By Royal Decree 488/2010 of 23 April 2010 on the protection of animal health products, the regulatory regulation in this field was adapted to the changes introduced in this respect in Law 8/2003 of 24 April 2002 on health Animal health products, including animal and animal health products, intended for the specific application of animal health products, are regulated in their development.

With the experience gained in its application, it is appropriate to make some modifications. On the one hand, it is appropriate to amend Article 12 in order to eliminate the authorisation of distributors and to specify the centres authorised to sell to the public authorities, as well as to adapt the models provided for in Parts A and B of the Annexes I and II thereto, to the current establishment plan of the Ministry of Agriculture, Food and the Environment.

On the other hand, in order to unify and clarify the information contained in these models, some of its headings and contents are modified, in order to improve and facilitate the processing of the application of the procedures.

Finally, two practical aspects have been observed that should reflect on this standard, and which, consequently, are changed, which refer to the products registered and to which they are to be imported.

The first, with respect to products that are already registered in the Zoosanitarios Register of Products (prior to authorization or after a responsible declaration, depending on the cases), it is a common practice for companies (to be registration of the product, the distributors, etc.), either because of the commercial requirements of the buyers, or because it is demanded by some Member States of the European Union or the third countries, voluntarily request certificates of free sale of the product, that is, that the same is of legal trade in Spain for being registered in the Register, subject to prior authorisation or prior submission of a responsible declaration. This aspect is not regulated in the rule, and you need to preview it in the actual decree, along with a request model for that certificate.

The second, when it is intended to import an animal health product in Spain (from a third country, which is therefore not part of the customs territory of the European Union), logically the same is not registered in the Register of Animal Health Products, therefore the importation (and registration of the product in the Register) must be authorized in advance, in order for the importer to accredit such fact to the Animal Health Inspection of the PIF of the port or airport where it will be the product entry in Spain. Contrary to the above case, this is an act for the importer, because he cannot import the product without that prior authorisation.

Therefore, a new article, the 11 bis, and a new paragraph in article 5 are introduced to contemplate both situations.

In the preparation of this provision, the autonomous communities and representative entities of the sectors concerned have been consulted.

In its virtue, on the proposal of the Minister of Agriculture, Food and Environment, with the prior approval of the Minister of Finance and Public Administrations, according to the State Council and prior deliberation of the Council of Ministers at its meeting on September 4, 2015,

DISPONGO:

Single item. Amendment of Royal Decree 488/2010 of 23 April 2010 on the control of animal health products.

Royal Decree 488/2010 of 23 April 2010 on animal health products is amended as follows:

One. A new paragraph 7 is added to Article 5, with the following content:

" 7. For the importation of an animal health product in Spain, the prior authorisation granted by the Directorate-General for Health of Agricultural Production shall be compulsory. Import applications shall be submitted in the format set out in Annex III.

However, in the case of a product other than the diagnostic reagents for animal diseases, the entry into the customs territory of the European Union has already been authorised in advance by the Commission. Another Member State shall accompany the application with the supporting documentation of such a fact, and the import authorisation shall be granted automatically. '

Two. A new article 11 bisis added, with the following content:

" Article 11a. Certificates of free sale and import.

All interested parties may, in respect of any product entered in the Register of Animal Health Products, voluntarily apply for a certificate of free sale of the same. Licence applications for the free sale shall be submitted in the format set out in Annex III. '

Three. Article 12 (1) is replaced by the following:

" 1. The distribution of the animal health products may be carried out directly from the working party to the end user, or through intermediary distributors.

For the purposes of Article 71 (2) of Law 8/2003, of 24 April, any establishment authorized for the sale of veterinary medicinal products as provided for in Royal Decree 109/1995 of 27 January 1995, veterinary medicinal products may distribute animal health products to the General Administration of the State and the Autonomous Communities without obtaining a specific authorisation. '

Four. The second final arrangement is replaced by the following:

" Final Disposition Second. Development and modification faculty.

The head of the Ministry of Agriculture, Food and the Environment is empowered to make the necessary provisions for the application and development of this royal decree.

The holder of the Ministry of Agriculture, Food and the Environment is also empowered to modify the models contained in the annexes of this royal decree. "

Five. Annexes I and II are replaced by Annexes I and II to this royal decree.

Six. A new Annex III is introduced, with the contents of Annex III of this royal decree.

Single end disposition. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, 4 September 2015.

FELIPE R.

The Minister of Agriculture, Food and the Environment,

ISABEL GARCÍA TEJERINA

ANNEX I

Marketing of animal health products

ANNEX II

Making and importing animal health products

LISTED 1

DISEASES, PHYSIOLOGICAL, BIOLOGICAL, ALLERGENIC AND OTHER PARAMETERS

A. Diseases:

1. ENZOOTIC ABORTION.

2. ACTINOBACILLUS PLEUROPNEUMONIAE.

3. CONTAGIOUS AGALAXIA.

4. ANAPASMOSIS CANINA.

5. AVIAN ANAEMIA.

6. EQUINE INFECTIOUS ANAEMIA.

7. ARTHRITIS ENCEPHALITIS.

8. EQUINE ARTHRITIS.

9. AUJESZKY.

10. BABESIOSIS.

11. CANINE BORRELIOSIS.

12. INFECTIOUS BRONCHITIS.

13. BRUCELLOSIS.

14. PORCINE CIRCOVIRUS.

15. CLAMIDOSIS.

16. CORONAVIRUS.

17. CRYPTOSPORIDIOSIS.

18. DERMATOPHYTOSIS.

19. BOVINE VIRAL DIARRHOEA.

20. DIROFILARIOSIS.

21. EHRLICHOOSIS CANINA.

22. CAPRINE ENCEPHALITIS.

23. AVIAN ENCEPHALOMYELITIS.

24. BOVINE SPONGIFORM ENCEPHALOPATHY.

25. TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES.

26. DISEASE OF THE BORDERS.

27. SCHMALLENBERG DISEASE.

28. AD MUCOSAL (MD).

29. SWINE VESICULAR DISEASE.

30. ENTRETITIS CANINA.

31. FOOT-AND-MOUTH DISEASE.

32. RIFT VALLEY FEVER.

33. Q. Q.

34. GIARDIASIS.

35. GUMBORO.

36. HAEMOPHILUS PARASUIS.

37. FELINE HERPES.

38. BENIGN PROSTATIC HYPERPLASIA.

39. PARASITIC INFECTIONS.

40. AVIAN INFLUENZA.

41. SWINE INFLUENZA.

42. FELINE IMMUNODEFICIENCY.

43. LARINGOTRAQUEITIS.

44. INTRACELLULAR LAWSONIA.

45. LEISHMANIOSIS.

46. BLUE TONGUE.

47. CANINE LEPTOSPIROSIS.

48. FELINE LEUKAEMIA.

49. AVIAN LEUKOSIS.

50. ENZOOTIC BOVINE LEUKOSIS.

51. LOQUE AMERICAN.

52. EUROPEAN LOQUE.

53. MAEDI VISIT.

54. MAL ROJO.

55. MAMITIS.

56. MICOPLASMOSIS.

57. MYXOMATOSIS.

58. MOFillo.

59. MYCOPLASMA HYOPNEUMONIAE.

60. BOVINE NEOSSUPARE.

61. NEOSRENATION CANINA.

62. PORCINE ENZOOTIC PNEUMONIA.

63. NEWCASTLE.

64. FELINE PANLEUCOPENIA.

65. PARATUBERCULOSIS.

66. PARVOVIROSIS.

67. PORCINE PARVOVIROSIS.

68. FELINE INFECTIOUS PERITONITIS.

69. AFRICAN HORSE SICKNESS.

70. AFRICAN SWINE FEVER.

71. CLASSICAL SWINE FEVER.

72. PIROPLASMOSIS.

73. PLEURONEUMONIA.

74. PNEEUMOVIRUS AVIAR.

75. RABIES.

76. REOVIRUS.

77. INFECTIOUS BOVINE RHINOTRACHEITIS (IBR).

78. ROTAVIRUS.

79. SALMONELLA ENTERITIDIS.

80. SALMONELLOSIS.

81. SCRAPIE/SCRAPIE.

82. SWOLLEN HEAD SYNDROME (SHS).

83. FALL SYNDROME OF THE LAYING.

84. PORCINE REPRODUCTIVE RESPIRATORY SYNDROME (PRSS).

85. BOVINE SYNTICAL RESPIRATORY SYNDROME.

86. TOXOPLASMOSIS.

87. Trichinella.

88. TUBERCULOSIS.

89. INFECTIOUS PUSTULAR VULVOVAGINITIS (IPV).

90. WEST NILE.

B. ANALYSIS OF PHYSIOLOGICAL, BIOLOGICAL, BIOCHEMICAL, ALLERGENIC AND OTHER PARAMETERS:

91. BILE ACIDS AND HORMONES.

92. SUBCLINIC CETOSIS.

93. DETECTION OF ACUTE PHASE PROTEINS.

94. BILE ACID DETERMINATION.

95. THYROID FUNCTION.

96. MICROALBUMINURIA.

97. BIOCHEMICAL PARAMETERS.

98. PREGNANCY DIAGNOSIS.

99. PROGESTERONE LEVEL.

100. ALLERGIES (IG GE CANINA).

101. MICROORGANISM/IDENTIFICATION OF MICROORGANISMS.

LISTED 2

TARGET SPECIES OR GROUP OF SPECIES

1. CANIDS.

2. FELINOS.

3. BOVINE.

4. OVINOS.

5. CAPRINOS.

6. EQUINS.

7. PORCINOS.

8. RODENTS.

9. BUFALSE.

10. MUSTELIDS.

11. LAGOMORPHS.

12. Bees.

13. POULTRY.

14. EXOTIC/CAGE BIRDS.

15. REPTILES.

16. AMPHIBIANS.

17. PECES.

LISTED

TARGET SPECIES OR GROUP OF SPECIES

1. CANIDS.

2. FELINOS.

3. BOVINE.

4. OVINOS.

5. CAPRINOS.

6. EQUINS.

7. PORCINOS.

8. RODENTS.

9. BUFALSE.

10. MUSTELIDS.

11. LAGOMORPHS.

12. Bees.

13. POULTRY.

14. EXOTIC/CAGE BIRDS.

15. REPTILES.

16. AMPHIBIANS.

17. PECES.

ANNEX III