Health may decide, if it is considered necessary, that companies and trade organisations provides the ministry with information concerning the production and sales of single medicinal products. For all veterinary medicinal products sold on prescription through pharmacies information on the veterinarians name, address, medicinal formulation, amount prescribed and date of issue is kept by the pharmacy. These informations may be coded for eventual registration. The amount of veterinary medical substances sold without prescription (H or V marked) are also registered by the pharmacies but less detailed. 6) "Husdyrsygdomsloven"7 , is the law regulating treatment of diseases in livestock. The law primarily ensure that diseases do not spread due to unexpected side effects due to the use of veterinary medicine. For certain veterinary medical products, e.g. vaccines, immunological products and antibiotics certain withdrawal times may be introduced before for example slaughtering or milk production. In fish farms withdrawal times are also introduced after antibiotic application. The Danish Medicines Agency regulates these withdrawal times for a substance in concern in connection with the registration of the compound. The Danish Veterinary and Food Administration inform all veterinarians on withdrawal times for new substances. 7) Dyrelægeloven8, is the law concerned with veterinarian praxis. The law guides the veterinarian with the application, prescription and handling of veterinary drugs. A veterinarian may only prescribe and hand over veterinary medicinal product in connection with personal treatment of the livestock. Hormones9 and hormone mimicking substances may not be used in livestock production with the purpose of growth promotion. Sulfadimidin may not be used for pigs. Treatment of livestock with antibiotics is specially regulated. Antibiotics may only be used as therapeutics to livestock when an infection is diagnosed.
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