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Royal Decree 1132/2010, Of 10 September, Amending Royal Decree 109/1995 Of 27 January On Veterinary Drugs.

Original Language Title: Real Decreto 1132/2010, de 10 de septiembre, por el que se modifica el Real Decreto 109/1995, de 27 de enero, sobre medicamentos veterinarios.

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TEXT

By Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products, Council Directives 81 /851/EEC of 28 September on the approximation of the laws of the Member States relating to veterinary medicinal products were incorporated into our legislation. the Member States on veterinary medicinal products, and 81 /852/EEC, of the Council of 28 September on the approximation of the laws of the Member States relating to analytical, pharmaco-pharmacological and clinical standards and protocols for testing of veterinary medicinal products, together with subsequent modifications of the same. Directive 91 /412/EEC of the Commission of 23 July laying down the principles and guidelines of good practice in the manufacture of veterinary medicinal products has been transposed and has been adapted for veterinary medicinal products, the Spanish legislation to Council Directive 87 /22/EEC of 22 December 1986 on the placing on the market of high-tech medicinal products, in particular those obtained by biotechnology and Council Directive 78 /25/EEC of 12 December 1986 1977 on the approximation of the laws of the Member States relating to: the materials which may be added to the medicinal products for colouring.

The above-mentioned Directives were set out in Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, subsequently amended by Directive 2004 /28/EC of the European Parliament and of the Council of 31 March 2004, which has been incorporated into our system by means of Law 29/2006 of 26 July 2004 on the guarantees and rational use of medicines and medical devices, and Royal Decree 1246/2008, of 18 July 2008, which regulates the procedure for authorisation, registration and pharmacovigilance of industrially manufactured veterinary medicinal products.

Without prejudice to this, it is necessary to make several amendments to the aforementioned Royal Decree 109/1995 of 27 January, in order to adapt its content to the new regulation that has been adopted in recent years, in particular to the It is necessary to carry out the regulatory development of the veterinary medicinal products in accordance with Law 29/2006 of 26 July of 26 July on the conditions for the prescription and supply of veterinary medicinal

.

This provision has been submitted to the autonomous communities and to the representative entities of the sectors concerned.

This royal decree is dictated by the power of regulatory development provided for in the fifth final provision of Law 29/2006, of July 26.

In its virtue, on the proposal of the Minister of the Environment, and the Rural and Marine Environment and the Minister of Health and Social Policy, with the prior approval of the Minister of the Presidency, in agreement with the State Council deliberation of the Council of Ministers at its meeting on 10 September 2010,

DISPONGO:

Single item. Amendment of Royal Decree 109/1995 of 27 January on veterinary medicinal products.

Royal Decree 109/1995 of 27 January on veterinary medicinal products is amended as follows:

One. Article 4 is replaced by the following:

" Article 4. General control over veterinary medicinal products.

1. No one may possess or have under his control veterinary medicinal products or substances possessing anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psycho-troop properties, or, where appropriate, of another type according to the the effect is adopted by the European Commission, which may be used as a veterinary medicinal product, unless it has an express authorisation issued by the competent bodies of the Autonomous Communities, is covered by the rules of this provision; or in the case of national reference laboratories, official laboratories of the autonomous communities or official laboratories of the General Administration of the State.

2. The autonomous communities and cities of Ceuta and Melilla shall forward to the Spanish Agency for Medicinal Products and Sanitary Products the list of manufacturers and distributors authorized to possess active substances which may be used in the manufacture of veterinary medicinal products and which possess the properties referred to in paragraph 1, which shall transfer that information to the Ministry of the Environment, and the Rural and Marine Environment. Such manufacturers and distributors shall keep detailed records, which may be electronically carried out, of all transactions relating to those substances. The records shall be made available to the competent bodies of the autonomous communities and cities of Ceuta and Melilla for inspection purposes for a period of at least five years from the date of completion. of the above transactions. "

Two. Articles 38, 39 and 40 are replaced by the following:

" Article 38. Requirements of the master formulae and of the official formulae or formulae intended for the animals.

1. The master formulae intended for animals shall have the status of a legally recognised veterinary medicinal product, if they are drawn up, on veterinary prescription, in a pharmacy office, and the premises of Article 81 are fulfilled. or of Article 82.

2. They will be prepared with substances of action and indication legally recognized in Spain, following the guidelines of the National Form and only in the offices of pharmacy that have the necessary means for their preparation. The production and quality control standards shall be observed in the production process.

3. For the purpose of dispensing, account shall be taken of the provisions of Article 83 (2) and shall be accompanied by a label containing the information set out in Article 40.

4. Each elaboration will have to be reviewed in the book of record of the pharmacy office with the data that was reflected in that label and the reference to the corresponding prescription.

Such information shall be kept at the disposal of official inspections which may be carried out by the competent bodies of the Autonomous Communities for at least five years.

5. The preparation of official preparations or formulas shall require compliance with the same requirements as set out in the preceding paragraphs.

Article 39. Self-vaccines for veterinary use.

1. Self-vaccines for veterinary use shall only be the condition of recognised veterinary medicinal products if the preparation is carried out on a veterinary prescription from the material collected in a particular animal or holding and for exclusive use. animal or animals of the same holding and provided that the premises of Article 81 or Article 82 are met.

2. The premises and facilities for the preparation shall have official recognition for the handling of pathogenic material of animal origin, shall have adequate means for the preparation and control of the referred preparations and processes. Manufacture and control shall comply with the rules of correct manufacture, in particular as regards health safety. In addition, in the case of self-vaccines other than inactivated bacteria, the working entities shall follow principles equivalent to the rules of correct manufacture of veterinary medicinal products for the purpose of ensuring quality. of such medicinal products.

Local recognition authorizations and preparation facilities will be granted by the competent bodies of the corresponding Autonomous Communities, giving the Ministry of the Environment, and Rural and marine environment, which in turn will give the Ministry of Health and Social Policy a move.

3. The supply may be made only from the working party to the prescribing veterinarian or the holding of destination or owner of the animals, and the packaging material shall be accompanied by the information set out in the Article 40.

4. Each lot shall be reviewed in the register book of the working party with the data on the issue label and reference to the veterinary prescription.

Such information shall be kept at the disposal of official inspections which may be carried out by the competent bodies of the Autonomous Communities for at least five years.

5. The working entities shall, at least quarterly, notify the competent authorities of the autonomous communities in which they radiate, the holdings of destination, of the self-vaccines provided, indicating the identity of the prescriber veterinarian. and reference to the recipe for the preparation of the self-vaccine, the holding of destination and the quantity supplied. In the case of pet animals, the information relating to the holding shall be replaced by the data of the owner of the animal.

The Autonomous Communities shall send to the Ministry of the Environment, and the Rural and Marine Environment, on an annual basis, a report on the characteristics and justification of the use of self-vaccines for the purposes of epizootic information general.

6. The working entities shall make available to the competent bodies of the autonomous communities the protocols for the production and control of the self-vaccines when they are required for this purpose. They shall also provide for their control, raw material information, intermediate products or final batch of immunological medicinal products when requested.

Article 40. Label of master formulas, preparations or official formulas and self-vaccines.

1. In the case of the master formulae and of the official formulae or formulae, a label shall be accompanied by the following particulars:

a) Identification of the pharmacy office and the prescriber veterinarian.

b) Number with which is listed in the pharmacy office log book.

(c) The words "Veterinary use formula" or "Official veterinary use formula or formula", as appropriate.

d) Date of elaboration.

e) Identification of the animals or the holding of destination.

f) The qualitative and quantitative composition in active substances per dose or in the form of administration, for a given volume or weight, using, where there is, the international common name recommended by the World Health Organization and, failing that, the usual common name.

g) To the extent that they affect the qualitative and quantitative composition of veterinary medicinal products in active substances, the provisions applicable to the effect of Annex I to Royal Decree 1246/2008 of 18 July 2008 on the that the procedure for the authorisation, registration and pharmacovigilance of industrially manufactured veterinary medicinal products is regulated.

h) The reference number for the identification in the production (manufacturing batch number).

i) The waiting time, even if it is null, for the veterinary medicinal products to be administered to food production animals for human consumption.

j) The expiration date in understandable language.

k) Special precautions for storage, if any, with the corresponding symbol if the cold contest is required.

l) Special precautions to be taken when removing unused medicinal products and waste products where appropriate.

Identical data, except as regards the changes of the pharmacy office by the working party and the mention in subparagraph (c) by "Self-vaccine for veterinary use", shall appear on the label accompanying them. products. "

Three. The content of Article 42 is replaced by the following:

"The use and prescription of narcotic drugs in veterinary medicinal products shall be in accordance with the provisions of international conventions and in the specific rules thereof."

Four. Article 75.2 (c) is replaced by the following:

" (c) Supplies of precise and determined quantities of veterinary medicinal products from one retailer to another, taking into account the specificities of the livestock sector under consideration, with an individualised control of these deliveries. "

Five. Article 80 is replaced by the following:

" Article 80. Prescription and prescription obligation.

1. Veterinary prescription shall be required by prescription for the supply to the public of all veterinary medicinal products subject to such a requirement in the marketing authorization and, in any case, in the cases provided for in paragraphs 1 and 2. 1 and 2 of Article 37 of Law 29/2006, of 26 July, and for medicinal gases.

Also, a prescription must be issued by the veterinarian in the case referred to in Article 93.5.

2. The quantity prescribed and dispensed shall be limited to the minimum necessary for the treatment in question, according to the criterion of the prescriber veterinarian, and taking into account the authorised formats of the veterinary medicinal product most appropriate for that purpose and provided that they are accompanied by the required documentation.

3. The recipe, as a document that endorses the prescription of veterinary prescription, will be valid throughout the national territory and will be published in the official language of the State and in the respective co-official languages in the autonomous communities. It is available. The electronic signature may be used in accordance with Law 59/2003 of 19 December of Electronic Signature, or the electronic prescription, in the latter case in the form and conditions to be established in accordance with the applicable law.

The prescription for the prescription of veterinary medicinal products, with the exception of narcotic drugs, which shall be in accordance with the rules laid down for such medicinal products, shall include at least an original part intended for the centre dispenser, and two copies, one for the owner or responsible for the animals and one for the repossession of the veterinarian who carries out the prescription. Where the veterinarian makes use of the medicinal products available for his professional practice, he shall also retain the original intended for the dispensing centre.

4. The recipe must contain at least the following information, without which it shall not be valid for the purpose of dispensing:

a) Over the prescriber: name and two surnames, full address, number of collegiate and province of collegiation.

(b) Denomination of the medicinal product which is perfectly legible, specifying the pharmaceutical form, the corresponding format of the medicinal product, if there are several, and the number of copies to be dispensed or administered.

c) Signature of the prescriber and date of the prescription.

In addition, where the prescription is issued for medicinal products for human consumption, the following additional data shall be provided:

(a) Code of identification of the holding provided for in Article 5 of Royal Decree 479/2004 of 26 March 2004 and animal species for which the medicinal product is intended to be used in the case of several species on the same holding, or, failing that, the identification code granted by the competent authority of the Autonomous Community.

b) The set timeout, even if the same time is zero days, in which case the wait time will also be stated.

c) Recipe number.

In the prescription, or in separate document, in the case of medicinal products for human consumption, the following data must be included: dosage, route of administration and duration of treatment.

In addition, in the recipe for an exceptional prescription the legend "EXCEPTIONAL PRESCRIPTION" will be shown, and the following minimum data: the number of animals to be treated, their individual or batch identification, the diagnosis, the route and the doses to be administered and the duration of treatment.

In any case, it will also be printed in the prescription, and may be used the reverse of the prescription, the indication that the same will expire in the thirty days for the dispensing of the prescribed medication, except in the case provided for in the second subparagraph of the following paragraph.

The instructions for the owner or the animal responsible for the use or administration of the medicinal product which the doctor may consider appropriate to record, may appear in the prescription or in separate document.

5. The prescribed medication in each prescription may refer to an animal or group of animals, provided that, in the latter case, they are of the same species and belong to the same holding or owner, as well as to provide for a single or all the medicinal products necessary for the disease in question, applied as a single treatment, and in the latter case the waiting time for the last administered medicinal product with the longest waiting time should be established.

The duration of the treatment prescribed in each prescription and the time limit for dispensing it shall not exceed 30 days, except in the case of chronic diseases or periodic treatments, which shall be stated in the prescription, in which The duration of treatment and the period of treatment may not exceed three months. For these purposes, it shall be periodic treatment, in the case of food-producing animals, provided for in the health programme of the holding, drawn up by the veterinarian responsible for the holding, or, in the case of holdings members of a Health Defence Grouping or of an entity or group provided for in Article 85 of this royal decree, including in the corresponding health programme, provided that the use of the routine treatment is not contemplated medicinal products containing narcotic substances or psychotropic substances, antimicrobials, gases medicinal products, masterways, official preparations, self-vaccines, and medicinal products falling within the scope of Royal Decree 2178/2004 of 12 November 2004 prohibiting the use of certain substances having a hormonal or thyrostatic action; and beta-agonists of use in livestock farming.

6. The veterinarian may authorise the use of a medicinal product which is left over from an earlier prescription kept in its original packaging on the same holding, provided that it is not expired and has been properly preserved and in the conditions laid down in the accompanying documentation of the medicinal product. To this end, it shall draw up a recipe containing, together with the corresponding data in paragraph 4, the words "Not valid for supply" or similar formula.

7. The provisions of this Article shall be without prejudice to the requirements for prescriptions for medicated feed in the regulatory framework for medicated feed.

8. The veterinary order for the preparation of a master formula or an official preparation or formula shall be extended in the standard recipe model, and the veterinarian must specify, in addition to the information referred to above:

a) The quantitative and qualitative composition.

b) The morbid process that is intended to be treated and the animal species to which it is intended.

c) Quantity to be drawn up.

For the production of self-vaccines for veterinary use, the identification of the animal or holding in which the micro-organism and strain from which the animal is to be prepared shall also be indicated in the recipe. self-vaccine, the date on which the sample was taken from which it is produced, as well as the entity duly authorised in accordance with the current rules, which shall draw up the sample.

9. Veterinary prescription is not required for the supply of medicated premixtures to establishments expressly authorised for the manufacture of medicated feed, but in order to be carried out, it will be necessary, in the order form, to extended, at least in duplicate, in addition to the identification of the petitioning industry, the name of a person responsible for the industry, his signature and the date. The copy will be returned with the shipment of the goods.

10. Where a compulsory programme for the surveillance, prevention, control, control, control or eradication of animal diseases is established, in which the competent authorities acquire the veterinary medicinal products, or in the case of purchase by the Public Administrations of such medicinal products for their administration to the animals of their property, the requirement of the prescription on prescription may be replaced by the corresponding administrative or other contract document having equivalent effect, duly signed and dated, issued by the Administration in question, which, in any case, should clearly identify:

a) The medication or medications to be referred to.

(b) Denomination of the medicinal product which is perfectly legible, specifying the pharmaceutical form or, if applicable, trade name, the corresponding format of the medicinal product, if there are several, including, where applicable, the commercial or commercial, and where appropriate, the number of copies to be purchased or to be administered.

When the medicinal products are administered by staff at the service of the corresponding Administration, and acquired by the Administration itself, the above data, the number of doses, shall be recorded in a document. administered, the date of administration, time of waiting, and the identification and signature of the person responsible for his administration, in accordance with the provisions of the relevant competent authority, in particular on the instructions for the owner or person responsible for the animals and on the use or administration of the medicinal product. In the case of medicinal products intended for food-producing animals for human consumption, the data shall be recorded in the register of veterinary treatments on the holding in accordance with the applicable rules.

11. The original prescriptions, once the dispensation has been made, shall be held by the dispensing centre for its file and control, as a justification for such an act or for the processing to be carried out by them, and must be entered in the the corresponding register and kept for five years. The same procedure shall be used to adopt the establishments expressly authorised for the manufacture of medicated feedingstuffs with the supporting documents for orders for medicated premixtures.

The copy of the recipe reserved to the owner or responsible of the animals will have to be presented in the dispensing center for sealing and dating. In addition, in the case of animals of food-producing species, such copy shall be retained for five years.

In case of transfer of animals from food-producing species, before the end of the waiting time prescribed by the veterinarian, and always before the end of the five-year period from the administration of the medicines, the corresponding copy of the prescription will also be made and, if different transfers are involved, each of the recipients of a copy of the prescription must be provided.

During treatment and waiting time, animals may not be slaughtered for human consumption, except for reasons of major cause, in which case the document shall accompany them to the slaughterhouse.

The veterinarian who prescribes, in the case of animals of food-producing species, will keep the copy of the recipes extended for, five years.

Prescription-related records and documents shall be made available to the competent authorities. "

Six. Articles 81 and 82 are replaced by the following:

" Article 81. Exceptional prescriptions for therapeutic vacuum in non-food-producing animals.

1. Where there are no veterinary medicinal products authorised for a disease in a non-food-producing animal species, including domestic animals, the veterinarian may, by way of exception and under his direct personal responsibility, in particular to avoid unacceptable suffering, treat the affected animal or animals with:

(a) A veterinary medicinal product with a similar therapeutic effect to the intended, authorised, for use in another species or for treating another disease in the same species, by the Spanish Agency for Medicinal Products and Sanitary Products; or by the European Commission in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and control of medicinal products for use The European Agency for the Environment, Public Health and the Environment, Public Health and Safety and Health, the latter case to the Register of Medicinal Products.

(b) If the medicine in the above letter is not available:

1. A medicinal product for human use authorised by the Spanish Agency for Medicinal Products and Sanitary Products or authorised by the European Commission in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council Council, of 31 March 2004, and incorporated ex officio in the latter case to the Register of Medicinal Products.

2. O a veterinary medicinal product, with a similar therapeutic effect, authorised in another Member State in accordance with European Community legislation for use in the same species or in other species for the disease which treat or other disease. In this case, the prescribing veterinarian of the medicinal product shall, in good time, communicate his intention to administer the medicinal product concerned to the competent authority of the autonomous community which may prohibit such use by animal or public health reasons within the maximum period of five days.

(c) In the absence of the medicinal products referred to in the preceding letters, and within the limits of this royal decree and other Spanish legislation in this field, the veterinarian may prescribe masterways, prepared Official or self-vaccines for veterinary use.

2. By way of derogation from the following Article, the provisions laid down in paragraph 1 of this Article shall also apply to the treatment of an animal of the family of equidae by a veterinarian, provided that such animal is declared as not intended for slaughter for human consumption, in accordance with Commission Decision 93 /623/EEC of 20 October 1993 laying down the identification document (passport) to accompany equidae registered or with Commission Decision 2000 /68/EC of 22 December 1999 amending the Decision 93 /623/EEC of the Commission and the identification of equidae for breeding and income is regulated.

3. Furthermore, and by way of derogation from the following Article, the list of substances essential for the treatment of equidae established by Commission Regulation (EC) No 1950/2006 of 13 December 2006 shall apply. establishing a list of substances essential for the treatment of equidae, in accordance with Directive 2001 /82/EC of the European Parliament and of the Council establishing a Community code on veterinary medicinal products, and the waiting time is at least six months, according to the documentary control mechanism provided for in Commission Decisions 93 /623/EEC of 20 October 1993 and 2000 /68/EC of the Commission of 22 December 1999.

4. Exceptional prescription, in accordance with paragraph 1 (b) .1. of a medicinal product for use exclusively in the hospital, authorised as a medicinal product for human use by the Spanish Agency for Medicinal Products and Sanitary Products or authorised by the Commission European Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 may only be carried out by the veterinarian and for the direct use or administration of the said medicinal product under Regulation (EC) No 726/2004, the appropriate conditions and requirements for use expressly provided for in the authorisation placing on the market, modifying its contents as necessary, in order to apply it to animals, provided that it has the means to apply the said medicinal product. In these cases, the competent authority shall establish the procedure and controls necessary for the supply of such medicinal products.

In any case, the veterinarian shall keep a detailed record of the medicinal products for use only in hospital prescribed, supplied and applied to the animal, which shall be at the disposal of the competent authority during a five-year period.

Article 82. Exceptional prescriptions for therapeutic vacuum in food-producing animals.

1. Where there are no veterinary medicinal products authorised for a disease in a food-producing animal species, the veterinarian may, by way of exception and under his direct personal responsibility, in particular to avoid suffering unacceptable, treat the affected animal or animals from a particular holding by administering:

(a) A veterinary medicinal product, with a similar therapeutic effect to that desired, authorised for use in another species or to treat another disease of the same species, by the Spanish Agency for Medicinal Products and authorised by the European Commission in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, and incorporated ex officio in the latter case into the Register of Medicinal Products.

(b) If the medicine in the above letter does not exist, either:

1. A medicinal product for human use authorised by the Spanish Agency for Medicinal Products and Sanitary Products or authorised by the European Commission in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council Council, of 31 March 2004, and incorporated ex officio in the latter case to the Register of Medicinal Products.

2. O a veterinary medicinal product, with a similar therapeutic effect, authorised in another Member State in accordance with European Community legislation, for use in the same species or in other food producing species for the disease in question or another disease.

(c) In the absence of the medicinal products referred to in the preceding letters, and within the limits of this royal decree and other Spanish legislation in this field, the veterinarian may prescribe masterways, prepared Official or self-vaccines for veterinary use.

Except in the case provided for in point (a) and provided that it is not a medicinal product to be administered by the veterinarian or under his responsibility, in all other cases the medicinal product shall be administered to the animal or animals. directly by the veterinarian or under his direct responsibility.

2. The provisions of paragraph 1 shall apply as long as:

(a) The pharmacologically active substances of the medicinal product are included in the cases referred to in Article 14.2 (a), (b) or (c) of Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009, establishing Community procedures for the fixing of the residue limits of pharmacologically active substances in foodstuffs of animal origin, Regulation (EEC) No 2377/90 of the Council is hereby repealed and amend Directive 2001 /82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council, in accordance with the classification of Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification as regards the maximum residue limits for foodstuffs of animal origin.

b) The veterinarian will set an appropriate waiting time.

If the medicinal product used indicates a waiting time for the species to be prescribed, the waiting time shall be at least that provided for in that authorisation. However, if the dosage or route of administration provided for in the marketing authorisation is modified, the veterinarian shall establish the appropriate waiting time.

If the medicinal product used does not indicate a waiting time for the species, the product established by the veterinarian may not be less than that established for the purpose by the European Commission, or shall be at least the following:

1. 7 days for eggs.

2. º 7 days for milk.

3. º 28 days for meat of poultry and mammals, including fat and craves.

4. 500 degrees-day for fish meat.

3. In the case of homeopathic veterinary medicinal products in which the active substance appears in the case referred to in Article 14.2 (c) of Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009, the the time-waiting period referred to in the previous paragraph shall be reduced to zero days.

4. In applying the provisions of paragraphs 1 and 2, the veterinarian shall keep a record of all relevant information, which shall contain at least:

a) The date of examination of the animals.

(b) The identification code provided for in Article 5 of Royal Decree 479/2004 of 26 March 2004 establishing and regulating the general register of livestock holdings, or, failing that, the identification code granted by the competent authority of the Autonomous Community. Only if the competent authority has not yet assigned it, shall the name, two surnames, or social reason, and address of the owner or person responsible for the animals, be entered.

c) The number of animals treated and their identification, individual or batch.

d) The diagnosis.

e) The prescribed medications.

f) The route and doses administered.

g) The duration of treatment.

h) The corresponding wait times.

However, the entry of the previously mentioned data, which are already in the recipe, may be replaced by the identification reference for that recipe, for the purposes of the register provided for in this Article.

This register, which may be carried by electronic means, shall be kept by the veterinarian at the disposal of the competent authorities for inspection purposes for a period of at least five years.

5. Exceptional prescription, in accordance with paragraph 1 (b) .1. of a medicinal product for use exclusively in the hospital, authorised as a medicinal product for human use by the Spanish Agency for Medicinal Products and Sanitary Products or authorised by the Commission In accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, it may be carried out by the veterinarian only for the direct use or administration of the said medicinal product under Regulation (EC) No 726/2004. the appropriate conditions and requirements for use expressly provided for in the authorisation placing on the market, modifying its contents as necessary, in order to apply it to animals, provided that it has the means to apply the said medicinal product. In these cases, the competent authority shall lay down the procedure and the checks necessary for the supply of such medicinal products. In any event, the veterinarian shall keep a detailed record of the medicinal products prescribed, supplied and applied to the animal, which shall be available to the competent authority for a period of five years.

6. In the case provided for in paragraph 1 (b) .2. the veterinary prescriber of the medicinal product shall, in good time, communicate his intention to acquire the medicinal product concerned to the competent authority of the autonomous community, which may prohibit such use on grounds of animal or public health, by means of a decision notified to that veterinarian within five days. '

Seven. Article 83 (2), (3) and (4) shall be replaced by the following:

" 2. Only the legally established pharmacy offices are authorized for the elaboration and dispensing of master formulas and official preparations. In addition, only the offices of pharmacy may provide veterinary medicinal products for use only in hospital. Consequently, the presence of such medicinal products on other commercial channels is prohibited.

3. The supply of veterinary medicinal products must be carried out in the original packages intact, unless the authorised forms of the medicinal product allow for a split dispensation without compromising the integrity of the veterinary medicinal product. the primary packaging of the medicinal product and provided that it is accompanied by the required documentation.

4. Where a dispensing centre does not have the prescribed veterinary medicinal product available, and replacement by a veterinarian is not possible, only the pharmacist may, with the knowledge and conformity of the person concerned, replace it with another medicinal product. veterinary medicinal product with a generic name or another mark having the same qualitative and quantitative composition as regards active substances, pharmaceutical form, route of administration and dosage, provided that it is also authorised for the species in question. This replacement will be logged to the back of the recipe and signed by the pharmacist responsible for the replacement.

By way of derogation from the preceding paragraph, in the case of medicinal products intended for animals of food-producing species, it shall also be necessary for the replacement medicinal product to have an equal waiting time or less than that of the medicinal product replaced, the time of waiting prescribed by the veterinarian being maintained.

In any case, the immunological veterinary medicinal products, as well as those others which, by reason of their characteristics of bioavailability and narrow therapeutic range, can be replaced, are exempted from this possibility. determine the Ministry of Health and Social Policy in agreement with the Ministry of the Environment, and the Rural and Marine Environment. "

Eight. Article 89 is amended as follows:

(a) Paragraph 1.b) is replaced by the following:

" b) Locate veterinary medicinal products separately from other products and fill in the specific requirements corresponding to the different types of veterinary medicinal products for which they are recommended and arranged by the manufacturer. Veterinary medicinal products shall be stored in the original packages intact, except in the case provided for in Article 83.3 for the split dispensation.

Other animal health products and medical devices authorised for veterinary use shall also be stored under the premises of a differentiated location and which, for their characteristics, must also be observed, according to type and character and equally recommendation of the manufacturer or other standards to be observed.

Products directed to animal feed, including additives, will also require location differences and for their specific characteristics to be observed.

In the same way, it will be used, and according to the standards to be observed, for the agro-phytosanitary products that may be marketed by these establishments. "

(b) The first sentence of paragraph 1 (e) is replaced by the following:

" Keep detailed documentation, which shall contain at least the following data for each transaction of entry or exit of medicinal products subject to veterinary prescription, or of all medicinal products if establishes the stand-alone community. "

c) Paragraph 1.g) is replaced by the following:

" The presence and professional performance of the pharmacist responsible for the pharmaceutical service or services shall ensure that the functions listed in Article 88 (1.1) of this Royal Decree are complied with. A pharmacist may be responsible for up to a maximum of six such services provided that he is assured of the due performance of the functions and responsibilities mentioned. "

d) Paragraph 2 is replaced by the following:

" 2. The documentation and records listed in the previous paragraph shall be available to the Autonomous Communities and Cities of Ceuta and Melilla for inspection purposes for a period of at least five years. Records may be carried by electronic means. "

Nine. The content of Article 90 is replaced by the following:

" The supply of medicated premixtures may be made directly or through the commercial channels authorized for the distribution or supply of veterinary prescription drugs and only with destination for establishments expressly authorised for the manufacture of medicated feed.

In any case they shall be subject to the requirements of storage, conservation and documentary control which, in general, are required for other veterinary medicinal products. "

Ten. The content of Article 91 is replaced by the following:

" 1. Medicinal products intended for terrarium animals, ornamental birds, aquarium fish and small rodents, and which do not require veterinary prescription, may be distributed or sold by establishments other than those provided for in this Regulation. royal decree, provided that such establishments comply with the requirements of storage, storage and, where appropriate, documentary check, for medicinal products, as referred to in Article 89, which sell the same in the intact package except in the case of In the case of Article 83.3, and in the commercial format of such medicinal products, state that they are exclusively intended for the species of such groups.

2. Prior to the commencement of their activity, they shall communicate such circumstances to the competent authority in whose field they are located, which shall be included in the relevant register. "

Once. Articles 93, 94 and 95 are replaced by the following:

" Article 93. Professional exercise of the veterinarian.

1. In accordance with Article 2.5 of Law 29/2006 of 26 July of 26 July, only the medicinal products necessary for the exercise of their professional activity may be sold or supplied directly to veterinary professionals. including medicinal gases, as provided for in this Article and in Article 94, subject to the necessary independence of the veterinarian in accordance with Article 3 of Law 29/2006 of 26 July.

The sale or supply of veterinary medicinal products to these professionals shall be carried out by the pharmacy office and the authorized retail establishments.

The supply will be carried out upon request of the veterinarian of the precise medications, by means of order, susceptible to carry out by any means or telematic system, in which case the document of order will be replaced by the delivery man. This document shall include: the personal identification and the collegial identification of the veterinary professional, the data relating to the name and quantity of medicinal products supplied, the supplier's identification, date and signature.

All documentation shall be kept at the disposal of the competent authority in the field of which the veterinarian is responsible for a period of five years.

The veterinarian, therefore, and for his professional practice, is authorized for the holding, transportation, application, use or administration of veterinary medicinal products, including medicinal gases, or cession in the case of provided for in the following paragraph, without involving commercial activity, for the purpose of the animals under its care or where the application has to be carried out by it.

2. The veterinarian who acquires or uses these medicinal products must:

(a) Communicate to the competent authority the existence of such medicinal products and their location, including the units of the ambulant clinic, which shall in any event meet the requirements for appropriate conservation in function of the accompanying documentation of the medicinal products or of the conditions laid down for such storage by the manufacturer.

(b) Take a record of each entry and each use or disposal of medicinal products subject to veterinary prescription, containing:

1. Date.

2. The precise identification of the medication.

3. º Number of the manufacturing batch.

4. ° Received quantity, or quantity administered, used or transferred to the owner of the animal.

5. º For entries: supplier name and address.

6. º For the medicinal products used or given: identification of the animal or animals, individual or batch, and, in the case of production animals, the identification code provided for in Article 5 of Royal Decree 479/2004, 26 March, or failing that, the identification code granted by the competent authority of the Autonomous Community.

This register, which may be carried by electronic means, shall be kept at the disposal of the competent authority in whose field the veterinarian is to be established, for a period of five years. In the case of medicinal products for animals of non-food-producing species, such records may be replaced by the corresponding clinical records provided that they contain the treatments administered.

(c) To issue and deliver the prescription to the owner or keeper of the animals, in the cases provided for in Article 80.

d) Apply or administer the medicines directly or under your responsibility. However, it may provide the owner or the person responsible for the animal exclusively with the medicinal products necessary for the continuity of the treatment initiated, where the treatment may be compromised.

3. The provisions of the preceding paragraphs shall also apply where the professional exercise is carried out by more than one veterinarian under the protection of legal entities, including professional societies. In this case, the medicinal products shall be of exclusive use by all the veterinary surgeons who are part of the legal entity concerned. The control, responsibility and use of the medicines will respond jointly and severally to all of them.

4. By way of derogation from the preceding paragraphs, in the implementation of official programmes for the prevention, control, control or eradication of animal diseases, only official, authorised or authorised veterinary surgeons may provide for the medicinal products necessary for such an official health programme, where free marketing is not authorised or restricted. In the case of a legal entity, which is entrusted by the competent authority for the implementation of the programme concerned, it shall also apply the provisions of this Article in the terms laid down by the competent authority.

5. Veterinarians in another Member State, not established in the national territory, and who provide their services in Spain, may carry with them and administer to animals, small quantities, not exceeding daily necessities, of medicinal products. Veterinarians provided that:

(a) This is not for veterinary immunological medicinal products not authorised in Spain.

(b) in the case of medicinal products with a marketing authorisation, or for their administration to animals, granted by the competent authorities of the Member State in which the said veterinarian is established.

c) The veterinarian transport the veterinary medicinal products in the original packaging of the manufacturer.

d) Veterinary medicinal products to be administered to food-producing animals have the same qualitative and quantitative composition, in terms of active substances, as authorised medicinal products in Spain

e) The veterinarian shall be informed of the correct veterinary practices in use in Spain, and ensure that the waiting period specified on the label of the veterinary medicinal product is observed, unless it can reasonably be assume that a longer waiting period would be indicated to suit the above mentioned veterinary practices.

(f) The quantities of medicinal products administered to animals or supplied to their owners or persons responsible are in accordance with Article 80.2. In addition, it shall only supply a veterinary medicinal product for the animals to be treated and shall only supply the minimum quantities of medicinal products necessary to complete the treatment of such animals.

g) The veterinarian shall keep detailed records of the animals undergoing treatment, the diagnosis, the veterinary medicinal products administered, the doses administered, the duration of the treatment and the duration of the treatment. waiting. These records shall be made available to the competent authorities for inspection purposes for a period of five years.

h) The therapeutic range and quantity of veterinary medicinal products carried by the veterinarian should not exceed the level usually required for the daily needs of a correct veterinary practice.

The veterinarian must deliver to the owner or responsible animal veterinarian, extended at least in Spanish, which will conform to the established in this royal decree for the exceptional prescription, of all the Medicinal products which are administered or prescribed, whether or not they are medicinal products for compulsory prescription.

6. Where the veterinarian is engaged in the extraordinary prerogatives provided for in Article 81 or in Article 82, or where the animal health situation and exceptionally prescribe one or more veterinary medicinal products in the conditions other than those provided for in the marketing authorisation, shall bear the relevant responsibility for the safety of the medicinal product or medicinal products, in animals or persons, including any adverse reactions or effects not intended (modification of the waiting time), without prejudice to the fact that the the safety requirements and indications under which the medicinal products or reports are authorised for the performance of the medicinal products.

For the purposes of the preceding paragraph, where the veterinarian modifies the dosage or route of administration of an authorised medicinal product, except for immunological or other medicinal products in which by its nature or characteristics this does not apply, animals of food-producing species shall set the appropriate waiting time.

Article 94. Medicinal gases.

1. For the possession and use by the veterinarian of medicinal gases, for veterinary or human use, the prior specific authorisation of the competent authority in the field of which the clinic is radiating, or where the exercise of the veterinary profession is carry out in more than one autonomous community, from that in which it radiating its registered office or registered office, prior to accreditation, at least, which is available to the veterinarian or the veterinary clinic, of the precise means to allow the necessary observation of the necessary safety and quality measures in the application or use of medicinal gases.

2. In the case of the veterinary clinical exercise, the application for medicinal gases other than those specifically authorised for veterinary or human use may be carried out provided that the following conditions are met:

(a) To obey the written and reasoned prescription of a veterinarian for a particular animal species.

(b) To be used in the manufacture of medicinal gases whose specifications are described in the Spanish Royal Pharmacopoeia, in the European Pharmacopoeia or, failing that, in other official pharmacopoeias of the Member States of the Union European, or another country to which the Ministry of Health and Social Policy recognises quality requirements equivalent to those referred to in the case of pharmacopoeas, and in concentrations other than those authorised.

c) That the processing be carried out with the same quality guarantees as the authorised products.

(d) The labelling of the package shall include at least the percentage composition; the identification of the prescriber; the animal species to which it is intended and the method of administration; the waiting time, even if is null, for the medicinal gases to be administered to the animals for the production of foodstuffs for human consumption; the social reason of the manufacturer's laboratory; the technical director of the manufacturer's laboratory; the date of expiry and the storage conditions, if any, and the number of manufacturing and control protocols.

The laboratory must notify the Spanish Agency of Medicines and Health Products within a maximum of 15 days from the receipt of the request, and file the written request of the prescriber along with the manufacturing protocol and the product release certificate.

3. The application may be made by a veterinarian in the form of a written and reasoned prescription, provided that the conditions described above are met and, in addition, specified in the application:

(a) The animal species to which it is intended and the method of administration.

b) The waiting time, even if it is null, for the medicinal gases to be administered to the food production animals for human consumption.

4. By way of derogation from the above paragraph, in the case of other uses in animals, such as stunning prior to slaughter or in research or animal testing centres, specific conditions shall be laid down upon request. written statement to the Spanish Agency for Medicines and Health Products.

5. The veterinarian may acquire the medicinal gases directly from the holder of his marketing authorization, or in his case from the importer, or through the offices of pharmacy and retail establishments provided for in the Article 86. For the distribution or delivery to the veterinarian of the medicinal gases by the centers or establishments suppliers will not be precise the recipe.

The acquisition by the veterinarian of such gases shall require delivery in the supplying entity of a document in which it appears, at least:

(a) The professional identification of the professional and his/her collegiate number. In the case of legal persons, including the Professional Societies, the Tax Identification Code of the same and the personal identification and number of collegian, at least one veterinarian who is part of the same.

(b) The date or approval number of the competent authority referred to in paragraph 1.

c) The name and quantity of gases purchased, with date and signature.

The supplying entity shall keep a record of the gases delivered for that purpose, and the veterinarian of the received. These records, which may be carried out by electronic means, shall be kept for a minimum period of five years and shall be made available to the competent authorities within that period.

6. During the transport of the liquefied medicinal gases to the storage tanks of veterinary clinics or research or experimentation centres, a signed and dated certificate or exit document shall be accompanied the labelling, which will be available to the health authorities. The recipient will archive a copy of the certification or document per shipment.

Direct delivery to the owners of the animals to be treated in the case of home therapy will require the presentation of the corresponding prescription duly completed by the optional prescriber.

Transport must be carried out in accordance with the conditions set out in Annex 6 of the Rules of Good Manufacturing of Medicinal Products in force in the European Union, published by the Ministry of Health and Social Policy.

Article 95. Observance of the timeout and other measures.

1. In order to avoid the unacceptable presence of certain substances or their residues in meat or other products of animal origin intended for human consumption, the owner or person responsible for the animals is obliged to respect the waiting time established for the treatment in question.

2. The obligation and cost of disposal or, where appropriate, valuation of residues of veterinary medicinal products, as well as of unused veterinary medicinal products or of which they have expired, shall be borne by the relevant agents. in accordance with the rules applicable to waste. However, where the competent authority establishes an integrated waste management system, in so far as the corresponding cost is covered, this obligation shall be assumed, in a proportional manner, by the agents obliged to agreement with the relevant regulations.

3. Establishments approved for the manufacture of medicated feed shall have appropriate systems for the collection of unused or expired medicated feed. '

Twelve. Article 96.1 is replaced by the following:

" 1. The owners or the person responsible for food producing animals for human consumption shall have to justify the purchase, possession and administration of such animals for veterinary medicinal products subject to prescription. for the five years following his administration, even if the animal is slaughtered within that five-year period, by the copy of the corresponding prescription, except in the case of transfer of the animal or animals before of the end of the five-year period provided that the copy of the recipe has been delivered to the new owner or person responsible for the animal.

The transport of veterinary medicinal products, once dispensed, shall be justified by the possession of the corresponding prescription, where the prescription is required for dispensing, or, in other cases, with the purchase invoice or Equivalent documentation. The veterinary surgeon who has medicinal products for his professional practice shall justify the carriage of the medicinal products with copies of the supporting documentation of the communication to the competent authority provided for in Article 93.2.a. In all other cases, the transport of veterinary medicinal products must be justified by the appropriate order, order note, administrative contract or equivalent documentation, in which they contain at least the following information: supplier, receiver or recipient, identification of the goods and quantity. "

Thirteen. Article 106 is replaced by the following:

" Article 106. Control and sanctioning regime.

1. The inspection, control and precautionary measures shall be as provided for in Law 29/2006 of 26 July.

2. In the event of non-compliance with the provisions of this Royal Decree, the regime of infringements and penalties laid down in Law 8/2003 of 24 April of 26 July of 26 July and, where applicable, other specific rules, shall apply. without prejudice to any possible civil, criminal or other liability that may arise. "

Fourteen. Articles 107, 108, 110, 111 and 112 are not contained.

Fifteen. The first transitional provision is without content.

Final disposition first. Competence title.

This royal decree is of a basic nature and is dictated by article 149.1.16. of the Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health, second indent.

Except for that character of basic regulation, paragraph four of the single article, which is issued under the provisions of Article 149.1.16a, third indent, of the Constitution, which confers exclusive competence on the State in the field of legislation on pharmaceutical products.

Final disposition second. Entry into force.

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

Given in Madrid, 10 September 2010.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

MARIA TERESA FERNANDEZ DE LA VEGA SANZ