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By Royal Decree 488/2010 of 23 April, which regulates animal health products, adapted regulation policy in this field to changes in this respect in law 8/2003, of April 24, animal health, regulating, in its development, said animal health products, including material and animal health tools intended for the application specifies of animal health products.
With the experience gained in its application, is suitable make some modifications. On the one hand, it is useful to modify article 12 to delete the authorization of distributors authorized to sell to the public administrations, as well as to adapt the models laid down in parts A and B of annexes I and II of the same, to the current organizational chart of the Ministry of agriculture, food and environment.
On the other hand, in order to unify and clarify the information contained in those models, amending some of its headings and content, in order to improve and facilitate the processing of the application procedures for citizens.
Finally, observed two practical aspects that need to be reflected in this standard, and that, as a result, pass to be modified, which refer to registered products and it will import.
He first, with regard to them products that already are registered in the register of products animal health (prior authorization or prior statement responsible, according to them cases), is a practice usual that them companies (are them holders registry of the product, them distributors, etc.), well by demands commercial of them buyers, or because so it require some States members of the Union European or them third countries , request voluntarily certified free sale of the product, i.e., that it is of lawful trade in Spain for being registered in the prior authorization or upon presentation of a responsible statement. This aspect is not regulated in the standard, and it is necessary to provide for it in the Royal Decree, together with a model of application for that certificate.
He second, when is aims to import a product animal health in Spain (from a country third, that therefore not form part of the territory customs of the Union European), logically the same not is registered in the register of products animal health, by what must authorize is previously it import (e sign is the product in the record), so the importer accredits such made before the inspection of Health Animal of the PIF of the port or airport by where goes to have input the product in Spain. Unlike that in the case above, is is of an Act obliged for the importer, because not can import the product without that prior authorization.
Therefore, it introduces a new article, the 11 bis, and a new paragraph in the article 5To contemplate both situations.
In the elaboration of this provision have been consulted them communities autonomous and them entities representative of the sectors affected.
By virtue, on the proposal of the Minister of agriculture, food and environment, with the prior approval of the Minister of finance and public administration, in accordance with the Council of State and after deliberation by the Council of Ministers at its meeting of September 4, 2015, HAVE: single article. Modification of Royal Decree 488/2010 of 23 April, which regulates animal health products.
He Royal Decree 488 / 2010, of 23 of April, by which is regulate them products animal health, is modified as follows: one. Added a new paragraph 7 to article 5, with the following content: "7. for the importation of an animal health product in Spain, will be mandatory prior authorization granted by the General direction of health of the agricultural production." Import applications should be submitted on the model provided for in annex III.
However the above, in the case of a product other than the reagents for diagnosis of the diseases of animals, whose entry into the customs territory of the European Union has already been authorized in advance by another Member State, will be accompanied to request supporting documentation of that fact, and the import authorisation shall be granted automatically.»
Two. Added a new article 11 bis, with the following content: «article 11 bis.» Certificates of free sale and of import.
All interested can, with regard to any product registered in the register of products animal health, request voluntarily a certificate of free sale of the same. «The requests of certificate of the free sale is presented in the model planned in the annex III.»
Three. The paragraph 1 of the article 12 is replaces by the following: «1. the distribution of them products animal health may perform is directly from the entity processing to the user end, or through distributors intermediaries.»
«To them effects of the paragraph 2 of the article 71 of the law 8 / 2003, of 24 of April, any establishment authorized for the sale of drugs veterinary according to it planned in the Real Decree 109 / 1995, of 27 of January, of drugs veterinary may distribute products animal health to the Administration General of the State and them communities autonomous without need of obtain an authorization specific.»
Four. The available final second is replaces by the following: «provision final second.» Faculty of development and modification.
It empowers the holder of the Ministry of agriculture, food and environment to enact the provisions necessary for the implementation and development of this Royal Decree.
Also empower the holder of the Ministry of agriculture, food and environment to modify the models contained in annexes to this Decree.'
5. It replaces annexes I and II by annexes I and II of this Royal Decree.
6. Introduces a new annex III, with the content of annex III of this Royal Decree.
Sole final provision. Entry into force.
This Royal Decree shall enter into force the day following its publication in the "Official Gazette".
Given in Madrid, on September 4, 2015.
The Minister of agriculture, food and environment, ISABEL GARCÍA TEJERINA ANNEX I ANNEX II manufacture animal health products marketing and import of animal health products LIST 1 DISEASE, PHYSIOLOGICAL, BIOLOGICAL PARAMETERS, ALLERGENS, and OTHER a. DISEASES: 1. ABORTION ENZOOTIC.
2. ACTINOBACILLUS PLEUROPNEUMONIAE.
3. CONTAGIOUS AGALACTIA.
4. CANINE ANAPLASMOSIS.
5. AVIAN ANEMIA.
6. EQUINE INFECTIOUS ANEMIA.
7. ARTHRITIS ENCEPHALITIS GOATS.
8. ARTHRITIS EQUINE.
11. BORRELIOSIS CANINE.
12. BRONCHITIS INFECTIOUS.
14. CIRCOVIRUS SWINE.
19. BOVINE VIRAL DIARRHEA.
21. CANINE EHRLICHIOSIS.
22. GOAT ENCEPHALITIS.
23. AVIAN ENCEPHALOMYELITIS.
24. BOVINE SPONGIFORM ENCEPHALOPATHY.
25. TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES.
26. DISEASE OF BORDERS.
27. DISEASE OF SCHMALLENBERG.
28. DISEASE MUCOSAL (MD).
29. DISEASE VESICULAR SWINE.
30. ENTERITIS CANINE.
31. FEVER AND MOUTH DISEASE.
32. FEVER OF THE VALLEY OF THE RIFT.
33. FEVER Q.
36 HAEMOPHILUS PARASUIS.
37 FELINE HERPES.
38. BENIGN HYPERPLASIA OF PROSTATE.
39. PARASITIC INFECTIONS.
40. AVIAN INFLUENZA.
41. SWINE FLU.
42 FELINE IMMUNODEFICIENCY.
44. INTRACELLULAR LAWSONIA.
46. TONGUE BLUE.
47. LEPTOSPIROSIS CANINE.
48. LEUKEMIA FELINE.
49. ENZOOTIC AVIAN.
50. ENZOOTIC BOVINE LEUKOSIS.
51. WHAT AMERICAN.
52. FOULBROOD EUROPEAN.
53. MAEDI VISNA.
54. EVIL RED.
59 MYCOPLASMA HYOPNEUMONIAE.
60. BOVINE NEOSPOROSIS.
61. CANINE NEOSPOROSIS.
62. SWINE ENZOOTIC PNEUMONIA.
64 FELINE PANLEUKOPENIA.
67. PARVOVIRUS PORCINE.
68. PERITONITIS INFECTIOUS FELINE.
69. AFRICAN HORSE SICKNESS AFRICAN.
70. PLAGUE SWINE AFRICAN.
71. PLAGUE SWINE CLASSIC.
74. PNEUMOVIRUS AVIAN.
77 INFECTIOUS BOVINE RHINOTRACHEITIS (IBR).
79 SALMONELLA ENTERITIDIS.
82 (SHS) SWOLLEN HEAD SYNDROME.
83 FALL OF PUTTING SYNDROME.
84. PORCINE REPRODUCTIVE RESPIRATORY SYNDROME (PRSS).
85. SINTICIAL BOVINE RESPIRATORY SYNDROME.
89 VULVOVAGINITIS PUSTULAR INFECTIOUS (IPV).
90 WEST NILE.
B. ANALYSIS OF PARAMETERS PHYSIOLOGICAL, BIOLOGICAL, BIOCHEMICAL, ALLERGENS, AND OTHER: 91. BILE ACIDS AND HORMONES.
92. SUBCLINICAL KETOSIS.
93. DETECTION OF ACUTE-PHASE PROTEINS.
94 DETERMINATION BILE ACIDS.
95. THYROID FUNCTION.
97. BIOCHEMICAL PARAMETERS.
98. DIAGNOSIS OF GESTATION.
99 LEVEL OF PROGESTERONE.
100 ALLERGY (CANINE IG GE).
101 ANTIBIOGRAM/IDENTIFICATION OF MICROORGANISMS.
LISTING 2 SPECIES OR GROUP OF SPECIES OF DESTINATION 1. CANIDS.
3. BOVINE ANIMALS.
14. EXOTIC BIRDS / BIRD CAGE.
SPECIES OR GROUP OF SPECIES OF DESTINATION 1. CANIDS.
3. BOVINE ANIMALS.
14. BIRDS EXOTIC / BIRD'S CAGE.
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