Chapter 1 Scope and definitions

Chapter 2 Allowed medicinal products for animals

Chapter 3 Prohibitions and limitations on the use of certain hormones and so on.

Chapter 4 Medicinal products for animals reserved for the use of animals

Chapter 5 Submission of medicinal products for animals

Chapter 6 Applicability, extradition and prescriptions of medicinal products

Chapter 7 Applicability, extradition and prescribing of antiparasitic medicinal products

Chapter 8 Preventive processing

Chapter 9 Reception of prescription medicinal products

Chapter 10 Treatment of equidae with medicinal products for which a maximum threshold is not fixed,

Chapter 11 Holding times

Chapter 12 The veterinarian's records, listing and reporting to Vetstat

Chapter 13 Procurement, storage, use, extradition and prescribing of prescription-only medicinal products for animals

Chapter 14 Penalty and effective provisions

Appendix 1

Appendix 2

Appendix 3

Publication of the use, extradition and prescribing of medicinal products for animals 1)

In accordance with section 11 (4), 1, 3 and 4, section 12 (2). 3 and 4, section 13 (3). 2, section 14 (4). 4 and 5, section 15, § 17, § 35, and § 38 (3). Amendment No 4. 433 of 9. June 2004 on veterinarians, as amended by law no. 401 of 21. April 2010, and section 9 (4). 3, and Section 72 (2). 2, in the apothecary (apothecary law) of the apothecary, cf. Law Order no. 855 of 4. This August 2008, and partly following the authorisation of the Minister for Food, Agriculture and Fisheries, shall be determined as follows :

Chapter 1

Scope and definitions

§ 1. The announcement concerns the procurement, storage, use, extradition and prescribing of medicinal products for animals. The notice also provides for authorised medicinal products for animals, non-authorised substances and prohibitions and restrictions on the use of certain hormones and so on.

§ 2. For the purposes of this notice :

1) ' Crew ` means a single or collection of food-producing animals or fur animals of the same animal species used for a particular purpose linked to a particular geographical location and which has an owner in the form of a legal or physical person. By means of a herd, the same species or the herd of the same species recorded on a CHR number is defined as a herd.

2) Animals in human care.

3) "Animal owner" means any man who has animals in his custody.

4) ' Food-producing animals ` : bovine animals, swine, sheep, goats, animals of the herder (hereafter referred to as horses), excluding horses excluded from human consumption, cf. Section 32, farmed herd animals and farther, ostrich, oilbirds, poultry, including pigeons, aquaculture animals, honeybees and other animals whose meat or products are intended for human consumption.

5) ' Pelsbeast ' shall mean the fox farmed in accordance with the proclamations of breeding and mink, ferret (ferret), matron, nutria, chinchilla and other animals to be raised in agricultural terms with a view to the exploitation of the fur.

6) ' Production animal ` means food-producing animals and fur animals.

7) ' bovine animals ` shall mean the male bovine animals less than 1 year and females that have not yet calved.

8) ' Voklate bovine animals ' shall mean the bovine animals over 1 years and females who have calved.

9) "GLP" : Good farming practice, cf. notices on health care contracts for pig-and-herd herds.

10) ' Medicinal product ' means a product presented as a suitable means for the treatment or prevention of animal diseases, or which may be used in or administered to animals, either in order to restore, alter or influence physiological functions by carrying out one ; pharmacologically, immunological or metabolic effect, or in order to provide a medical diagnosis.

11) ' medicinal products on release ' means medicinal products which, according to the authorisation of the Medicinal Products Agency, in accordance with the law on medicinal products, may be used for animals and humans.

12) 'Magistrelt medicinal product' means a medicinal product which, according to the law on medicinal products, is prepared in a pharmacy in accordance with the prescribed by a veterinarian.

13) Antibiotics : Antibiotics and chemotherapy incarcaated medicinal products.

14) ' Homopathic medicinal product ` means a medicinal product obtained from substances (homeopathic tribes) according to a homeopathic manufacturing method described in the European Pharmacopoeia, which has official status in an EU/EEA country. A homeopathic medicinal product may contain several active components.

15) ' Non-permissible substances ` means substances whose introduction to animals is prohibited in accordance with applicable rules.

16) ' Maximum residue limit (MRL) ` means the maximum residue concentration of a pharmacologically active substance (expressed as mg / kg or micrograms of wet weight) which may be permitted in food of animal origin, cf. Article 1 (1). The provisions of paragraph 1 (a) of Regulation (EC) No (EC) No (EC) 470/2009 of 6. May 2009 laying down Community procedures for the establishment of limit values for residues of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2 ; Council Regulation (EC) No 2377/90 and amending Parliament and Council Directive 2001 /82/EC and of the European Parliament and of the Council. 726/2004.

17) ' Ordination Period ` means the number of days to which the veterinarian is to prescribe medicinal products.

18) "Processing Period" means the exact number of days within the period of the period during which the animals are to be treated for the diagnosed disease.

(19) ' Disease diagnosis ` means the diagnosis of a disease that occurs on a regular basis in the crew and characterized by the symptoms described by the veterinarian.

20) ' Microchip ` means a transponder, as defined in Article 2 (1). (b) 2 (b) of Commission Regulation No 2, 504/2008 of 6. June 2008 on the implementation of Council Directive 90 /426/EEC and 90 /427/EEC in respect of methods for the identification of equidae.

21) ' Committable vaccination ` shall mean Vaccination imposed by the Food Authority in accordance with the law.

(22) ' Goldtreatment ` means the treatment of a laboratory-diagnosed bacterial infection by the use of antibiotics in the udder in the case of milking.

23) ' Therapetuous treatment ` means the introduction of a medicinal product for food-producing animals of a medicinal product of :

a) Beta-agonists for the treatment of respiratory problems, hoar-senor or deceptenacity or to convesitation (tocolyse).

b) Allyeneenbolon (altrenogest) to heat control of competition-or circushest.

c) The progesterone and derivatives, which, by the hydrolysis, form the original connection after absorption from the place of administration, to the treatment of disturbances in the ovarian.

24) ' Zootechnical treatment ` means the submission of a medicinal product to animals with :

a) The estrogen or caste effects for the use of heat and pre-treatment of donor and recipient in the context of embryo transplantation in food-producing animals.

b) The Androgenic effect for the gender conversion of aquaculture animals in a group of breeding animals.

25) ' Illegal treatment ` shall mean the use of non-authorised substances and the use of medicinal products for other purposes or in conditions other than those laid down in accordance with the applicable rules.

Chapter 2

Allowed medicinal products for animals

§ 3. For the treatment of animals, medicinal products for marketing authorization to animals from the Medicinal Products Management Board or the Community marketing authorisation for animals in the European Union shall be subject to the rules laid down by the Council for the European Union.

§ 4. If there is no medicinal product approved for marketing, cf. in paragraph 3, the veterinary surgeon may be, exceptionally, under his direct personal responsibility, in particular in order to avoid the unacceptable suffering of the animals concerned, use, supply or prescribe the following medicinal products for the treatment of a condition :

1) A medicinal product which has a marketing authorisation from the Medicinal Products for the Medicinal Products or Community marketing authorization to another species or the same animal species to another species or, if such a medicinal product does not exist,

2) a medicinal product which has a marketing authorisation from the Medicinal Products Management Board or Community marketing authorisation for human use, or a medicinal product on release from the Medicinal Board, or, if such a medicinal product does not exist,

3) a magic-made medicinal product, as shown in Annex 2, to the species and indications as shown in the Annex.

Paragraph 2. The Food Safety Management Board may, on application, be able to dispense with the requirement set 1, no. 3, so that other medicinal products other than those indicated in Annex 2 may be used if this is necessary in the case of animal health.

§ 5. For the treatment of food-producing animals, it is also a condition for applying the rule in § 4, that the pharmacologically active substances of the medicinal product are listed in Table 1 of Annex to Commission Regulation (EU) No 2. 37/2010 of 22. In December 2009 on pharmacologically active substances and their classification with regard to maximum residue levels in foodstuffs of animal origin and that the veterinary surgeon provides for an appropriate detention period, cf. § 34.

§ 6. Homeopathic medicinal products for animals may, irrespective of section 4, be used for the treatment of animals other than food-producing animals under the responsibility of the veterinarian.

§ 7. Homeopathic medicinal products intended for food-producing animals, and whose active substances are listed in Table 1 of Annex to Commission Regulation (EU) No 2 ; 37/2010 of 22. In December 2009 on pharmacologically active substances and their classification in respect of maximum residue levels in foodstuffs of animal origin, any section 4 may be used for the treatment of food-producing animals under the responsibility of the veterinarian.

§ 8. Vaccine, which does not have a marketing authorisation from the Medicinal Products for the Administrative Board or the Community marketing authorisation, may notwithstanding Article 3, be applied to compulsory vaccination.

Chapter 3

Prohibitions and limitations on the use of certain hormones and so on.

§ 9. The use of the medicinal products or substances referred to in Annex 3 to food-producing animals shall be prohibited.

§ 10. The use of medicinal products or substances with the androgen, gestagen or estrogen, and of beta-agonists for production animals shall be prohibited, cf. however, § § § -16.

§ 11. The use of medicinal products or substances with hormone-hormonal or hormonal equivalent effect to production animals for growth or performance-enhancing purposes shall be prohibited.

Therapeutic and zootechnical treatment

§ 12. Therapeutic and zootechnical treatment, cf. § 2, nr. The animals shall not be carried out on farm animals, including the animals for breeding, cf. however, § § § -16.

§ 13. Therapeutic treatment, as mentioned in section 2, no. 23 (a) and (c) is authorized on condition that :

1) treatment is carried out by the veterinarian in person, cf. however, paragraph 1 2,

2) the treatment, cf. § 2, nr. 23 (c) only happens in the form of injections or vaginal cycle on uniquely identified food-producing animals ;

3) only medicinal products which comply with the conditions laid down in section 3 or 4 (4) are used for processing. 1, no. 1 or 2, which have a maximum retention time of not more than 15 days, for beta-agonists not more than 28 days, and

4) the veterinarian shall make a record in accordance with section 35 (3). 1.

Paragraph 2. For the post-treatment of a horse treated in accordance with paragraph 1. 1 with beta-agonists against respiratory problems, the main inflammation or tenuation, the veterinarian may extradite or prescribe prescription medicinal products containing beta-agonists, on condition that :

1) the treatment is carried out under the responsibility of the veterinarian ;

2) the prescribed medicinal products or prescribed medicinal products comply with the conditions laid down in section 3, or section 4 (4). 1, no. 1 or 2 is for submission through the mouth, and has a withdrawal period of not more than 28 days,

3) the veterinarian shall make a record in accordance with section 35 (3). 1, and

4) the veterinarian shall enter the date of initiation and termination of the treatment.

§ 14. Therapeutic treatment is permitted on condition that :

1) the medicinal product shall be administered peroral by the veterinarian or under his responsibility ;

2) treatment only on animals that are uniquely identified ;

3) only medicinal products which comply with the conditions laid down in sections 3 or 4 (4) are used for processing. 1, no. 1 or 2 and which have a detention time of not more than 15 days ; and

4) the veterinarian shall make a record in accordance with section 35 (3). 1.

§ 15. Zootechnical treatment is permitted on condition that :

1) the treatment is carried out by the veterinarian or under his responsibility ;

2) treatment shall be carried out on breeding animals which do not show signs of reproduction disturbances, and which are clearly identified ;

3) only medicinal products which comply with the conditions laid down in sections 3 or 4 (4) are used for processing. 1, no. 1 or 2, which are not implants or tablets for implantation, which have a maximum retention time of not more than 15 days ; and

4) the veterinarian shall make a record in accordance with section 35 (3). 1.

§ 16. The veterinarian prescribes prescription-only medicinal products with the androgenic effects for the treatment of breeding farms for the purposes of the gender conversion, cf. § 2, nr. 24 (b), on condition that :

1) the treatment is carried out under the responsibility of the veterinarian ;

2) the treatment is carried out on the breeding of steam fish in less than three months ;

3) treatment only uses medicinal products that meet the conditions laid down in section 3 to 4 and which are prescribed in a prescription for disposable provision and which are not implants or implants for implantation,

4) the person responsible for the crew shall be instructed in writing to ensure that hormone treated animals must not be used for human consumption ;

5) the veterinarian immediately after processing shall inform the foodstuff, the name and address of the farm, the name and the quantity of the medicinal products used, and the time of introduction and completion of the treatment ; and

6) the veterinarian shall make a record in accordance with section 35 (3). 1.

Chapter 4

Medicinal products for animals reserved for the use of animals

§ 17. The treatment of animals using the prescribed medicinal products with the following shall be carried out only by the veterinarian in person, and the veterinarian must not give up or prescribe the medicinal products :

1) medicinal products with analgetic effect to injections, excluding non-steroids, anti-inflammatory medicinal products,

2) anaetics for inhalation or injection,

3) opioids, opiates, barbiturates, benzodiazepins and psychosedativa,

4) self-containing medicinal products for injections ;

5) parasympatomimetic for injection and parasympolytic injection to injections ;

6) sympathomime for injections and sympatholytics for injections ;

7) the following hormones and compounds of hormonal equivalent effect to injection :

a) Adrenocorticotrope hormones,

b) natural and synthetic binyrebarksteroids,

c) oxytocin and oxytocinilanaloger,

d) prostaglandins and prostaglandinanalogues, as well as

8) medicinal products exclusively approved for intravenous submission, cf. however, section 19 (1). 2.

Paragraph 2. However, the veterinarian may, notwithstanding paragraph, 1, no. 3, extraditing or prescribe opioids, opiates, barbiturates, benzodiazepins and psychosedativa to the administration through the mouth for the treatment of other animals other than food-producing animals. For the treatment of horses which are excluded from the use intended for human consumption, the veterinarian may only give out or prescribe the products referred to in paragraph 1. 1, no. 3, mentioned medicinal products for use up to four weeks in the case of retraining after serious disease.

Paragraph 3. However, the veterinarian may, notwithstanding paragraph, 1, no. 7 (c) extradite or prescribe oxytocin and oxytocinilanalog for the treatment other than vestimulation for use in

1) pigs ' herds without a health advisory agreement or with a preprocessing agreement for up to 5 days on condition that the veterinarian has opened the processing of each animal,

2) pigs in swine herds with a health care consulting agreement for up to 35 days, however, in the case of category GLP, until 42 days ;

3) bovine herds with a health advisory agreement with an added addition to 35 days, however, into the herds of category GLP until 42 days, as well as in

4) bovine herds with a health advisory agreement with the addition of mode module 2 for 35 days.

Paragraph 4. In the cases referred to in paragraph 1. 3, no. However, 2 to 4 the veterinarian may only supply medicinal products for the first five days.

Paragraph 5. In particular, the FDA may grant a derogation from paragraph 1 in specific cases. 1.

Chapter 5

Submission of medicinal products for animals

§ 18. Subcutaneous and intramuscular injections must be carried out as closely as possible to the ears of sheep and goats in the middle of the neck, in the middle of the neck, or on the side of the bow, and on the horses in the middle of the neck or in the bringen. In pigs, vaccination by means of particular equipment which does not involve the use of needles shall also be carried out at the carrot. Subcutaneous injection of irons and vitamin preparations may be made in the lightweights of piglets.

Paragraph 2. The submission of medicinal products with local anesthesia, local painkillers or other local effects to injections shall be exempt from paragraph 1. 1.

§ 19. Injection in arteries, in the arghulen, in the heebodes and at the spinal tract / spinal tract, and the placing of medicinal products in the womb may only be carried out by the veterinarian in accordance with the veterinary medicinal product. however, paragraph 1 2-4.

Paragraph 2. The veterinarian may be able to crew responsible, which have entered into agreement on health advice in cattle herds 2 and which have received authorization from the Food Authority to treat queues suffering from the sledding fever, hand over or prescriptive ; calcium-containing non-magnesium inmediate medicinal products authorised for intra-venous toxins if a beta diagnostics are available for sleepovers.

Paragraph 3. The veterinarian may be able to crew responsible, which have entered into an agreement on health advice in cattle herds 2 and which have undergone one of the FDA approved course in the owner-inseminating bovine animals in accordance with the said Annex. for any period applicable to the semen collection and inseminal treatment of bovine animals, or any equivalent of the Food Authority approved course, supply or prescribe the uterites if a stock diagnosis is available for the infection.

Paragraph 4. The veterinarian may, with the herds of aquaculture animals, hand over or prescribe vaccine for injections in the bughule of the fish.

20. veterinarians may conduct a course for the crew responsible for the use of medicinal products for production animals.

Paragraph 2. The course of training and content must be approved by the food registration.

Paragraph 3. Course provider must notify the delivery of the cursuction to the day of training and the time of reference to the approved course, cf. 3 weeks prior to the training of the courier. paragraph 2.

Chapter 6

Applicability, extradition and prescriptions of medicinal products

§ 21. Treatment of animals with antibiotics must be carried out only if the treatment is directed towards concrete, diagnosed infections and has a recovery aim.

Paragraph 2. Notwithstanding paragraph 1 1 is authorized by antibiotic treatment in connection with operational intervention, which shall entail a special risk of infection.

§ 22. Treatment of production animals in accordance with section 23 to 25 presupms that the animals are clinically sick or deemed to be in a well-defined disease ' s incubation phase.

-23. In herds which are not covered by an agreement on health advice, and in bovine animals and pig herds with the basic health advice, the veterinary surgeon must hand over or prescribe prescription medicinal products for use up to 5 days to date ; the processing of a disease in which the veterinarian in connection with the visit to the crew of the crew has been diagnosed with the following type of production animals :

1) Individuals, other than adult bovine animals, subject to the condition that the veterinarian himself has begun the treatment of each animal.

2) A Group of

a) lamb and goat kid less than 1 year and young bovine animals,

b) deer,

c) pigs,

d) poultry and farther,

(e) fur animals, or

(f) aquaculture animals.

Paragraph 2. In the treatment of fur animals, the veterinarian may, however, be treated as such. 1, no. 2 (e) prescribe prescription-only medicines for up to 35 days.

Paragraph 3. For the treatment of aquaculture animals, the veterinary surgeon must be treated in any way. 1, no. 2 (f) prescribe prescription-only medicines for up to 10 days. Medicinal products for the anaesthetic of aquaculture animals have been exempted from this time limit.

Paragraph 4. For the treatments referred to in paragraph 1. 3, the veterinarian may only supply prescription medicinal products for the first five days.

Paragraph 5. Reception-only medicinal products authorised for the marketing of animals for preventive treatment are exempt from paragraph 1. 1-3, cf. § 29. However, this does not apply to antibiotics.

§ 24. In bovine herds covered by an agreement on health advice, with the addition of the case of access Module 1, the veterinarian may extradited or prescribe medicinal products for use within five days of the treatment of adult bovine animals of a disease, which is : the veterinarian himself has begun the examination of each animal.

Paragraph 2. In bovine herds for the treatment of young bovine animals and in swine herds covered by an agreement on health advice, with the addition of the addition of the addition of a selection module, the veterinarian may be treated as a veterinarian for the treatment of a disease in which the veterinarian is treated ; The experience of a visit to the crew itself has been diagnosed and knows its near knowledge of the crew will experience the presence of other animals in the crew (beta diagnostics), prescribe prescription medicinal products for use in the age of 35 days. For the purposes of category GLP, the veterinarian may prescribe prescription-only medicinal products for the age of 42 days. For the treatment of a disease for which a stock market is not available, the veterinarian may prescribe prescriptions only in accordance with the rules laid down in section 23 (1). 1.

Paragraph 3. In the case of bovine animals and swine herds, which consist solely of slaughter animals and which are covered by an agreement on health advice, with the addition of the addition of the addition of a selection module, the veterinarian may be treated as a veterinarian for the treatment of a disease that the veterinarian is in ; The experience of a visit to the crew itself has been diagnosed and knows its near knowledge of the crew will experience the presence of other animals in the crew (stock-market diagnosis), prescribe prescription medicinal products for use until 63 days. For the treatment of a disease for which a stock market is not available, the veterinarian may prescribe prescriptions only in accordance with the rules laid down in section 23 (1). 1.

Paragraph 4. In bovine herds covered by an adden-Module 2 health advice, the veterinarian prescribe prescription-responsibility medicinal products for the treatment of crew diagnoses for use in the period of 35 days. For the treatment of a disease for which a stock market is not available, the veterinarian may prescribe prescriptions only in accordance with the rules laid down in section 23 (1). 1.

Paragraph 5. In the herds of sheep and goats or with aquaculture animals which are covered by an agreement on health advice, the veterinarian may be treated in the treatment of a disease the veterinarian in connection with a visit to the crew has been diagnosed ; and knows its near knowledge of the crew has experience, will result in other animals in the crew, prescribe prescription drugs for use in the age of 35.

Paragraph 6. The veterinarian may be able to do the treatment referred to in paragraph 1. 2-5, only extraditing prescription drugs for the first five days.

Paragraph 7. In the cases referred to in paragraph 1, the veterinarian may in the cases referred to in paragraph 1. Two-five, on the basis of a telephone consultation, prescribe prescription medicinal products for the addition of the medicinal products prescribed or represcribed at his last consulting time. Complementary coordination on the basis of telephone consultation may only be performed within a period of time after the last consulting time, which corresponds to the specified ordination period. In the case of additional coordination on the basis of telephone consultation, it is not necessary to renew the instructions.

Paragraph 8. Medicinal products for the anaesthetic of aquaculture animals have been exempted from the time limit referred to in paragraph 1. 5.

Niner. 9. Reception-only medicinal products authorised for the marketing of animals for preventive treatment are exempt from paragraph 1. 1-5, cf. § 29. However, this does not apply to antibiotics.

Antibiotics

§ 25. For the treatment of production animals, however, the veterinary surgeon may use, extradite or prescribe medicinal products containing fluorococolons for five days, if a current resistant survey carried out in a laboratory with one accredited method has been documented that other recorded antibiotics are not applicable.

Paragraph 2. In the case of acute illness, treatment may be treated, 1 shall be implemented before the result of the resistance study is available, on condition that :

1) there is a resistance study from the corresponding pathcases in the crew,

2) the resistance survey has been carried out within the last eight days in a laboratory with an accredited method,

3) the resistance survey documents that other recorded antibiotics are not applicable ; and

4) the veterinarian may prove an acute disease flow with a high mortality rate in the crew.

Stop. 3. The treatment referred to in paragraph 1. 1 and 2 must, within 14 days of the end of the treatment, be reported to the food court to which the veterinarian is to be notified, with information on the date of departure and completion, which and the number of animals processed, diagnosis, result of : the resistant study (copy of laboratory), the CHR number of the crew, the veterinarian ' s approval number and the signature of the veterinarian.

SECTION 26. Goldtreatment with antibiotics can only take place if, in the last 35 days, the presence of pathogenic micro-organisms has been detected in at least one church sample from that animal. Grain samples must be taken out by a veterinarian, a quality adviser from the Mejeria / Danish Kwall or by the person responsible for the crew. Samples must be analysed by the veterinarian or a laboratory with an accredited laboratory examination. Detection of pathogenicity micro-organisms must be accompanied by a resiliency study, cf. however, paragraph 1 2. In laboratories, the resistant examination must be accredited.

Paragraph 2. Testing for pathogenic microorganisms and subsequent resilient resistance studies may be replaced by PCR study and the lactamase test.

Paragraph 3. The veterinarian must include the results of the laboratory examination, cf. paragraph 1 and 2, in the selection of antibiotics for the goldtreatment.

Paragraph 4. The veterinarian may be able to crew responsible for the health advice on health advice, prescribe or extraditing antibiotics to the person in question in paragraph 1. 1 of the customs treatment referred to above. The medicinal products must be prescribed or provided in the form of disposing devices and only one-night device shall be ordared per one-night device. The gland.

§ 27. When the veterinary surgeon for the treatment of bovine animals uses and for treatment is provided or prescribing other antibiotics other than simple penicillin, the veterinarian must take out milk for bacteriological examination and resistance to resistance before treatment is initiated. The milk sample must be analysed by the veterinary surgeon or a laboratory with an accredited method.

Chapter 7

Applicability, extradition and prescribing of antiparasitic medicinal products

§ 28. For the treatment of animals, the veterinarian may, however, be referred to in paragraph 23, 1, and section 24 (4), 1 5, extraditing or prescribe antiparasitic medicinal products for the execution of one treatment of the animal or animal for which the veterinarian has made a diagnosis.

Paragraph 2. Antiparasitic medicinal products may, in exceptional circumstances, be used, provided or prescribed without any prepares of parasitic stress. In such cases, the veterinarian must keep records which justify the use, extradition or the prescribed. The records shall be kept for five years and shall be presented to the inspection authority at the request of the requesting or extraditing authority.

Chapter 8

Preventive processing

§ 29. Medicinal products approved for the marketing of animals for preventative treatment may be used, provided or prescribed without any disease prior to the condition that the veterinarian has such knowledge of the animal or animal ' s animal or animal ' s animals ; state of health that it is perfectly justifiable to submit the medicinal product to the animal or the animals, cf. however, paragraph 1 3.

Paragraph 2. The vet can, regardless of paragraph. 1, in the case of statutory vaccination, extradited or prescribe a vaccine without having a special knowledge of the crew and to the health of the animals.

Paragraph 3. Antibiotic medicinal products are not covered by paragraph 1. 1.

Paragraph 4. In specific cases, the Food Authority may grant an exemption to the use of medicinal products other than those referred to in paragraph 1. One mentioned.

Chapter 9

Reception of prescription medicinal products

-$30. The veterinarian may only prescribe the residues of prescription-only medicinal products within the period of the prescribed period and on condition that the veterinarian is placing a new visit to the crew and thereby ;

1) personally, a current diagnosis shall be made available for the reage of the prescribed medicinal products concerned ; or

2) in the knowledge of the crew, evaluate that processing requirements will occur within the period of the next coordination period.

Paragraph 2. Reoration assumes that the veterinarian is once again giving the crew responsible for a demonstration in accordance with the instructions of the veterinarian. $35.

Chapter 10

Treatment of equidae with medicinal products for which a maximum threshold is not fixed,

§ 31. If there is no suitable medicinal product for the treatment of horses, the veterinary surgeon may use substances listed in the Annex to Commission Regulation (EC) No 2 under his direct personal responsibility. 1950/2006 of 13. In December 2006, laying down a list of substances which are indispensable for the treatment of the equine family. Applicable use shall be made in accordance with the provisions of this Regulation, including the fixing of a minimum withdrawal period of not less than 6 months. If the horse has a passport with Section IX, the veterinarian must fill in the section IX of the passage, Part III.

§ 32. There is no suitable medicinal product, cf. section 3-5 and section 31, the veterinary surgeon for the treatment of horses using substances of active substances which are not listed in Table 1 of Annex to Commission Regulation (EU) No 1 may be used. 37/2010 of 22. December, 2009.

Paragraph 2. The veterinarian shall be treated for the treatment of horses in accordance with paragraph 1. 1, at the latest in relation to the treatment, mark the horse with a microchip (transponder). The transponder must be implanted at the centre of the centre in the centre of the horse between the neck and the mane in the transition between muscle and spasm, cf. Article 11 (1). TWO, ONE. in the Commission Regulation No 2, 504/2008 of 6. June 2008 on the implementation of Council Directive 90 /426/EEC and 90 /427/EEC in respect of methods for the identification of equidae. The transponder must be placed on the left side of the horse's neck.

Paragraph 3. Exempted from paragraph 1. Two are horses that pre-treatment are labelled with microchip.

Paragraph 4. In the context of the treatment, the veterinary certification and animal owner, with his signature, confirm that the treatment excludes the horse from the use of human consumption.

Paragraph 5. If the horse has a passport with Section IX, the veterinarian must, in the course of processing, complete the section IX, Part II, cf. Article 20 of the paragraph in paragraph 1. 2 mentioned Regulation. If the horse is labelled with microchip in connection with the treatment, the veterinarian must inform it of the horse in question the carpting of the chip number for the registration of the ICC in accordance with the relevant database. the one in paragraph 1. 2 mentioned Regulation.

Paragraph 6. If the horse does not have a passport with section IX, the veterinarian must, in the course of processing, complete the form "Declaration on Hestes from human consumption" which may be obtained on the Food Management home page at the following address : www.fvst.dk under " Blanquettes & Certificates '. The veterinarian must send the statement with the one self-adhesive label with the bar code of the chip on it for the horse in question, at the same time, at the request of the owner to issue a passport for the horse, cf. Article 5 of the paragraph in paragraph 1. 2 mentioned Regulation, or updating the passport with Title IX. The veterinarian must submit the declaration no later than two days after the treatment.

Paragraph 7. At the same time, the veterinarian must insert the other self-adhesive label with the chip code of the passport in the passport in the box ' Identification marking (wood-, freeze, or Smartbranding) `.

Paragraph 8. Horses before the entry into force of this notice have been excluded from human consumption shall continue to be accompanied by a 'Veterinary and Owning Animal Family Animal Health certificate treated with medicinal products excluding the animal from human consumption' until such time as there is issued a passport for the horse in accordance with the provisions referred to in paragraph 1. This Regulation shall show the exclusion of the horse from which the horse is excluded from human consumption. In the process of re-examination, as described in paragraph 1, 1, the owner must anchor the horse in the forefront of the passport in accordance with the provisions of paragraph 1. 2 mentioned Regulation.

Chapter 11

Holding times

§ 33. When the veterinary surgeon for food-producing animals uses or on the instructions, cf. § 35, paragraph. 2, shall indicate a higher dose of a medicinal product other than specified in the approved product summary, the veterinarian must provide for an appropriate longer withdrawal time to ensure that residues are not present that exceed the maximum limit values, when : The retention time has expired.

§ 34. Where the animal species concerned is not given a detention period for the medicinal products referred to in section 4, the veterinary surgeon for treated animals whose meat or products is intended for human consumption may in any case provide for an adequate detention period. This withdrawal period shall be at least :

1) Twenty-eight days before slaughter,

2) 7 days before the supply of milk and eggs ; and

3) 500 gradual days, e.g. 100 days at 5 ° C water temperature before delivery of fish.

Paragraph 2. The detention time referred to in paragraph 1. 1, shall be set to zero for homeopathic medicinal products for animals whose active substances are included in Table 1 of Annex to Commission Regulation (EU) No 2 ; 37/2010 of 22. In December 2009, with a comment that MRLs are not required.

Chapter 12

The veterinarian's records, listing and reporting to Vetstat

$35. In the case of use, extradition or prescribing of prescription-only medicinal products for production animals, the veterinarian must carry out a legible record of the following :

1) Name and approval number of the veterinarian,

2) the name and address of the crew responsible ;

3) the CHR number in which the animals are located ;

4) the and the number of animals treated / processing (unique identification or, if this is not possible, number, weighing and stinting or stables, or similar division),

5) the products used, provided or prescribed, and the quantity thereof,

6) date of use, extradition or coordination ;

7) the exact indication of the dosage, administration and processing period of the medicinal products,

8) the diagnosis made, and

9) they announced the withdrawal times.

Paragraph 2. The veterinarian must provide written, legible instructions, with the information provided for in paragraph 1. 1, for the crew responsible.

Paragraph 3. In order to be prescribed for more than 5 days, the veterinarian must also give written instructions to the crew responsible for :

1) Clinical symptoms to be observed before treatment begins,

2) the period of coordination ;

3) what is agreed in order to resolve the problem, so that the need for treatment is terminated, and

4) the grounds for which the animals are deemed to be in a well-defined disease ' s incubation phase, as defined in the case of the animals, in accordance with the explanatory statement of the animal. section 22, or that the disease will spread to the crew.

Paragraph 4. The view must be signed by the veterinarian. In order to be provided and prescribed, the instructions shall also be signed by the person responsible for the crew.

Paragraph 5. The veterinarian shall, for five years after the date of use, extradition, the prescribing or reage of prescription-only medicinal products, together, and in the date order, keep copies of instructions and request for exhibitions or extradited ; these for the inspection authority.

Paragraph 6. The treatment of horses finds paragraph 1. 1, no. 3, not applicable.

Paragraph 7. In the treatment of fur animals, paragraph 1 shall apply. 1, no. 9, do not apply.

Paragraph 8. In the case of prescription-only medicines for the treatment of aquaculture animals for up to 10 days, paragraph 1 shall apply. 3 shall not apply.

Niner. 9. Medicinal products approved for the marketing of animals for preventive treatment have been excluded from the requirement for instructions. However, this does not apply to antibiotic-containing medicines.

§ 36. At least once a month, the veterinarian must report information on any use or supply of prescription-only medicines, including vaccines and sera, to the production animals to the Vetstat. This information shall include the following :

1) Date of use or extradition,

2) the veterinary approval number of the veterinarian ;

3) the CHR number of the crew,

4) the product ' s product number,

5) the quantity used,

6) code for animal species, cf. Annex 1,

7) age group code, cf. Annex 1, and

8) Coordination group code, cf. Annex 1.

Paragraph 2. The veterinarian shall electronically report the information referred to in paragraph 1. One, to the Vetstat. All data for a calendar month must be reported by the 10th year at the latest. in the following month. The veterinarian must keep the data for at least one year after notification and on request foresee, or extraditing them to the inspection authority.

Paragraph 3. The obligation to report in paragraph 1. 1 and 2 shall not apply to horses.

Paragraph 4. The CHR number that is reported, cf. paragraph 1, no. 3, shall be the CHR number in which the animals in question are located.

§ 37. veterinarians must conduct a logbook of all advice visits to herds covered by a health advisory agreement. The log book must have sequential numbered, fixed pages, and run in the date order.

Paragraph 2. For each advisory visit, the logbook shall at least be recorded as follows :

1) Date of the visit,

2) the date of the visit,

3) the date of completion of the visit,

4) Signature of the veterinarian,

5) the CHR number of the crew, and

6) the signature of the crew responsible.

Paragraph 3. The veterinarian must keep the logbook for two years from the date of the visit and request for the inspection, or to extradited it to the inspection authority.

Chapter 13

Procurement, storage, use, extradition and prescribing of prescription-only medicinal products for animals

§ 38. veterinarians must buy prescription medicines at pharmacies or other medicinal products approved by the Medicinal Products Agency.

Paragraph 2. veterinarians must keep medicinal products at the time of the practice, under clean and decent conditions and inaccessible to them.

Paragraph 3. Medicinal products must not be repoured or wrapped, cf. however, section 39 (4). 4.

§ 39. When the veterinary medicinal product is supplying medicinal products to production animals, the veterinary surgeon must supply the packaging with the following information :

1) CHR number,

2) the name of the crew responsible,

3) animal species,

4) set hold time,

5) date of delivery, and

6) the authorization number of the veterinarian.

Paragraph 2. When the veterinarian extradies medicinal products to other animals other than production animals, the veterinary surgeon must supply the packaging with the following information :

1) Name of the animal owner,

2) animal species,

3) diagnosis,

4) dosage, administration and processing period,

5) date of delivery, and

6) the authorization number of the veterinarian.

Paragraph 3. The information that, cf. paragraph Paragraph 1 and paragraph. In the case of medicinal products, the packaging shall be read in accordance with a label placed on the packaging. If the packaging is made up of several parts, the label shall, as far as possible, be placed on the inside wrapping.

Paragraph 4. In the case of the supply of medicinal products, the veterinarian may not breach the outer packaging for the fragmentation of the wrapping in smaller packs (inpacks) unless these are fitted with separate item number and, by the way, with the same information, as the original outer packaging.

Paragraph 5. In the case of the supply of medicinal products to horses, paragraph shall be 1, no. One, do not apply.

Paragraph 6. In the supply of fur animals, paragraph 1 shall apply. 1, no. Four, not use.

Paragraph 7. Information referred to in paragraph 1 1 may be replaced by a pre-printed label with a numbered system, which clearly refers to the particular reference in question, cf. $35.

§ 40. veterinarians shall, by means of use or of supplying medicinal products for the treatment of animals other than production animals, fix the price of the consumer for the used or delivered packing as referred to in section 1 in the notice of the calculation of consumer prices and so on on medicinal products.

Paragraph 2. For medicinal products for production of production, cf. Article 60 (3) of the medicinal product. 3, the consumer price of the veterinarian's purchase price from a pharmacy or establishment approved for the negotiation of such medicinal products according to Article 39 of the medicinal product.

Paragraph 3. When the veterinarian uses or delivers a package that forms part of a multipacking, the consumer price must be calculated proportionately from the consumer price of the multipaca.

Paragraph 4. When the veterinarian is only using part of a package, the consumer price must be calculated proportionally from the consumer price of the packing used with an appendix of 10%.

§ 41. veterinarians using or supplying magistrell produced medicinal products shall calculate the price of the consumer for the used or delivered packing after Article 8 in the notice on the calculation of consumer prices etcetera on medicinal products.

§ 42. In addition, in the case of the supply of medicinal products, veterinarians may charge up a fee up to 5%. of the consumer price.

§ 43. The veterinarian must ensure that payment for the medicinal products used and the medicinal products delivered shall not be paid in payment for granted veterinary medical treatment. In the case of bills, the amount shall be shown separately with the name of the medicinal product and the quantity used and the quantity used for each individual supplied or used.

Chapter 14

Penalty and effective provisions

§ 44. With fine punishment, the one who :

1) Clause section 3, section 4, paragraph 4. 1, section 5, sections 9-16, section 17, paragraph. 1-4, section 18, paragraph 18. 1, section 19-20, section 21, paragraph. 1, § § 22-25, section 26 (4). paragraphs 1, 3 and 4, section 27 to 28, section 29 (4). One and three, section 30-31, section 32, paragraph. 2 and paragraph 1. 4-8, section 33, section 34, paragraph. 1, section 35 (4). 1-5 and paragraph 1. 9, section 36, paragraph. Paragraph 1 and 2 and paragraph 3. 4, section 37-38, section 39, paragraph. 1-4, and section 40-43,

2) infringe Article 16 of Regulation (EC) No, 470/2009 on Community procedures for the establishment of limit values for residues of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2 ; Council Regulation (EC) No 2377/90 and amending Parliament and Council Directive 2001 /82/EC and of the European Parliament and of the Council. 726/2004, or

3) shall not comply with the conditions laid down in Article 4 (1). 2, section 17, paragraph. 5, or Section 29 (3). 4.

Paragraph 2. For the infringement of the provisions set out in paragraph 1. The penalty shall be 1 in accordance with section 38 (1). 4, in the case of veterinarians, to prison for up to two years, if by the action or omission, the offence has been committed with a set of or gross negligence, and there is a breach in the infringement proceedings ;

1) any injury to human or animal health or induced danger ; or

2) obtained or intended for the economic benefit of the person concerned itself or others, including in savings.

Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

§ 45. The announcement shall enter into force on 1. July, 2010.

Paragraph 2. At the same time, notice No 482 of 29. May 2007 on the use, extradition and prescribing of medicinal products for animals.

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Appendix 1

Codes for use by reporting to the Vetstat, cf. § 36, paragraph. 1, no. 6-8

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Appendix 2

List of magus medicinal products, cf. Section 4 (4). 1, no. 3

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Appendix 3

List of banned substances

List A : Messente substances

Thyreostatics

Stillbenes, stilts derivatives, salts and esters

Østradiol 17 beta and ester-like derivatives thereof

List B : Prohibied substances with exceptions

Beta-agonists.

1) The notice contains provisions that implement parts of Council Directive 96 /22/EEC of 29. April 1996 banning the use of certain substances having a hormonal and thyrostatic action and of beta-agonists in livestock farming and repealing Directives 81 / 6 0 2 / EEC, 88 /146/EEC and 88 /299/EEC (OJ 1996 L 125 s. Directive 3), as last amended by Directive 2008 /97/EC of the European Parliament and of the Council of 19. November 2008 (EUT 2008, L318, p. 9). Furthermore, parts of Council Directive 96 /23/EC of 29 are implemented. April 1996 on the control measures to be implemented for certain substances and residues thereof in live animals and their products and repealing Directives 85 /358/EEC and 86 /469/EEC and Decides 89 /187/EEC and 91 /664/EEC (OJ 1996 L125 s. Regulation (10), as last amended by Regulation (EC) No, 596/2009 of 18. June 2009 (EUT 2006, L188, p. EUR 14), and parts of Directive 2001 /82/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community Code for Veterinary Medicinal Products (OJ 2001, L311, s. Regulation (1), as last amended by Regulation (EC) No 2 of the European Parliament and Council. 596/2009 of 18. June 2009 (EUT 2006, L188, p. 14). The notice has been reproduced by Regulation (EC) No 2 of the Regulation of the European Parliament and of the Council. 470/2009 on Community procedures for the establishment of limit values for residues of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2 ; Council Regulation (EC) No 2377/90 and amending Parliament and Council Directive 2001 /82/EC and of the European Parliament and of the Council. EUR 726/2004 (EUT 2009, L152, s. Commission Regulation (EC) No 11 (11) and Commission Regulation 504/2008 of 6. June 2008 on the implementation of Council Directive 90 /426/EEC and 90 /427/EEC in respect of methods for the identification of equidae (EUT 2008, L149, s. 3). -Yeah. Article 249 of the EC Treaty shall apply to a Regulation immediately in each Member State. The rendition of these provisions in the notice is therefore justified in practical terms and does not affect the immediate validity of the said Regulations in Denmark.