JOHN CARLOS I

KING OF SPAIN

To all who present it and understand it.

Sabed: That the General Courts have approved and I come to sanction the following Law.

EXPLANATORY STATEMENT

Animal health legislation has had its fundamental basis in the Epizootic Act of 20 December 1952 and in the implementing Regulation adopted by Decree of 4 February 1955 and has constituted an instrument of great value in the prevention, control and control of animal diseases, both epizootic and enzootic, which were settled in the first half of the last century in Europe and in the world.

The important socio-political, economic and technological changes that have occurred in recent years have made it necessary to update and adapt legislation to the new guidelines of national and context

The main structural changes produced, which affect animal health in full, are as follows:

(a) The modification of the structure of the State, with the implementation of the State of the Autonomies, and the assumption by the autonomous communities of exclusive competence in the field of animal husbandry, as well as of legislative development and implementation of the basic State legislation on animal health.

b) The incorporation of Spain, as a full member, to the European Union.

(c) The disappearance of internal borders between Member States for intra-Community trade, which increases the risk of the spread of infectious diseases of animals and other diseases.

(d) The application of a new technology in order to reduce production costs and to make farms viable from an economic point of view, which has led to the concentration of animal populations, with the the risk of increasing the spread of diseases, and which has led to what is known as the "pathology of mass caterers", with the greatest danger, both for the domestic and wild animal populations, and for the human population.

e) The need for livestock farms whose activity is respectful of the environment and the natural environment, in particular from the point of view of the proper management of the waste.

Therefore, it is essential to enact a new Law on Animal Health in which all these cases are contemplated, and to contribute to facilitating the prevention and rapid eradication of any disease.

I

Animal health is considered a key factor in the development of livestock farming, and it is vital to both the national economy and public health, as well as to the maintenance and conservation of animal diversity. of animal species. For public health, for the possible transmission of diseases from animals to humans, and for the harmful effects which may cause the use of certain products in order to increase animal productivity.

For the national economy, not only because of the direct losses that the disease produces on the affected farms, but also because of the indirect losses that arise from the restrictions that can be produced in the markets internal and external to the affected animals and their products, determining the use of important State resources and, in extreme cases, being able to acquire proportions whose consequences could well be qualified catastrophic.

The situation of contagion between the same species of domestic and wild animals for the same disease, as well as the possible creation of reservoirs in the natural environment, make the health actions inseparable both in a medium as in another. Epizootic diseases, even in their milder concept, can have much more serious consequences in the natural environment, and can affect the entire ecological pyramid and cause irreparable damage to wildlife.

II

The establishment of an intra-Community market without frontiers makes it necessary to avoid, as far as possible, the introduction of diseases in Spain from the external markets, by regulating the Health at the border, as a first defensive barrier, formed by well-informed veterinarians of the behavior and evolution of the exotic diseases worldwide, that participate quickly in their control, complemented with the necessary coordination between Spanish public administrations with powers in the field of animal health. To this end, the necessary methods of detection and with human equipment prepared and framed in a structure that allows, within the framework of the current legislation, to act quickly and effectively to jugular any of the epizootic disease that may appear.

Specifically, the need to implement and maintain the techniques of diagnosis of exotic diseases and the ceparians of the pathogens that produce them, as well as to manage them within maximum conditions biological safety, coordinating and approving the techniques of all the laboratories involved, and promoting the continuing training of the technical staff employed in them, requires the designation of central health laboratories. animal.

The rules of action before the introduction of epizootic diseases attach great importance to the immediate knowledge of any disease outbreak and to the rapid and effective action of public administrations through coordination. of their actions and the availability of adequate means, including the possibility of immediate slaughter of animals who are sick or suspected of being, and the fair and compensatory compensation to the particular affected, importance in the law.

III

There is no doubt that the basis of good animal health is in the existence of adequate health management in the productive sector. The establishment of basic sanitary conditions on farms, support for the creation of livestock health advocacy groups and the regulation of health status deserve special consideration in the law.

International organisations such as the Food and Agriculture Office (FAO) and the International Office of Epizootics (OIE) have warned the European Union of the serious increase in the risk of epizootic diseases due to the increase in trade relations and the increase in the number of animals in the long distance. It is therefore considered essential to determine the hygienic and sanitary conditions of transport, as well as the health regulations of those cattlemen and, with special attention, the centres of animal concentration, where the Meeting and subsequent dispersal of animals involve additional health risks of particular importance.

Another important element in the animal preventive health chain is represented by the slaughterhouses, epidemiological observation centres that allow to guide the actions in the field of animal health.

For this reason, it is necessary to establish coordinated systems that timely channel the information that is generated in them, so that it serves as a reference for the plans and actions in the field of animal health.

IV

The pharmaceutical industry has made it available to produce powerful and effective products to preserve health, but which may have a significant adverse effect on the consumer of meat or livestock products when they are (i) the Commission is not prepared to take the necessary steps to ensure that the animal body is removed from the market. For this reason, it is necessary to monitor their application, as well as the withdrawal waiting time and the control of drug levels in products intended for consumption. In addition to ensuring the economic objectives, the health of meat and livestock products at the time of consumption is guaranteed.

The prior administrative authorisation of animal health products should also be regulated, with particular attention to the limitations on the holding of diagnostic reagents for the diseases of animal diseases. national action programmes.

Finally, the necessary prior administrative authorisation for animal feed cannot be forgotten, given the importance it attaches to animal health, as well as to public health.

V

Even if this law seeks to improve animal health by means of a preventive system that is effective in preventing the occurrence and development of diseases, there will always be actions that, in a negligent or intentional manner, Violate established rules.

Consequently, it is necessary to establish a sanctioning system, which is also justified by the need for full integration of Community rules into the internal legal system, while at the same time providing for necessary controls and inspections to ensure compliance with the law, granting authority to the acting inspectors.

VI

Finally, the competition rates of the General Administration of the State in the field of animal health are regulated, in compliance with the principle of legality.

This law is issued under the provisions of Article 149.1.10.a, 13.a, 14.a, 16. and 23.ade of the Constitution, which reserves the State exclusive competence in matters of foreign trade, bases and coordination of the general planning of economic activity, general finance, external health, bases and general coordination of health and legislation on pharmaceutical products, and basic legislation on environmental protection, respectively.

TITLE I

General provisions

Article 1. Purpose and purpose of the law.

1. This law aims to:

(a) The establishment of the basic standards and coordination in the field of animal health.

b) The regulation of external health as regards animal health.

2. They are the purposes of this law:

(a) Prevention, control, control and eradication of animal diseases.

b) The health improvement of animals, their holdings, their products and the fauna of natural ecosystems.

(c) Prevention of the introduction into the national territory, and in the rest of the European Union, of animal diseases, also preventing the spread of existing ones.

(d) The protection of human and animal health by means of the prevention, control and, where appropriate, eradication of diseases of animals susceptible to being transmitted to the human species or involving health risks to compromise the health of consumers.

e) The prevention of risks to human health arising from the consumption of foodstuffs of animal origin which may be carriers of harmful or fraudulent substances or additives, as well as harmful residues of animal health products or any other elements of use in veterinary therapy.

(f) The prevention of animal health risks arising from the incorrect use of animal health products, the administration of harmful products and the consumption of products for animal nutrition containing substances capable of triggering the occurrence of diseases in animals.

g) The assessment of risks to animal health in the national territory, taking into account existing scientific evidence and evidence, relevant production processes and methods, economic activity underlying, loss of income, relevant methods of inspection, sampling and testing, prevalence of specific diseases, existence of disease-free zones and ecological and environmental conditions.

h) Achieve an optimal level of protection of animal health against its potential risks, taking into account the economic factors of livestock activity and, among them, possible injury to loss of production or sales in the event of entry, spread or spread of a disease, control or eradication costs and the cost-benefit ratio of other possible methods to limit the risks.

Article 2. Scope.

The scope of this law includes:

(a) All animals, holdings and crops, as well as their specific and derived products.

(b) Animal health products, animal feed products and other means of animal production in respect of their manufacture, storage or preservation, transport, marketing, application or supply and residual presence, where appropriate, in animals and products of animal origin.

(c) Livestock accommodation, land, grassland, ponds and natural ecosystems, aquaculture holdings, facilities and tools, materials, means of transport and slaughter of animals, as well as storage or storage of their productions.

d) The activities of natural or legal persons, of a public or private nature, insofar as such activities are related to any of the purposes of this law.

Article 3. Definitions.

To the object of this law, it is understood by:

1. Health protection group: the association of owners or holders of holdings of animals constituted for the raising of the sanitary and productive level and the improvement of the zootechnical conditions of their holdings, by means of establishment and implementation of programmes for the prevention, control of animal diseases and improvement of their hygienic and productive conditions. For these purposes, agricultural cooperatives may also be constituted as health-defence groupings.

2. Production animals: animals for production, reproduction, bait or slaughter, including fur animals or for hunting or for hunting, keeping, priming or reared for the production of foodstuffs or products of animal origin for any industrial or other commercial or lucrative purpose.

3. Pet animals: animals held by man, provided that his or her tenure is not intended for consumption or for the use of his or her productions, or is not carried out in general for commercial or profit purposes.

4. Domestic animals: pet animals belonging to species that breed and traditionally have a man, in order to live in domestic domesticity, as well as those of accompanying, driving and helping people who are blind or with severe or severe visual impairment.

5. Wild fauna: the set of species, subspecies, population, and animal individuals that live and reproduce naturally in the wild in the national territory, including those in reverse or in passing, with independence of their autochthonous character or aloctone, and the possibility of their use of it. Animals of such species which are of a domestic character, bred for production or use of the same or their production or crops, and those for experimental or scientific research with the same species shall not be understood as including animals. proper authorization.

6. Competent authority: the competent bodies of the autonomous communities and the cities of Ceuta and Melilla; the competent bodies of the General Administration of the State in the field of external health and marketing authorization animal health products; and the competent bodies of local authorities in their own or complementary functions as Law 7/1985, of 2 April, Regulatory of Local Government Bases, and any other sectoral laws entrusts to those entities.

7. Centre for the concentration of animals: those plants, including holdings or certamenes, in which livestock from different holdings are gathered to form lots of animals for subsequent trade, competition or exposure, as well as animal testing centres.

8. Livestock event: that authorized activity in which the livestock is gathered in suitable facilities, for commercial transaction, for reproduction, bait or slaughter or for other use, or for display or display, or their assessment and subsequent award, where appropriate, and in which all the farmers or persons concerned may participate, which in each case meet the requirements required.

9. Enzootia: disease of animals with normal frequency or regular and constant presence in an animal population of a given territory.

10. Epizootic: infectious-contagious disease of animals that determines a significant and relatively rapid increase in the number of cases in a given region or territory.

11. Natural space bounded: any space or natural terrain that is fenced or signposted, preventing the passage of people beyond that. It corresponds to dehesas, rangelands, communal mountains, game reserves, natural parks, national parks, hunting grounds or any place subjected to special regime of animal or fishing animal exploitation.

12. Holding of animals: any installation, construction or, in the case of outdoor breeding, any place where animals are held, reared or handled or are exposed to the public, with or without profit. For this purpose, it shall be understood to include zoos, slaughterhouses and other places where the slaughter of animals is carried out, the centres in which taurine shows are carried out, the facilities of the commercial operators and the concentration centres.

13. Export: the departure of animals, products of animal origin, animal health products and products for animal nutrition, from the Spanish territory covered by the customs territory of the European Union, to third countries or to third territories.

The person, whether natural or legal, who applies for the export or, where appropriate, the completion of the veterinary inspection at the border referred to in Article 11 shall be considered as an exporter.

14. Focus: occurrence of a disease on a given farm or site. If this limitation is not possible, a focus is on the part of the territory in which it is not possible to guarantee that the animals have not been able to have any contact with the sick animals.

15. Import: the entry of animals, products of animal origin, animal health products and animal feed products in the Spanish territory covered by the customs territory of the European Union from third countries or from third countries third territories.

The person, whether natural or legal, who requests the importation or, where appropriate, the completion of the veterinary inspection at the border referred to in Article 12 shall be considered as an importer.

16. Integration: the livestock contractual relationship in which a party, called integrator, is obliged to provide the animals and/or products for animal nutrition, medical devices and veterinary assistance, and the other, called It provides the services of livestock housing, facilities, manpower and care to animals. For this purpose, the integrator or the integrated person may be natural or legal persons, including agricultural associative entities of any kind.

17. National reference laboratory: laboratory officially designated by the General Administration of the State for a particular disease of the animals or for a certain residue in products of animal origin, being responsible for the coordination of the necessary actions with the laboratories of all public administrations, in order to ensure that the results obtained in the field of this responsibility are homogeneous in all of them. This laboratory shall also comply with all other functions that are necessary and shall be detailed in its designation.

18. Animal health products: active substances or ingredients, as well as formulations or preparations containing one or more of them, intended for the diagnosis, prevention, treatment, alleviation or cure of diseases or diseases of the animals, to modify body functions, to induce or to strengthen the organic defences or to achieve reactions which show them, or to their use in the environment of animals or in activities closely related to their exploitation, in the fight against the vectors of animal diseases or against species unwanted animals, or products of specific use in the livestock field, in the terms laid down in the implementing rules.

This definition shall include, together with other animal health products, veterinary medicinal products and biocidal products for livestock use, which shall be governed by their specific rules of application, without prejudice to the provisions of this Regulation. expressly regarding them in this law.

19. Biocidal products for livestock use: those animal health products consisting of active substances or ingredients, as well as formulations or preparations containing one or more of them, used for veterinary hygiene purposes, intended for use in the environment of animals or in activities closely related to their exploitation.

20. Products of animal origin: any part of the animal, in a natural or transformed state, intended for human or animal consumption, or for technical or industrial uses.

Including ova, semen or embryos, derivatives or by-products of animal origin, embryos of animals, animal or animal trophies, excretions and animal carcasses shall be understood.

21. Products for animal feed: feed, premixtures, additives, raw materials and substances and products used in animal nutrition.

22. Official veterinarian: the veterinary master at the service of a public administration, for this purpose by the competent authority.

23. Approved or authorised veterinarian: the veterinary certificate recognised by the competent authority for the performance of the duties to be regulated, in particular by the veterinarian of the health defence groupings and the Farm veterinarian. The veterinary surgeon or veterinary undertaking which is in the service, whether or not exclusively on a temporary or permanent basis, for the provision of the services and tasks of the profession, shall be understood as a veterinarian. the veterinarian to be entrusted by the operator or responsible for the holding.

24. Border inspection post: any inspection post designated and approved by the Community rules and with facilities for carrying out veterinary checks prior to import or export.

25. Inspection centre: any separate installation or centre, including at a border inspection post, where veterinary checks are carried out prior to importation. Such centres shall in any case be included in the relevant customs offices. In addition, any premises authorised by the competent authority of the General Administration of the State where veterinary checks on the goods for export are carried out shall be deemed to be an inspection centre.

26. Quarantine centre: authorised premises, consisting of one or more separate units operating and physically, including or attached to a border inspection post, intended for the introduction of animals with the same health status, for keep them in isolation and clinical observation pending their health status.

27. Tracing: the introduction of animals of the species susceptible to an epizootic disease in all the lodgings of a holding or, where appropriate, of an area already healed, where animals affected by the disease were kept, with the object of evidence the non-persistence of the causal agent.

28. Residues in products of animal origin: any substance, including its metabolites, which remains in the production or in the animal, and, after slaughter, in any of its tissues as a result of treatment, intake or exposure of the animal animal, including environmental contaminants, or as a result of the administration of unauthorised substances or products.

29. Waste of special treatment: packaging of medicines, vaccines, expired medicines, disposable syringes and all kinds of scanning or application utensils, as well as disposable surgical material.

30. Operating by-products: any removable organic material generated in the holding of animals, such as manure, slurry, litter and altered feed unfit for consumption.

31. Vector: means transmitter, mechanical or biological, which serves as the transport of pathogens from one animal to another.

32. Zoonoses or anthropozoonoses: disease transmitted from animals to humans, and vice versa, in a direct or indirect form.

Article 4. Principle of proportionality.

The measures taken by public administrations in the field of this law, for the protection and protection of animals, will be proportional to the result to be obtained, after assessment of the health risk, in accordance with technical and scientific knowledge at any time, and shall take into account the objective of minimising, as far as possible, the negative effects they may have on the trade in animals and their products.

Article 5. Obligation of communication.

Any person, natural or legal, public or private, shall be obliged to communicate to the competent authority immediately and, in any event, in the form and time limits, all the information centres of knowledge of diseases of an epizootic nature, or which, due to its special virulence, extreme gravity or rapid diffusion, implies a potential risk of contagion for the animal population, including domestic or wild animals, or a risk to public health or the environment. In cases where a specific time limit is not provided for in the applicable legislation, it shall be a maximum of 24 hours for notifiable diseases.

It will be equally obligatory to communicate any pathological process, which, even if not gathering the mentioned characteristics, causes the suspicion of being a disease of those included in the lists of diseases of mandatory declaration.

All events or activities involving a suspicion of risk and serious danger to human, animal or environmental health in relation to animal and animal health products shall also be reported. animal feed.

This principle will, in a special way, affect private animal health laboratories in relation to the samples they process.

Article 6. Coordination of animal health.

Public administrations shall adopt the necessary programmes and actions in the field of animal health in the field of their respective competences.

Coordination in animal health matters shall include:

(a) The establishment of common minimum rates or criteria for assessing the needs of animal and production health programmes, on the basis of epizootiological maps.

(b) The determination of the common minimum objectives or objectives in the field of prevention, promotion and veterinary health care.

c) The establishment of common minimum criteria for the assessment of the effectiveness of animal health programmes.

TITLE II

Prevention, control, control and eradication of animal diseases

CHAPTER I

Prevention of animal diseases

Article 7. Obligations of individuals.

1. The owners or persons responsible for the animals, traders, importers, exporters, carriers, and professionals engaged in activities related to animal health, whether natural or legal persons, shall:

(a) To monitor animals, products of animal origin, products for animal nutrition, animal health products and, in general, other means of animal health, which they have or have had under their responsibility.

(b) Provide any information required by the competent authority on the health status of animals and products of animal origin, animal health products, animal feed products and, in general, the other means related to animal health, which they have or have had under their responsibility.

(c) Apply and carry out all the health measures imposed by the legislation in force in each case, as well as the mandatory health measures to be established to prevent animal diseases, or to consent to their implementation, as well as putting in place the necessary means to enable such measures to be carried out with due security guarantees, both for the animals which are the subject of those measures and for the staff to implement them.

d) Have their animals properly identified, in the form and conditions imposed by the applicable regulations.

e) Communicate to public administrations, in time and form, the health data required by the applicable regulations in each case, in particular those relating to births, deaths, entrances and exits of animals, as well as the repeated appearance of dead animals of the wild fauna.

(f) Proceed for the disposal or destruction of the carcasses of animals and other products of animal origin, which are under their responsibility, in the form and conditions laid down in the rules applicable in each case.

g) Do not abandon the animals under their responsibility, or their dead bodies.

(h) To comply properly with the obligations relating to veterinary medicinal products, in particular monitoring and due observance of the time-limits laid down in the case of the treatment of animals with such medicinal products.

i) Taking into account the costs of custody, transport, storage, feeding, slaughter, destruction and, in general, of all types, in relation to their animals, products of animal origin, animal health products and products for animal nutrition, which are responsible for animal nutrition and are derived from the health measures, including safeguard measures and the use of such protective measures as may be adopted by the competent authorities.

j) Request the health certificates or documentation required for the import and export, in the form and conditions provided for in regulation.

It shall also be for the importer or exporter to bear the costs arising from custody, transport, storage, feeding, slaughter, destruction and, in general, of all kinds, in relation to animals, products of animal origin, animal health products and animal feed products, which have as their destination the import or export, until the veterinary inspection at the border provided for in Chapter II of this Title is carried out and, where appropriate, after.

k) Maintain in good health its animals, products of animal origin, animal health products and products for animal feed, and, where appropriate, carry out checks and modifications to the facilities which decrease the risk of disease occurrence.

l) Maintain adequate sanitary conditions of the cynetic species in order to avoid the occurrence of diseases.

m) Communicate to the competent authority the diseases of the animals referred to in Article 5, of which they are suspected.

n) In general, comply with the obligations imposed on animal health by the applicable regulations.

2. In addition, the integrations are obligations of the integrator and of the integrated one:

a) The integrator must:

1. Communicate the competent authority of the autonomous community in which it radiuses the relation of the holdings it has integrated, with their respective locations.

2. Vellar for the proper health of the animals and their proper transport, as well as to ensure that the veterinary medicines and application guidelines correspond to the established regulations, being responsible for this.

3. To communicate to the competent authority the diseases of the animals referred to in Article 5, which have occurred in the holdings of their integrated animals and of which they are suspected.

4. Ensure that animals or products obtained on the holding are in adequate health conditions when placing them on the market and that their transport complies with the conditions of animal health and protection established by the applicable rules.

b) And the integrated, for its part, corresponds to:

1. Communicate to the competent authority of the autonomous community in which to radiate the identification of the integrator.

2. Velar for the health care of the livestock deposited on their farm by the integrator, in a joint way with this one, especially for their proper handling and hygiene and the correct application of the medication, following the guidelines indicated by the integrator's veterinary assistance service, as well as complying with and enforcing health standards as regards entry into the holding of persons and vehicles.

3. To communicate to the integrator any suspicion of any infectious disease affecting the animals deposited by it on their holding.

Article 8. Safeguard health measures.

1. To prevent the introduction or dissemination in the national territory of animal diseases of compulsory declaration provided for in the International Animal Health Code of the International Office of Epizootics or in national legislation or The General Administration of the State or the competent bodies, in particular those of high dissemination, or to prevent the spread of such diseases in the event of suspected or confirmed cases or serious health risks, of the autonomous communities, either ex officio or at the request of the former, may adopt the following precautionary measures:

(a) The precautionary prohibition of movement and transport of animals and products of animal origin or by-products of exploitation, in a given area or territory or throughout the national territory, a precautionary prohibition of entry or the departure of those on holdings, or their precautionary detention in certain places or facilities.

b) Mandatory slaughter of animals.

(c) Seizure and, where appropriate, mandatory destruction of products of animal origin, animal health products and animal feed products, in a given area or territory or throughout the national territory.

(d) Seizure and, where appropriate, the slaughter of those animals that do not comply with current health or identification regulations.

(e) A precautionary suspension of the holding of any certamenes or concentrations of livestock, in a given area or territory, or throughout the national territory.

(f) The precautionary suspension of hunting or fishing activities.

g) Realization of a mandatory vaccination program.

(h) Prohibition or limitations of the importation or entry into Spain, or of departure or export of the national territory, of animals, products of animal origin, animal health products and products for animal nutrition, or change or restrictions of their use or destination, with or without transformation.

i) the suspension of authorisations, the temporary prohibition or temporary closure of establishments producing, manufacturing, producing, distributing, dispensing or marketing animal health products; and products for animal nutrition, as well as the closure or temporary suspension of slaughterhouses or centres where the slaughter of animals, cleaning and disinfection centres and other animal health establishments is carried out.

j) In general, all measures, including disinfection or diseasement, are necessary to prevent the introduction into the national territory of diseases of compulsory declaration animals, in particular those of high diffusion, or the extension of such diseases in the event of suspected or confirmed cases, as well as in situations of serious health risk.

2. Where such measures concern or concern a Member State of the European Union and, where appropriate, third countries, in particular the prohibition on the entry into Spain of certain animals or products of animal origin, it shall be requested to the European Commission in advance of the necessary measures. Pending the adoption by the European Commission of the appropriate measures or decisions, those deemed to be essential may be provisionally established.

3. The competent ministry shall inform the European Commission and the other Member States or third countries concerned, through the appropriate course, of the measures taken or to be taken in accordance with the provisions of this Directive. Article.

Article 9. Health emergency management plans.

In order to improve the response capacity of all the structures of the Veterinary Health Alert System in the face of the emergence of serious health emergencies, assess the health risks, develop protocols, prepare coordination measures, designing policies, procedures and tasks, preventing strategic allocation, mobilization of resources, education, training, information and community work, public administrations, in the field of respective powers, shall establish and develop in a coordinated manner, simulations and simulation exercises for health emergencies, both empirical and in real scenarios.

Article 10. Introduction of infectious material.

The introduction into the national territory of infectious material, whatever its subsequent destination, will require prior authorization from the Ministry of Agriculture, Fisheries and Food.

Article 11. Duty of information.

The public authorities will provide each other with the information they require about the activity they carry out in the exercise of their own powers, in particular as regards the scope and intensity of the activities. epizootic diseases and zoonoses, and those other which have a particular impact and have been detected in their territorial area, as well as the health measures taken.

CHAPTER II

Exchanges with third countries

Article 12. Border inspections.

1. The importation of animals, products of animal origin and animal health products, whatever their subsequent destination, or the entry of other elements which may present a serious health risk and their inspection, shall be carried out only through of the border inspection posts or inspection centres approved for that purpose, and in the case of products for animal nutrition, through the entry points authorised for that purpose by the General Administration of the Status.

The export of animals, products of animal origin, animal health products and animal feed products, whatever their subsequent destination and inspection, will be carried out only through the border inspection or inspection centres, premises or exit points approved for that purpose by the General Administration of the State.

2. The goods referred to in the preceding paragraph shall be inspected, and inspections or health tests shall be carried out at the border inspection posts, inspection centres, points or enclosures referred to in paragraph 1. previous. In the case of exports, inspections or health tests may also be initiated at production establishments approved for this purpose by the General Administration of the State. In any case, the corresponding health authorisation will be required to be cleared by customs.

3. The abovementioned border inspection posts, centres, points or enclosures shall be equipped with premises, means and personnel necessary for carrying out the relevant inspections of the goods referred to in paragraph 1 and, in the case of be authorised for the entry of animals, sufficient space and means for compliance with animal welfare standards. The competent bodies of the General Administration of the State shall ensure the suitability of these facilities and shall make any adaptations to them.

4. Animals, products of animal origin, animal health products and animal feed products, subject to veterinary inspection at the border, shall be those laid down in the relevant implementing rules in each case.

Article 13. Import.

1. The competent bodies and, where appropriate, the health inspectors acting, shall take the measures referred to in Article 8 for the importation of animals, products of animal origin, animal health products and products. for the animal feed in which one of the following cases occurs:

a) Cuya introduction is prohibited.

(b) In respect of which there is evidence, or a suspicion founded on the non-prohibited, that they are affected by animal diseases, which contain residues exceeding the maximum permitted limits or which are accompanied by suspected false or incorrect documentation or health certificates.

(c) Where there is evidence, or a well-founded suspicion, of non-compliance with the existing legislation resulting from or may result in serious health risk. In this case, the measures taken shall be transferred to the autonomous community where the border inspection post, approved inspection centre or entry point is located.

In these cases, the immediate re-dispatch to a third country, with provisional seizure, if appropriate, of the health documentation, may also be taken as an additional precautionary measure.

2. All expenditure incurred as a result of the implementation of these measures shall be borne by the importer. However, provided that the level of health guarantee is not affected, the importer shall be granted the possibility to choose between the measures referred to in the previous paragraph, that or those measures which he considers to be more appropriate.

3. Veterinary checks at border inspection posts shall be of a unique nature. Once carried out, a veterinary official certificate shall be issued which shall accompany the goods in the internal displacements. This certificate shall replace the official health certificate established for internal movement.

However, Community or national provisions may establish enhanced control procedures in certain cases.

Article 14. Export.

1. For exports, after the inspection and health checks provided for in Article 12, the corresponding health certificate shall be issued or refused, as appropriate, by the competent staff for the purpose of the post of border inspection, inspection centre, enclosure or exit point in question.

2. Where, for the purposes of a third importing country, other tests or health checks are required, prior to those laid down in the preceding paragraph, they may be carried out by the non-competent authority of the Administration. General of the State, directly or through entities accredited for these purposes.

3. Export without the prior procurement of the health certificate shall be the sole responsibility of the exporter.

Article 15. Procedure.

1. The procedure for carrying out the pre-import or export inspections and checks, as laid down in this Chapter, shall be initiated at the request of the person concerned or on his own initiative.

2. The carrying out of pre-import inspections and controls shall be subject to the prior clearance of the relevant fees.

CHAPTER III

Fight, control and eradication of animal diseases

Article 16. Obligations of individuals.

1. They correspond to holders of livestock holdings, including blacklisted holdings, and, in general, to owners or responsible animals, including wild animals, of the following obligations:

a) Keep the animals in good health.

(b) Apply the mandatory health measures to be established to fight, control or eradicate animal diseases, or to consent to their application, and to put in place the necessary means to enable them to be carried out (i) measures with appropriate security guarantees, both for the animals which are the subject of the security and for the staff to carry them out.

c) Carry out revisions and modifications to the facilities, which reduce the risk of disease occurrence.

d) Maintain the balance of wildlife in their health aspects.

2. In the case of integrations, compliance with the obligations laid down in the previous paragraph is appropriate:

(a) Integrated as long as the animals remain on the holding, unless the ultimate decision-making power in respect of the obligation in question is of the integrator, and its implementation or application is to be carried out by the integrator, whose case shall be jointly and severally liable for compliance.

b) The integrator in the rest of the assumptions.

3. Traders, importers or exporters shall maintain in good health their animals, products of animal origin, animal health products and animal feed products, and, where appropriate, carry out the compulsory health measures. to be established on suspicion or confirmation of an animal disease, as well as to carry out checks and modifications to facilities which reduce the risk of spreading diseases.

Article 17. Immediate actions in case of suspicion.

1. The communication referred to in Article 5 shall give rise to an emergency intervention by the competent authority, which shall be in the place of the presumed focus, by issuing a preliminary clinical diagnosis, taking, if appropriate, the samples the situation requires and immediate referral of the situation to the relevant diagnostic laboratory or, where appropriate, to the national reference laboratory for the disease whose incidence is suspected.

Also, precautionary measures will be taken to prevent the possible spread of the outbreak and to establish the identification of the disease, which, in addition to those provided for in the current rules of application case, may be as follows:

(a) Inmobilisation of the animals on the holding concerned or on the premises authorised for that purpose.

(b) The official Censado of all animals of the holding, and, where appropriate, special marking of such animals, at the same time, in particular, even having an identification adjusted to the current regulations. In addition, holdings, the means of transport relating to the focus or areas subject to special control may be marked.

(c) Temporary prohibition of entry or exit from the holding or enclosure of animals of any species, products of animal origin, animal feed products, utensils, sprouts and, in general, any the product, substance, by-products or waste of special treatment, which may be susceptible to the pathogen-producing pathogen agent.

(d) Temporary prohibition of entry or exit from the holding or enclosure of vehicles, or restriction, where appropriate, by determining the hygienic and sanitary conditions to be met.

(e) Temporary prohibition of entry of persons or determination of the relevant hygiene measures necessary to reduce the risk of the spread of the pathogen or vector, to which any person who enters or exit from the holding or enclosure.

(f) Temporary suspension of authorisations, where appropriate, for the operation of commercial or animal transport establishments, products of animal origin, animal health products and food products animal as well as, where appropriate, the ratings for issuing health certificates.

g) The compulsory slaughter of sick and suspected animals, as well as, as the case may be, the destruction of animal carcasses, animal products and animal feed products, or any material Susceptible to vehicular the pathogen.

In natural spaces it may be the control and decrease of the populations of the affected species.

h) The establishment at the site of the presumed focus, and in an area around it, of a vector control program when the nature of the disease so advises.

The systematic nature of the intervention measures will be adapted to the peculiarities of the situation in the cases of confinement at the address of the owner of his pet animals, or when the health incidence has arisen in Those or grassland, mountain areas and natural spaces bounded, or when they affect the transport of livestock or animals under transhumance, taking the additional emergency measures required by each situation.

The carcasses of dead and slaughtered animals shall be disposed of in a hygienic manner or, where appropriate, destroyed in accordance with the provisions of the rules in force, with the exception of parts of the animal which must be be kept. Subsequently, the cleaning of the livestock facilities will be carried out, as well as the application of disinfection and disintering measures, and the destruction of all the substances that are presumed to be polluting, except those that the current regulations specify. The replacement of animals shall be kept in place and shall not be authorised until the sampling and tracing of the animals have been carried out.

2. The intervention may also include the establishment of protection, surveillance and, where appropriate, safety zones, with varying degrees of demand in the area and in the measures applicable in these areas on detention, movement of animals, disinfection, de-rastisation, temporary ban on certams and livestock concentrations, as well as the health status of each holding, which may include relevant diagnostic investigations. Without prejudice to this, provided that the health conditions and regulations applicable in each case so permit, and in a restrictive manner, the competent authority may permit the movement of animals from the surveillance zone or from the security. In exceptional cases, vaccination may be used, subject to the authorisation, where appropriate, of the European Union.

3. The competent authority shall, in each case, proceed as soon as possible to the end, or to reinforce or extend, if necessary, the precautionary measures taken, extending them within the geographical limits of the area of protection, surveillance and, where appropriate, security, to be determined, to the extinction of the suspicion or focus and the consequent disappearance of the risk of the spread of the disease.

Article 18. Confirmation and official declaration of the disease.

1. The final confirmation of the existence of the disease shall determine that the official declaration of its existence is made by the autonomous community, in the terms laid down in the implementing rules, making its notification official to the Ministry of Agriculture, Fisheries and Food, acting in the manner established in each case and proceeding with the ratification, supplementing or rectification of the measures referred to in the previous article.

2. Where the confirmation is of a disease contained in the lists of compulsory declaration or subject to intra-Community or international restrictions, the Ministry of Agriculture, Fisheries and Food shall communicate, in the form and the time limits laid down, such impact on the health authorities of the European Union, as well as those of third countries and international bodies with whom such an eventuality would have been concluded. In addition, where the confirmation is of a zoonosis listed in List A of the International Animal Health Code of the International Office of Epizootic Diseases, the Ministry of Agriculture, Fisheries and Food shall communicate to the Ministry of Health and Consumption.

3. The Ministry of Agriculture, Fisheries and Food shall communicate to the National Committee of the Veterinary Health Alert System the set of measures adopted for the eradication of the epizootic outbreak, in order to be able to be analyzed and evaluated. To this end, the Commission will monitor the results obtained by formulating the appropriate proposals or guidelines for action.

Article 19. Treatments and vaccinations.

1. In cases where vaccination or other treatment of animals is prohibited by the European Union, the application for such treatments or vaccinations which may be applied shall be submitted by the competent authority. emergency or urgent need to the Ministry of Agriculture, Fisheries and Food, which will, where appropriate, request the appropriate authorization from the competent European Community bodies.

2. They may be established by the General Administration of the State, for the entire national territory, heard by the Autonomous Communities, and as a result of agreements taken within the European Union or through the implementation of harmonization programmes. international health, schedules or guidelines for vaccinations, treatments or measures of simple diagnosis, which must be carried out compulsorily, as well as prohibitions which may be considered relevant for their potential danger or to alter the effectiveness and sensitivity of the usual techniques of diagnosis.

3. In addition, the Ministry of Agriculture, Fisheries and Food, heard by the National Committee of the Veterinary Health Alert System, may establish, in cases where there is no Community legislation on this matter, provided that it is diseases with a serious health hazard for the national territory, diseases in which vaccination or treatment is prohibited, as well as the application of vaccines and treatments which shall be compulsory and subject to conditions particular on which such an application is to be performed.

4. Vaccines and products for treatments that are required to be applied, in accordance with the provisions of the previous paragraph, shall be checked in advance by the relevant national reference laboratory, national or, where appropriate, European.

5. The General Administration of the State may have a vaccine bank for the diseases listed in List A of the International Animal Health Code of the International Office of Epizootics.

Article 20. Mandatory slaughter.

1. Both at the time of suspicion, and once the diagnosis of the disease has been confirmed, by the competent authority concerned, the compulsory slaughter of suspected, sick animals, which are at risk of being affected, may be established, or in respect of which it is necessary as a result of epidemiological surveys, as a measure to preserve the disease and in the case of a disease of high diffusion and of difficult control, or where it is deemed necessary.

2. The slaughter of animals must be carried out in slaughterhouses or approved plants for that purpose. For the slaughter of animals in slaughterhouses, the prior report of the Health Administration of the corresponding Autonomous Community shall be required.

However, on-site slaughter may be authorised if there is a risk of spreading the disease or if the health circumstances make it necessary.

3. The destruction and transfer, where necessary, of the carcasses of the animals and, where appropriate, of the contaminated materials, shall be regulated.

4. The slaughter of wild animals will be adapted to the special circumstances of the environment in which they are found. This intervention may be limited to a population control up to a sufficient degree to ensure the minimum risk of spreading the disease.

5. However, the competent authority may provide for certain exceptions to the compulsory slaughter of animals for the preservation of endangered genetic resources, provided that appropriate health measures are maintained and this does not apply. affect the health of animals, people or the environment.

Article 21. Compensation.

1. The compulsory slaughter of animals and, where appropriate, the destruction of the means of production which are considered to be contaminated shall give rise to the corresponding compensation by the competent authority, on the basis of the officially approved scales. and in the form and conditions laid down in regulation.

2. Animals which die for direct cause after having undergone preventive treatment or treatment or for diagnostic purposes or, in general, those who have died in the context of measures for the prevention or control of the disease, shall be compensated. a disease as a result of the performance of actions imposed by the competent authority.

Equally, other serious harm that occurs, such as abortions or permanent productive disabilities, will be compensated as long as the cause and effect relationship with the applied treatment is demonstrated and accredited.

3. In order to be entitled to compensation, the animal health legislation applicable in each case must have been complied with by the owner of the animals or means of production.

Article 22. Sanitation of the foci.

1. Once the slaughter and the hygienic disposal of the corpses, food and any other material of risk have been carried out, the owner must submit the facilities to a process of cleaning, disinfection, dispossession, deratization and works of health adequacy, if necessary.

2. This action will be complemented by the evacuation of the operating by-products, with the prior treatment of these being determined to destroy the disease pathogens that could survive in these materials.

3. The health measures for specific disinfection shall be laid down in regulation and, where appropriate, the periods of sanitary emptying during which the closed and sealed holdings shall remain.

Article 23. Repopulation of the holding.

After completion of the depopulation and sanitation of the affected holding, the competent authority shall supervise the performance of a trace, if possible, prior to the repopulation of the holding, with a number of reduced animals, complying with the rules to be established for each disease. Repopulation shall be authorised once the absence of risk of persistence of the pathogen is verified.

Article 24. Official extinction of the disease.

1. The official declaration of the extinction of the disease shall be made by the same organ and procedure by which it was declared its existence, after all intervention and sanitation measures have been carried out and the time limits have elapsed in each case. are determined.

2. The termination of the health measures shall take place without prejudice to the establishment of the precautionary measures which are estimated to have been taken.

3. The extinction shall be communicated by the competent ministry, through the appropriate course, to the European Commission, as well as to the third countries and international bodies to which the declaration of the disease has been notified.

Article 25. National programmes for the prevention, control, control and eradication of animal diseases.

1. They shall be subject to national programmes for the prevention, control, control and eradication of animal diseases to be determined by the General Administration of the State, consulted on a prior basis by the Autonomous Communities and consulted. the National Committee of the Veterinary Health Alert System, in the light of its economic, health and social implications. Such programmes shall be governed by the provisions of this Article, with the exception of the application, in the absence of express provision, of the provisions of this Chapter.

2. Where the development of the programmes provides for the compulsory slaughter of the animals concerned, the animals concerned shall be slaughtered immediately or, where appropriate, within a time limit to be determined by the applicable legislation. In these cases, the slaughter of the animals and the compensation shall be governed by the provisions of Articles 20 and 21.

Article 26. Health emergency situations.

In exceptional situations where there is a serious danger of spread within the national territory of epizootic diseases or zoonoses of high transmissibility and diffusion, the declaration of the disease by the competent authority shall entitle the the General Administration of the State to exercise, where appropriate, and in a reasoned manner, the functions necessary for the adoption of urgent measures designed to effectively prevent its transmission and spread to the rest of the national territory, (a) special measures provided for in this Title and to ensure proper implementation; coordination and monitoring of those until the restoration of normal health throughout the national territory, including the actions of the State Security Forces and Corps, according to the authority that the Constitution and the laws grant.

CHAPTER IV

National Veterinary Health Alert System Committee

Article 27. Nature.

The National Committee of the Veterinary Health Alert System is the coordinating body for animal health, between the Ministry of Agriculture, Fisheries and Food and the Autonomous Communities.

Article 28. Composition and functions.

1. The National Committee of the Veterinary Health Alert System shall have the composition to be determined, and of it shall be composed of representatives of the General Administration of the State and of each of the Autonomous Communities and, in its case, of the local entities.

2. The main functions of the Committee shall be as follows:

(a) Coordinate the actions between the different administrations in the field of animal health.

b) To study measures for the prevention, control, control and eradication of diseases covered by national programmes.

c) Follow the evolution of the epidemiological situation of animal diseases, at national, European and international level.

d) Propose the relevant measures.

e) Propose the procedure to be followed in the health inspection required for export and prior to export, as referred to in Article 12.

The rest of the functions, and the working arrangements of the Committee, will be established in a regulated manner.

3. By agreement of the National Committee of the Veterinary Health Alert System, an advisory committee on animal health may be set up, under which the national agricultural organizations and associations will be represented. of greater representativeness and, where appropriate, the Veterinary Collegial Organization, and whose main functions will be to advise the National Committee of the Veterinary Health Alert System on how many questions are requested, as well as to raise the consideration of the same number of questions as appropriate. In cases where matters affecting a specific sector are to be dealt with in the advisory committee, the main associations or national organisations representing the respective sector shall also be integrated into this sector.

CHAPTER V

Laboratories

Article 29. National reference laboratories.

1. The General Administration of the State shall designate the State reference laboratories, the nature of which is necessarily public, of:

(a) The diseases of the mandatory declaration animals.

(b) The analyses and controls on animal health products, in particular veterinary medicinal products, and on substances and products used in animal nutrition.

(c) Waste in animals and products of animal origin for veterinary medicinal products and for substances and products used in animal nutrition.

(d) The analyses and controls on animal health products and other means used for the prevention, control, control and eradication of animal diseases.

e) The analysis and controls in the field of unauthorized substances or products.

2. The functions of the national reference laboratories in the specific field for which they are designated, apart from those which are determined in each case, shall be as follows:

(a) Coordinate the necessary actions with the laboratories of all public administrations, or approved private ones, in order to ensure that the laboratory techniques are homogeneous in all of them.

b) Establish the necessary collaboration with research centers, public or private, national, community or foreign, when such centers investigate topics related to the reference laboratory.

c) Transfer to the official laboratories of the Autonomous Communities and the General Administration of the State the information and new techniques developed by the reference laboratories of the European Union and the International Office of Epizootics.

d) To carry out the analyses or tests which, for the purpose of the purposes or for other purposes, are requested.

e) Confirm laboratory diagnosis in cases of suspicion, or diagnosed as suspected or positive by the official laboratories of the Autonomous Communities, in the case of disease of declaration mandatory.

f) Homologating the diagnostic methods of the official laboratories of the autonomous communities in the national programs of prevention, control, control and eradication of animal diseases.

g) Organize comparative tests and collaborative trials with the official laboratories of the Autonomous Communities.

Article 30. Official laboratories of the Autonomous Communities.

Autonomous communities may establish laboratories of a public nature or, where appropriate, recognize or designate those of a private nature, competent for the analysis and diagnosis of animal diseases, for analysis and control of the substances and products used in animal nutrition, as well as for the analysis and control of residues of such substances and veterinary products or medicinal products, both in animals and in products of origin animal.

Article 31. The official character of the analyses.

1. Only animals subject to national programmes of prevention, control, control and eradication, or any pathological process of animals for collective presentation or mass circulation, may be made available for diagnosis or analysis of animal diseases. national reference laboratories, the public laboratories of the Autonomous Communities, or expressly recognised or designated for that purpose, and the official laboratories of the General Administration of the State.

Only such laboratories may possess, be under their control, or use diagnostic products for such diseases.

2. The analysis carried out by the national reference laboratories and by the public laboratories of the Autonomous Communities or expressly recognised or designated for that purpose shall be exclusively official in character and validity. in relation to the analytics for which they have been designated as such.

Article 32. Official laboratories of the General Administration of the State.

1. Without prejudice to the functions of the national reference laboratories, the central animal health laboratories of the General Administration of the State shall, in the field of animal health, have the following functions:

(a) Inform precept of the approval, where appropriate, of the new techniques for the diagnosis or analysis of animal diseases and of good laboratory practice in public or private laboratories working in the field in animal health.

b) Maintain high-risk, highly infectious and exotic pathogenic germ ceparium.

(c) to have the techniques of diagnosis of the diseases produced by the pathogens mentioned in the previous paragraph, and, where appropriate, of any other pathology or morbid process affecting animal health.

d) Transfer the scientific technology to the laboratories that the Administration determines in each case.

e) To support the ongoing technical training of staff working in any of the official laboratories of both the General Administration of the State and the Autonomous Communities.

f) Act as a national reference laboratory for the diagnosis of a particular disease or any other disease or morbid disease affecting animal health, or by a specific method of analysis, if not a specific national reference laboratory is designated.

2. The other official laboratories of the General Administration of the State may carry out tasks of support and collaboration of the national reference laboratories, of the official laboratories of the autonomous communities and of the laboratories animal health plants.

Article 33. Minimum safety conditions for laboratories.

The government, after consulting the autonomous communities, will dictate the rules regarding the minimum safety conditions for animal health to be collected by laboratories, public or private, that handle risk material. and, in particular, as regards:

a) The right infrastructure and material and personal means, as well as the regulation of operation to minimize risks.

b) Security rules, in accordance with the type of material they work with.

(c) The means and standards for the hygienic disposal of waste of special treatment that occur.

d) Standards in animal testing.

Article 34. National register of animal health laboratories.

The General Administration of the State shall, for information purposes, establish a national register of all public and private laboratories carrying out analyses related to animal health, based on information that provides and provides the autonomous communities.

Article 35. Analysis in laboratories in another country.

For the performance of any type of analysis provided for in this law, in a laboratory, public or private, located outside the national territory and, in particular, analysis in the field of animal diseases, The competent authorities of the General Administration of the State and the corresponding autonomous community shall communicate, prior to the submission of the sample or samples.

TITLE III

Sector Health Organization

CHAPTER I

Sanitary management of animal holdings

Article 36. Basic sanitary conditions.

1. Holdings of animals newly installed, or the extension of existing ones, must comply with minimum distances to be established for stocks, roads, roads and other holdings or installations which may represent a possible source or means of contagion of diseases, in addition to the prior authorisation of the competent authority.

2. The basic health conditions to be met by animal holdings shall be those laid down by the rules in force. In any case, intensive farms and accommodation in the extension must be isolated, in such a way as to limit and regulate the free access of persons, animals and vehicles.

3. For the authorisation of any new plant or extension of the existing plant, the competent authority shall give preference, in cases where there are limitations in the rules in force for establishing or extending them, to: holdings or production systems which, by virtue of their characteristics, means or infrastructure, make it possible to ensure proper health conditions for livestock or to prevent the spread of diseases, with particular attention being paid to the high level of stocking density.

4. The replacement of animals on holdings must always be carried out with animals of the same or higher health status.

Article 37. Disposal of waste from exploitation.

Any activity of animal exploitation shall be subject to the hygienic disposal of effluents, by-products of exploitation, waste of special treatment and bodies, in accordance with animal health rules, public health and environmental protection.

Article 38. Registration and book of exploitation.

1. All animal holdings must be registered in the autonomous community in which they radiate, and the basic data of these records shall be included in a national register of information.

2. Each holding of animals shall keep up to date an operating book in which the data subject to the applicable rules of the holding shall be recorded, for which the holder of the holding shall be responsible.

Article 39. National animal identification system.

1. The General Administration of the State shall establish the bases and coordination of a single and homogeneous national identification system for the different animal species.

2. The animals must be identified in accordance with the provisions of the European Community legislation or with the system established by the Government. The mandatory identification shall also be extended to the seminal doses, eggs for reproduction and embryos of any animal species.

3. The identification obligation corresponds to the holders of the livestock holdings to which the animals belong, or to the owners or owners of the animals.

CHAPTER II

Livestock Health Defense Pools

Article 40. Authorization requirements.

For the start of their activity, livestock health protection groups must be previously recognized by the competent authority of the autonomous community in which they radiate, to which they must have

legal personality and own statutes, an officially approved common health programme, meet the conditions laid down by the rules in force, and be under the technical direction of at least one veterinarian, who develop such a health program.

Article 41. National Register.

1. The General Administration of the State will create, for information purposes, a National Register of Health Defense Groups, which will be nourished by the information provided by the autonomous communities.

2. The data collected by the Registry and its coordinated operation with the Autonomous Communities shall be established in a regulated manner.

Article 42. Extent of the health program in the pool.

In the event that a livestock health protection group comprises at least 60% of the holdings located within the geographical area defined by the holdings of that group, or a geographical area previously determined for the purpose by the competent authority of the community, all holdings of livestock of the same species or species to which the group relates, irrespective of the census they hold, shall carry out the the same officially approved health programme for the health defence group livestock, in all those aspects relating to national or regional programmes for the prevention, control, control and eradication of animal diseases.

Article 43. Public aid.

Public administrations, in order to promote the establishment of livestock health advocacy groups, will be able to provide support lines aimed at subsidising health programmes.

CHAPTER III

Healthcare Rating

Article 44. Health status of holdings.

The Government, consulted by the Autonomous Communities, shall establish the criteria and requirements for the health status of the holdings, as well as for the loss and suspension of the holdings.

Article 45. Other health qualifications.

The health status may also be obtained by a municipality or, in general, by a given area or territory, where all the holdings are free of a disease or are qualified sanitarily.

CHAPTER IV

Animal market health management

Section 1. Trade, transport and livestock movement within the national territory

Article 46. Trade in animals.

1. Trade in animals shall be governed by the provisions of this law and the other applicable rules.

2. The street sale of animals is prohibited, with exceptions which may be established in a regulation in the interest of the species or species concerned, or their relationship with sporting, cultural or scientific activities, and provided that it is ensured the absence of risk to animal health and public health.

Article 47. Requirements of the means of transport.

1. The means of transport of animals, other than domestic animals, must be authorized, as well as the owner undertaking, by the autonomous community in which they radiate, comply with the hygienic and animal health conditions and establish regulations, as well as to carry the indicative labels that apply in each circumstance.

2. In any case, drivers must carry on board the vehicle the relevant transfer documentation specified in this Law, as well as the administrative authorisation referred to in the previous paragraph.

3. A specific and simplified scheme for the authorisation provided for in paragraph 1 may be established by the Government in the case of beekeeping, in the case of the transfer of hives from small holdings.

Article 48. Activity Log.

Companies engaged in the transport of animals shall have for each vehicle a record or computer support which they shall maintain for a minimum period of one year, and where all movements of animals shall be reflected performed, with the indication of the species, number, origin and destination of those.

Article 49. Cleaning and disinfection.

1. Vehicles or means of transport used, after the unloading of animals, other than those of domestic animals and those carried over by bee hives, must be cleaned of solid waste, washed and disinfected with products approved at the nearest cleaning and disinfection centre for this purpose, which shall provide proof of the work carried out, which shall accompany the transport.

2. In the case of transport and unloading in a slaughterhouse, the vehicle shall have to be removed from the vehicle, which is not necessarily empty, clean and disinfected.

3. Slaughterhouses shall have at their facilities a centre for the cleaning and disinfection of vehicles for the transport of animals.

The requirements for your installation and the excepted situations of such a requirement will be established.

Article 50. Official certification of movement.

1. For the movement of animals, other than domestic animals, and for the movement of ova, semen or embryos, the issue of a health certificate of origin issued by an official veterinarian or, where appropriate, by authorised or authorised veterinarian shall be specified. for the purpose of the competent bodies of the Autonomous Communities.

However, such a certificate shall not be required where animals of production, ova, semen or embryos are transferred from one holding to another, provided that the holder of the two and of the livestock, ova, semen or embryos is the same, those holdings are located within the same municipal term, and one of them is not a slaughterhouse or a concentration centre. In situations of crisis or health risk, in particular in case of suspicion or confirmation within the municipality of a notifiable disease or notifiable notification, the competent authority may suspend for the necessary time this derogation, establishing the need for health certification for such movements.

2. The basic data of the health certificate and the period of validity of the health certificate shall be established.

3. Regulations may be regulated by the Government or by the autonomous communities in their territorial area, once the epidemiological surveillance networks have been established, exceptions to the health certificate when the document may be replaced by another system which presents the same guarantees provided that the characteristics of the animal species concerned or its marketing justify it.

4. Special certificates shall be established for the transport of animals subject to specific restrictions or risk products or health emergencies, in accordance with the rules laid down by the implementing rules in each case.

Article 51. Movement of animals between autonomous communities.

1. Where a movement of animals is carried out, with the exception of domestic animals, provided that they are accompanied by their owners and without profit, the autonomous community of origin must communicate it to the destination. The autonomous community of origin shall also communicate such movement to the autonomous community or autonomous communities of transit, where animals or products of animal origin are considered to be at risk or where restrictions are in place. health in these, in the form and conditions that they regulate are determined.

2. The transfer of bodies or parts thereof, in officially approved cases, shall be communicated to the autonomous community of destination.

3. Where the movement relates to animals or products of animal origin considered to be at risk, where there are health restrictions or in situations of health risk, it shall be subject to prior communication by the autonomous community of origin to the movement. of the destination at least 48 hours in advance, and the authorization by the target community, in the cases which are determined to be determined.

Article 52. Transhumance.

1. Animals in transhumance shall be covered by the official health certificate issued by the official veterinarians or, where appropriate, by veterinarians authorised or authorised for that purpose by the autonomous communities, and, in the case of such animals, It shall be established in a regulated manner, the transhumance shall be authorised by the autonomous communities of transit.

2. Transhumance may be carried out only from those holdings which are qualified as a whole and which have a health level equal to or greater than that existing in the target areas.

3. Exceptions to the provisions of the previous two paragraphs may be regulated, in particular for the transhumance of bees based on settlement programmes.

Article 53. Communication of the movement of animals within the national territory.

The General Administration of the State shall establish a national registration of an information character, in the form and conditions to be determined regulatively, in which the basic data of the movements of animals shall be included. of the national territory.

Section 2. Cattle Certamenes and Animal Concentration Centers

Article 54. Requirements for the authorisation of the certamenes.

1. Livestock waffters must be previously authorised by the competent authority of the autonomous community in which they radiate, to which effect they must at least comply with the following requirements:

(a) Having a hygienic site, with appropriate facilities, and being away from livestock holdings or facilities that may be a source or vehicle for animal diseases.

b) Dispose of the human, material and technical means necessary to ensure the correct development of the event.

(c) Dispose of a cleaning and disinfection centre in at least the national livestock plants or in which the animals are intended to be used for intra-Community trade.

2. The other specific requirements shall be established regulatively.

Article 55. Operation of the certamenes.

1. Only duly identified and documented animals shall be permitted to enter and exit, and always after inspection by the official veterinarian, authorised or authorised for that purpose by the competent bodies of the autonomous community.

2. The data on holdings of origin and destination, the number of animals and species, their individual identification in the cases in which it is mandatory and the dates of entry and exit, as well as the data of the holdings of origin and destination, shall be reflected in a register. the health certificates accompanying them. Such registration shall be the responsibility of the address of the event, and shall be at the disposal of the competent authority.

3. Animals participating in the same event within the same time period shall be from holdings with equal health status.

Article 56. Requirements of the concentration centres.

1. They shall be subject to special requirements as regards their infrastructure, location and health control, in particular as regards the health status of the holdings of origin of each consignment of animals entering these animals. facilities, where appropriate, establishing the need for all animals to come from holdings with a particular health status.

2. In their book of exploitation, all entries and exits of animals shall be reflected, details of the origin or destination, as appropriate, and the animal identification in cases where it is mandatory. They shall keep the supporting documents for the official health certificates and the proof of disinfection of vehicles of all consignments of animals received and issued. Each month they shall communicate to the competent organ of their autonomous community the movement of animals.

3. They must be assisted by an official veterinarian or, where appropriate, authorised or authorised by the competent authority of the autonomous community, in charge of monitoring compliance with the rules in force for such centres.

4. The step in the centre of concentration shall be clearly marked on the exit health certificates.

5. The competent bodies of the autonomous communities shall, where appropriate, authorise the concentration centres of animals located on their territory.

Section 3. Mates

Article 57. Requirements.

1. The presence of at least one official or authorised veterinarian, or, where appropriate, authorised or authorised, responsible for the application of the rules in force in the field of animal and animal welfare, and in particular of the animals, shall be compulsory. Following aspects:

(a) Realisation, on the arrival of animals, of a review of the identification and health inspection "in vivo", as well as the verification that they are accompanied by the prescriptive health documentation, where appropriate, appropriate samples for the analyses that are accurate.

(b) After slaughter and post-mortem inspection in accordance with the regulatory procedure, appropriate samples shall be taken, where appropriate, for the analyses that are accurate.

(c) Communication of suspected animal diseases or of possible breaches of existing animal health and animal welfare legislation to the competent authority of the autonomous community in which the slaughterhouse.

2. The official veterinarian, or the approved or approved slaughterhouse, at the request of the competent authorities, shall participate in the sampling, whenever deemed necessary, in the national programmes of prevention, control, control and the eradication of animal diseases, as well as in national programmes for the investigation of residues in fresh animals and meat, and in all circumstances in all circumstances.

3. Slaughterhouses shall have a cleaning and disinfection centre within their premises.

4. The Ministry of Agriculture, Fisheries and Food shall establish the basis for the effective integration of slaughterhouses into the Veterinary Health Alert System.

Section 4. Treatment rooms and hunting workers

Article 58. Treatment rooms and hunting workers.

Treatment rooms, workers and reception centres for the species of the species are obliged to comply with the same requirements as those referred to in Article 57.

CHAPTER V

epizootiological maps

Article 59. Epizootiological maps.

The General Administration of the State will carry out epizootiological maps at national level, in collaboration with the autonomous communities, based on the information available, derived from the epidemiological surveillance networks, Veterinary Health Alert System, including summaries of infectious pathology incidents found in slaughterhouses, or provided by national or international entities.

TITLE IV

Animal and animal feed products

CHAPTER I

Veterinary medicines

Article 60. Authorisation of biological products.

For the marketing authorisation and registration of veterinary medicinal products of biological origin obtained from microbial agents responsible for the infectious diseases of animals, as well as for their authorization as a product under clinical investigation outside the field of experimentation or laboratory, the report which, for reasons of animal health, shall be binding shall be binding on the representative of the Ministry of Agriculture, Fisheries and Food on the Committee for the Evaluation of Medicinal Products for Veterinary Use.

Article 61. Limitations.

No one may possess or have under his control biological products of animal diseases subject to national programmes of prevention, control, control and eradication of animal diseases, or substances which may be used as such, unless it has an express authorisation issued by the competent bodies of the autonomous communities, is covered by the applicable rules or is concerned with national reference laboratories, official laboratories of the Autonomous Communities or the General Administration of the State.

Article 62. Dispensing and distribution of veterinary medicinal products.

The presence and professional performance of the pharmacist responsible for the pharmaceutical service or services, the livestock groups or groups and the retail establishments, duly authorized for the supply of veterinary medicinal products, shall ensure compliance with the relevant functions and responsibilities laid down in the basic rules for veterinary medicinal products. A pharmacist may be liable for more than one of those services provided that he is assured of the due performance of the functions and responsibilities mentioned.

Article 63. Prior contrast.

The batches of biological products of the notifiable diseases must be checked, prior to their distribution, supply or supply, by the national laboratory or, where appropriate, the European reference laboratory. disease in question.

Article 64. Information.

The representative of the Ministry of Agriculture, Fisheries and Food in the Committee for the Safety of Medicinal Products for Veterinary Use, of the Spanish Medicines Agency, will supply the National Committee of the Health Alert System Veterinary veterinary medicinal product, which is necessary for the performance of its duties, as regards veterinary pharmacovigilance.

CHAPTER II

Other animal health products

Article 65. Authorisation of animal health products.

1. No animal health product other than veterinary medicinal products may be placed on the market without the prior authorization issued by the Ministry of Agriculture, Fisheries and Food, in the form and conditions laid down regulentarily.

2. In cases where this is the case, the Ministry of Agriculture, Fisheries and Food shall also be authorised prior to the establishment of those animal health products by the Ministry of Agriculture, Fisheries and Food.

3. The maximum period for resolving the application and notifying the person concerned shall be one year.

4. The provisions of this Article shall not apply to biocidal products for livestock use, which shall be governed by their specific rules.

Article 66. Biological diagnostic reagents.

1. The biological reagents used for the diagnosis of notifiable diseases shall be checked, in advance for authorization, by the national reference laboratory officially designated for that purpose by the Ministry of Agriculture, Fisheries and Food.

2. Similarly, in situations of health crisis, the prior testing of biological reagents used for the diagnosis of other diseases may be extended, under the conditions that are regulated.

3. Batches of biological products used for the diagnosis of diseases listed in List A of the International Animal Health Code of the International Office of Epizootic Diseases and those under national programmes of prevention, control, control and the eradication of animal diseases shall be checked, in advance for distribution or supply, by the national laboratory or, where appropriate, European reference laboratory for the disease concerned.

Article 67. Validity and cancellation of authorizations.

1. Except for reasons of justified health, zootechnical or technological reasons, shorter or more experimental periods, the authorisation of an animal health product referred to in this Chapter, or the authorisation of an entity shall be established. The manufacturer, and its corresponding register, shall have a period of validity of five years, at the end of which it shall be cancelled; unless, in advance, its renewal is requested, in which case, and if the conditions under which it was have been amended, the entities concerned will be required to provide additional information is considered accurate. In the latter case, the procedure from such an act shall be similar to that established for the application of a new authorisation.

2. The provisions of this Article shall not apply to biocidal products for livestock use, which shall be governed by their specific rules.

Article 68. Exceptional authorizations.

1. In cases of occurrence of an exotic disease, or where urgent reasons for animal health so require, and there is no appropriate animal health product among those referred to in this Chapter, in particular diagnosis of the disease in question, or where there is a risk of shortages, the Ministry of Agriculture, Fisheries and Food may authorise the placing on the market of appropriate animal health products for controlled use and limited for a period of not more than one year, in accordance, where appropriate, with the rules community.

2. The provisions of this Article shall not apply to biocidal products for livestock use, which shall be governed by their specific rules.

Article 69. Amendment of the authorisations and safeguard clause.

1. The authorisations provided for in this Chapter may be amended, suspended or revoked by the Ministry of Agriculture, Fisheries and Food, at the request of the holder or of the trade, where the animal or animal health reasons do so. required.

2. Similarly, where there are valid reasons, veterinary or scientific reasons, to consider that an animal health product authorised or to be authorised, in particular in the case of diagnostic reagents, constitutes or may constitute a risk unacceptable for animal health, the environment, or the proper implementation of national programmes for the prevention, control, control and eradication of animal diseases, the Ministry of Agriculture, Fisheries and Food may to restrict, suspend or provisionally prohibit, as a precautionary measure, the use or placing on the market of the product.

3. The provisions of this Article shall not apply to biocidal products for livestock use, which shall be governed by their specific rules.

Article 70. Limitations.

No one may possess or have under his control reagents for the diagnosis of diseases of animals covered by national programmes for the prevention, control, control and eradication of animal diseases, or substances which may be used as such, unless it has an express authorisation issued by the competent bodies of the autonomous communities, is covered by the applicable rules or is concerned with national reference laboratories or official laboratories of the Autonomous Communities or the General Administration of the State.

Article 71. Distribution and supply of animal health products other than veterinary medicinal products.

1. The means and channels for the distribution of the animal health products referred to in this Chapter shall be those laid down in regulation.

2. The General Administration of the State and the Autonomous Communities may acquire directly from the manufacturer, manufacturer or importer, or from any approved distribution centre, diagnostic reagents and other animal health products which are precise.

CHAPTER III

Products for animal feed

Article 72. Administrative authority.

1. Products for animal nutrition may not be placed on the market without prior authorisation, in terms of the rules applicable. Without prejudice to the foregoing, and provided that it is considered advisable for reasons arising from the protection of public health, animal health or the public interest, the products referred to above may not be placed on the market without the prior the authorisation issued by the competent authority of the autonomous community or, where appropriate, without prior notification to that authority, in the form and conditions laid down in regulation.

2. Likewise, establishments or intermediaries engaged in the manufacture, manufacture, import, export, distribution, transport or marketing of products for animal nutrition, as referred to in the preceding paragraph, they shall be authorised, subject to the exercise of their activity, in the terms of the rules applicable. Without prejudice to the foregoing, and where it is considered advisable for reasons arising from the protection of public health, animal health or the public interest, the exercise of the above activities shall require prior authorisation or, where applicable, the prior registration in the relevant records by the competent authority of the autonomous community, in the form and conditions laid down in the regulations.

Article 73. Limitations.

The holding or use, in the holdings of animals, of products for animal feed, in cases which are specifically established in the light of their potential risk to animal health or public health, shall require the prior authorisation or, where applicable, registration in the relevant registers, by the competent authority of the autonomous community, in the form and conditions laid down in the regulations.

Article 74. Safeguard clause.

1. The administrative authorisations provided for in the previous Articles may be revoked, suspended or amended, where this is necessary for the proper protection of public health, animal health or the public interest.

2. In situations of serious health risk, or where it is advisable for reasons arising from the protection of public health, animal health or the public interest, the need for prior administrative authorisation may be extended for the placing on the market of animal feed products in which the rules applicable only require their prior notification to the competent authority of the autonomous community, and for the exercise of the activity of the manufacture, manufacture, import, export, distribution, transport or marketing of those products, where the applicable rules only require their prior registration in the relevant registers.

TITLE V

Inspections, Violations and Sanctions

CHAPTER I

Inspections

Article 75. Competencies.

1. It is up to the various public administrations, in the field of their respective powers, to carry out the inspections and controls necessary to ensure compliance with the provisions of this law and the provisions of the Autonomous communities applicable in the field.

2. In particular, it shall be for the General Administration of the State to carry out the following inspections and controls:

(a) For the import and export of animals, products of animal origin, animal health products and animal feed products.

(b) The precise conditions for the authorisation of animal health-producing entities.

Article 76. Controls.

1. The competent authorities of public administrations shall establish the necessary official controls to ensure compliance with the provisions of this law. Such controls may be systematic or random at any time or place where animals or products of animal origin are circulating or are found.

2. Checks on the manufacture, manufacture, placing on the market and use of products for animal nutrition and animal health products shall pay particular attention to compliance with good manufacturing practice and monitoring of the levels of residues and prohibited substances, present in animals and products of animal origin, and in foods prepared with them.

Article 77. Precautionary measures.

1. The competent authorities and, where appropriate, the accredited inspectors may, on a reasoned basis, for reasons of urgency or necessity, take provisional measures of a precautionary nature, if the preliminary action taken in respect of the inspection or control would lead to the existence of an immediate risk of occurrence or spread of an epizootic disease, or the existence of a certain and serious risk to public or animal health.

2. The precautionary measures may be any of the measures referred to in Article 8 (1), the seizure of allegedly false or incorrect health documents, or of any documents deemed necessary to prevent the spread of the disease or identify its source, as well as the temporary suspension of activities, facilities, premises or means of transport which do not have the necessary authorisations or registers.

3. Where the precautionary measures are taken by the inspectors, they shall be notified immediately to the competent body for the initiation of the sanctioning procedure, which shall, by means of a reasoned decision, proceed as soon as possible, which, In any event, it shall not exceed 15 days, ratify, amend or lift them and, where appropriate, supplement them, establishing those other guarantees and precautions that they deem appropriate. Where necessary, for reasons of urgency or need, the inspectors shall take the precautionary measures in a verbal manner and must reflect the agreement and their statement of reasons in writing as soon as possible and in any event not later than more than three days, giving the person concerned a transfer, and the competent body for the initiation of the sanctioning procedure, for the purposes referred to in this paragraph.

4. Such measures shall in any event be consistent with the intensity, proportionality and technical needs of the objectives to be ensured in each particular case, and their duration shall not exceed that of the risk situation which motivated them.

5. The competent health authority shall, on confirmation of the existence of a health risk for public health or animal health, make known immediately, by the means specified, the ratio of feedingstuffs to animals, affected animals or products, placed on the market. The communication shall contain the detailed indication of those and the precise characteristics of the identification, the risks involved and the measures to be taken in order to prevent its spread.

Article 78. Inspector staff.

1. The official staff at the service of the public authorities, in the exercise of the inspection duties set out in this law, shall have the status of an agent of the authority, being able to obtain from the competent authorities and, in general, from those who exercise public functions, including the State Security Forces and Bodies or regional and local police forces, the contest, support and protection that they are required to do. The appropriate management centres shall provide the inspection staff with the means of identification which they give due consideration to the performance of their actions.

2. In situations of serious health risk, the competent authorities may, temporarily, enable the carrying out of inspection duties, to staff at his/her service who does not have the status of an official and who is in possession of the certificate. the academic requirement in each case.

Such an enabling, temporary and non-final, will confer the status of agents of the authority, and end in the disappearance of the situation of serious health risk. In no case shall the performance of those duties entitle the acquisition of the character of a career officer.

Article 79. Inspection actions.

1. Officials who develop the inspection functions shall be authorised to:

(a) Free access, without prior notification, to any establishment, installation, vehicle or means of transport, or place in general, in order to verify the degree of compliance with the provisions of this law, respecting In any case, the basic hygiene and prophylaxis standards are in line with the situation. When carrying out an inspection visit, they must prove their status to the employer, their representative or person who is present at the place. If the inspection is carried out at the address of the physical person concerned, they must obtain their express consent or, failing that, the required prior judicial authorization.

(b) Proceed to practice any research, examination or test that they consider necessary to check the health status and the degree of compliance with the applicable health provisions.

(c) Require the appearance of the owner or the person responsible for the undertaking or installation, or the staff of the company, at the place where the inspection actions are taking place, and may require such information on any a subject that presumably has health significance, as well as the active collaboration required by the inspection.

(d) Take samples of the animals or of any suspected material, in accordance with the procedure laid down in regulation, in order to carry out or propose the tests, clinical or laboratory examinations; and (a) a comparison of the relevant

.

(e) Examine the identification of animals, documentation, record books, files, including those kept on magnetic media and computer software, for the inspected operation or transport, and with transcendence in the verification of compliance with health regulations.

(f) Adopt the precautionary measures provided for in Article 77.

g) Incautar and, where appropriate, order the slaughter, in the case of those suspected animals that do not comply with the current health or identification regulations.

2. The inspection may be carried out at any place where there are indications or possibilities for obtaining the necessary tests for the investigation of the health incidence detected and for the fulfilment of the conditions laid down in this Regulation. provided for in this law.

Article 80. Inspection report.

1. The inspector shall draw up the record of the data relating to the undertaking or the holding inspected and the person to whom the inspection is carried out, the measures which he has ordered and all the relevant facts of the inspection, in particular those which may have an impact on an eventual sanctioning procedure.

2. The facts set out in the minutes, observing the relevant legal requirements, shall be of probative value, without prejudice to the evidence which, in defence of the respective rights or interests, may be indicated or provided by the administered authorities.

3. Such minutes shall be forwarded to the body responsible for initiating the proceedings, proceedings or appropriate procedures, including the sanctioning procedure.

Article 81. Obligations of the inspection.

1. Natural or legal persons to whom an inspection is carried out shall be obliged to:

(a) Provide all kinds of information about facilities, products, animals, services and, in general, about those aspects that will be requested, allowing their verification by the inspectors.

b) Facilitate copying or reproduction of the information.

(c) Allow the appropriate testing, or free sampling of animals, products, substances or goods, to be carried out in the quantities that are strictly necessary.

d) And, in general, to consent and collaborate in carrying out the inspection.

2. Inspectors shall be required to keep the due confidentiality and confidentiality of all data or facts of any nature they have known in the exercise of their inspection.

CHAPTER II

Violations

Article 82. Rating of infringements.

The infringements contained in this Chapter are classified as minor, serious and very serious, in the form expressed in the following Articles, taking into account the criteria for public health, animal health or the environment. environment, degree of intentionality, severity of potential damage and difficulties for surveillance and control.

Article 83. Minor infractions.

These are minor violations:

1. The holding of less than 10 per cent of animals, where the identification is compulsory, in relation to the animals held, or, in the case of production animals, in relation to those belonging to the holding, whose identification lack any of the elements provided for in the specific legislation.

2. The lack of communication to the competent authority for the birth, entry or exit of the animals for the production of a holding, or in general of data and information of interest in animal health, where such communication comes required by the applicable rules, or the delay in the communication of such data, where it is twice or more than the time limit laid down in the specific rules.

3. The communication of suspected occurrence of an animal disease, or the communication of an animal disease, where it is done in both cases outside the time limit laid down in the rules in force, and is not qualified as a serious or very serious infringement severe.

4. Deficiencies in record books or as many documents require the enforcement of existing provisions of interest in animal health, provided that such non-compliance is not classified as serious or very serious.

5. The opposition and lack of collaboration with the inspection and control of public administrations, when it does not prevent or seriously hinder its implementation.

6. Insufficient or defective labelling, in accordance with the applicable rules, of feed, premixtures, additives, raw materials, substances and products used in animal nutrition, which cannot be classified as a serious or very serious infringement severe.

7. Manufacture, manufacture, import, export, distribution, placing on the market, transport, or recommendation or prescription for the use of feed, premixtures, additives, raw materials, substances and products used in animal nutrition conditions not permitted by the rules in force, or the use of which has been expressly prohibited or restricted, provided that it cannot be classified as serious or very serious.

8. The use or holding on the holding, or in the premises, of feed, premixtures, additives, raw materials, substances and products used in animal nutrition, the use of which has been expressly prohibited or restricted, under conditions not permitted by the current rules, which cannot be qualified as a serious or very serious infringement.

9. The introduction into or out of the national territory of animals, products of animal origin, animal products or animal health products other than veterinary medicinal products, where prohibited, in the national territory or out of that territory or limited for reasons of animal health, or in breach of the requirements for their introduction, including veterinary control at the border in cases where it is necessary, provided that the prohibition or limitation is a temporary one. timely advertising.

10. The pursuit of manufacturing, production, marketing, research, processing, movement, transport and, where appropriate, destruction of animals, products of animal origin or animal health products other than medicinal products veterinarians, subject to the requirement of prior authorisation, without having applied for renewal, or without fulfilling purely formal requirements, or under conditions other than those laid down in the rules in force, provided that this is not typified as severe or very severe.

11. The lack of identification of the animals transported, in cases where the identification is compulsory, up to 10% of the consignment, or the non-correspondence of the number of the animals transported with that indicated in the documentation move health.

12. Do not properly fill in the health documentation required for movement and transport of animals, where it is not classified as severe or very serious.

13. Non-compliance by animal health care technicians or, in the case of animal health products other than veterinary medicinal products, by the persons responsible for their control and even their preparation of the obligations Health and safety regulations applicable to them, provided that it cannot be classified as serious or very serious.

14. Simple irregularities in observing the rules laid down in this law without direct relevance to public health or animal health, which are not included as serious or very serious infringements.

Article 84. Serious infringements.

These are serious violations:

1. The holding in a holding of production animals, the identification of which is compulsory in accordance with the applicable rules, and cannot be established by any of the identification elements provided for in the specific legislation of identification, or holding of more than 10% of animals, in relation to the animals held or, in the case of production animals, in relation to those belonging to the holding, where such identification is compulsory for agreement with the applicable rules and lack any of the elements provided for in that regulation specific regulations.

2. The start of the activity in a new installation animal holding, or the extension of an existing holding, without the prior administrative authorisation or registration in the relevant register.

3. Failure to communicate the death of the production animal, where such communication is required by the applicable legislation.

4. The absence of notification by slaughterhouses of the entries and sacrifices of animals from areas affected by an epizootic or zoonosis, as well as, where appropriate, by the slaughterhouse veterinarian.

5. The concealment, lack of communication, or communication exceeding twice the time limit laid down, of diseases of animals which are of compulsory declaration or notification, provided that they are not of special virulence, extreme severity and rapid diffusion, nor is it a zoonosis.

6. The declaration of false data on the production animals held, in the communications to the competent authority providing for the specific rules.

7. The lack of records of records that were mandatory, or their extension without completing the data that were essential to check compliance with animal health standards, and which is not typified as a slight lack.

8. The opposition, obstruction or lack of collaboration with the inspection and control of the public administrations, when it prevents or seriously hinders its performance, as well as the supply to the inspectors, knowingly, of information inaccurate.

9. Insufficient or defective labelling, in accordance with the applicable rules, of feed, premixtures,

additives, raw materials, substances and products used in animal nutrition, where such non-compliance carries a risk to animal health.

10. Manufacture, manufacture, import, export, distribution, placing on the market, transport and recommendation or prescription for use of feed, premixtures, additives, raw materials, substances and products used in animal nutrition; or animal health products other than veterinary medicinal products, under conditions not permitted by the rules in force, or the use of which has been expressly prohibited or restricted, where such non-compliance carries a risk to animal health.

11. The use or holding on the holding or in premises of feed, premixtures, additives, raw materials, substances and products used in animal nutrition or animal health products other than veterinary medicinal products, under conditions not permitted by the rules in force, or the use of which has been expressly prohibited or restricted, where such non-compliance carries a risk to animal health.

12. The introduction into or out of the territory of the national territory, for commercial purposes, of animals, products of animal origin, animal feed products or animal health products other than veterinary medicinal products, without authorisation, where it is necessary and prescriptive, or in breach of the requirements for its introduction, including veterinary control at the border in cases where it is necessary, provided that it cannot be considered to be very serious.

13. The introduction into the national territory of animals, products of animal origin or animal health products other than veterinary medicinal products, making use of false health certification or documentation, provided that it cannot be considered to be very serious.

14. The sale or entry into circulation, of a different destination for human consumption, of suspected or ill animals diagnosed with a disease of a compulsory declaration or notification, or of their products, derivatives or by-products, where its express prohibition is set, provided that it is not typified as a very serious fault.

15. Failure to comply with or breach of the precautionary measures taken by the Administration for specific situations in order to prevent the spread of diseases or harmful substances or of the health measures adopted by the Administration for the prevention, control or eradication of diseases or harmful substances, or resistance to their execution, where it is not classified as very serious.

16. The supply to the animals, or the addition to their products, of substances in order to correct defects, by unauthorized processes, or to conceal a disease or alteration in those, or to mask the results of the methods of diagnosis or detection of waste.

17. The omission of the tests, tests and tests for the detection of diseases to which animals are not intended for human consumption, as well as their non-performance in the laboratories designated by the competent body of the Community autonomous, or the omission of the serological controls established by the implementing rules in each case, or their performance in breach of the deadlines, requirements and obligations imposed by the current regulations.

18. The removal of specified risk materials in relation to the transmissible spongiform encephalopathies of animals, by unauthorised subjects or in centres not permitted by the rules in force, or by non-compliance with the obligations provided for in the existing rules on the treatment of such specified risk materials prior to their destruction.

19. The removal of specified risk materials in relation to the transmissible spongiform encephalopathies of the animals, in breach of the technical and health conditions required or not in compliance with the administrative authorisations corresponding.

20. The abandonment of animals, their carcasses or of products or raw materials which pose a health risk to animal health, to public health or to pollution of the environment, or to their dispatch to destinations which are not authorised, provided that they are not typified as very serious.

21. The lack of disinfection, disinterment and the number of sanitary measures shall be established in regulation, for holdings and means of transport of animals.

22. The use of defective health documentation for the movement and transport of animals, or the lack of identification of the animals transported, in cases where identification is mandatory, in numbers greater than 10% of the item.

23. The absence of the required health documentation for the movement and transport of animals, or the non-correspondence of the animal with the origin, destination, type of animal or territorial scope of application, where it is not typified as a minor fault.

24. The completion of official documents for the transport of animals suspected of being affected by a notifiable disease or compulsory notification, by official veterinarians, authorised or authorised for this purpose, or animals affected by a disease of that class, or are located in areas subject to restrictions on movement of animals, provided that they are not qualified as very serious.

25. Non-compliance by animal health care technicians or, in the case of animal health products other than veterinary medicinal products, by the persons responsible for their control and even their preparation of the obligations health requirements imposed on them by the applicable rules, where they are at risk for animal health.

26. The recidivism in the same minor infraction in the last year. The time limit shall begin to be counted from the day following the day on which the decision is final.

27. The slaughter of animals suspected or affected by infectious or parasitic diseases without the relevant authorisation.

Article 85. Very serious infringements.

These are very serious violations:

1. The serious infringements referred to in paragraphs 1, 3, 5, 6 and 25 of the previous Article, which may result in a risk to the health of persons.

2. The concealment or lack of communication of cases of diseases of animals which are of compulsory declaration, in the case of zoonoses, or of diseases which occur on an epizootic basis, provided that they have a special virulence, extreme severity and rapid diffusion.

3. The unauthorised manufacture, falsification, handling or fraudulent use of the identification marks of the animals or identification documents which cover them, or of the books of registration of the holdings, which are set out in the specific regulations governing their identification and registration.

4. Provide false documentation, knowingly, to the inspectors of the Administration.

5. The serious infringements referred to in paragraphs 9, 10 and 11 of the previous Article, where such non-compliance carries a risk to public health.

6. The serious infringements referred to in paragraphs 12 and 13 of the previous Article, where they pose a risk to human health, animal health or the environment.

7. The destination for human consumption of animals or products of animal origin, where their express prohibition is established.

8. The sale, or simply put into circulation, of suspected or ill animals diagnosed with an epizootic of those referred to in paragraph 14 of this Article, from which the introduction of the disease may be derived in other holdings or areas free of such holdings, unless their transfer to a body processing industry is expressly authorised.

9. The handling, transfer or disposal in any form of the animals, products of animal origin, animal feed products or animal health products other than veterinary medicinal products, whether or not they are intended for use, non-compliance with the intervention measures.

10. The omission of the tests, tests and tests for the detection of the diseases to which the animals are to be subjected to human consumption, as well as their non-performance in the laboratories designated by the competent organ of the autonomous community.

11. Failure to comply with the obligation to extract, have or mark all the specified risk materials in relation to transmissible spongiform encephalopathies, by those who are obliged to comply with them and who are authorised to do so realization.

12. The abandonment of animals or their bodies, previously diagnosed with a disease of those considered in paragraph 15 of this article.

13. The use of false health documentation for movement and transport of animals.

14. The transport of animals, sick or suspected, who can spread diseases of high health risk.

15. The official documents for the transport of animals from a holding or installation where a disease has been diagnosed shall be completed by the official veterinarian or by the authorized or authorized for that purpose. a mandatory declaration or notification which is presented on an epizootic basis, provided that they have a special virulence, extreme gravity and rapid diffusion, and are capable of causing obvious damage to animal health or to public health.

16. Diagnosis or analysis of diseases submitted to national eradication programmes by laboratories not expressly recognised by the competent authority in the field of animal health.

Article 86. Liability for violations.

1. Natural or legal persons who commit them, even in the form of simple negligence, shall be held liable for infringements of this law.

When compliance with the obligations provided for in this law corresponds to several persons together, or if the infringement is attributable to several persons and it will not be possible to determine the degree of participation of each person (a) they shall respond in solidarity to the infringements which, where appropriate, are committed and to the penalties imposed. They shall be liable for failure to comply with the supervision obligations laid down by this law in order to prevent the commission of administrative infringements by other natural and legal persons on whom such obligations are imposed. relapse.

2. In particular, they will be held responsible:

(a) In the trade of animals or products of animal origin, treating or traders, wholesalers, distributors or buyers.

(b) In the case of animals, products of animal origin or raw materials, imported or for export, the importer or exporter of those animals.

(c) In the case of infringements in raw materials or packaged products, with complete closure, the natural or legal person whose name or social name is on the label, unless proof of falsification or miskeeping by the tenner, provided that they are known, or specified in the original packaging, the storage conditions.

(d) For infringements committed in raw materials or bulk products, the holder of such goods or bulk products, except where the holder can identify and prove the liability of a previous holder.

e) In integrations, it will be considered responsible:

1. The integrated one, the offences committed while the animals remain on the holding, in particular the incorrect application of the medication and the non-compliances in the matter of entry into the exploitation of persons and vehicles. However, if the ultimate decision-making power on the effective enforcement of the obligation or precept concerned is the responsibility of the integrator, and its implementation or application to the integrated one, it shall in principle be considered responsible for both solidarily.

2. The integrator, in the rest of the assumptions.

3. In the case of serious or very serious infringements, where an offence is imputed to a legal person, persons who are members of their decision-making or management bodies may also be held liable, provided that the offence is liable to their intentional or negligent conduct, in which case the penalty provided for in Article 88 (1) (b) may be imposed.

4. Without prejudice to the penalties provided for, those responsible for infringing activities shall be obliged to compensate for any damage or damage caused.

5. The administrative responsibility for the offences referred to in this law shall be independent of any civil, criminal or other liability which may, where appropriate, be required.

CHAPTER III

Sanctions

Article 87. General provisions.

1. Infringements in the field of animal health shall be subject to the appropriate administrative penalties, subject to the instruction of the appropriate file.

2. A sanctioning procedure is initiated, if the facts could be presumed to constitute a crime or a fault, it shall be brought to the attention of the Prosecutor's Office, with reference to the act, in order for it to carry out the criminal action, where appropriate corresponding. The criminal proceedings before the Courts of Justice shall suspend the processing of the administrative file of penalties which has been initiated by the same facts and, where appropriate, the effectiveness of the administrative acts of taxation of sanction.

3. In no case shall a double sanction be imposed for the same facts and on the basis of the same protected public animals, but other responsibilities which are deducted from other concurrent infringements shall be required.

4. By reasoned agreement, the provisional measures necessary to ensure the effectiveness of the decision which may be placed on it and, where appropriate, to prevent the effects of the infringement or the risk situation from being maintained, may be adopted. health. At any time the measures taken or replaced by more appropriate measures may be left without effect.

Article 88. Classes.

1. The penalties that may be applied by the commission for the infringements provided for in this law are as follows:

(a) In the case of very serious infringements, a fine of 60,001 to 1,200,000 euro shall apply.

(b) In the case of serious infringements, a fine of EUR 3,001 shall be applied to EUR 60,000.

c) In the case of minor infractions a fine of 600 to 3,000 euros or warning will be applied. The warning shall only be imposed if it has not been mediated by it and in the last two years the person responsible would not have been punished on the administrative basis by the commission of any other infringement of the provisions of this law.

2. In any event, the upper limit of the fines provided for in this Article may be exceeded up to the amount of the benefit obtained by the infringer, where that benefit exceeds the maximum amount of the fine.

Article 89. Circumstances for the graduation of the penalty.

1. The penalty will be graduated according to the following criteria: the circumstances of the person responsible, the characteristics of the holding or the production system, the degree of guilt, the reiteration, the participation, the benefit obtained or (a) to obtain, the number of animals concerned, the damage caused or the danger posed by the health of the animals or the health of the animals, the failure to comply with previous warnings, the social disturbance which may occur and, in their case, for acts of professional intrusion.

2. Where a single event is a constituent of two or more infringements, it shall be punishable only by the most serious.

Article 90. Ancillary sanctions.

1. The body to which the sanctioning file is to be resolved may, as ancillary penalties, agree on the following:

a) Measures of correction, security or control, which prevent continuity in the production of damage.

(b) Neglect of animals, products or materials that may pose a serious risk to animal health or any type of risk to human health.

(c) Destruction of animals or products of animal origin, if their use or consumption constitutes a danger to public health or animal health, or where Community legislation so provides.

The expenses arising from the operations of intervention, deposit, confiscation, transport and destruction, and, in general, the derivatives of the ancillary sanctions, shall be on behalf of the infringer. If the confiscation is not possible, it may be replaced by the payment of the amount of the market value of the goods by the infringer.

2. In the case of offences committed by persons, natural or legal persons, who develop an activity subject to administrative authorisation or registration, the body to which the sanctioning file is to be resolved may also agree, as a sanction the cessation, termination of the activity concerned or, where appropriate, proposing to the competent authority, the review, the temporary suspension for a maximum period of one year, the withdrawal or the non-renewal of the administrative authorisation or record in question.

3. In the case of serious infringements, the closure or closure of the undertaking, holding, premises or establishment may be agreed for a maximum period of five years, and additional measures may be taken for the full effectiveness of the decision taken.

4. In the case of serious infringements, it may be agreed as an ancillary sanction to disqualify for grants or public aid for a maximum period of five years.

5. In the case of offences committed by veterinarians authorised or authorised for the issue of health certificates and documentation with official validity, the withdrawal, non-renewal or cancellation of the certificate may be agreed as an ancillary sanction. authorisation to issue such certificates and documentation, with a prohibition on reclaiming for a period of not less than three months and not more than five years.

Article 91. Sanctioning power.

1. In cases where, in accordance with the applicable regulations, the sanctioning authority corresponds to the General Administration of the State, it shall be exercised by:

(a) The Minister of Agriculture, Fisheries and Food in the case of minor and serious infringements, without prejudice to the possibility of delegation.

(b) The Council of Ministers in the case of very serious infringements.

2. In any case expressly not regulated, the penalties shall be governed by the provisions of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

CHAPTER IV

Execution media and other metrics

Article 92. Periodic penalty payments.

1. If the person concerned does not carry out the obligations laid down in this law, or the competent authority decides to apply the precautionary measures provided for in Articles 8, 13, 17 and 77, the latter may require the persons concerned to (a) sufficient time to comply with those, with a warning that, if not, a periodic penalty payment shall be imposed, with an indication of the amount, if any, and up to a maximum of EUR 3 000, without prejudice to any penalties which may be imposed; be applicable.

2. The competent authority may, in the event of non-compliance, carry out successive requirements, increasing the periodic penalty payment by 20% of the one agreed in the previous requirement.

3. The time limits granted must be sufficient to enable the measure concerned to be carried out, as well as to avoid any damage that may arise from failure to implement the measure in due time.

Article 93. Subsidiary execution.

In the event that those concerned do not, in due time and form, carry out the measures or obligations that correspond to them in accordance with the provisions of this law, the competent authority shall execute them with their own (a) means or using non-foreign services, at the cost of the obligation, the amount of which may be required by way of award, irrespective of the penalties or periodic penalty payments.

Article 94. Other measures.

The competent authority may agree on the following measures, which shall not be of a sanction:

(a) The closure or closure of undertakings, facilities, holdings, premises or means of transport, which do not have the necessary authorisations or registers, or the temporary suspension of their operation until they are rectified the defects or the requirements for their authorisation are met.

(b) The drawback of any unduly perceived public aid or subsidies.

Article 95. Replenishment.

Without prejudice to the sanctions that may be imposed, those responsible for infringing activities will be obliged to replenish the situation they have before the infringement.

TITLE VI

Rates

CHAPTER I

Common application provisions

Article 96. Legal regime.

The rates set out in this Title will be governed by this law and by the other regulatory sources that are set out in Article 9 of Law 8/1989, of April 13, of Public Fees and Prices.

Article 97. Payment and management.

1. The payment of the fees shall be made in cash by entering the amount of deposit authorized by the Ministry of Finance, which shall be verified in accordance with the rules contained in the General Rules of Collection of 20 December 1990.

2. Fees shall be the subject of self-validation by the taxable person concerned.

3. The management and collection of the fees shall be carried out by the Ministry of Agriculture, Fisheries and Food, without prejudice to the powers which, where appropriate, correspond to the Ministry of Public Administrations in relation to the regulated rate in Chapter II of this Title.

Article 98. Tax infringements and penalties.

In all matters relating to the classification of tax offences, as well as the determination of the corresponding penalties, in each case, the provisions of Articles 77 et seq. of Law 230/1963 of 28 May 1977, December, General Tax.

CHAPTER II

Rate for inspections and veterinary checks on live animals entering national territory from non-Community countries

Article 99. Taxable fact and amounts.

1. It is the taxable fact of the fee for the provision or realisation by the veterinary services of the border inspection of the General Administration of the State, attached to the places where live animals are introduced from countries third parties, of the services or activities relating to the inspection and veterinary inspection of the importation of live animals related to the following paragraph.

The fee shall not apply to veterinary checks on pet pets other than equidae which accompany non-profit travellers.

2. The rate amounts shall be as follows:

(a) For the following animal groups, the tax quota shall be that resulting from the application of EUR 4,916519 per tonne of live weight, with a minimum of EUR 29,486856 per lot: bovine, solipeds/equidae, pigs, sheep, goats, birds, rabbits, minor featherweight and hair, and other game animals, such as wild boars and ruminants.

(b) For the other animals, the tax rate will be the result of applying EUR 10,053730 for each number of units shown below, multiplied by the factor resulting from dividing the units that make up the lot for the units in each previous group, with a minimum of EUR 29,486856 per batch: bees: 20 hives; live weight animals less than or equal to 0,1 kg (except live baits for fishing): 10,000 animals; live weight animals exceeding 0,1 kg: 200 animals; live weight animals exceeding 1 kg up to 20 kg:

20 animals; other live weight animals exceeding 20 kg: an animal; and live baits for fishing: 100 kg.

c) These rates will be increased by 50 percent when the performances have to be performed in night time or Saturday or in public holidays.

(d) In the case of imports from third countries, with which there are comprehensive equivalence agreements with the European Union on veterinary guarantees, based on the principle of reciprocity of treatment, the quota Tax will be the result of the implementation of such agreements.

Article 100. Taxable persons.

They are taxable persons, as taxpayers, persons, natural or legal, for which the services and activities described in the previous article are carried out.

Article 101. Responsible.

1. Customs agents participating in the introduction of animals into the national territory from third countries shall be responsible for the levy.

This liability shall be of a solidarity nature when acting in its own name and on behalf of the taxable person, and subsidiary when acting in the name and on behalf of the taxable person.

2. The persons and entities referred to in Section 2. of Chapter III of Title II of Law 230/1963 of 28 December, General Tax, shall be liable for the tax debts arising from this fee. is.

Article 102. Accrual and refund.

1. The fee shall be payable at the time when the inspection and control activities are requested to be carried out in the establishments or facilities in which those activities are carried out. The fee shall be paid before the start of the inspection and control activities, the performance of which is the taxable event. However, their payment may be required at the time when such inspection and control actions are requested, where they are to be carried out within a period not exceeding 24 hours from the request. The animals may not leave the border post without the payment being made.

The fee will be paid before inspection and control activities begin. The animals may not leave the border post without the payment being made.

2. The amount of the fee shall be reimbursed, at the request of the taxable person, where the administrative action which constitutes the taxable event is not carried out because it is not attributable to the taxable person.

Article 103. Prohibition of dispatch and restitution.

1. The authorities may not authorise the release for free circulation in the territory of the European Union without the payment of the fee being credited.

2. The amount of the corresponding fee may not be the subject of a refund to third parties, either directly or indirectly.

CHAPTER III

Rate for authorization and registration of other animal health products

Article 104. Taxable fact and amounts.

1. The taxable fact of the fee is the provision or performance by the competent authorities of the General Administration of the State of the following services or activities relating to animal health products and working entities, other than in both cases of veterinary medicinal products and biocidal products for livestock use:

(a) Procedure for the authorisation of the opening of an animal health product making body.

(b) Presentation of the notification of the transmission of the ownership of the opening authorisation of an entity making animal health products.

(c) Procedure for revalidation of the opening authorisation granted to an entity making animal health products.

(d) Procedure for the modification of the authorisation already granted for the opening of an entity making animal health products.

e) A procedure for granting authorization for the placing on the market and registration of an animal health product.

(f) The notification procedure for the transmission of the ownership of the authorisation for the placing on the market and registration of an animal health product.

g) Procedure for the modification of the authorisation for the placing on the market and registration of an animal health product.

(h) Five-year renewal procedure for the authorisation for the placing on the market and registration of an animal health product.

i) Procedure for issuing certifications.

2. The amounts are as follows:

(a) Procedure for the authorisation of the opening of a working entity for animal health products: EUR 588,51.

(b) Presentation of the notification of the transmission of the ownership of the opening authorisation of an entity making animal health products: EUR 67.43.

(c) Procedure for revalidation of the opening authorisation granted to an animal health-producing entity: EUR 116,47.

(d) Procedure for the modification of the authorisation already granted for the opening of a working entity for animal health products: EUR 588,51.

(e) A procedure for granting authorization for the placing on the market and registration of an animal health product: EUR 398,47.

(f) The notification procedure for the transfer of ownership of the authorisation for the placing on the market and registration of an animal health product: EUR 67.43.

g) Procedure for the modification of the authorisation for the placing on the market and registration of an animal health product: EUR 98.03.

(h) Five-year renewal procedure for the authorisation for the placing on the market and registration of an animal health product: EUR 134,86.

i) Certification procedure: 18.39 euros.

Article 105. Taxable person.

It shall be taxable persons of the natural or legal persons who request the provision of services or the performance of the activities that constitute the taxable event.

Article 106. Accrual.

1. The fee shall be payable at the time when the service is requested or the administrative activity is carried out. Where the serious charge for the issue of documents is due to the time of submission of the application initiating the file.

2. No application shall be processed which is not accompanied by the supporting evidence of the applicable fee.

TITLE VII

Information, training and awareness

Article 107. Programs and projects.

The competent authorities will promote the training of livestock farmers in animal health, including their study in all training programmes developed in the Ministry of Agriculture, Fisheries and Food. as well as the implementation of educational and scientific projects, all in order to promote the knowledge of animal health and its impact on the health of people and the environment.

Additional disposition first. Administrative silence.

In compliance with the provisions of article 43 of Law 30/1992, of November 26, of the Legal Regime of the Public Administrations and of the Common Administrative Procedure, the expiration of the maximum period for resolving, without If the person concerned has been notified, the following procedures shall be deemed to be negative administrative silence:

(a) Marketing authorisation procedures and registration in the register of animal health products other than veterinary medicinal products, as well as their renewal, modification and notification of transmission of the entitlement.

(b) Procedures for the opening of authorisation for the processing of animal health products other than veterinary medicinal products, as well as for the revalidation, modification and notification of transmission of the veterinary medicinal products. entitlement.

(c) Procedure for the issue of certificates of animal health products other than veterinary medicinal products, and of bodies working with veterinary medicinal products.

(d) Procedures for the carrying out of veterinary checks prior to the import or export of animals, products of animal origin, animal feed products or animal health products.

Additional provision second. Ceuta and Melilla.

1. The introduction into the territory of the cities of Ceuta and Melilla of animals, products of animal origin and animal health products, whatever their subsequent destination, shall be carried out only through the border inspection or inspection posts. the inspection centres approved for this purpose and, in the case of products for animal nutrition, through the entry points approved for that purpose by the General Administration of the State.

The departure of Ceuta and Melilla from animals, products of animal origin, animal health products and animal feed products, whatever their subsequent destination, will be carried out only through the border inspection or inspection centres, premises or exit points approved for that purpose by the General Administration of the State.

Such goods must be inspected, and health inspections or tests shall be carried out at the aforementioned border inspection posts, centres, enclosures or points approved by the General Administration of the State. Animals, products of animal origin, animal health products and animal feed products, subject to veterinary inspection, shall be those laid down in the relevant implementing rules in each case.

2. The entry into the rest of the national territory of animals, products of animal origin and animal health products originating in Ceuta and Melilla shall be carried out only through border inspection posts or inspection centres. approved for that purpose, and, in the case of products for animal nutrition, through the points of entry approved by the General Administration of the State. Such goods shall be inspected and inspections or health tests shall be carried out at the above border inspection posts, inspection centres or entry points. Animals, products of animal origin, animal health products and animal feed products, subject to veterinary inspection, shall be those laid down in the relevant implementing rules in each case.

Additional provision third. Competencies of other ministries.

The provisions of this law, when affecting animals attached to the Ministries of Defense and the Interior and its public bodies, shall be applied by the competent organs of the said departments, except in the case of import or export, in which the provisions of Chapter II of Title II of this Law shall apply.

In any case, the Ministries of Defense and Interior shall communicate to the Ministry of Agriculture, Fisheries and Food all information regarding their animals that is necessary for the Department to exercise their competence in the field of animal health.

Additional provision fourth. National plan for the removal of special waste.

The National Committee of the Veterinary Health Alert System will develop and establish a national plan for the removal of waste of special treatment for exceptional situations that will ensure in all autonomous communities its realization. This plan shall contain the scope and scope of the waste concerned.

First transient disposition. Inspection procedure.

Until specific procedures are established in the field of inspections, the provisions of the Royal Decree 1945/1983 of 22 June 1983 governing infringements and penalties in respect of consumer protection and agri-food production, in all cases which do not object to the provisions of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure, and their development regulations, without prejudice to the powers of the autonomous communities.

Second transient disposition. Regulatory standards for animal health.

Until such time as new provisions on the respective matters are laid down in this law, all the rules laid down in the field of animal health remain in force, in which they do not object to the In this law, and in particular the Law of Epizootic Law, adopted by Decree of 4 February 1955.

Transitional provision third. Register of holdings.

The holders of holdings of animals which, at the time of entry into force of this law, are not registered in the corresponding autonomous community in accordance with the provisions of Article 38, shall have a a maximum period of two years to apply for such registration, provided that the competent autonomous community has not established other lower deadlines.

Single repeal provision. Regulatory repeal.

All provisions of equal or lower rank shall be repealed as set forth in this law, and expressly the following:

a) The Epizootic Act of December 20, 1952.

(b) Article 19 of Law 66/1997 of 30 December 1997 on fiscal, administrative and social order measures.

(c) Article 8 and Article 103 (2), (3) and (4) of Law 50/1998 of 30 December 1998 on fiscal, administrative and social order measures.

(d) Group X "Animal Health Products" in Article 117 (1) of Law 25/1990 of 20 December of the Medication.

(e) Law 26/2001 of 27 December establishing the system of infringements and penalties in respect of transmissible spongiform encephalopathies.

Final disposition first. Competitive titles.

This law has the character of basic regulation under the provisions of article 149.1.13.a, 16.ay 23. of the Constitution, which reserves the State exclusive competence in the field of bases and coordination of planning General economic activity, bases and general coordination of health and basic legislation on environmental protection.

The regulation contained in Articles 12 to 15 of this Law, as well as the sanctioning regime relating to imports and exports provided for therein, which is issued under the terms of the provisions of the Treaty, is exempted from the basic regulation. Article 149.1.10. and 16.a, first indent, of the Constitution, which attributes to the State exclusive competence in the field of foreign trade and health, respectively, and the regulation contained in Articles 96 to 106, which is (a) it is required by Article 149.1.14 of the Constitution, which confers on the State the exclusive competence in the field of general finance.

Likewise, the regulation contained in Articles 60 to 63 of this Law is made in accordance with the provisions of Article 149.1.16.a, third indent, of the Constitution, which confers on the State exclusive competence in matters of legislation on pharmaceutical products.

Final disposition second. Amendment of Law 25/1990 of 20 December of the Medication.

A paragraph 4 is added to Article 50 of Law 25/1990 of 20 December of the Medication, with the following content:

" 4. Public administrations, in the exercise of their powers, may acquire veterinary medicinal products, in particular vaccines, which are accurate, directly from manufacturers or from any approved distribution centre. "

Final disposition third. Sanctions update.

The government is empowered to update, by means of a royal decree, the amount of the penalties provided for in this law, according to the rates of consumption prices of the National Statistics Institute.

Final disposition fourth. Amendment of the amount of the fee for inspections and veterinary checks on animals entering national territory from non-Community countries.

1. The parameters for quantifying the rate provided for in Article 99 of this Law shall be:

(a) In the case of paragraph 2 (a), the tonne by weight and a minimum per lot.

(b) As regards the provisions of paragraph 2.b), the number of units in each group of animals and a minimum per lot.

2. The amount of the above parameters may be modified by ministerial order.

Final disposition fifth. Application and development faculty.

The Government is authorized to dictate how many provisions are necessary for the application and development of this law.

Therefore,

I command all Spaniards, individuals and authorities, to keep and keep this law.

Madrid, 24 April 2003.

JOHN CARLOS R.

The President of the Government,

JOSÉ MARÍA AZNAR LÓPEZ