Notice Of The Application To Veterinary Surgeons, Dispensing And Prescribing Of Medicines For Animals

Original Language Title: Bekendtgørelse om dyrlægers anvendelse, udlevering og ordinering af lægemidler til dyr

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Read the untranslated law here: https://www.retsinformation.dk/Forms/R0710.aspx?id=132613

Overview (table of contents) Chapter 1 scope and definitions Chapter 2 Authorised medicinal products for animals Chapter 3 prohibition and restriction of use of certain hormones, etc.
Chapter 4 drugs for veterinary use reserved animals Chapter 5 Submission of medicines for animals Chapter 6 Apply, dispensing and prescribing prescription drugs Chapter 7 Use, dispensing and prescribing of antiparasitic drugs Chapter 8 Chapter 9 Genordinering preventive treatment of prescription drugs Chapter 10 Treatment of horses with medicines for which there is no established an MRL withdrawal periods Chapter 11 Chapter 12 Veterinarian records , manual and reporting to Vetstat Chapter 13 Veterinary purchasing, storage, use, supply and prescription of prescription medicines to animals Chapter 14 criminal and effective provisions Annex 1 Annex 2 Annex 3 The full text of the notice of application to veterinary surgeons, dispensing and prescribing of medicines to dyr1) under section 11, paragraph 1, 3 and 4, § 12, paragraphs 3 and 4, article 13, paragraph 2 , section 14, paragraphs 4 and 5, § 15, § 17, section 35 and section 38, paragraph 4, of law No. 433 of 9. June 2004 about veterinarians, as amended by Act No. 401 of 21. April 2010, and section 9, paragraph 3, and section 72, paragraph 2, of the law on pharmacy business (pharmacy Act), see. lovbekendtgørelse nr. 855 of 4. August 2008, and partly under the authority of the Minister of food, agriculture and fisheries, fixed: Chapter 1 scope and definitions article 1. The Decree deals with the veterinary surgeon procurement, storage, use, supply and prescription of drugs for animals. The Ordinance also provides for authorised medicinal products for animals, non-authorised substances and prohibition and restriction of use of certain hormones, etc.
§ 2. In this notice, the term: (1)) ' Herd ' means A single or a collection of food-producing animals or fur-bearing animals of the same species that is used for a particular purpose, which are linked to a specific geographical location, and which has an owner in the form of a legal or physical person. In addition, the means or the herd flocks of the same species, that are registered on a CHR-number.
2) ' Animals ' means animals in human care.
3) ' owner ' means any Animal which has animals in his or her possession.
4) ' food-producing animals ": bovine animals, swine, sheep, goats, animals of the horse genus (hereinafter referred to as horses), except for horses, which is excluded from human consumption, without prejudice. § 32, farmed cervids and feathered, ratites, rabbits, poultry, including pigeons, aquaculture animals, honey bees and other animals whose flesh or products are intended for human consumption.
5) ' Fur ': Foxes bred in accordance with Ordinance on breeding of foxes and mink, raccoon dog, ferret (ferret), nutria, chinchilla and other animals that may be reared agriculturally in order to take advantage of the coat.
6)» production animals ': Food-producing animals and fur animals.
7) ' young bovine animals ': under 1 year Male as well as female, which has not yet Calved.
8)» adult bovine animals ': male over 1 year, and female animals that have Calved.
9)» GLP ': Good farming practice, see. notices of health consultancy contracts for the pig and cattle herds.
10) ' medicinal product to animals ' shall mean a product which is presented as an appropriate means for the treatment or prevention of animal disease, or which may be used in or administered to animals, either to restoring, or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
11)» medicines on compassionate use permit ' shall mean a medicinal product subject to authorization by the Danish Medicines Agency in accordance with the law on medicinal products can be used for animals and people.
12)» Magistrally drug ' means any drug that in accordance with the law on medicines prepared in a pharmacy in accordance with a prescription from a veterinarian.
13) ' antibiotics ': Antibiotics-and kemoterapeutikaholdige drugs.
14) ' homeopathic medicinal product ' shall mean a medicinal product prepared from substances (homeopathic stocks) in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia that has official status in an EU/EEA country. A homeopathic medicinal product may contain several active constituents.
15) ' unauthorized substances ' means substances the administering to animals is prohibited in accordance with the applicable rules.
16) ' maximum residue limit (MRL) concentration ' means the maximum residue of a pharmacologically active substance (expressed as mg/kg or µ g/kg wet weight), which may be permitted in food of animal origin referred to in article 6. Article 1, paragraph 1, point (a), of the European Parliament and Council Regulation (EC) No 1782/2003. 470/2009 of 6. May 2009 on Community procedures for the establishment of maximum levels for residues of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90. 2377/90 and amending European Parliament and Council Directive 2001/82/EC and European Parliament and Council Regulation (EC) No 1782/2003. 726/2004.
17)» Prescription period ' shall mean the number of days during which the veterinarian may prescribe medication.
18) ' treatment ' means the exact number of days within the prescription period, which the animals must be treated for the diagnosed disease.
19) ' Crew ' diagnosis: the diagnosis of a disease, which appear regularly in the crew, and which is characterized by the by the veterinarian specifically described symptoms.
20) ' microchip ': a transponder, as defined in article 2, paragraph 2, point (b) of Commission Regulation No 2454/93. 504/2008 of 6. June 2008 implementing Council Directive 90/426/EEC and 90/427/EEC as regards methods for the identification of equidae.
21)» Statutory vaccination ' means Vaccination, which is imposed by the veterinary and Food Administration in accordance with law.
22) ' treatment ' means Treatment of Gold which have very good laboratories diagnosed a bacterial infection by lodging of antibiotics in the udder in connection with the cessation of milking.
23) ' therapeutic treatment ' shall mean an individual filing for food-producing animals of a medicinal product containing: a) Beta-agonists to horses to treat respiratory problems, hovsenebensbetændelse or laminitis, or to the development of vesvækkelse (tocolyse).
(b)) Allyltrenbolon (altrenogest) for heat management of the competition-or circus horses.
c) Progesterone as well as the derivatives by hydrolysis readily forming the original connection after absorption from the Administration site, for the treatment of disorders of the ovarian function.
24) ' zootechnical treatment ' shall mean the submission of a medicinal product to the animals with: a) Estrogen or progestogen effect for the purpose of synchronizing oestrus and treatment of donor and recipient in connection with embryo transfer in food-producing animals.
(b)) for the purposes of gender conversion androgenic effect of aquaculture animals in a group of breeders.
25) ' illegal treatment ' shall mean the use of unauthorized substances, as well as the use of drugs for purposes or under conditions other than those laid down in accordance with the applicable rules.
Chapter 2 section 3 Authorised medicinal products for animals. For the treatment of animals to be used drugs that have marketing authorisation for animals from the Danish Medicines Agency or community marketing authorisation to have animals in The European Union in accordance with the rules laid down to that effect by the Council of the European Union.
§ 4. There is not a drug, which is approved for marketing, in accordance with article 3. § 3, by way of exception, the veterinarian can under his direct personal responsibility, in particular to avoid causing unacceptable suffering to the animals concerned, use, dispense or prescribe the following medicinal products for the treatment of a condition: 1) a medicinal product has a marketing authorisation from the Danish Medicines Agency or community marketing authorisation for another species or the same species against another State, or, if such a medicinal product does not exist, 2) a medicinal product , which has a marketing authorisation from the Danish Medicines Agency or community marketing authorisation for use to humans, or a drug on a compassionate use permit from the Danish Medicines Agency, or, if such a medicinal product is not available, 3) a magistrally drug, as is set out in annex 2, to the species and indications, which are listed in the annex.
(2). Food agency may, on application, grant a derogation from the requirement referred to in paragraph 1, no. 3, so that other drugs than those covered by Annex 2 listed can be used, if this is necessary, taking into account animal health.
§ 5. For the treatment of food-producing animals, it is also a condition for the application of the rule in paragraph 4 that the drug's pharmacological active substances are listed in table 1 of the annex to Commission Regulation (EU) No. 37/2010 of 22. December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in food of animal origin, and that the veterinarian establishes an appropriate withdrawal period referred to in article 6. § 34.
§ 6. Homeopathic medicines for animals, regardless of section 4 is used for the treatment of animals other than food-producing animals under the veterinarian's responsibility.

§ 7. Homeopathic medicinal products intended for food-producing animals, and if active substances are listed in table 1 of the annex to Commission Regulation (EU) No. 37/2010 of 22. December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in food of animal origin, regardless of section 4 is used for the treatment of food-producing animals under the veterinarian's responsibility.
§ 8. Vaccine, which does not have a marketing authorisation from the Danish Medicines Agency or community marketing authorisation, regardless of section 3 apply to compulsory vaccination.
Chapter 3 prohibition and restriction of use of certain hormones, etc.
§ 9. Application of the annex 3 mentioned drugs or substances for food-producing animals is prohibited.
§ 10. Use of medicinal products or substances with androgenic, gestagenic or estrogen effect and of beta-agonists for production animals is forbidden, see. However, sections 13-16.
§ 11. Use of medicinal products or substances with hormonal or hormone-like effect for production animals for growth promotion or performance purposes is prohibited.
Therapeutic and zootechnical treatment section 12. Therapeutic and zootechnical treatment, see. § 2, nr. 23 and 24, shall not be carried out on animals, including breeding animals at, see. However, sections 13-16.
§ 13. Therapeutic treatment, as mentioned in section 2, no. 23 (a) and (c), is permitted on the condition that: 1) the treatment shall be carried out by the vet personally, see. However, paragraph (2), 2) reading, see. § 2, nr. 23, point (c) only happens in the form of injection or vaginal spiral on uniquely identified food-producing animals, 3) for reading only used drugs that meet the conditions set out in section 3, or section 4, paragraph 1, no. 1 or 2, and which have a withdrawal period not exceeding 15 days, for beta-agonists, however not more than 28 days, and 4) the veterinarian shall make records in accordance with section 35, paragraph 1.
(2). For after treatment of a horse that is treated in accordance with paragraph 1 with beta-agonists for respiratory problems, hovesenebensbetændelse or laminitis, veterinarian can provide or prescribe prescription medicines containing beta-agonists on the condition that: 1) the treatment shall be carried out under the veterinarian's responsibility, 2) the forms provided or prescribed prescription medicines complies with the conditions laid down in section 3, or section 4, paragraph 1, no. 1 or 2, is for submission through the mouth, and have a withdrawal period not exceeding 28 days, 3) the veterinarian shall make records in accordance with section 35, paragraph 1 and 4) the veterinarian shall indicate the date of initiation and termination of treatment.
§ 14. Therapeutic treatment is allowed, on condition that: 1) the medicinal product shall be submitted orally by the veterinarian or under his responsibility, 2) the treatment shall be carried out only on animals, which is uniquely identified, 3) for reading only used drugs that meet the conditions set out in section 3, or section 4, paragraph 1, no. 1 or 2, and which have a withdrawal period not exceeding 15 days, and 4) the veterinarian shall make records in accordance with section 35, paragraph 1.
§ 15. Zootechnical treatment is allowed, on condition that: 1) the treatment shall be carried out by the veterinarian or under his responsibility, 2) treatment shall be carried out on the breeding animals that do not show signs of reproductive disorders, and which is clearly identified, 3) for reading only used drugs that meet the conditions set out in section 3, or section 4, paragraph 1, no. 1 or 2, and which are not implants or tablets for implantation, and which have a withdrawal period not exceeding 15 days, and 4) the veterinarian shall make records in accordance with section 35, paragraph 1.
§ 16. The veterinarian may prescribe prescription drugs with androgenic effect for the treatment of juveniles of aquaculture animals for the purpose of gender conversion, see. § 2, nr. 24, point (b), provided that: 1) the treatment shall be carried out under the veterinarian's responsibility, 2) treatment shall be carried out on juveniles of farmed fish in under 3 months, 3) who only used drugs to the treatment which meets the requirements of § § 3-4, and as is prescribed by a medical prescription for single release, and which are not implants or tablets for implantation, 4) the person in charge of the crew instructed in writing about that hormone-treated animals must not be used for human consumption, 5) the veterinarian immediately after treatment in writing inform the food region, under which fish farming belongs, of the names and addresses of fish farming, the name and quantity of used medicines, as well as time for initiation and completion of the treatment, and 6) the veterinarian shall make records in accordance with section 35, paragraph 1.
Chapter 4 drugs for veterinary use § 17 reserved animals. Treatment of animals with prescription medicines with the following contents shall only be carried out by the vet personally, and the veterinarian shall not disclose or prescribe medicines: 1) drugs with analgesic effect for injection, however, with the exception of non-steroidal anti-inflammatory drugs, anesthetics for inhalation or injection) 2, 3) opioids, opiates, barbiturates, benzodiazepines and psychosis dativa, 4) selenholdige drugs for injection, 5) parasympathomimetics to injection and parasympatolytika for injection , 6) sympathomimetics for injection and sympatolytika for injection, 7) the following hormones and compounds with hormone-like effect for injection: a) adrenocorticotrope hormones, b) natural and synthetic adrenocortical steroids, c) oxytocin and oxytocinanaloger, d) prostaglandins and prostaglandin derivatives, as well as 8) drugs that solely approved for intravenous administration, see. However, section 19, paragraph 2.
(2). However, the veterinarian may, notwithstanding paragraph 1, no. 3, extradite or prescribe opioids, opiates, barbiturates, benzodiazepines and psychosis dativa to administration by mouth for the treatment of animals other than food-producing animals. For the treatment of horses, which are excluded from use for human consumption, must vet only extradite or prescribe in paragraph 1, no. 3, mentioned drugs for use in up to 4 weeks for rehabilitation after serious illness.
(3). However, the veterinarian may, notwithstanding paragraph 1, no. (c) extradite or prescribe oxytocin and oxytocinanaloger to other vestimulation for use in disease treatment than 1) swine herds without health advisory agreement or with a basic agreement to after treatment for up to 5 days on the condition that the veterinarian has initiated the examination of each animal, 2) swine herds with health advisory agreement with opt-in module for up to 35 days for crews in the category however, GLP in until 42 days , 3) cattle herds with health advisory agreement with opt-in module 1 for up to 35 days for crews in the category however, GLP in until 42 days, as well as in 4) bovine herds with health advisory agreement with opt-in module 2 in up to 35 days.
(4). In the cases referred to in paragraph 3, no. 2-4, however, the only veterinarian must supply medicinal products to the first 5 days.
(5). Food agency may request, in exceptional cases, grant derogations from paragraph 1.
Chapter 5 Submission of medicines for animals § 18. Subcutaneous and intramuscular injections should be performed as close at pigs behind the ears as possible, on sheep and goats in the middle of the neck, on cattle in the middle of the throat or immediately in front of the shoulder, and on horses in the middle of the throat or bringen. On pigs can vaccination using special equipment, which do not involve the use of needle, also be carried out at the base of the tail. Subcutaneous injection of iron and vitamin preparations can be made in the groin fold on piglets.
(2). Submission of medicines with local anesthetic, local analgesic or other local power for injection, are exempt from the provisions of paragraph 1.
§ 19. Injection in veins, in the abdominal cavity, in part, in seneskeder and in spinal cord/spinal channel and the placing of medicines in the womb shall only be carried out by the veterinarian, see. However, paragraphs 2 to 4.
(2). The veterinarian may for crew responsible, which has signed an agreement on health advice in herds with opt-in module 2, and which has received approval from the Food Agency to treat cows sufferer of calving fever, extradite or prescribe drugs without given contents of magnesium, which is approved for intravenous administration, if there is a crew of calving fever diagnosis.
(3). The veterinarian may for crew responsible, which has signed an agreement on health advice in herds with opt-in module 2, and which have undergone one of the Food Agency approved course in ejerinseminering of cattle, see. the rules in force at any time on bovine semen and artificial insemination of animals of the bovine species, or an equivalent of Food Agency approved course, dispense or prescribe uteritorier, if there is a crew diagnosis for børbetændelse.
(4). The veterinarian may for crew responsible with herds of aquaculture animals provide or prescribe the vaccine for injection into the abdominal cavities of the fish.
§ 20. Veterinarians can hold responsible for crew training in use of the medicinal products for production animals.
(2). Course schedule and content must be approved by the food the region.
(3). Course provider shall, not later than 3 weeks before the course the Organization inform the food region of course location and time with reference to the approved course, see. (2).
Chapter 6 Apply, dispensing and prescribing prescription drugs § 21. Treatment of animals with antibiotics may only take place if the treatment is directed towards concrete, diagnosed infections and have a healing aid.

(2). Notwithstanding the provisions of paragraph 1 is antibiotic therapy allowed in connection to the mutilations, which involves a special risk of infection.
§ 22. Treatment of production animals pursuant to § § 23-25 assumes that the animals are clinically ill or deemed to be in a well-defined disease incubation phase.
§ 23. In herds which are not covered by an agreement on health advice, and in cattle-and pig herds with basic agreement on health advice, veterinarian must extradite or prescribe prescription medicines for use in up to 5 days to the crew officer's treatment of a disease, as a veterinarian in connection to the visit to the crew themselves have diagnosed with following animals: 1) the items, with the exception of adult bovine animals, provided that the vet even has initiated the examination of each animal.
2) a group of lambs and kids of a) under 1 year and young cattle, b), c) pigs, deer d) poultry and feathered game, e) fur animals or f) aquaculture animals.
(2). For the treatment of fur animals must vet notwithstanding paragraph 1, no. 2 (e), prescribe prescription medicines for up to 35 days.
(3). For the processing of aquaculture animals must vet notwithstanding paragraph 1, no. 2 (f) prescribe prescription medicines for up to 10 days. Drugs for anaesthesia of aquaculture animals shall be exempted from this time limit.
(4). For the treatments referred to in paragraph 3 shall only disclose the veterinarian prescription medicines for the first 5 days.
(5). Prescription drugs that are approved for marketing to animals for preventive treatment, are exempted from paragraphs 1 to 3 of the basic regulation. section 29. However, this does not apply to antibiotics.
§ 24. In bovine herds covered by an agreement on health advice with opt-in module 1, the veterinarian can provide or prescribe medicines for use in up to 5 days to the crew officer after treatment of adult bovine animals of an illness, which the vet even has begun the processing of on each animal.
(2). In cattle herds in the treatment of young bovine animals and in swine herds, which are covered by an agreement on health advice with respectively opt-in module 1 and opt-in module, veterinarian for the crew officers treating a disease, as a veterinarian in connection to a visit to the crew themselves have diagnosed and by his close knowledge of the crew have experience, will occur in other animals in the herd (herd diagnosis) , prescribe prescription medicines for use in up to 35 days. For herds in the category GLP can vet, however, prescribe prescription medicines to use for up to 42 days. For the treatment of a disease for which there is no crew diagnosis, the veterinarian can only prescribe prescription medicines in accordance with the rules laid down in article 23, paragraph 1.
(3). In cattle and swine herds, which alone consists of animals for slaughter, which are covered by an agreement on health advice with respectively opt-in module 1 and opt-in module, veterinarian for the crew officers treating a disease, as a veterinarian in connection to a visit to the crew themselves have diagnosed and by his close knowledge of the crew have experience, will occur in other animals in the herd (herd diagnosis) , prescribe prescription medicines for use up to 63 days. For the treatment of a disease for which there is no crew diagnosis, the veterinarian can only prescribe prescription medicines in accordance with the rules laid down in article 23, paragraph 1.
(4). In bovine herds covered by an agreement on health advice with opt-in module 2, the veterinarian may prescribe prescription medicines to the officer's treatment of crew crew diagnoses for use for up to 35 days. For the treatment of a disease for which there is no crew diagnosis, the veterinarian can only prescribe prescription medicines in accordance with the rules laid down in article 23, paragraph 1.
(5). In herds of sheep and goats or with aquaculture animals which are the subject of an agreement for health advice, veterinarian for the crew officer's treatment of a disease, as a veterinarian in connection to a visit to the crew themselves have diagnosed and by his close knowledge of the crew have experience, will occur in other animals in the herd, prescribe prescription medicines for use in up to 35 days.
(6). The veterinarian may for the treatment, which is referred to in paragraphs 2 to 5, only hand over prescription drugs for the first 5 days.
(7). The veterinarian may in the cases referred to in paragraphs 2 to 5, on the background of a phone consultation prescribe prescription medicines to the complement of the medicinal products which the vet prescribed or genordinerede by his latest advisory visits. Supplementary prescribing, on the basis of telephone consultation may only be carried out within a period of time after the last Advisory visits, corresponding to the specified prescription period. For additional prescription on the basis of telephone consultation is not required renewed instructions.
(8). Drugs for anaesthesia of aquaculture animals shall be exempted from the time limit referred to in paragraph 5.
(9). Prescription drugs that are approved for marketing to animals for preventive treatment, are exempted from paragraphs 1 to 5, see. section 29. However, this does not apply to antibiotics.
Antibiotics § 25. For the treatment of production animals must vet regardless of § § 23-24 only use, disclose or prescribe drugs containing fluorokinoloner, for use in up to 5 days, if by a current resistance study done on a laboratory with an accredited method is proven to other registered antibiotics is not usable.
(2). Acute disease treatment may notwithstanding the provisions of paragraph 1 shall be initiated before results of resistance examination are available on condition that 1) there is a resistance study from similar cases of disease in the herd, 2) resistance study is conducted within the last 8 days in a laboratory with an accredited method 3) resistance study documenting that other registered antibiotics is not usable, and 4) vet can demonstrate an acute illness with high mortality in the herd.
(3). The treatment referred to in paragraphs 1 and 2, shall, within 14 days after the end of treatment shall be reported to the food region, to which the vet hears, with information on the dates of the beginning and end of which and how many animals treated, the diagnosis, results of resistance test (copy of test results), the crew's CHR-number, the approval number and signature of the veterinarian.
section 26. Gold treatment with antibiotics may only take place if there within the last 35 days is identified pathogenic micro-organisms in at least one gland sample from the animal concerned. Gland specimens should be collected by a veterinarian, a quality Advisor from Dairy Association/Danish Cattle or by the person responsible for the crew. Samples must be analyzed by the veterinarian or a laboratory with an accredited laboratory testing. Detection of pathogenic micro-organisms must be accompanied by a resistance study, see. However, paragraph 2. At the laboratories must be accredited study resistance.
(2). Study of pathogenic micro-organisms and subsequent resistance study may be replaced by PCR study and β-lactamase test.
(3). Veterinarian is to include the result of the laboratory examination referred to in article 6. paragraphs 1 and 2, by the choice of antibiotics for gold processing.
(4). Veterinarian responsible for crew, who may have contracted the health advice with opt-in module, prescribe or supply antibiotics to the gold treatment referred to in paragraph 1. Medicinal products may only be prescribed or dispensed in the form of disposable applicators, and there may only be prescribed or dispensed one disposable applicator per gland.
§ 27. When the veterinarian for the treatment of mastitis in cattle using and for finishing shall provide or prescribe other antibiotics than simple Penicillins, veterinarian, take milk sample to bacteriological examination and resistance study before treatment begins. The milk sample must be analyzed by a laboratory with an accredited veterinarian or method.
Chapter 7 Use, dispensing and prescribing of antiparasitic drugs § 28. For the treatment of animals can vet regardless of article 23, paragraph 1, and article 24, paragraphs 1 to 5, extradite or prescribe antiparasitic medicines for implementation of one treatment of the animal or animals, for which the vet has made a diagnosis.
(2). Antiparasitic drugs may in exceptional cases, where there is a veterinary professional justification, used, dispensed or prescribed without prior found parasite load. In these cases, the veterinarian shall keep a record, justifying the use, disclosure or the prescription. The records must be kept for five years and on request or handed over to the supervisory authority.
Chapter 8 Preventive treatment section 29. Drugs that are approved for marketing to animals for preventive treatment, can be used, shall be handed over or be prescribed without prior is an established disease provided that the veterinarian has such a knowledge of the animal or animals ' health condition, that it is fully justified to submit the drug to the animal or animals, see. However, paragraph 3.
(2). The veterinarian may, notwithstanding paragraph 1, in connection with compulsory vaccination use, disclose or prescribe the vaccine, without the vet has a special knowledge of the crew and to the animals ' health status.

(3). Antibiotikaholdige drugs are not covered by paragraph 1.
(4). Food agency may, on application, grant a derogation in specific cases, to the use of other drugs than those referred to in paragraph 1.
Chapter 9 Genordinering of prescription medicines section 30. The veterinarian may only genordinere residues of prescription medicines within the prescription period and on condition that the veterinarian shall report a new visit to the crew and thereby 1) personally provide a current diagnosis justifying genordinering by the relevant prescription medicines, or 2) at its closely familiar with the crew speculates that treatment needs will occur within the next prescription period.
(2). Genordinering assumes that the vet again gives the crew responsible a guide, see. section 35.
Chapter 10 Treatment of horses with medicines for which there is no established an MRL section 31. There is not a suitable drug for the treatment of horses, can vet regardless of § § 3-5 under his direct personal responsibility use substances which are listed in the annex to Commission Regulation (EC) No 1782/2003. 1950/2006 of 13. December 2006 laying down a list of substances essential for the treatment of equidae. The application must be in accordance with the regulation stated, including the fixing of a withdrawal period of at least 6 months. If the horse has a passport with Title IX, the veterinarian must complete the passport section IX, part III.
section 32. In the absence of a suitable medicinal product referred to in article 6. sections 3-5 and section 31, veterinarian for the treatment of horses can use medicinal products containing active substances not listed in table 1 of the annex to Commission Regulation (EU) No. 37/2010 of 22. December 2009.
(2). The veterinarian must when treating horses in accordance with paragraph 1 at the latest in connection with reading, mark the horse with micro chip (transponder). The transponder must be implanted parenterally under aseptic conditions on the horse's neck in the middle between the neck and withers at the transition between muscle and spækkam, see. Article 11, paragraph 2, 1. section of Commission Regulation No 2454/93. 504/2008 of 6. June 2008 implementing Council Directive 90/426/EEC and 90/427/EEC as regards methods for the identification of equidae. The transponder must be placed on the left side of the horse's neck.
(3). Excluded from the scope of paragraph 2 are horses, which prior to treatment are marked with microchip.
(4). In the context of treatment must vet certify and animal owner with his signature to confirm that the processing excludes the horse from use for human consumption.
(5). If the horse has a passport with Title IX, the veterinarian in dealing with filling in the passport section IX, part II, of the basic regulation. Article 20 of the regulation referred to in paragraph 2. If the horse shall be marked with microchip in relation to the treatment, must notify the veterinarian for that horse Passport Agency on the chip number for registration of chip number in the Organization's database, see. the regulation referred to in paragraph 2.
(6). If the horse does not have a passport with Title IX, the veterinarian in dealing with filling in the form "Declaration of horses ' exclusion from human consumption", which can be downloaded from the homepage of the Danish Food Administration at the following address: www.fvst.dk under "forms & certificates". The veterinarian must send the Declaration with one sticker with transparent bonding over to the chip's barcode for that horse issuing organisation, with at the request of the owner for the issuance of passports for the horse, see. Article 5 of the regulation referred to in paragraph 2, or update of the passport with Title IX. Veterinarian is to submit the Declaration within 2 days after the treatment.
(7). At the same time with the labelling must vet insert the second sticker with chip's barcode to the passport under the rubric "Identity marking (burn, freeze-or chip labelling)".
(8). Horses, who before the entry into force of this order have been banned from human consumption, must continue to be accompanied by a "Veterinarian and ejererklæring for equidae which are treated with drugs which would exclude the animal from human consumption", until there is issued a passport for the horse, in accordance with the regulation referred to in paragraph 2, and of which the horse's exclusion from human consumption. Upon reconsideration, as described in paragraph 1, the owner must call the horse bear a passport in accordance with the regulation referred to in paragraph 2.
Chapter 11 withdrawal periods § 33. When the vet for food-producing animals are using or on instructions, see. section 35 (2), a larger dose of a drug than indicated in the approved summary of product characteristics, the veterinarian shall establish an appropriate longer withdrawal period in order to ensure the absence of residues exceeding the MRLs when the withdrawal period has expired.
§ 34. Is there not for the species concerned set a withdrawal period for medicinal products referred to in paragraph 4, to the vet for treated animals whose flesh or products are intended for human consumption, in all cases, establish an appropriate withdrawal period. This withdrawal period shall be at least: 1) 28 days before the slaughter, 2) 7 days before delivery of milk and eggs, and 3 500 degree days), eg. 100 days á 5 ° c water temperature, before delivery of the fish.
(2). The withdrawal period referred to in paragraph 1 shall be set to zero for homeopathic medicinal products for animals, whose active substances are included in table 1 of the annex to Commission Regulation (EU) No. 37/2010 of 22. December 2009 with the observation that the MRL is not required.
Chapter 12 Veterinarian records, manual and reporting to Vetstat section 35. Through the use, supply or prescription of prescription-only drugs for food animals must vet make legible records of the following: 1) the veterinarian's name and approval number of the establishment, 2) the officer's name and address, crew 3) the CHR-number, where the animals are, 4) which and how many animals are treated/must be treated (unique identification or, if this is not possible, quantity, estimated weight and stinummer or barn section , or equivalent partitioning), 5) used, supplied or prescribed medicines and the quantity thereof, 6) date of use, supply or prescription, 7) the precise wording of the medicinal dosage, route of administration and treatment period, 8) the diagnosis, as well as 9) the announced withdrawal periods.
(2). The veterinarian must provide a written, legible prescription with the information provided for in paragraph 1, to the crew in charge.
(3). By prescription for more than 5 days ' consumption should also writing give the crew the veterinarian responsible manual about: 1) Clinical symptoms, which must be found before treatment begins, 2) prescription period, 3) what has been agreed in order to solve the problem, so that the need for treatment is terminated, as well as 4) veterinarian, reason why the animals are estimated to be in a well-defined disease incubation phase, see. section 22, or that the disease will spread in the herd.
(4). Instructions for use must be signed by the veterinarian. By dispensing and prescribing instructions must also be signed by the person responsible for the crew.
(5). The veterinarian must be in 5 years from the date of the application, dispensing, prescribing, or genordinering of prescription medicines for production animals, overall, uncluttered and in date order, copies of the instructions and on request or disclose these to the inspection authority.
(6). When treating horses, paragraph 1, no. 3, do not apply.
(7). In the treatment of fur animals shall (1). 9, do not apply.
(8). By prescribing prescription drugs for the treatment of aquaculture animals for up to 10 days, paragraph 3 shall not be applied.
(9). Drugs that are approved for marketing to animals for preventive treatment, are exempt from the requirement for manual. However, this does not apply to antibiotikaholdige drugs.
§ 36. The veterinarian shall at least once a month report information about any use or dispensing of prescription medicines, including vaccines and serums for production animals to Vetstat. The information must include the following: 1) date of application or extradition, 2) veterinarian approval number 3) crew CHR-number 4) medicinal product item number 5) used quantity 6) code for the species referred to in article 6. Annex 1, 7) code for age group, see. Annex 1, as well as 8) code for prescription group, see. Annex 1.
(2). The veterinarian must electronically transmit the information referred to in paragraph 1, to Vetstat. All data for a calendar month must be reported no later than the 10. in the following month. The veterinarian must retain data for at least 1 year after the date of notification and on request or disclose these to the inspection authority.
(3). The reporting obligation referred to in paragraphs 1 and 2 shall not apply to horses.
(4). The CHR-number reported, see. (1). 3, must be the CHR-number, where those animals are.
section 37. Veterinarians shall keep a logbook of all advisory visit in herds that are the subject of a health advisory agreement. The logbook must be consecutively numbered, jammed pages and will be in date order.
(2). In the log-book shall be recorded for each Advisory visit at least the following: 1) Date for the visit, 2) time of start of the visit, 3) point for the end of the visit, 4) the veterinarian's signature, 5) crew CHR-number, as well as

6) the signature of the crew.
(3). The veterinarian shall keep the log book for 2 years from the date of the visit and on request or disclose this to the inspection authority.
Chapter 13 Veterinary purchasing, storage, use, supply and prescription of prescription medicines for animals, § 38. Veterinarians must buy prescription medicines in pharmacies or from other by the Danish Medicines Agency approved dealers.
(2). Veterinarians may only keep medicines in practice address, under clean and proper conditions and out of reach of unauthorized persons.
(3). Medicinal products shall not omhældes or repacked, see. However, § 39, paragraph 4.
§ 39. When the vet supply drugs for food animals, veterinarian provide the package with the following information: 1) CHR-number 2) the crew officers name, 3) species, 4) provided for the withdrawal period, 5) date of dispensing, as well as 6) veterinarian approval number.
(2). When the vet supply medicinal products for animals other than domestic animals, veterinarian provide the package with the following information: 1) the animal owner's name, 2) species, 3) diagnosis, dosage, route of Administration) and 4 treatment period, 5) date of dispensing, as well as 6) veterinarian approval number.
(3). The information referred to in article 6. paragraph 1 and paragraph 2, shall be affixed on the pharmaceutical package, legibly appear on a label placed on the packaging. If the gasket is made up of several parts, labels shall as far as possible, be placed on the inner packaging.
(4). The veterinarian may in connection with the dispensing of medicinal products does not break the outer packaging with a view to splitting of the Pack in smaller packages (inderpakninger), unless these are provided with separate item number and, incidentally, with the same information as the original outer packaging.
(5). By dispensing of medicines to horses, paragraph 1, no. 1, shall not apply.
(6). By extradition to fur animals shall (1). 4, shall not apply.
(7). The information referred to in paragraph 1 may be replaced with a preprinted label with a number system that uniquely refers to the instructions, see. section 35.
§ 40. Veterinarians shall use or dispensing of drugs for the treatment of animals other than domestic animals set the consumer price for the used or supplied gasket under section 1 of the Consolidated Act on calculation of consumer prices etc. on medicines.
(2). For medicinal products for animals, see. the Danish Medicines Act section 60, paragraph 3, the consumer price of the veterinarian's purchase price from the pharmacy or company approved to sell such drugs after the Danish Medicines Act section 39.
(3). When the veterinarian uses or provide a package that is part of a Multipack, the consumer price is calculated proportionally according to the multi pack consumer price.
(4). When the vet uses only a part of a package, should the consumer price is calculated proportionally according to the consumer price of the used gasket plus 10 per cent.
§ 41. Veterinarians who use or supply magistrally manufactured medicinal products must calculate the consumer price for the used or supplied gasket under section 8 of the Consolidated Act on calculation of consumer prices etc. on medicines.
§ 42. By dispensing of drugs may also charge you a fee of up to vets 5 per cent of the consumer price.
section 43. Veterinarian is to ensure that payment for the used and supplied by the veterinarian medicines not included in payment for provided veterinary help. On bills to the amount for each dispensed or used medicinal product shall be shown separately, indicating the name of the medicinal product and the used and supplied quantity.
Chapter 14 Penalties and effective provisions in section 44. With fine punished anyone who: 1) violates section 3, section 4, paragraph 1, § 5, §§ 9-16, § 17, paragraphs 1 to 4, article 18, paragraph 1, §§ 19-20, § 21 (1), sections 22-25, section 26, paragraph 1, 3 and 4, §§ 27-28, § 29, paragraphs 1 and 3, § § 30-31, section 32, paragraph 2 and paragraph 4-8, § 33, article 34, paragraph 1, article 35, paragraphs 1 to 5 and paragraph 9, section 36 (1) and (2) and (4) , sections 37-38, article 39, paragraphs 1 to 4, and sections 40-43, 2) violate article 16 of Regulation (EC) No 1782/2003. 470/2009 on the Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90. 2377/90 and amending European Parliament and Council Directive 2001/82/EC and European Parliament and Council Regulation (EC) No 1782/2003. 726/2004, or 3) not to comply with the terms set out under section 4 (2), section 17 (5) or section 29, paragraph 4.
(2). In violation of the provisions set out in paragraph 1, can the penalty pursuant to section 38, paragraph 4, of the law on veterinary surgeons increase to prison for up to 2 years, if it knows the action or failure occurred violations are committed with intent or gross negligence, and there in the infringement is 1) caused damage to human or animal health or caused danger for doing so, or 2) achieved or intentional gained an economic advantage for the person themselves or other , including savings.
(3). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.
§ 45. The notice shall enter into force on the 1. July 2010.
(2). At the same time repealed Executive Order No. 482 of 29. May 2007 for veterinary use, dispensing and prescription prescription of drugs for animals.

Food Agency, the 25. June 2010 Jan Mousing/Anne Rath P Annex 1 Codes to use when reporting to Vetstat, see. section 36 (1) (8). 6-8







Dyreart


 



Kvæg


12



Får, geder


13



Svin


15



Pelsdyr


24



Fjerkræ


30



Akvakulturdyr


51



Andre produktionsdyr


95



 
 


 
 
 


Aldersgruppe


 


 



Svin


Pattegrise, polte, avlsdyr


55



 


Fravænningsgrise


56



 


Slagtesvin, salgspolte


57



 


 


 



Kvæg


Køer, tyre


61



 


Kalve under 12 mdr.


62



 


Ungdyr, stude over 12 mdr.


63



 


 


 



Får, geder


Dyr over 12 mdr.


68



 


Lam/kid under 12 mdr.


69



 


 


 



Fjerkræ


Slagtefjerkræ


75




 


Æglæggere


76



 


Opdræt


77



For andre produktionsdyr udfyldes feltet med erstatningskoden 00.



 


Prescription groups of bovine animals, swine sheep goats and fur animals Reproduction, urogenital system 10 Udder 11 gastrointestinal disorders 12 Respiratory Disorders 13 joints, limbs, nails, central nervous system, skin, digestion, metabolism 14 circuits


15



Andet (kan kun anvendes ved mink)


16



 
 


Ordineringsgrupper for akvakulturdyr

 


Rødmundsyge


20



Furunkulose


21



Yngeldødelighedssyndromet (YDS)


22



Andet


23



 
 


Ordineringsgrupper for fjerkræ

 


Coccidiose


30



Enteritis


31



Hepatitis


32



Salpingitis


33



Andet


34



Respirationsveje og -organer


35



By veterinary prescription for other production animals than the above mentioned field is filled in with the replacement code 00.



By veterinary prescription of vaccines and sera field is filled in with the code 99.





Annex 2 list of extemporaneous medicaments, see. § 4 (1) (8). 3 list of extemporaneous medicaments referred to in article 6. § 4 (1) (8). 3



 


Lægemiddelstof(fer)


Dyreart


Lægemiddelform


Styrke


Pakningsstørrelse


Indikation(er)


Varenummer



Acetylcystein


Heste


Klysma


40 mg/ml


200 ml


686189 Acetylcysteine in foals-Gen Mekoniumforstoppelse tamycin Dogs and cats eye drops 50 mg/ml 3 mg/ml 5 ml eye disorders, corneal ulcer, obstructs hensmeltende kollagenaseeffekt 686190 ammonium chloride All animals Infusion concentrate


5,3 g/l


100 ml


Væsketerapi


686171



Apomorphin­hydrochlorid


Hunde


Injektionsvæske


10 mg/ml


1 ml


Induktion af vomitus


686137



Atropinsulfat


Fødevareproducerende dyr


Solution for injection 10 mg/ml 10 ml Præanæsteticum and treatment of poisoning with Atropine sulphate small animals 686172 esterasehæmmere solution for injection 1 mg/ml 10 ml Præanæsteticum and treatment of poisoning with esterasehæmmere 686149



Bromhexidhydro­chlorid


Heste


Pulver


30 mg/gr


125 g


Mukolytisk


686191



Citrat-glukose, stærk


Alle dyr


Opløsning


Citronsyre 8 mg/ml, natriumcitrat 22 mg/ml, glukose 25 mg/ml


100 ml
 


Blodstabilisering i forbindelse med transfusion


686173



Glucose


Alle dyr


Infusionskoncentrat


50 %


1000 ml


Væsketerapi


686174



Kalium/Natrium/Glu­kose



Alle dyr


Infusionskoncentrat


KCl 15 g/l, NaCl 23 g/l, Glukosemono-hydrat 500 g/l


1000 ml


Væsketerapi


686175



Kaliumbromid


Hunde


Mikstur


100 mg/ml
200 mg/ml


500 ml
500 ml


Epilepsi


686192
686193 



Kaliumchlorid


Alle dyr


Infusionskoncentrat


14,9 g/l


20 ml


Væsketerapi


686176



Kaliumcitrat


Katte


Tabletter


500 mg


100 stk.


Forebyggelse af urinvejssten


686194 



Kaliumiodid


Kvæg


Afdelte pulvere


100%


5 g


Actinobacillose (trætunge)


686177



L-lysinhydrochlorid


Katte


Tabletter


500 mg


20 PCs.


Oculære virusinfektioner hos kat


686195



Lobelinhydrochlorid


Heste


Injektionsvæske


10 mg/ml


10 ml


Diagnostik af luftvejslidelser


686154 



Medicinsk kul


Heste


Mikstur


160 mg/ml


1 liter


Kolikbehandling


686196 



Mepyramin


Heste1)



Injektionsvæske


25 mg/ml


20 ml


Antihistamin


686197 



Methyltestosteron, 17 alfa


Akvakulturdyr


Opløseligt pulver


100% 20 mg Gender conversion – only FRY during 3 months.


686178



Natriumbicarbonat


Alle dyr


Infusionsvæske


84 mg/ml


500 ml


Væsketerapi


686179



Natriumchlorid


Alle dyr


Infusionskoncentrat


90 g/l


1000 ml


Væsketerapi


686180



Natriumchlorid


Alle dyr


Infusionsvæske


75 g/l


1000 ml


Væsketerapi


686181



Natriumdioctyl-sul­fosuccinat


Heste2)



Mikstur


50 mg/ml


100 ml


Forstoppelse


686155



Neostigmin


Fødevareproducerende dyr


Injektionsvæske


2,5 mg/ml


10 ml


Ileus, samt vomatoni og løbedislokation


686182



Polyvidon


Heste1)



Skyllevæske


20 mg/ml


500 ml


Kejsersnit, bughuleoperation


686198 



Prednisolon


Heste


Afdelte pulvere


100 mg
500 mg


20 stk.
10 PCs.


Luftvejs- og hudlidelser


686199 



Prednisolon og me­pyramin


Heste1)



Afdelte pulvere


40 mg og 1 g


10 stk.


Allergic respiratory tract infection 686201 Calling acetate All animals



Infusionsvæske


MgCl 200 mg/l,
KCl 300 mg/l, C aCl 440 mg/l,
Natriumacetat 4,1 g/l,
NaCl 5,6 g/l


250 ml


Væsketerapi


686183



Ringer chlorid


Alle dyr


Infusionskoncentrat


KCl 3 g/l,
CaCl 5 g/l, NaCl 8,6 g/l


1000 ml


Væske therapy 686184 Sulfacombin: Sulfadiazine, sul fadimidin, sul famerazin, sac, sac charose, charinnatrium and car boximethyl cellulose slim little creatures Potion 100 mg/ml 40 ml infections in small animals except the dog and cat.


686202 



Taurin


Smådyr


Tabletter


250 mg


100 stk.


Hjerteproblemer


686203 



Thiaminhydrochlorid


Kvæg


Injektionsvæske


250 mg/ml


10 ml


CNS-forstyrrelser hos kalve


686144



Zinkchlorid


Heste, hunde og katte


Vandig opløsning


50 %


100 ml


Ætsning af hypergranulerende sår


686204 



Zinkoxid


Svin


Premix


80 % Zn


1 kg
5 kg
10 kg
25 kg


Diarre hos grise indenfor de første 14 dage efter fravænning, maks. 2500 mg Zn/kg fuldfoder


686167
686168
686169
686170
 



Zinkoxid


Svin


Oralt pulver


80 % Zn


1 kg
5 kg
10 kg
25 kg


Diarre hos grise indenfor de første 14 dage efter fravænning, maks. 2500 mg Zn/kg of complete feedingstuff.


686185 686186 686187 686188 1) may only be used for horses, which is excluded from human consumption, since there is no established MRL values for one or more of the active ingredients.




2) may be used for horses, see. section 31, on condition that there should be a withdrawal period of at least 6 months.





Annex 3 list of prohibited substances List a: prohibited substances thyrostatic substances stilbenes, stilbene derivatives, their salts and esters Oestradiol 17 beta and its ester-like derivatives List b: prohibited substances with derogations Beta-agonists.
Official notes 1) Ordinance contains provisions that implement elements of Council Directive 96/22/EEC of 29 October 1993. April 1996 concerning the prohibition on the use of certain substances having a hormonal or thyrostatic action and of beta-agonists in stockfarming and repealing directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ 1996 L 125 p. 3), as last amended by European Parliament and Council Directive 2008/97/EC of 19. November 2008 (OJ 2008, L318, p. 9). In addition, implemented parts of Council Directive 96/23/EC of 29 April 2004. April 1996 on the control measures to be implemented for certain substances and residues thereof in live animals and animal products and repealing directives 85/358/EEC and 86/469/EEC and decisions 89/187/EEC and 91/664/EEC (OJ 1996 L125 p. 10), as last amended by European Parliament and Council Regulation (EC) No 1782/2003. 596/2009 of 18. June 2009 (OJ 2006, L188, p. 14), and parts of the European Parliament and Council Directive 2001/82/EC of 6 May 2003. November 2001 establishing a Community code relating to veterinary medicinal products (OJ L311, 2001, p. 1), as last amended by European Parliament and Council Regulation (EC) No 1782/2003. 596/2009 of 18. June 2009 (OJ 2006, L188, p. 14). In the notice are rendered certain provisions of European Parliament and Council Regulation (EC) No 1782/2003. 470/2009 on the Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90. 2377/90 and amending European Parliament and Council Directive 2001/82/EC and European Parliament and Council Regulation (EC) No 1782/2003. 726/2004 (OJ L152, 2009, p. 11) and Commission Regulation (EC) No 1782/2003. 504/2008 of 6. June 2008 implementing Council Directive 90/426/EEC and 90/427/EEC as regards the methods for identification of equidae (OJ 2008, L149, p. 3). According to art. 249 of the EC Treaty where a regulation is directly applicable in each Member State. The reproduction of these provisions in the decree are thus justified in practical terms and shall not affect the validity of the said regulations look in Denmark.