Royal Legislative Decree 1/2015, Of July 24, Approving The Revised Text Of The Law On Guarantees And Rational Use Of Medicines And Medical Devices Are Approved.

Original Language Title: Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios.

Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-8343

I

The fourth final provision of Law 10/2013 of 24 July, which are incorporated into Spanish law Directive 2010/84 / EU of the European Parliament and of the Council of 15 December 2010 on pharmacovigilance, and 2011/62 / EU of the European Parliament and of the Council of 8 June 2011 on prevention of counterfeit drugs into the legal supply chain of drugs, and amending Law 29/2006, of July 26 of guarantees and rational use of medicines and health products, it authorizes the government to prepare a revised text of the law on guarantees and rational use of medicines and medical devices. This authorization, for a period of two years from the entry into force of the enabling statute, aims to consolidate in a single text, successive amendments that have been incorporated since its entry into force in the Act and it includes the possibility of regularizing, clarifying and harmonizing the legal texts that should be consolidated.

The authorization that covers the present revised text has its rationale in the need to provide greater legal certainty to a regulation that has been characterized by a continuous succession of rules that have completed or modified, very unevenly the original text of law 29/2006 of 26 July, which advises the adoption of a single text that included duly harmonized all the provisions applicable in the field of this law. The resulting text should thus a vocation of stability, once they have successfully completed the necessary processes of consolidation and adapted as necessary to ensure continuity of health public provision and improved pharmacovigilance mechanisms and chain protection of supply.

Law 29/2006 of July 26, tried, like the Law 25/1990 of December 20, Medicines, repealed by it, give the Spanish society of an institutional instrument that would allow the drug problems were addressed by few social agents they were involved in its management, in view of the improvement of health care. Elapsed since the adoption of both legal texts to suggest that time has largely achieved the intended target consecrating pharmaceutical services as a universal service.

The provision includes pharmaceutical drugs and medical devices, as well as the set of actions to ensure that patients receive and use appropriate to their clinical needs and the precise manner according to their individual dose requirements during the period appropriate time, with the information necessary for proper use and at the lowest possible cost.

It is necessary to make a positive assessment of what they are and what they represent medicines and medical devices for the National Health System so that the pharmaceutical policy developed in recent decades has been oriented in the direction of ensuring their availability to meet the needs of patients.

In this regard, the role of industry professionals has been instrumental in these achievements. The doctor is a central figure in strategies for boosting quality pharmaceutical services given the role assigned to it in the care of the patient's health and therefore, prevention and diagnosis of disease and and prescription, if any, treatment with medication. The work that pharmacists and other health professionals perform in pharmaceutical care procedures also have an essential importance as it ensures accessibility to medicine offering, in coordination with the medical, health advice, pharmaceutical care and professional support to patients.

The challenge remains, much more in the current economic situation, ensure the quality of provision across the NHS in a decentralized framework capable of promoting the rational use of medicines and in which the main objective is that all citizens continue to have access to the medication they need, when and where they need, in terms of effectiveness and safety.


II

The transfer of powers to the autonomous communities in health is now a reality in the health decentralization under Law 14/1986 of 25 April, General Health completed. Thus, since the beginning of 2002, all regions have assumed the roles he occupied and the services it had been providing the National Institute of Health (INSALUD), representing a complete decentralization of health care from the National Health System including pharmaceutical services.

The management of the autonomous communities in health comprises a wide range of policies on priorities in the treatment of health problems, introduction of new technologies and new treatments, promoting more efficient alternatives in diagnostic processes and therapeutic developed by professionals in the respective regions, as well as incomes policies affecting remuneration systems and economic professionals and health centers incentives, all within the broad margin for the exercise of the powers assumed in the under the criteria established by Law 16/2003 of 28 May, of cohesion and quality of the National Health System and other state regulations on the matter.

Pharmaceutical have established policies aimed at intensifying the rational use of drugs strategies can highlight geared to providing quality information, and periodic independent health professionals to ensure adequate training on the rational use of medicines , reinforcing the need for the prescription as an essential document for patient safety, or those relating to the modification of the prospects of drugs to make them intelligible to citizens, helping achieve the necessary adherence to treatment so that it can be achieved therapeutic success provided by the doctor with the indispensable cooperation of the pharmacist.

It is necessary that our National Health System healthcare professionals ensure that the information, training and trade promotion of drugs are central elements of development scientific rigor, transparency and ethics in the practice of these activities.

Although drugs have been instrumental in improving the hope and increased quality of life of citizens, sometimes pose problems of effectiveness and safety that must be known by health professionals. For this reason, it is particularly important the role that this law gives the Spanish pharmacovigilance system National Health System, a more innovative approach, which incorporates the concept of pharmacoepidemiology and risk management, as well as ensuring continuous monitoring of benefit / risk balance of authorized medicinal products.

The next few years paint a picture characterized by a significant increase in the population, but with a marked aging of the same and therefore, with greater health needs resulting from this phenomenon, as well as the chronicity of many diseases. These needs must be guaranteed in a rigorous framework regarding the requirements of safety and efficacy of medicines for the benefit of the quality of care for citizens.

The sustained growth of the needs of pharmaceutical services will therefore necessarily be framed strategies of rational use of medicines and pharmaceutical spending control that will allow further ensuring universal provision of quality contributing to the sustainability of National system of health.

In this sense, the law considers that the selective and not indiscriminate financing of medicines is made depending on the therapeutic usefulness of themselves and their need to improve the health of citizens. It is recalled that in recent years the emergence of generic drugs, proven and cheaper clinical efficacy, at the expiry of the period of data exclusivity of the original drug, ensures identical conditions of quality, safety and efficacy at lower prices.


III
This revised text addresses all these issues by incorporating the amendments made in this area since the entry into force of Law 29/2006 of 26 July.


The first modification of this law was introduced by Law 51/2007 of 26 December on the General State Budget for 2008, with the sole purpose of fixing the various rates of the fee for the provision of services and performance of activities of the General State Administration regarding drugs.

Two years later, Law 25/2009, of 22 December, amending various laws to adapt to the Law on free access to service activities and its exercise modified, among many other standards, Law 29/2006, of July 26, in order to adapt it to the provisions of Law 17/2009 of 23 November, on free access to service activities and their exercise, and remove requirements or unjustified or disproportionate obstacles with the clear aim of boosting economic activity.

Practically without interruption Law 28/2009 of 30 December, amending Law 29/2006, of 26 July, on guarantees and rational use of medicines and health products was approved in order contemplating participation in the prescription of medicines and health products health professionals other than doctors and dentists, as was the case of nurses and podiatrists.

As a result of the economic crisis that began in 2008, the Law 29/2006 of July 26, has continued to experience various modifications. Some of them are technical, such as those relating to guarantees of efficacy, safety and quality of medicines and health products, but the most significant occurred on the economic aspects, the most notorious pertains to initiatives control of pharmaceutical expenditure. The need for this control was not due only to the required efficiency in public expenditure management, especially in a situation of serious crisis, but such control was also needed as to the technological improvement of the drugs themselves, as well as the appearance of new drugs, some of which introduced substantial advances in the therapeutic and therefore the health. The positive technological developments took place when most of the world's countries had incorporated into national law the agreements on aspects of Intellectual Property Rights (TRIPS), which in the pharmaceutical field means full protection of patented discoveries. This phenomenon led to an increase in the prices charged for the pharmacological innovations which, along with other factors, determined, ultimately, an increase in the budgets of pharmaceutical expenditure which rose above the parameters characterizing the wealth of nations - Gross Domestic product (GDP) per capita or the level of development of the State of welfare Percentage of GDP spent SANITARY -The assistance. Spain, where coverage of drug spending by the NHS is very high, more than other countries suffered the brunt of the economic crisis, forcing incorporate efficiency policies in healthcare spending.

Thus, containment of pharmaceutical expenditure required urgent reforms and, to this end, several rules were enacted, in particular the Royal Decree Law 4/2010 of 26 March, rationalizing pharmaceutical expenditure with under the National Health System, Royal Decree-law 8/2010, of May 20, by which extraordinary measures to reduce the public deficit are adopted, and one year later, the Royal Decree-law 9/2011, of August 19, measures to improve the quality and cohesion of the National Health System, contribution to fiscal consolidation and raising the maximum amount of State guarantees for 2011, which introduced discounts and limitations of a general nature, affecting the supply of drugs.

The Royal Decree Law 4/2010 of 26 March, was the first reaction to the economic crisis that began years before and pursued the urgent goal of changing public financing of medicines and health products under Law 29 / 2006 of July 26, to facilitate the application of reference pricing system and introduce discounts and limitations that reduce drug costs under the National Health system.

The subsequent Royal Decree Law 8/2010 of 20 May, addressed the establishment of complementary to those already adopted within the framework of pharmaceutical services to establish new deductions and price reductions measures.


The reference price system under Law 29/2006 of July 26, he underwent a new variation by Law 34/2010, of 5 August, amending Law 30/2007, 30 October, Public Sector Contracts, 31/2007 of 30 October, on contractual procedures in the water, energy, transport and postal services, and 29/1998 of 13 July, regulating the administrative courts for adaptation to Community law of the first two, while the system of incompatibilities of health professionals was also amended by Law 14/2011, of 1 June, Science, Technology and Innovation.

Finally, Royal Decree-Law 9/2011 of 19 August, was to generalize the prescription of drugs by active ingredient, modify the reference price system, making it more agile and easier to manage, and improve the criteria for selective financing of medicines, the provision incorporating those that offer substantial improvements in treatments.

Because of its special significance in the scope of consolidation of public health provision, and not only in relation to the amendment of Law 29/2006 of 26 July, to which he devoted his chapter IV highlights the Real Decree-law 16/2012, of 20 April, on urgent measures to ensure the sustainability of the National Health System and improve the quality and safety of its performance measures, standard addressed a substantial reform of global character introducing reforms on demand. The introduced reform rationalizes drug financing by excluding public financing of medicinal products for the treatment of minor symptoms, introduces a structural change to the system of pricing of medicines, with an innovative scheme selected prices, marking a shift towards selective funding criteria such as cost-effectiveness and budget impact assessment, alongside other qualitative elements that have enabled modular portfolio of medicines reimbursed. And certainly noteworthy, as a measure of greater social transcendence, which is to establish the contribution of beneficiaries to pharmaceutical expenditure according to their economic capacity, looking for a more responsible for providing use and a more equitable and sustainable distribution the funding effort, thereby improving the system initially maintained by the Law 29/2006 of 26 July, which was in force since the eighties of the last century.

A new modification of the Law 29/2006 of July 26, held by Royal Decree-Law 28/2012 of 30 November on measures to consolidate and guarantee social security system, which redefined ambulatory pharmaceutical provision considering as such that the patient is dispensed by prescription or dispensing hospital order through offices or pharmacy services.


The latest draft reform of Law 29/2006, of July 26, was operated by Law 10/2013, of July 24, which just joined the authorization of Parliament to the Government for approval this revised text. The main purpose of this law was to incorporate into Spanish law Directive 2010/84 / EU of the European Parliament and of the Council of 15 December 2010, pharmacovigilance, and 2011/62 / EU of the European Parliament and of the Council of 8 June 2011 on prevention of counterfeit drugs into the legal supply chain of drugs. But, beyond to satisfy that purpose, other material aspects of the law outside the aforementioned European standards, including notably the technical adequacy of the disciplinary procedure and the system of public revenue performances were changed the Spanish Agency for medicines and health products or the introduction of a series of consistent improvements in extending the scheme so far apply to medicinal products for human use also to veterinary medicines, medical devices, cosmetics and care products staff, to provide a complete general regulation under Law 29/2006 of 26 July, subject to the relevant regulatory developments. Also, in order to expedite the pharmaceutical industry some forecasts that until then regarding authorizations, established the possibility of notifications, to the extent that this proves possible, since the authorization is certainly not the only control mechanism were incorporated activities that Law 29/2006 of 26 July refers to. Finally, a significant change was made in the report of therapeutic positioning as a key tool in the correct and efficient use of new drugs.

Finally, the last amendment of Law 29/2006 of 26 July, prior to the adoption of this revised text has been operated by Law 36/2014 of 26 December on State Budget 2015, to modify two charges for the provision of services and performance of activities of the General State Administration for medicines, health products, cosmetics and personal care products.
IV

Tight synthesis
exposed realizes the convenience of framing the sustained growth of the needs of pharmaceutical services within strategies rational use of medicines and pharmaceutical spending control that will allow further ensuring universal provision of quality, contributing to the sustainability of the National Health System in specific times of economic difficulty and technological change.

The normative integration of all the changes in this matter requires a systematic unification must therefore, in accordance with the authorization contained four of Law 10/2013, of 24 July, on the final disposition is approved this consolidated text following the criteria set out below.

First, we proceeded to integrate in a single text all existing amendments to the Law 29/2006 of July 26, through various laws that have redraft certain provisions or have introduced new provisions to that. As a result of the foregoing, and pursuant to the authority granted to regulating, clarifying and harmonizing the legal texts that must be consolidated, it is set the location and numbering of the articles as well as referrals and matches between them, and have homogenised certain terms used in it.

Should be noted that, in pursuance of this legislative delegation, only regularized, clarify and harmonize those provisions of the legal texts that have expressly modified Law 29/2006, of July 26, rewording or including new provisions to that law, since the legislature clearly established as regulatory framework for recasting the consolidation of different standards that have modified the law 29/2006 of 26 July, which is not extensible, therefore, legal rules have not been given redrafting or have not added new provisions to it.


On the other hand, and also under this power granted to the Government, have been taken into account other rules whose application required the adaptation of certain aspects contained in Law 29/2006 of 26 July. It is issues such as the elimination of forecast update certain amounts or amounts in accordance with the Consumer Price Index with, in application of Law 2/2015 of 30 March, of deindexation of the Spanish economy, or updating the amount of fees in accordance with the provisions of Law 36/2014 of 26 December.

Not the same as it has occurred, however, with adaptation to the Law 20/2013, of December 9, assurance market unit, a comprehensive review of the Law 29/2006 of July 26 , to adapt to that it had exceeded the authorization granted for regulating, clarifying and harmonizing the legal texts that should be consolidated. However, it should be clear that the approval of this revised text does not prevent, of course, to continue working on a general review of it in order to adapt to the criteria set forth by Law 20/2013 of 9 December revision, in any case, must undergo regular channels and procedures provided for amending legislation.
I
Finally, under the authorization received have been reviewed and modified additional, transitional and final provisions of Law 29/2006 of 26 July, by the need to adapt their content to the time elapsed since its adoption and its subsequent amendments.

Thus, the content of the twelfth additional provision on the participation of nurses in the field of medicinal products subject to medical prescription, has been incorporated, for systematic reasons, Article 79 of the revised text for its intimate connection therewith.

As regards the transitional provisions of Law 29/2006 of July 26, some of them, specifically numbered as fourth, fifth, sixth, seventh and ninth, have not been included in the text consolidated having exhausted its effect by the passage of time space provided therein. It is, respectively, of those concerning the adaptation of authorizations to serve distribution activities, the deadline to include instructions in Braille on packaging and leaflets of medicines, relative to pharmaceutical innovations, relative to the indication of the period in which should start to apply the system of contributions to the National Health System to which the sixth additional provision relates and, finally, relative to the period of adaptation of certain guarantees of information.

Moreover, the content of other transitional provisions as contained in the Act, specifically those numbered as third and eighth, appear incorporated in the revised text as additional provisions fifteenth and sixteenth, to be its own content of a provision of this nature. It is, respectively, of those relating to the application of the system of periodic safety reports to drug authorizations renewed after the entry into force of Law 29/2006 of 26 July, and the application of fastening system prices in medical devices authorized prior to the entry into force of this law.

Finally, it has made the corresponding adjustment of the first final provision to adapt the reference titles based on competence which regulates each of the matters covered by this standard to the new structure of it.

This royal legislative decree, on which it has granted audience to the affected sectors have been subject to consultation both of the Autonomous Communities and Cities of Ceuta and Melilla, and the Spanish Federation of Municipalities and Provinces.

It has also been informed by the Economic and Social Council, the National Commission Markets and Competition, by the Spanish Data Protection Agency, by the Council of Consumers and Users and the Consultative Committee and the Council Interterritorial National Health System.

By virtue of the proposal of the Minister of Health, Social Services and Equality, according to the Council of State and after deliberation by the Council of Ministers at its meeting on July 24, 2015,

DECREE:

Sole Article. Adoption of the revised text of the law on guarantees and rational use of medicines and medical devices.

The revised text of the law on guarantees and rational use of medicines and medical devices was adopted, the text is inserted below.


Sole additional provision. Remissions regulations.

Normative References in other provisions to Law 29/2006 of 26 July, on guarantees and rational use of medicines and health products, shall be construed as made to the relevant provisions of the consolidated text is approved.

Single derogatory provision. Repeal legislation.

Are repealed all provisions of equal or lower rank opposing the provisions of this law and, in particular, the Law 29/2006 of 26 July, on guarantees and rational use of medicines and health products, except for its final provisions second, third and fourth.

Single final provision. Entry into force.

This royal legislative decree and approving the revised text shall enter into force on the day of its publication in the "Official Gazette".

Given in Madrid, on 24 July 2015.
FELIPE R.


The Minister of Health, Social Services and Equality,
ALFONSO ALONSO Aranegui

PRELIMINARY TITLE

General provisions


Article 1. Purpose and scope of the law.

This law regulates the scope of the powers of the State:

A) human medicines and medical devices, clinical research, evaluation, authorization, registration, manufacture, processing, quality control, storage, distribution, circulation, traceability, marketing, information and advertising, import and export , prescribing and dispensing, monitoring of the benefit-risk as well as the management and rational use procedure, where appropriate, the public funding. The regulation also extends to substances, excipients and materials used for its manufacture, preparation or packaging.

B) Action by the natural or legal persons as involved in industrial or commercial circulation and the prescribing or dispensing of medicines and medical devices.

C) The general criteria and requirements applicable to veterinary medicinal products and, in particular, special, such as master formulas, and those relating to industrially processed, including premixes for medicated feeds.

D) The cosmetics and personal care products and in particular, the precautionary measures and the system of offenses and penalties applicable to them.

Article 2. Definitions.

For the purposes of this Act shall mean:

A) 'medicinal product' means any substance or combination of substances presented as having properties for treating or preventing disease in humans or that can be used in humans or administered to humans in order restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic, or making a medical diagnosis action.

B) 'veterinary medicinal product' Any substance or combination of substances presented as having curative or preventive properties with regard to animal diseases or which may be administered to the animal in order to restore, correct or modify physiological functions exerting a pharmacological, immunological or metabolic, or to establish a veterinary diagnostic action. "Veterinary drugs" the "premixes for medicated feed" developed to be incorporated into a feed will also be considered.

C) "Active ingredient" or "active substance" means any substance or mixture of substances intended for the manufacture of a medicament and, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action in order to restore, correct or modify physiological functions or establish a diagnosis.

D) "Excipient" means any component of a drug other than the active substance and the packaging material.

E) 'Feedstock' Any substance or inactivated -Activates used in the manufacture of a medicament, and remains unchanged, modified or disappear during the process.

F) "Dosage form" or "dosage form": The provision to which the active ingredients and excipients are adapted to provide a drug. It is defined by the combination of the form in which the pharmaceutical product is presented by the manufacturer and how it is managed.


G) 'generic medicine': Any drug that has the same qualitative and quantitative composition in active substances and the same pharmaceutical form, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered the same active substance, unless they differ significantly in properties with regard to safety and / or efficacy. Different oral pharmaceutical forms of immediate release shall be considered a single dosage form. The applicant may be exempted from filing bioavailability studies if it can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.

H) 'intermediate product' intended for further industrial processing by an authorized manufacturer.

I) "master formula": The medicament for an individual patient, prepared by a pharmacist or under his direction, specifically according to a detailed prescription of the active ingredients including, according to the rules of proper preparation and control quality established for that purpose, dispensed in pharmacy or pharmaceutical service and proper information to the user in the terms provided in Article 42.5.

J) 'preparation oficinal' One medicine made according to the rules of proper preparation and quality control established for that purpose and guaranteed by a pharmacist or under his direction, dispensed in pharmacy or pharmaceutical service, listed and described by the National formulary, intended for direct patients to those served by the pharmacy or pharmaceutical service delivery.

K) 'Investigational medicinal product': a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including products with authorization when used or assembled, in the formulation or packaging , different from the authorized form, or when used for an unauthorized indication or for more information about an authorized use.

L) 'medical device' means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and / or therapeutic purposes and for its proper application intended by the manufacturer to be used for human beings for:

1st diagnosis, prevention, monitoring, treatment or alleviation of disease;

2nd diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap;

3rd investigation, replacement or modification of the anatomy or of a physiological process;

4th control of conception,

And does not achieve its principal intended action get inside or on the surface of the human body, immunological or metabolic pharmacological means but whose function may contribute to such means.

M) "personal care product" are substances or mixtures, regardless of the legal consideration of medicines, medical devices, cosmetics or biocides, are intended to be applied to the skin, teeth or mucous membranes of the human body in order to hygiene or aesthetics, or to neutralize or remove ectoparasites.

N) "Cosmetic product" means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and mucous mouth, with exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.

O) 'falsified medicinal product' Any medicinal product with a false representation of:

1st His identity, including its packaging and labeling, name or composition with respect to any of its components, including excipients, and strength of those ingredients;

2nd source, including the manufacturer, country of manufacture, country of origin and the holder of the marketing authorization; or,

3.º its history, including the records and documents relating to the distribution channels used.

This definition does not include unintentional quality defects and is without prejudice to the violations of intellectual property rights.


P) "wholesale distribution of medicinal products': All activities consisting of procuring, storing, holding, supplying or exporting medicinal products, excluding dispensing to the public thereof.

Q) 'Warehouse contract' entity that acts as a third party with which a laboratory or a wholesale store signs a contract to perform certain activities of drug distribution.

R) "Brokering of medicinal products': All activities related to the sale or purchase of drugs, except for those included in the definition of wholesale distribution, as defined in this article, which do not include physical contact the same and that consist of negotiating independently and on behalf of another legal or natural person.
TITLE
I
Guarantees and general obligations


Article 3. Guarantees of supply and dispensing.

1. Pharmaceutical companies, distribution entities, importers, pharmacies, pharmacy services of hospitals, health centers and other structures of health care are obliged to provide or dispense medicines and health products that are requested in the legal conditions and statutorily established.

2. Those responsible for the production, distribution, sale and dispensing of medicines and medical devices must respect the principle of continuity in the provision of service to the community.

3. The Government, to ensure the supply of drugs, may take special measures in relation to manufacture, import, distribution and dispensing. In the case of "orphan drugs", in accordance with Regulation (EC) No 141/2000, and the "orphan drugs" the Government may, in addition to the above measures, taken as regards the system economic and fiscal of such drugs. For these purposes, as well as under Article 121.1, the term "orphan drugs" those for which there is absence or insufficient supply in the domestic market, being necessary for the treatment of certain diseases or conditions.

4. Prescribing and dispensing of medicines and medical devices must be in accordance with the basic criteria of rational use set forth in this law.

5. sale by mail order and by electronic procedures, medicines and health products subject to prescription is prohibited. The implementing regulations establish the requirements and regulate those selling arrangements regarding drugs non-prescription guaranteeing, in any case, that human medicines are dispensed by an office licensed pharmacy, with the intervention of a pharmacist prior prevent personal advice under articles 19.4 and 86.1, and compliance with applicable depending on the drugs being sold or selling arrangement and compliance with information requirements stipulated by Law 34/2002, of 11 July, services of information society and electronic commerce and in the case of veterinary drugs are dispensed by one of the establishments described in paragraphs a) and b) of Article 38.2, with the intervention of a pharmacist and must also comply with the requirements of Law 34/2002 of 11 July.

, Doorstep selling and any type of indirect sale to the public of medicines is prohibited also. The health authorities, for reasons of public health or safety of persons, they may restrict, condition or prohibit the canvassing and any form of indirect public sale of medical devices.

The provisions of this section shall not prejudice the allocation, distribution or supply to the legally authorized for dispensing to the public.

The implementing regulations establish the requirements to be sold directly to medical professionals, dentistry, veterinary medicine and podiatry exclusively medicines necessary for the exercise of their professional activity.

6. Custody, storage and dispensing of medicinal products for human use shall only:

A) A offices open to the public pharmacy, legally authorized.


B) A pharmacy services in hospitals, health centers and primary care structures of the National Health System for application within those institutions or for drugs that require special surveillance, monitoring and control of the multidisciplinary team of health care, in accordance with the rating given by the Spanish Agency for medicines and health Products for such drugs.

C) Within the National Health System, in addition to the drugs specified in paragraph b) correspond to pharmacy services in hospitals custody, storage and dispensing of medicinal products for human use in the Ministry of Health, Social Services and Equality agreed to establish unique reserves, limiting their dispensing without visas to non-hospitalized patients.

However, in the case of clinical trials conducted in research centers that do not have pharmacy services shipment of investigational medicinal products by the developer to the research center will be possible, assuming the researcher of the center responsibilities relating to the proper administration, custody and delivery of such medicines as specified in the study protocol.

7. dispensing, sale or marketing of any drug that is returned or delivered by patients or the general public, to the pharmacy is prohibited.

Article 4. Guarantees of independence.

1. Without prejudice to the incompatibilities established for the exercise of public activities, the clinical practice of medicine, dentistry, veterinary and other health professions faculty to prescribe or indicate the supply of medicinal products, it is incompatible with any class of derivatives direct economic interests of the manufacture, processing, distribution, trading and marketing of drugs and medical devices. It exempted from the above provisions in the Law 14/2011, of 1 June, of the Science, Technology and Innovation, regarding the participation of staff of research centers under the Public Administrations or entities created participated by those with the objective provided for therein.

2. Also, the practice of pharmacists in pharmacy, in retail business establishment, entities or livestock groups or services hospital and other pharmacy care structures will be incompatible with any kind of direct economic interests of pharmaceutical companies, intermediary entities and / or distribution entities.

3. The clinical practice of medicine, dentistry, veterinary medicine and other health professions faculty to prescribe or indicate the dispensing of medicines will be incompatible with the performance of professional activity or ownership of pharmacy.

4. Membership of the committees of the Spanish Agency for Medicines and Health Products, the Ethics Committees of Clinical Research or committees or advisory or consultative bodies established by the health authorities of the autonomous communities will be incompatible with any kind of interest arising from the manufacture and sale of medicines and medical devices.

5. The exercise of health professionals involved in the cycle of prescription, dispensing and administration of drugs is incompatible with the functions of delegates of medical visit, representatives, commission agents or informers of pharmaceutical companies.


6. To ensure the independence of decisions related to prescribing, dispensing and administering medications from commercial interests, direct or indirect offering any incentives, bonuses, discounts, premiums or gifts is prohibited by anyone with interests direct or indirect in the production, manufacture and marketing of medicines to health professionals involved in the cycle of prescription, dispensing and administration of medications or their relatives and people living together. This prohibition shall also apply when the offer to healthcare professionals who prescribe medical devices are made. Excepted from the previous ban discounts for early payment or volume of purchases made by distributors to pharmacies. These could reach a maximum of 10% for drugs financed by the National Health System, provided that the purchase of a product is no incentive against their competitors and reflected in the invoice.

Article 5 guarantees defense of public health.

1. the development, manufacture, import, export, distribution, sale, prescribing and dispensing products, preparations, substances or combinations thereof that are presented as drugs without being legally recognized as such is prohibited.

2. promotion, advertising or information for the public of the products listed in paragraph 1 is expressly prohibited

3. The provisions of the preceding paragraphs shall apply to products presented as medical devices or cosmetic products without having such consideration, as well as medical devices and cosmetics products marketed without following the procedures laid down in their regulations specific.

4. The breach of the above prohibitions will result in the responsibilities and penalties provided in Chapter II of Title IX, regardless of precautionary measures as appropriate and civil or criminal liability that may apply.

Article 6. Obligations of Public Administrations and participation of professionals.

1. In order to safeguard the needs of public health and safety, public administrations are obliged to communicate how much data, performances or information arising from the exercise of their powers and are necessary for the proper application of this law.

2. All professionals who provide services in the NHS or the public system of scientific research and Spanish technological development have the right to participate and the duty to collaborate with the health authorities in the assessment and control of drugs and medical devices.

3. The committees under this Act shall comply with the provisions on corporate bodies in the regulations.

Article 7. Transparency in decision-making by health administrations.
Health administrations
ensure maximum transparency in its decision-making on drugs and health products, without prejudice to the right of industrial property. Participation in such decision-making processes will be incompatible with any kind of personal interests arising from the manufacture, marketing, representation, distribution and sale related to drugs and medical devices.
TITLE II


From drugs
CHAPTER
I

Of the medicinal products covered by the law and their classes

Article 8. Drug legally recognized.

1. It will only take medications which are listed below:

A) medicinal products for human and veterinary use industrially processed or manufactured by an industrial process involved.

B) master formulas.

C) Preparations oficinales.

D) Special drugs under this Act.

2. They have the legal treatment of drugs, for the purposes of the application of this law and its general control, or combinations of substances authorized for use in clinical trials or research in animal substances.

3. It corresponds to the Spanish Agency for Medicines and Health Products ruling on the attribution of the status of medicine.

4. The nostrums are prohibited. They will be considered secret those products for which its composition and characteristics are unknown.


5. It must be declared to the health authority known all the characteristics and properties of drugs.

6. In case of doubt, where a product may fall within the definition of medicine will apply this law, even if that product is you could apply the definition in another standard.
CHAPTER II


From the qualifications of medicinal products for human use produced industrially and conditions of prescription and dispensing of the same guarantees

Article 9. Authorization and registration.

1. No medication developed industrially may be placed on the market without prior authorization from the Spanish Agency for Medicines and Health and registration Products in Drug Registration or without obtaining authorization in accordance with the provisions of European standards that establish Community procedures for the authorization and supervision of medicinal products for human and veterinary use and regulating the European medicines Agency.

2. When a drug has obtained a permit in accordance with the preceding paragraph, any dosage, dosage form, route of administration and additional presentations, and any other modifications and extensions to file authorization to be introduced, should be subject to authorization or notification under it is available in the rules governing the procedure for authorization, registration and dispensing conditions of medicinal products for human use manufactured industrially. All these changes are considered as belonging to the same global marketing authorization, in particular for the purposes of the application of data exclusivity periods.

3. Any modification, transmission and extinction of authorizations of medicines must be recorded in the Register of Drugs that these effects will, just as registration, constitutive character.

4. The Spanish Agency for Medicines and Health Products will proceed to the incorporation to the Registry of Drug authorizations granted by the European Commission under Regulation (EC) No. 726/2004 / EC.

Article 10 guarantees required for the authorization of medicinal products.

1. The Spanish Agency for Medicines and Health Products grant authorization to a drug if it satisfies the following conditions:

A) To achieve the quality requirements to be established.

B) Be sure not occurring in normal use toxic or undesirable effects disproportionate to the benefit sought.

C) effective in the therapeutic indications for Being offered.

D) be correctly identified.

E) Provide accurate information in accessible and understandable form by the patient format for correct use.

2. The evaluation of the positive therapeutic effects of the drug will be appreciated in relation to any risk relating to the quality, safety and efficacy of the drug for the patient's health or public health, understood as benefit / risk ratio.

3. The provisions of this article shall also apply to changes that occur in the authorization and must be observed throughout the life of the drug.

4. The authorization holder or, where appropriate, the manufacturer must have the material and human resources, organization and operational capacity sufficient for proper manufacture.

Article 11. Guarantees quality.

1. All medication must be well established its qualitative and quantitative composition. Alternatively, in the case of biological substances like where this is not possible, their preparation processes must be reproducible.

2. The person holding the Ministry of Health, Social Services and Equality establish the type of enforceable controls the laboratory holder of the marketing authorization and the manufacturer to ensure the quality of raw materials, intermediate products, the manufacturing process and product end, including packaging and preservation, the purpose of the authorization and registration, maintaining such controls as long as the production and / or marketing of the drug. The quality control procedures should be amended in accordance with the advance of technology.

3. The Spanish Royal Pharmacopoeia is the code that sets the quality to be met by active ingredients and excipients in the composition of medicinal products for human and veterinary use. It will be updated and published periodically.


The Ministry of Health, Social Services and Equality, through the Spanish Agency for Medicines and Health Products, fix and publish in the "Official Gazette" the date of the enactment of successive volumes of the Real Spanish Pharmacopoeia.

4. The Spanish Royal Pharmacopoeia consists of monographs contained in the European Pharmacopoeia of the Council of Europe and, in justified cases, by the Spanish peculiar monographs. For substances manufactured in countries outside the European Union rules, in the absence of the European Pharmacopoeia, the monograph of the pharmacopoeia of the country manufacturer and, failing that, a third country. Pharmacopeia will include conveniently sorted and coded with the specifications of identity, purity and richness of at least monographs, active ingredients and excipients, as well as official analytical methods and general texts necessary for the proper application of the monographs. The specifications defined in monographs constitute mandatory minimum requirements. All raw materials brought under a scientific or common name of the Pharmacopoeia in force must meet the same specifications. The Ministry of Health, Social Services and Equality may recognize the validity in Spain to specific foreign pharmacopoeia monographs.

5. Pharmacies, pharmaceutical services, distribution entities and pharmaceutical companies must ensure that they have access to the Royal Spanish Pharmacopoeia.

6. The Spanish Agency for Medicines and Health Products and the autonomous communities establish programs for quality control of medicines to check compliance with the conditions of the authorization and the other to apply. For the purposes of coordinating these programs, under the Interterritorial Council of the National Health System unit criteria concerning the extent, intensity and frequency of checks to be carried out will be established.

7. The authorities and health professionals and laboratories and distributors are obliged to cooperate actively in such programs quality control and communicate anomalies which they are aware.

Article 12. Guarantees security.

1. Drugs, active ingredients and raw materials that make up those will be the subject of toxicological and clinical studies to ensure their safety under normal conditions of use and shall be related to the expected duration of treatment.

2. Toxicological studies include trials of acute and chronic toxicity tests of teratogenicity, embryotoxicity, fertility, mutagenicity testing and, where appropriate, of carcinogenesis and in general, those that are considered necessary for a proper assessment of the safety and tolerance of a drug in normal use and depending on the duration of treatment. In any case, the rules will be fulfilled on the protection of animals used for scientific purposes. These studies should be conducted in accordance with good laboratory practices established.

3. In addition to toxicological studies and clinical trials, applicants for authorization must prove the ability to perform adequate post-marketing surveillance of drug safety. They must also submit specific plans pharmacovigilance and risk management in accordance with national and European guidelines, are considered necessary, as well as reliable commitment to developing and implementing them.

4. Guarantees safety of the drug will be extended to risks relating to their use and in particular any risk of undesirable effects on the environment.

5. Without prejudice to its own responsibility, all the authorities and health professionals and pharmaceutical laboratories and distribution entities are obliged to cooperate actively in the knowledge of product safety. Also, health professionals, pharmaceutical manufacturers and distribution entities are required to report to health authorities anomalies which have news, as provided in Chapter VI of this title.

Article 13. Guarantees of effectiveness.

1. The effectiveness of medications for each of its indications should be established based on previous pre-clinical studies and clinical trials that comply with the regulatory requirements and those arising from advances in scientific knowledge of the matter.


2. Animal studies should be designed and conducted in a manner that reveal the overall pharmacological profile of the substance. In any case, the rules will be fulfilled on the protection of animals used for scientific purposes.

3. Clinical trials are planned and carried out in such a way that allow to obtain the information necessary to understand the behavior of the substance in the body and assess the effectiveness of the drug. The therapeutic effect should be quantified for different doses and in all major indications. In all trials established ethical requirements for research with human beings they are respected.

Article 14. Guarantees of identification.

1. Each active ingredient will be assigned a Spanish official name (DOE) by the Spanish Agency for Medicines and Health Products. The Spanish official name will be mandatory, notwithstanding that can also be expressed in the corresponding official languages ​​of the autonomous communities.

The Spanish official designation must be equal, or as nearly as possible, saved the language needs, the international nonproprietary name (INN) set by the World Health Organization.

The Spanish official names of active compounds will be in the public domain. The Spanish Agency for Medicines and Health Products will publish a list of Spanish official names of the active ingredients authorized in Spain, to be updated regularly.

Public bodies will promote the use of Spanish official names, if any, or, failing that, international nonproprietary names or, in the absence thereof, of the common or scientific names.

2. The name of the medicinal product may consist of a name which can not be confused with the common name or a common or scientific name accompanied by a trademark or the name of the holder of the marketing authorization.

The name of the medicinal product may not be confused with a Spanish official name or an international nonproprietary name nor misleading as to the therapeutic properties or nature of the drug.

Generics should be designated with a Spanish official name of active ingredient and, failing that, with good international or common name, if it did not exist, with the usual scientific or common name of the substance, accompanied, case, brand name or the owner or manufacturer; they may also be called with a brand if it can not be confused with a Spanish official name or an international nonproprietary name nor misleading as to the therapeutic properties or nature of the drug.

May be identified with the initials EFG (Generic Pharmaceutical Equivalent) drugs that determine the Spanish Agency for Medicines and Health Products because of their interchangeability.

3. The Ministry of Health, Social Services and Equality establish a National Drug Code of general application that facilitates early identification and may require that their numbers or keys shown on the labeling of medicines.

Article 15. Guarantees of information.

1. The Ministry of Health, Social Services and Equality regulate aspects concerning the guarantees of information and, in particular, features, extension, details and locations should appear. In any case, for the preparation of this information about the drug, its operator shall provide sufficient written information on identification, directions and precautions to be observed in use. This information will be presented, at least in the official Spanish language of the state and with it the data sheet, the package insert and labeling developed.

The texts and other characteristics of the data sheet, the package insert and labeling are part of the authorization of medicines and must be previously authorized by the Spanish Agency for Medicines and Health Products. His amendments also require prior authorization or notification, as appropriate.


2. The data sheet or summary of product characteristics reflect the authorized conditions of use for the drug and synthesize the essential scientific information for health professionals. The Spanish Agency for Medicines and Health Products approve the data sheet in the sheet containing sufficient data on drug identification and owner, as well as the therapeutic indications for which the drug has been approved, according to studies supporting its authorization . A sheet is, mandatorily, updated information will accompany the price of the drug and, when possible, the estimated cost of treatment.

The Spanish Agency for Medicines and Health Products sheet will available health services of the autonomous communities, schools or professional organizations, doctors, dentists, podiatrists and pharmacists in exercise and, if necessary , veterinary practitioners. The authorization holder shall be required to put the updated summary available to health authorities and professionals in all their promotional activities and information on the terms established by regulation.

3. The prospectus, which will be developed in accordance with the content of the data sheet, provide patients enough information about the name of the active ingredient, drug identification and the owner and instructions for its administration, use and conservation, as well as the effects adverse interactions, contraindications, especially the effects on driving motor vehicles, and other data specified in the regulations in order to promote their correct use and compliance with the prescribed treatment, as well as measures to be taken in case of poisoning. The prospectus must be legible, clear, ensuring their understanding by the patient and minimizing the terms of a technical nature.

4. The labeling information on the drug, such as the name of the active ingredient, the authorization holder, route of administration, quantity contained, batch number of manufacture, expiry date, storage precautions, dispensing conditions and other data by regulation. In each package will include coded data from the National Drug Code, lot and unit identification allowing individually by mechanical, electronic and computer media, in the form determined by regulation. In the package should include a blank space to be filled by the pharmacist where it can describe the dosage, treatment duration and frequency of shots. By dispensing a drug, the pharmacy must issue a receipt stating the name of the drug, its retail price and input the patient is made. In the case of drugs that are subject to the advertising provided for in Article 80, the receipt shall, in addition, the discount, if any, had been made.

5. To ensure access to information for the blind or visually impaired, in all medicine packaging must bear printed in Braille data necessary for proper identification. The authorization holder shall ensure that, upon request of the associations of patients affected, the prospectus is available in formats appropriate for the blind and partially sighted people.

6. Medications are processed and presented in a way that the reasonable prevention of accidents, especially in relation to children and persons with disabilities are guaranteed. Packagings shall, where appropriate, a sealing device that ensures the user that the drug keeps the composition, quality and quantity of the packaged product by the laboratory. Also, the packaging will include authorized by the Spanish Agency for Medicines and Health Products in order to facilitate the application and development of waste collection system of medicines and promote environmental protection symbol.

Article 16. Authorisation procedure and its modifications. Requirements and guarantees transparency.

1. The Spanish Agency for Medicines and Health Products may require the applicant to provide documentation, studies, data or additional information, being applicable Community rules, the specific development of this law and, failing that, the rules governing the administrative procedure common.


2. In the process of drug evaluation, the Spanish Agency for Medicines and Health Products will, for the purpose of issuing reports correspond with advisory committees or bodies that include qualified experts from the scientific and professional world.

3. In the authorization procedure you may submit the medicinal product, its raw materials, intermediate products and other components for examination of official control laboratories of the Spanish Agency for Medicines and Health Products, which may request assistance from another national laboratory approved for that effect by the own Agency of a Community control official laboratory or a third country.

4. To ensure transparency of its proceedings, the Spanish Agency for Medicines and Health Products ensure public access to its decisions on authorizations of medicines, as amended, suspensions and revocations, when all of them are firm, and the summary of the characteristics of product. Also publicly accessible evaluation report will be motivated, after deletion of any confidential commercial information. Confidentiality shall not prevent the publication of acts of decision of the collegiate bodies of technical and scientific advice of the Ministry of Health, Social Services and related to the authorization of medicinal products, as amended, suspensions and revocations Equality.
Article 17. Record
authorization.

1. The record for the authorization of a medicinal consist of all documents relating to administrative information, summaries of experts, chemical information, pharmaceutical and biological drug containing principles active chemical and / or biological, the results of pharmaceutical tests, pre-clinical and clinical and any other determined by regulation. The applicant or holder of an authorization shall be responsible for the accuracy of documents and data submitted.

2. The request for authorization of medicinal products will appear, including identification data, complete and accurate qualitative and quantitative composition including not only active but also all excipients and solvents, although the latter disappear in the manufacturing process.

Also, the application shall contain the information on the precautions and security to be taken when storing the drug, when administered to patients and the disposal of waste products, together with an indication of any potential risks the drug could present for the environment.

The request shall state that the applicant has a qualified person responsible for pharmacovigilance and has the necessary to report any adverse reaction suspected has already occurred or may occur infrastructure.

3. The applicant shall not be required to provide the results of the established preclinical and clinical trials if he can demonstrate that the drug is a generic of a reference medicinal product which is or has been authorized for eight years at least in any Member State of the European Union, or by the European Union, even when the reference medicinal product was not authorized in Spain, without prejudice to the law relating to the protection of industrial and commercial property.

4. When a biological medicinal product which is similar to a reference biological product does not meet the conditions of the definition of generic drug, particularly due to differences relating to raw materials or differences in the manufacturing process of the biological medicinal product and the reference biological medicine shall be provided in the results of appropriate preclinical or clinical trials relating to these conditions and other requirements established by regulation.

5. The applicant may replace the results of clinical trials and preclinical studies a literature appropriate scientific documentation if he can demonstrate that the active ingredients of the medicinal product have been well established for at least ten years within the European Union medical use and with recognized efficacy and an acceptable level of safety.

6. In the case of a drug that has the same qualitative and quantitative composition in active substances and the same pharmaceutical form another already authorized and registered, the applicant may use the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal always authorized with the consent of the owner.


7. Medicinal products containing active ingredients in the composition of authorized medicinal products, but have not been combined for therapeutic purposes, must provide the results of new clinical trials and preclinical studies on the combination without providing the documentation to each individual active ingredient.

8. Granted authorization for a drug, any changes requested in connection therewith shall meet the documentary requirements established by regulation.

9. The holder of the authorization of a drug shall maintain updated the file provided for it, incorporating the same few data, reports or technological changes imposed by the advances of science and standards of good manufacturing and control. It shall also submit periodic safety update reports established in the legislation in order to keep updated the file security.

10. The competent public authorities may, at any time, justifying the pharmaceutical laboratory performing quality control and few others are established in the regulations.

Article 18. Data exclusivity.

1. Without prejudice to the law relating to the protection of industrial and commercial property, generic drugs approved in accordance with the provisions of Article 17.3 may not be marketed until ten years from the date of the initial authorization of the reference product.

This ten-year period of data exclusivity will be extended to a maximum of eleven years if, during the first eight years of the ten, the authorization holder of the reference product obtains an authorization for one or more new indications therapeutic and, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.

2. In the event that for a substance for medical use well established a new indication is authorized, based on significant clinical trials or preclinical studies, a non-cumulative period of data exclusivity shall be granted one year.

3. When, based on clinical trials or significant preclinical studies, the authorization of medicinal product subject to medical prescription has been modified by non subject to medical prescription or vice versa medication, it is granted a period of one year of data exclusivity for them.

Article 19. Conditions of prescription and dispensing of medicines.

1. The authorization of the drug, the Spanish Agency for Medicines and Health Products will determine the conditions of prescription classifying, as appropriate, in the following categories:

A) Medicinal product subject to medical prescription.

B) Medicinal product not subject to medical prescription.

2. They will be in any case subject to medical prescription drugs that are in any of the following cases:

A) may present a danger either directly or indirectly, even under normal conditions of use, if used without medical supervision.

B) a hazard to health are frequently used, and very significantly, in abnormal conditions of use, and this may involve, directly or indirectly.

C) contain substances or preparations based on these substances, the activity and / or adverse reactions of which require further investigation.

D) is administered parenterally, except in exceptional cases, by prescription.

3. The Spanish Agency for Medicines and Health Products may, in the drugs that can be dispensed only by prescription, the following subcategories:

A) dispensing drugs under renewable or non-renewable medical prescription.

B) medicinal products subject to special medical prescription.

C) Medication dispensing prescription restricted, reserved for use in certain specialized areas.

Reglamentariamente the criteria for their application set.


4. The Spanish Agency for Medicines and Health Products may qualify as medicinal products not subject to medical prescription those that are intended for processes or conditions that do not require an accurate diagnosis and whose data toxicological evaluation, or clinical use and route of administration does not require prescription medical, so that these drugs can be used for self-care by dispensing in the pharmacy by a pharmacist, to inform, advise and instruct on proper use.

5. Prospects and labeling of medicines that do not require a prescription, in addition to the provisions of Article 15.1, contain those warnings that suit their nature and in particular those aimed at preventing misuse.

6. The Ministry of Health, Social Services and Equality establish the minimum requirements, characteristics and validity of prescriptions and hospital prescriptions and special requirements for prescribing and dispensing drugs psychoactive substances and others who by their nature require or for particular treatments.

7. Dispensing drugs shall comply with the conditions established prescription.

8. The Spanish Agency for Medicines and Health Products, in order to set the units dispensed by pharmacies to the duration of treatment, may authorize the dispensing of specific units within six months from the determination of relevant groups drugs and / or pathologies. These units may be dispensed from the fractionation of a container of an authorized and registered medicine, respecting the integrity of the primary packaging, except when under projects or authorized by that Agency programs, whether from its docketed overhaul and guaranteeing conditions conservation medicine and patient information.

For cases provided in this section, the Ministry of Health, Social Services and Equality set the price calculation system retail and marketing margins corresponding.

9. In order to ensure the rational use of medicines, the Spanish Agency for Medicines and Health Products shall take all measures necessary to adapt the content of all containers of new drugs authorized for the duration of treatments in clinical practice. It also will conduct annual reviews, to the same effect, already authorized medicines, realizing semiannually to Interterritorial Council of the National Health System.

Article 20. Refusal of authorization.

The authorization of a medicinal product may be refused for the following reasons:

A) When the risk-benefit ratio is not favorable.

B) When not sufficiently justify the therapeutic efficacy.

C) When the drug does not have the qualitative and quantitative composition declared or lack of adequate quality.

D) When data and information contained in the documentation of the application for authorization are incorrect or breach the rules applicable in the matter.

Article 21. Validity of authorization.

1. Authorization of medicinal products will last for five years.

2. The authorization may be renewed after five years, subject to re-evaluation of the benefit / risk ratio. The renewal of the authorization will be indefinite unless pharmacovigilance reasons justify submission to a new renewal procedure.

3. The authorization holder shall expressly to the Spanish Agency for Medicines and Health Products placing on the market for the first time an authorized and registered by the Agency and shall make an annual declaration of marketing in the terms established by regulation medicine.

4. The authorization of a medicinal product shall be deemed expired if, within three years, the holder does not do the actual marketing of the same or once authorized, registered and sold longer actually present on the market for three consecutive years. This shall not apply where attend for health reasons or health interest, in which case the Spanish Agency for Medicines and Health Products uphold the validity of the authorization and may require the actual marketing of the product.

Article 22. Suspension and revocation of the authorization.


1. The authorization shall be temporarily suspended or permanently revoked by the Spanish Agency for Medicines and Health Products in the following cases:

A) When the drug has no quantitative or qualitative composition authorized or where the quality guarantees are breached or when the quality controls required by this law are not implemented.

B) When, based on data on safety and / or efficacy of the drug has an unfavorable benefit / risk.

C) If the drug proves not to be therapeutically effective.

D) When data and information contained in the documentation of the application for authorization are incorrect or breach the rules applicable in the matter.

E) If, for any cause, assume a foreseeable risk to the health or safety of persons or animals.

F) In any other case in which the European Medicines Agency they have been agreed.

G) When it fails to comply with the requirements of the conditions for marketing authorization for pharmacovigilance.

2. Also, the Spanish Agency for Medicines and Health Products at the request of the holder of the authorization may temporarily suspend or revoke the authorization of a medicinal product, on justification in technological reasons, scientists or any others that are proportionate and provided that the decision does not lead therapeutic gap in the pharmaceutical provision of the national health system and not collide with the criteria established in this law for the inclusion of drugs in that provision.

Article 23. Amendments authorization for reasons of general interest.

The Spanish Agency for Medicines and Health Products may change justifiably and notifying the holder of the marketing authorization, the authorization of medicines that require it for reasons of public interest or protection of health or safety of persons . This is without prejudice to the obligation of the holder of the marketing authorization to ensure that your product information is updated based on the latest scientific knowledge, including the evaluation findings and recommendations published in the European web portal on medicines and on the web site of the Spanish Agency for Medicines and Health Products.

Article 24. Guarantees availability of drugs in specific situations and special authorizations.

1. In exceptional circumstances, the Spanish Agency for Medicines and Health Products may be granted subject to an undertaking by the applicant to meet certain annually reviewable conditions authorization. These conditions remain, in particular concerning the safety of the medicine, information to the competent authorities of any incident relating to its use, and action to be taken. Regulations the criteria for granting such authorizations be established.

2. The Spanish Agency for Medicines and Health Products may, on its own initiative or at the request of the autonomous communities concerned by objective and the reasons for health reasons restrain unique reserves the authorization of medicines that require by their nature or characteristics and conditions general prescribing and dispensing.

3. Prescription and application of unapproved drugs to patients not enrolled in a clinical trial in order to serve as compassionate use special treatment needs of clinical conditions of individual patients will be governed by regulation, with full respect for the provisions of the current legislation regarding patient autonomy and rights and obligations regarding clinical information and documentation.

The person head of the Ministry of Health, Social Services and Equality set the conditions for prescription medicines authorized when used other than those authorized, which in any case is exceptional conditions.

4. The Spanish Agency for Medicines and Health Products may authorize the importation of unauthorized medicinal products in Spain provided they are legally marketed in other States, where this importation is necessary for the prevention, diagnosis or treatment of specific pathologies not exist in Spain alternative properly authorized for that particular stock-outs or warrant that indication.


5. The Spanish Agency for Medicines and Health Products may temporarily authorize the distribution of unauthorized drugs in response to the suspected or confirmed of a nuclear pathogen or chemical agent, toxin or radiation capable of causing damage propagation. In these circumstances, if any recommended or required by the competent authority of the use of drugs in indications unauthorized or unapproved drugs, the and authorization holders other professionals involved in the process would be exempt from civil or administrative liability for any the consequences of the use of medication, except for damage caused by defective products.

6. The Spanish Agency for Medicines and Health Products exceptionally authorize the production and distribution of free samples under the conditions established by regulation. In any event, no free drug samples of psychoactive substances that cause dependence and those which determine the Spanish Agency for Medicines and Health Products is authorized.

7. The Spanish Agency for Medicines and Health Products may establish procedures for specific authorization for drugs, according to a specific resolution of the same, are deemed necessary to meet special requirements, as long as they are intended for use by an individual patient under prescription an optional accredited and under his direct responsibility.
CHAPTER III


Of the guarantees required veterinary medicinal products produced industrially and conditions of prescription and dispensing of the same

Article 25. Authorisation and registration.

1. No veterinary medicinal product prepared industrially may be placed on the market without prior authorization from the Spanish Agency for Medicines and Health and registration Products in Drug Registration or without obtaining authorization in accordance with the provisions of European rules establishing procedures Community for the authorization and supervision of medicinal products for human and veterinary use and regulating the European medicines Agency. For the purposes of the provisions of this article and, in general, in this chapter, the Spanish Agency for Medicines and Health Products act in accordance with the issued criteria Ministry of Agriculture, Food and Environment and in accordance with the rules of animal health.

2. When a veterinary medicinal product has obtained a permit in accordance with the preceding paragraph, any dosage, dosage form, route of administration and additional presentations, and any other modifications and extensions to file authorization to be introduced, should be subject to authorization or notification , as it provided in the regulations governing the authorization procedure, registration and pharmacovigilance of veterinary medicinal products manufactured industrially. All these changes are considered as belonging to the same global marketing authorization, in particular for the purposes of the application of data exclusivity periods.

3. Any modification, transmission and termination of authorizations for veterinary medicinal products must be recorded in the Register of Medicines for this purpose, will, just as registration, constitutive character.

4. The Spanish Agency for Medicines and Health Products will proceed to the incorporation to the Registry of Drug authorizations granted by the European Commission under Regulation (EC) No. 726/2004 / EC.

Article 26 guarantees required for the authorization of medicinal products.

1. The Spanish Agency for Medicines and Health Products authorized a veterinary medicinal product if it satisfies the following conditions:

A) meet minimum quality requirements to be established.

B) be safe.

C) effective in the therapeutic indications for Being offered.

D) be correctly identified.

E) Provide accurate information.

2. The evaluation of the positive therapeutic effects of the drug will be appreciated in relation to any risk related to quality, safety and efficacy of the drug for animal health or public health, understood as benefit / risk ratio. Statutorily this evaluation will be tailored to the specific needs in the case of medicines for terrarium animals, house birds, aquarium fish, small rodents and other existing veterinary prescription.


3. The provisions of this Article shall also apply to changes that occur in the authorization of the drug.

Article 27. Guarantees quality.

1. All medication must be well established its qualitative and quantitative composition. Alternatively, in the case of biological substances like where this is not possible, their preparation processes must be reproducible.

2. The Ministry of Health, Social Services and Equality, in coordination with the Ministry of Agriculture, Food and Environment, set the type of enforceable controls the laboratory holder of the marketing authorization and the manufacturer to ensure the quality of raw materials, intermediate products of the manufacturing process and the final product, for the purposes of authorization and registration, maintaining such controls as long as the production and / or marketing of the drug. The quality control procedures should be amended in accordance with the advance of technology.

3. The competent health authorities conduct regular quality checks of existing in the market, raw materials and intermediates medicines as well as the packaging material and the conditions of storage, transportation and sale.

Article 28. Guarantees security.

1. Medicines, medicinal substances and excipients that make up those will be the subject of toxicological and clinical studies to ensure their safety under normal conditions of use and shall be related to the expected duration of treatment.

2. The studies include trials of acute and chronic toxicity tests of teratogenicity, embryotoxicity, fertility, mutagenicity testing and, where appropriate, of carcinogenesis and in general, those that are considered necessary for a proper assessment of the safety and tolerance a drug in normal use and depending on the duration of treatment. In any case, the rules will be fulfilled on the protection of animals used for scientific purposes.

3. Veterinary drugs should be investigated and further testing to guarantee their safety, which will take into account:

A) when food producing animals intended for human consumption are administered must know the appropriate wait time to eliminate risks to people arising from residues or metabolites of those.

B) The impact on the people that operate primarily for products intended for mixing with feed.

C) The influences on the environment, as they can lead to a residual action through waste products.

D) In ​​the case of biological products and vaccines in particular epizootic repercussions.

4. Without prejudice to its own responsibility, all the authorities and health professionals and pharmaceutical laboratories and distribution entities are obliged to cooperate actively in the knowledge of product safety. Also, health professionals, pharmaceutical manufacturers and distribution entities are required to report to health authorities anomalies which have news, as provided in Chapter VI of this title.

Article 29. Guarantees of effectiveness.

1. The effectiveness of veterinary drugs should be established a right for each of the species and indications for which they are intended by the prior conduct of clinical trials and preclinical studies sufficiently controlled so skilled.

2. These studies must reproduce the effects of different doses applied to the substance of the form established by regulation and also include one or more groups treated or not with a reference product control.

Article 30. Guarantees of identification.

1. Each active ingredient for veterinary use use the corresponding Spanish official name (DOE) as set out in Article 14.


2. may be designated a veterinary medicinal product with a mark or a Spanish official name of active ingredient and, failing that, with good international or common name, if it did not exist, with the usual scientific or common name of the substance. Regulations may regulate the circumstances under which may be designated a generic drug with a trade name or a trademark. The name of the drug, when is a trademark or trade name, can not be confused with a Spanish official name of active ingredient or an international nonproprietary name nor misleading as to the therapeutic properties or nature of the drug.

3. The Spanish Agency for Medicines and Health Products establish a National Code of Veterinary medicine of general application that facilitates early identification and also may require that their numbers or passwords appearing on the package, labeling and packaging of veterinary medicines.

Article 31. Guarantees of information.

1. The Ministries of Agriculture, Food and Environment, and Health, Social Services and Equality regulate aspects concerning the guarantees of information and, in particular, features, extension, details and locations should appear. In any case, for the preparation of this information on the veterinary medicinal owner provide sufficient written information on identification, directions and precautions to be observed in use. This information will be presented, at least in the official Spanish language of the state and with it the data sheet, the package insert and labeling developed.

The texts and other characteristics of the data sheet, the package insert and labeling are part of the authorization of veterinary medicines and must be previously authorized by the Spanish Agency for Medicines and Health Products. Amendments also require prior authorization or notification, as appropriate.

2. The data sheet will summarize the essential scientific information on the veterinarian refers to medicine. The Spanish Agency for Medicines and Health Products approve the technical data sheet which shall contain sufficient information on the identification of the veterinary medicinal product and its owner, the information required for a therapeutic action and correct pharmaceutical care, according to studies supporting authorization.

The Spanish Agency for Medicines and Health Products sheet will available to the autonomous communities, schools or professional organizations and veterinarians and pharmacists practicing. The authorization holder shall be required to put the updated summary available to professionals in all their promotional activities and information on the terms established by regulation, and when it is you requested.

3. The prospectus will provide sufficient information on the identification of the veterinary medicinal product and its owner and instructions for its administration, use and conservation, as well as adverse effects, interactions, contraindications, waiting time, if applicable, and other data specified in the regulations with in order to promote their correct use and compliance with the prescribed treatment and measures to be taken in case of poisoning. In addition, the prospectus shall not contain terms of technique to ensure easy reading and understanding nature.

4. The packaging and packaging contain the information the veterinary medicinal product, the holder of the authorization, route of administration, quantity contained, batch number of manufacture, expiry date, storage precautions, dispensing conditions, waiting time, if appropriate, and other data by regulation.

By dispensing a drug, pharmacies, authorized retail shops and pharmacy services entities or livestock groups shall issue a receipt stating the name of the drug and its retail price is made .

5. To ensure access to information for blind or visually impaired people, by regulation the necessary measures will be developed for the packaging of medicines for pets appear printed in Braille data necessary for proper identification, and that the holder of the authorization to ensure that, upon request of associations of people affected, the prospectus is available in formats appropriate for the blind and partially sighted people.


6. Regulations the requirements will be established to facilitate the implementation and development of a system for collecting unused veterinary drugs or have expired.

Article 32. Authorisation procedure and its modifications. Requirements and guarantees transparency.

1. In accordance with the provisions of this law, the Government shall regulate the procedure for obtaining authorization and registration in the Register of Medicinal Products, in accordance with the procedures and deadlines set by the European Union under the EU harmonization. The Government shall regulate, in accordance with Community legislation, the procedure for notification and authorization of any modifications occur in the initial authorization.

2. The Spanish Agency for Medicines and Health Products may require the applicant to provide documentation, studies, data or additional information, whichever is the specific regulations implementing this law and, failing that, the regulations governing the common administrative procedure.

3. In the process of evaluation of veterinary drugs, the Spanish Agency for Medicines and Health Products, in coordination with the Ministry of Agriculture, Food and Environment, will, for the purpose of issuing reports correspond with committees or bodies incorporating qualified advice of the autonomous communities and scientific experts and professional world.

4. In the authorization procedure you may submit the medicinal product, its raw materials, intermediate products and other components for examination of official control laboratories of the Spanish Agency for Medicines and Health Products or, where appropriate, other national laboratory approved for that effect by the Agency or an official laboratory community control or a third country.

5. Authorizations for veterinary medicinal products, as amended, suspensions and revocations, when all of them are firm, and the summary of product characteristics, be publicly accessible. Also publicly accessible evaluation report will be motivated, after deletion of any confidential commercial information. Notwithstanding the foregoing, the contents of the records of authorization of veterinary medicines will remain confidential. However, inspectors for the development of their duties will have access to all the information they need.
Article 33. Record
authorization.

1. The record for the authorization of a veterinary medicinal product shall consist of all documents relating to administrative information, summaries of experts, chemical information, pharmaceutical and biological for veterinary medicinal products containing principles active chemical and / or biological safety tests and residue studies and preclinical and clinical trials, and any other determined by regulation. The applicant or holder of an authorization shall be responsible for the accuracy of documents and data submitted.

2. In the application for authorization of veterinary medicinal products shall contain, among identification data, complete and accurate qualitative and quantitative composition including not only medicinal substances, but also all excipients and solvents, although the latter disappear in the process manufacturing.

3. Without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of safety tests and residue studies or the established preclinical and clinical trials if he can demonstrate that the drug is generic a reference veterinary medicinal product is or has been authorized and registered, at least eight years ago, in any member State of the European Union, or the European Union, even when the reference medicinal product was not authorized in Spain.

4. Where a biological veterinary medicinal product which is similar to a reference biological product does not meet the conditions of the definition of generic drug, particularly due to differences relating to raw materials or differences in the manufacturing process of biological medicine and biological medicine reference shall be provided in the results of appropriate preclinical or clinical trials relating to these conditions and other requirements established by regulation.


5. The applicant may replace the results of safety tests and residue studies and preclinical or clinical trials by appropriate literature and scientific documentation if it can demonstrate that the active ingredients of the veterinary medicinal product have been well-established veterinary use, least ten years, within the European Union and have recognized efficacy and an acceptable level of safety.

6. In the case of a veterinary medicinal product which has the same qualitative and quantitative composition in active substances and the same as another already authorized dosage form, the applicant may use the pharmaceutical, safety, study of residues, pre-clinical and clinical documentation contained in the record of authorized veterinary medicinal provided with the consent of the owner.

7. The veterinary medicinal products containing active ingredients in the composition of authorized veterinary medicinal products but have not been combined for therapeutic purposes must provide the results of safety tests and residue studies, if necessary, and the results of new clinical trials and preclinical relating to the combination without providing the documentation relating to each individual active ingredient.

8. Granted authorization for a veterinary medicinal any changes requested in connection therewith shall be documented as established by regulation.

9. The holder of the authorization for a veterinary medicinal product shall maintain updated the file provided for it, incorporating the same few data, reports or technological changes imposed by the advances of science and standards of good manufacturing and control. It must also submit periodic reports established safety regulations in order to keep updated the file security.

10. The Spanish Agency for Medicines and Health Products or regions may, at any time, justifying the pharmaceutical laboratory performing quality control and few others are established in the authorization and registration of that.

Article 34. Data exclusivity.

1. Without prejudice to the law relating to the protection of industrial and commercial property, generic veterinary medicinal products authorized under Article 33.3 may not be marketed until ten years from the date of initial authorization of the reference. However, records of veterinary medicinal products for fish, bees and other species to be determined in the context of the European Union, will have a data exclusivity period of thirteen years.

For veterinary medicinal products for food-producing species the ten-year period to which the preceding paragraph may be extended for up to thirteen years under the conditions established by regulation.

2. In the event that a substance veterinary use well established is granted, based on new residue studies and new clinical trials authorization for another food-producing species shall be granted to the species a period of data exclusivity three years.

Article 35. Grounds for refusal, suspension or revocation of the authorization.

1. They will be grounds for refusal, suspension or revocation of the authorization of a veterinary medicinal product:

A) the risk-benefit balance of the veterinary medicinal product is not positive under the authorized conditions of use. When a veterinary medicinal product for zootechnical use it refers benefits are taken into account especially in health and animal welfare and consumer safety.

B) the veterinary medicinal product has no therapeutic effect or is insufficiently substantiated about animal species to undergo treatment.

C) the veterinary medicinal its qualitative or quantitative composition declared.

D) the waiting time is inadequate to ensure that foodstuffs obtained from treated animals do not contain residues which may present health hazards consumer, or is insufficiently substantiated.

E) the veterinary medicinal product is offered for sale for unauthorized use.

F) Failure to comply with the obligations established by regulation.

G) Any other case in which the European Medicines Agency they have been agreed.


2. The suspension and revocation in the preceding paragraph relates to occur, as established in it, following appropriate control and inspection activities carried out by the General State Administration, if any, or by the autonomous communities.

3. Resolutions denial, suspension or revocation of the authorization of a veterinary medicinal product will be motivated and the report of the competent committee of the Spanish Agency for Medicines and Health Products in evaluation of veterinary drugs, which must be represented be adopted by the Ministry of Agriculture, Food and Environment.

Article 36. Validity of authorization.

1. The authorization of veterinary medicinal products will last for five years.

2. The authorization may be renewed after five years, subject to re-evaluation of the benefit / risk ratio. The renewal of the authorization will be indefinite unless pharmacovigilance reasons justify submission to a new renewal procedure.

3. The authorization holder shall, expressly, the Spanish Agency for Medicines and Health Products placing on the market for the first time of an authorized medicinal product and a statement made annually marketing in the terms established by regulation.

4. The authorization of a veterinary medicinal product shall be deemed expired if, within three years, the holder does not do the actual marketing of the same or once authorized, registered and sold longer actually present on the market for three consecutive years. This shall not apply where attend for health reasons or health interest or exceptional circumstances; In this case, the Spanish Agency for Medicines and Health Products uphold the validity of the authorization and may require the actual marketing of the product.

Article 37. Prescription of veterinary drugs.

1. In order to protect human health and animal health, a veterinary prescription is required for dispensing to the public the following veterinary medicinal products:

A) drugs for which veterinarians must take special precautions in order to avoid unnecessary risks to species which they are used, to the person administering the drug to animals and the environment.

B) intended for treatments or pathological processes which require a precise prior diagnosis or the use of which may cause effects which impede or interfere with subsequent diagnostic or therapeutic measures.

C) psychoactive drugs supply or use substances subject to restrictions arising from the implementation of the relevant conventions of the United Nations Organization against illicit traffic in narcotic drugs and psychotropic substances or under Community legislation.

D) veterinary medicinal products for food-producing animals. However, the Ministry of Health, Social Services and Equality, after consulting the Ministry of Agriculture, Food and Environment, may derogate from this requirement in accordance with the decisions taken by the European Commission on this matter.

E) Drugs used in cases of exceptional prescription therapeutic void, including oficinales prepared, master formulas and autogenous vaccines.

F) Immunological.

2. Also, prescription shall be required for new veterinary medicinal products containing an active substance whose use in veterinary medicinal product for less than five years authorized.

3. Regulations prescriptions exceptional regime will be established.

4. Without prejudice to the cases provided for that purpose in the current legislation would require the administration directly by, or under the responsibility of all those veterinary drugs in which so provided in the marketing authorization and those referred to in paragraphs a) , c) and f) of paragraph 1

5. The veterinary prescription shall be valid throughout the national territory and will be published in the official Spanish language of the State and the respective co-official languages ​​in the regions that have it. Reglamentariamente the data to be recorded in the veterinary prescription shall be established.

Article 38. Distribution and dispensing of veterinary medicines.

1. The Government will develop the rules of basic character on the distribution and dispensing of veterinary medicines.


2. Dispensing of medicines to the public will be made exclusively by:

A) legally established offices pharmacy, which also will be the only authorized for the preparation and dispensing of magisterial formulas and officinal preparations.

B) The authorized retail commercial establishments, provided they have a pharmaceutical service responsible for the custody, storage and dispensing of these drugs.

C) institutions or livestock groups that have authorized service pharmacist responsible for the custody, storage and dispensing of these drugs for the exclusive use of its members.

Reglamentariamente the performance of the pharmacist in each of the establishments described above in paragraphs b) and c) as a condition and prerequisite for ensuring effective control in dispensing to the public veterinary medicinal products will be regulated.

Notwithstanding the foregoing, medicines for dogs, cats, terrarium animals, house birds, aquarium fish and small rodents that do not require veterinary prescription may be distributed and sold in other stores, under the terms established by regulation.

3. For reasons of urgency and distance from the pharmacy kits veterinary drugs may be used under the conditions prescribed by regulation.

4. Regulation regime procurement, distribution and dispensing of veterinary medicines by authorized entities or groups that have livestock pharmaceuticals and veterinary services for the exclusive use of its members will be established.

Also be established by regulation regime by which animal feed industries and farms may directly acquire the medicated premixes authorized, intended for the production of medicated feed.

5. Public administrations, in the exercise of their powers, may acquire veterinary drugs, especially vaccines that are accurate, directly from pharmaceutical companies or any authorized distribution center.

Article 39. Guarantees availability of veterinary medicines in specific situations and special authorizations.

1. In exceptional circumstances, the Spanish Agency for Medicines and Health Products may be granted subject to an undertaking by the applicant to meet certain annually reviewable conditions authorization. These conditions remain, in particular concerning the safety of the medicine, information to the competent authorities of any incident relating to its use, and action to be taken. Regulations the criteria for obtaining these authorizations will be established.

2. Subject to the possibility of exceptional provisions, the Ministry of Health, Social Services and Equality, according to the Ministry of Agriculture, Food and Environment, regulate, exceptionally, the use of drugs by veterinarians under conditions other than authorized in order to ensure animal welfare and avoid unnecessary animal or animal health grounds suffering. This regulation should be established, in any case, in accordance with the provisions of the legislation on animal health.

3. In case of serious animal diseases, the Spanish Agency for Medicines and Health Products request and mandatory report of the Ministry of Agriculture, Food and Environment, may provisionally allow the use of immunological veterinary medicinal products without authorization, if no proper medication, reporting previously on their conditions of use to the European Commission.

Article 40. Clinical trials with veterinary drugs.

1. For the purpose of this law is understood clinical trial in animals with an investigational drug, to any investigation through its administration or application to the target species, or a particular category of the same, which is to allocate future treatment, designed to confirm when deemed appropriate pharmacodynamic effects and / or pharmacokinetic and / or establish efficacy for a therapeutic indication and / or know the profile of its adverse reactions and establish security and / or tolerance under normal conditions use.


2. Clinical trials on investigational medicinal animals shall be subject to authorization scheme of the Spanish Agency for Medicines and Health Products accordance with the procedure established by regulation. It must also comply with regulations applicable for the protection of animals used for experimental and other scientific purposes.

Article 41. System Spanish Pharmacovigilance of veterinary drugs.

1. The Spanish Pharmacovigilance System for veterinary medicinal products concerns the identification, quantification, evaluation and prevention of risks of using veterinary drugs and monitoring of possible adverse effects of these animals, people or the environment, as well as the alleged lack of efficacy and detection of inadequate waiting times.

2. Reglamentariamente the Spanish Pharmacovigilance System for veterinary medicinal products, coordinated by the Spanish Agency for Medicines and Health Products and in accordance with article 57 be developed, it will integrate the activities that health authorities conducted to collect and process information on adverse drug reactions veterinarians.

3. Pharmaceutical laboratories, veterinarians, pharmacists and other health professionals have a duty to inform the Spanish Agency for Medicines and Health Products in the manner determined by regulation, suspected adverse reactions which are aware and which may have It has been caused by veterinary drugs.
CHAPTER IV


Of health guarantees magisterial formulas and officinal preparations

Article 42. Requirements for master formulas.

1. The master formulas will be prepared with substances action and indication legally recognized in Spain, in accordance with Article 44.1 and in accordance with the guidelines of the National Formulary.

2. The master formulas will be prepared in the pharmacy and legally established pharmaceutical services that have the necessary means for their preparation according to the requirements set out in the National Formulary.

However, pharmacies and pharmaceutical services that do not have the means, exceptionally and without prejudice to the provisions of Article 66.2, may entrust an entity under this law, authorized by the health authorities competent, performing one or more stages of processing and / or control of master formulas.

3. In the preparation of master formulas correct production standards and quality control of magisterial formulas and officinal preparations are observed.

4. Magistral formulas intended for animals shall be prescribed by a veterinarian and an individual animal or a small number of animals on a particular holding that are under the direct care of the physician will go. They will be prepared by a pharmacist or under his direction, in your pharmacy.

5. The master formulas shall be accompanied the name of the pharmacist to prepare them and sufficient information to ensure correct identification and conservation, and their safe use.

6. Compounding substance or unauthorized drugs in Spain will adjust the system provided for in Article 24

Article 43. Requirements for officinal preparations.

1. The officinal preparations must meet the following conditions:

A) be listed and described in the National Formulary.

B) Comply with the rules of the Royal Spanish Pharmacopoeia.

C) Be developed and guaranteed by a pharmacist at the pharmacy or pharmaceutical service that dispenses.

D) Introduce and dispensed necessarily under active ingredient or, failing that, under a common or scientific name or expressed in the national form and in any case, under trademark.

E) accompanied by the name of the pharmacist to prepare and sufficient information to ensure correct identification and conservation, and their safe use.

2. Exceptionally, and subject to the provisions of Article 66.2, pharmacies and pharmaceutical services that do not have the means may be entrusted to a legally authorized entity for that purpose by the competent health authorities carrying out one or several phases processing and / or control exclusively oficinales those prepared to respond to a prescription.


3. The officinal preparations for animals shall be drawn up in pharmacies in accordance with the indications of a form and will be delivered directly to the end user.

Article 44. National Formulary.

1. The National Formulary contain the magisterial formulas and officinal preparations typified recognized as drugs, their categories, indications and raw materials involved in its composition or preparation, and the rules of proper preparation and control of those.

2. Pharmacies and pharmaceutical services must ensure that they have access to the documentation for the National Formulary.

3. advertising magisterial formulas and officinal preparations is expressly prohibited.
CHAPTER V


Of the health guarantees of special medicines

Article 45. Vaccines and other biologics.

1. Vaccines and biological products used as drugs are subject to the regime of these with the particulars provided in this Act or the regulations established according to their nature and characteristics of own application.

2. individualized preparation of vaccines and allergens for a single patient, which may take place only under the conditions and facilities that meet the particularities established by regulation is exempt from the provisions of the preceding paragraph.

3. In the case of biological products, when necessary in the interest of public health, the Spanish Agency for Medicines and Health Products may be subject to prior authorization each batch of finished product and marketing to determine compliance. You can also submit a prior authorization source materials, intermediate products and bulk and condition compliance use in manufacturing. The aforementioned controls are deemed to be effected when documentary proof that have been made in the home country, with identical requirements to those established by this law and provided they have maintained the original condition of the product.

Article 46. Drug human origin.

1. The derivatives of blood, plasma and other substances of human origin (fluids, glands, excretions, secretions, tissues and any other substances) and their corresponding derivatives, when used for therapeutic purposes, be considered drugs and will subject to the rules provided by this law, with the particularities established by regulation according to their nature and characteristics.

2. Blood, plasma and their derivatives and other substances mentioned human origin in paragraph 1 and their corresponding derivatives, must be obtained from authorized centers under control and monitoring of these centers shall in all cases of donors identified through the corresponding donor registry. These licensed centers must adopt the necessary measures of control, monitoring and traceability to prevent the transmission of infectious diseases.

3. The import authorization as medicines derived from blood and plasma may be refused or revoked if it is not from altruistic donations in blood banks or plasmapheresis centers, located in Member States of the European Union who meet the fair trial.

4. The import authorization as medicines of other substances mentioned human origin in paragraph 1 and their corresponding derivatives, will be denied or revoked if not relevant donor identified by the corresponding register or when you have not obtained in approved centers meeting the precise control measures, monitoring and traceability required in paragraph 2.

5. Authorization as medicines from blood products and plasma may be made conditional to the presentation by the applicant of documentation demonstrating that the price of the drug does not include illegitimate profit on donated blood altruistically.

The health Administrations shall promote altruistic blood donations and the development of the production and use of blood products from these donations.

Article 47. Advanced therapy medicinal.


1. 'Medicinal gene therapy "is considered, the product obtained by a set of manufacturing processes for transferring, in vivo or ex vivo, a prophylactic gene, therapeutic or diagnostic, such as a nucleic acid fragment, human cells / animals and its subsequent expression in vivo. The gene transfer involves an expression system contained in a distribution system known as vector which can be viral or nonviral origin. The vector can also be included in a human or animal cell.

2. 'Medicinal somatic cell therapy "is considered, the use in humans of living somatic cells, both autologous from the own patient, allogeneic, from another human being, or xenogeneic, from animals whose biological characteristics have been altered substantially as a result of their manipulation to obtain a therapeutic, diagnostic or preventive effect on metabolic, pharmacological and immunological means. This manipulation includes the expansion or activation ex vivo autologous cell populations, such as adoptive immunotherapy, and the use of allogeneic and xenogeneic cells associated with medical devices used ex vivo or in vivo, such as microcapsules, intrinsic matrix, biodegradable scaffolds or nonbiodegradable.

3. The general criteria and requirements of this law and European legislation concerning the required guarantees and conditions of authorization, shall apply to advanced therapy medicinal products referred to in this article whenever manufactured industrially.

The government shall determine the application of this law to advanced therapy when even concurring in them the characteristics and conditions set out in the definitions of "gene therapy medicinal product" or "somatic cell therapy medicinal product" not they were manufactured industrially.

Article 48. Radiopharmaceuticals.

1. For the purposes of this Act shall mean:

A) 'radiopharmaceutical' Any product which, when ready for use with therapeutic or diagnostic purposes, contains one or more radionuclides (radioactive isotopes).

B) "Generator": Any system incorporating a radionuclide (parent radionuclide) that its disintegration origine other radionuclide (radionuclide son) to be used as an integral part of a radiopharmaceutical.

C) 'kit': Any industrial preparation to be combined with the radionuclide to obtain the final radiopharmaceutical.

D) "Precursor" means any industrially produced radionuclide for radiolabelling of another substance prior to administration.

2. Without prejudice to the other obligations that are imposed by law or regulation, industrial manufacturing and licensing and registration of generators, kits, precursor and radiopharmaceuticals require the prior authorization of the Spanish Agency for Medicines and Health Products, issued according with the general principles of this law and of the requirements and procedures established by regulation.

3. The authorization referred to in the preceding paragraph shall not be required for the extemporaneous preparation of a radiopharmaceutical in a unit of radiopharmaceutical authorized, under the supervision and control of a specialist in radiopharmaceutical for application in a facility or institution legally empowered to do so, if it has done exclusively from generators, kits and authorized and in accordance with the manufacturer's instructions precursors.

4. The authorization referred to in paragraph 2 shall not be required for the preparation of autologous samples where participate radionuclides, as well as the extraction of single doses of radiopharmaceuticals ready for use in a unit of radiopharmaceutical authorized, under the supervision and control of a specialist in radiopharmaceutical for application in a facility or institution legally empowered to do so.

5. The authorization referred to in paragraph 2 shall not be required for the preparation of radiopharmaceuticals PET (positron emission tomography) in a unit of radiopharmaceutical authorized, under the supervision and control of a specialist in radio-pharmacy, provided it is done under the conditions and certain regulatory requirements.

6. The provisions of this law shall be without prejudice to the provisions of the legislation on radiation protection of persons undergoing medical examinations or protection or public health and workers treatments.

Article 49. Drugs psychoactive substances with addictive potential.


1. Psychoactive substances included in the lists annexed to the 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances and drugs containing them, shall be governed by this law and by specific regulations.

2. such substances are subject to restrictions arising from its obligations to the United Nations in combating illicit trafficking in narcotic drugs and psychotropic substances.

Article 50. Homeopathic medicines.

1. homeopathic medicine, human or veterinary use, it is considered that obtained from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or the Royal Spanish Pharmacopoeia or, failing that, in a pharmacopoeia with used of officially in a member State of the European Union. A homeopathic medicinal product may contain several active ingredients.

2. Authorization requirements by regulation of homeopathic medicines addressing their special conditions are established. In particular, a simplified procedure for those products whose quality and safety guarantees permit procedure be established.

3. The Spanish Agency for Medicines and Health Products may authorize the marketing and distribution of homeopathic preparations containing a component called 'nosodes', provided that the holder of the product stating, sufficiently, that the benefit-risk of such preparations it is favorable. To this end, they are understood by "nosodes" those pathological products of human or animal origin as well as pathogens or their metabolic products and decomposition products of organs of human or animal origin.

4. The Ministry of Health, Social Services and Equality establish a national code to facilitate their early identification and also require that their numbers or passwords appearing on the package, labeling and packaging of homeopathic drugs with the same criteria as other drugs.

Article 51. Drug medicinal plants.

1. Plants and mixtures thereof, as well as preparations obtained from plants in the form of extracts, lyophilisates, distillates, tinctures, decoctions or any other galenic preparation submitted with therapeutic, diagnostic or preventive value will follow the system of magisterial formulas, officinal preparations or industrial medicines, as appropriate and with the specificities established by regulation.

2. The Ministry of Health, Social Services and Equality draw up a list of plants whose sale to the public is restricted or prohibited because of their toxicity.

3. They may be freely sold to the public plants traditionally regarded as medicinal and which are offered without reference to therapeutic, diagnostic or preventive properties, their peddling prohibited.

Article 52. Medical gases.

1. Medical gases are considered drugs and are subject to rules provided by this law, with the particularities established by regulation.

2. Without prejudice to the provisions of Article 3.6, incumbent firms, manufacturers, importers and distributors of liquefied medicinal gases may supply them, as determined by the competent health authorities, health care centers, social care to patients with respiratory therapy address, as well as legally authorized veterinary clinical settings. For this purpose, the term liquefied medicinal gases liquid oxygen, liquid nitrogen and liquid nitrogen, nitrous oxide and any others with similar characteristics and use, can be manufactured in the future.
CHAPTER VI


Guarantees of monitoring of the benefit / risk drugs

Article 53 Pharmacovigilance and obligation to declare.

1. Pharmacovigilance is the public health activity that aims at the identification, quantification, evaluation and prevention of risks of using drugs once marketed, allowing the monitoring of possible adverse effects of medicines.

2. Health professionals have an obligation to report promptly to the competent bodies pharmacovigilance of each region suspected adverse reactions which are aware and which may have been caused by drugs.

3. The autonomous communities transferred the information received to the Spanish Agency for Medicines and Health Products.


4. The authorization holders are also required to bring to the attention of the competent health authorities for pharmacovigilance suspected adverse reactions which are aware and which they may have been caused by drugs that produce or market, in accordance with the guidelines European on Good Pharmacovigilance Practices. They are obliged to constantly update information product safety, the implementation of pharmacovigilance schemes and programs risk management and conducting a continuous assessment of the benefit / risk ratio of the drug, according to the guidelines national and European level in the field. When health authorities consider that such information on security interests relevant to public health form, ensure public access to it.

Article 54. Spanish Pharmacovigilance System.

1. The Spanish Pharmacovigilance System, coordinated by the Spanish Agency for Medicines and Health Products, integrates the activities that health authorities made permanent and ongoing basis to collect, process and, if necessary, to process all the useful information for monitoring drug and in particular, information on adverse drug reactions as well as for the realization of few studies considered necessary to evaluate the safety of medicines.

2. The Spanish Agency for Medicines and Health Products evaluate the information received from the Spanish Pharmacovigilance System and other sources of information. The adverse reaction data detected in Spain will be integrated in European and international networks pharmacovigilance, of which Spain is part, with the guarantee of protection of personal data required by current regulations.

3. In the Spanish Pharmacovigilance system they are required to work all health professionals.

4. Health authorities may suspend those programs where serious pharmacovigilance see defects in the procedures for data collection and processing of information obtained. Such suspension shall require the prior favorable report by the competent committee on safety of medicines of the Spanish Agency for Medicines and Health Products.

Article 55. Pharmacoepidemiology and risk management.

The Spanish Agency for Medicines and Health Products will promote the realization of pharmacoepidemiology studies necessary for evaluating the safety of authorized and registered drugs in actual use conditions. It also aimed to establish the management of the risks identified appropriate measures, including training and information needed. The health authorities of the autonomous communities and health professionals involved in conducting these studies and collaborate in the dissemination of knowledge about the safety of medicines in the health care setting.

Article 56. Objectivity in the safety assessment.

The Spanish Agency for Medicines and Health Products will, for the development of tasks related to pharmacovigilance in the National Health System, a committee of independent experts to advise and assist in the evaluation of new evidence on drug safety authorized and registered. The committee will propose the necessary measures to minimize the risks associated with the use of medicines and to maintain proper balance in the benefit / risk of the same, especially as regards new drugs. Evaluation reports of new evidence of safety of authorized medicinal products and the committee's recommendations shall be public.

Article 57. Veterinary Pharmacovigilance.

1. The Spanish Agency for Medicines and Health Products ensure the maintenance of security assurances of veterinary drugs, both for animals and for people or the environment.


2. The Spanish Agency for Medicines and Health Products evaluate the information of suspected adverse reactions attributable to veterinary drugs received from the professionals involved in prescribing, distribution and use, as well as holders of veterinary drugs laboratories. It will also promote the implementation of programs and integrate veterinary pharmacovigilance in the relevant European and international networks detected information on adverse reactions. It will promote the realization of farmacoepizootiología studies necessary for evaluating the safety of authorized veterinary medicinal products in actual use conditions.

3. In order to evaluate the information on the safety of medicines, the Spanish Agency for Medicines and Health Products will have a committee of independent experts who advise and participate in the evaluation of new evidence on the safety of veterinary drugs. The committee will propose the necessary measures to minimize the risks associated with drug use so that it is possible to maintain the right balance in the benefit / risk of the same, both for animals and for public health.
TITLE III


Investigation of medicinal products for human use and their guarantees

Article 58. Clinical trials and observational studies.

1. For the purposes of this Act, the term "clinical trial" means any research done on humans in order to determine or verify the clinical, pharmacological and / or other pharmacodynamic effects effects, and / or detect adverse reactions, and / or to study absorption, distribution, metabolism and elimination of one or more investigational medicinal product in order to determine their safety and / or effectiveness.

All clinical trials, including bioavailability and bioequivalence studies, shall be designed, conducted and reported in accordance with the rules of 'good clinical practice' and with respect for the rights, safety and well-being of trial subjects , which take precedence over the interests of science and society.

Health authorities should facilitate the conduct of clinical trials in the National Health System, both in the field of primary care and the hospital. The conditions of development of clinical trials on health services of the National Health System will be established under the agreements established between the promoter and health services of the autonomous communities with transparent criteria, as provided in this Act . These agreements include all aspects necessary for the proper conduct of the trial, participants including professionals, resources involved and the compensation to be established.

2. For the purposes of this Act, the term "observational" study in which drugs are prescribed in the usual manner, in accordance with the conditions set out in the authorization. The assignment of a patient to a particular therapeutic strategy is not decided in advance by a trial protocol but is determined by the usual practice of medicine. The decision to prescribe a particular drug will be clearly dissociated from the decision to include the patient in the study. Patients will not apply any intervention, whether diagnostic or monitoring, other than the usual clinical practice. epidemiological methods for analyzing the data collected will be used. In any case, observational studies shall not be subject to the provisions of this title.

Article 59. Guarantees of suitability.

1. Clinical trials with investigational medicinal products shall be subject to authorization scheme by the Spanish Agency for Medicines and Health Products accordance with the procedure established by regulation.

2. The Spanish Agency for Medicines and Health Products may, at any time conducting a clinical trial or require amendments to the protocol, in the following cases:

A) If the law is violated.

B) If the conditions of authorization are altered.

C) If ethical principles are not met referred to in Article 60.

D) To protect the health of the trial subjects.

E) In defense of public health.


3. The health authorities have inspectors powers regarding clinical trials and may even investigate individual medical records of the trial subjects, always keeping it confidential. They may make the precautionary interruption of the trial for any of the reasons mentioned in the preceding paragraph, immediately notifying the Spanish Agency for Medicines and Health Products.

4. The health authorities shall ensure compliance with the rules of 'good clinical practice', making the appropriate inspections, with people of adequate qualifications and university training in medicine, pharmacy, pharmacology, toxicology or other relevant materials.

5. For the purposes specified in paragraph 2, the investigator in a trial must immediately notify the sponsor all serious adverse events except in the case of those mentioned in the protocol as events that do not require immediate communication. The developer, in turn, notified in the shortest possible time to the Spanish Agency for Medicines and Health Products serious and unexpected adverse reactions that arise throughout the test and additionally send periodic safety reports. In addition, the sponsor shall keep detailed records of all adverse events which are notified, the notification to the health authorities and the Ethics Committee for Clinical Research must be made in the terms and deadlines established by regulation.

6. The method of clinical trials should be such that the evaluation of the results obtained with the application of the substance or medication being tested remains controlled by comparison with the best benchmark, in order to ensure objectivity, the exceptions imposed by the nature of their own research.

7. The completion of the test shall be adjusted in any case, the content of the research protocol of each test according to which authorization has been granted, as well as its subsequent amendments.

8. Favorable or unfavorable of each clinical trial, whether it comes to an end as if the investigation is left, shall be communicated to the Spanish Agency for Medicines and Health Products, without prejudice to its communication to the regions results in which they have made these clinical trials.

Article 60 guarantees respect for ethical principles.

1. Clinical trials must be conducted under conditions of respect for the fundamental rights of the person and ethical postulates affecting biomedical research that are affected humans, being followed, for these purposes contained in the Declaration of Helsinki and any other international instruments signed by Spain in this matter.

2. You can not start any clinical trial as there are sufficient scientific data and, in particular, pharmacological and toxicological tests on animals, to ensure that the risks involved in the person that is done are admissible.

3. In order to avoid obsolete or repetitive research, only clinical trials can begin to demonstrate the efficacy and safety of therapeutic changes proposed, provided that on them there is reasonable doubt.

4. The test subject freely given consent, expressed in writing, after being informed of the nature, significance, implications and risks of the clinical trial. If the test subject is unable to write, you can give, in exceptional cases, verbal consent in the presence of at least one witness greater age and capacity to act. The subject participating in a clinical trial or his representative may revoke at any time, their consent without cause.

For people who can not freely express their consent, it must be given by his legal representative prior instruction and exposure to the same scope and risks of the trial. It is also necessary compliance represented if their conditions allow you to understand the nature, importance, scope and risks of the trial.

5. The provisions of the preceding paragraph shall be without prejudice to the provisions of Article 9.2 of Law 41/2002 of 14 November, regulating patient autonomy and rights and obligations regarding clinical information and documentation, in terms established by regulation.


6. No clinical trial can be conducted without prior favorable report of a Clinical Research Ethics Committee, which is independent of the promoters and researchers and health authorities. The Committee shall be accredited by the competent body of the Autonomous Community corresponding, which will ensure the independence of the former. The accreditation will be communicated to the Spanish Agency for Medicines and Health Products by the competent body of the respective Autonomous Community.

7. Ethics Committees of Clinical Research will be formed at least by a team of doctors, pharmacists, primary and hospital care, clinical pharmacists, nurses and people outside the health professions interdisciplinary team of which at least one shall be a graduate in law specialist in the field.

8. The Clinical Research Ethics Committee weigh the methodological, ethical and legal aspects of the proposed protocol and the balance of risks and anticipated benefits arising out of the trial.

9. Ethics Committees of Clinical Research may require full information on the sources and amount of financing the testing and distribution expenses, among others, the following sections: reimbursement to patients, payments for special analysis or technical assistance, purchase of appliances, equipment and materials, payments to hospitals or research centers that are developed through the use of its resources and compensation to investigators.

10. Reglamentariamente the procedure for the appointment of the Ethics Committee reference for obtaining single opinion valid throughout the territory, with the aim of boosting clinical research in the National Health System will be established. The Ministry of Health, Social Services and Equality develop actions that allow the Ethics Committees of Clinical Research can share accredited quality standards and criteria appropriate and consistent evaluation.

Article 61. Guarantees of accountability.

1. Conducting a clinical trial require that, by hiring insurance or the establishment of another financial guarantee, the coverage of damages to the person that takes effect might result from that previously guaranteed .

2. When, for any reason, the insurance does not fully cover the damage, the trial sponsor, the researcher responsible for it and the hospital or that it had incurred jointly liable for those, even if no fault incumbiéndoles the burden of proof. Neither the administrative authority nor the report of the Ethics Committee for Clinical Research exempt them from responsibility.

3. , Unless proven otherwise, it is presumed that damage affecting the health of the person subject to trial, during the making of it and for a period of one year from completion, have occurred as a result of the trial. However, once the year ended, the subject thereof is required to prove the damage and a link between the trial and damage.

4. The clinical trial sponsor is the natural or legal person who has an interest in its realization, signing the authorization request addressed to the Ethics Committee for Clinical Research and the Spanish Agency for Medicines and Health Products and responsible for it.

5. He is principal investigator who leads the performance of the assay and promoter binding signature on the application, corresponsabilizándose with him. The condition of promoter and principal investigator may attend in the same individual.

Article 62. Guarantees of transparency.

1. Authorized by the Spanish Agency for Medicines and Health Products Clinical trials form part of a national registry of public and free clinical trials which will be accessible under the conditions determined by regulation.

2. The developer is obliged to publish clinical trial results, whether positive or not. The publication will be made, after deletion of any confidential commercial information, preferably in scientific journals and, if not possible, through the media and the deadlines established in the regulations. In the publication the Clinical Research Ethics Committee reported that will be mentioned.

3. When public studies and research on medicinal products aimed at the scientific community are made, the funds obtained from the author or for implementation and funding source should be stated.


4. If not published the results of clinical trials and when they demonstrate that the drug presents amendments to its efficacy or safety profile, the Spanish Agency for Medicines and Health Products will publish the results.

5. All information about the clinical trial should be recorded, handled and stored so that it can be communicated, interpreted and verified accurately, while protecting the confidentiality of records of the trial subjects.

6. The Government, after a report of the Inter-Territorial Council of the National Health System, and basic character, regulate the common requirements for the implementation and funding of clinical trials, ensuring good clinical practice and the conditions of its realization. The centers, services, institutions and health professionals involved in the conduct of clinical trials according to these common requirements and financing conditions and those in development to establish the relevant health authorities.
TITLE IV


Of the guarantees required in the manufacture and distribution of drugs
CHAPTER
I

In the manufacture of drugs

Article 63. Authorization pharmaceutical laboratory.

1. For the purposes of this law, natural or legal persons engaged in the manufacture of drugs or any of the processes that it can understand, including fractionation, preparation and presentation for sale, must be previously authorized by the Spanish Agency medicines and Health Products. This authorization shall also be required for the import and marketing of medicines and even assuming that the drug is manufactured exclusively for export. The Spanish Agency for Medicines and Health Products will authorization and amendments thereto and the extinction of the same public.

2. For pharmaceutical laboratory authorization, the applicant must meet the following requirements:

A) Itemize drugs and dosage forms intended to be manufactured, and the place, establishment or laboratory and manufacturing control.

B) Have local, technical and control, adequate and sufficient for proper manufacturing, control and conservation that meets the legal requirements team.

C) Have a responsible technical director, responsible for a responsible manufacturing and quality control. They must meet the professional and functional conditions established by regulation. Laboratories that manufacture small quantities or simple products may give the control function to the coach, but the machine direction must correspond to different person.

Article 64. Guarantees for the correct manufacture of medicines and raw materials.

1. Without prejudice to the other obligations that are imposed by law or regulation, the pharmaceutical company must meet the following obligations:

A) have sufficient staff and the necessary to ensure the quality of medicines and enforcement of controls from the provisions under the law with technical skills.

B) providing medicines according to the law.

C) Having supplied the market with registered products adequately and continued to enable compliance with the performance requirements listed in Article 69.1, such supply may be suspended only in exceptional cases justified after having the authorization of the Spanish Agency for Medicines and Health Products.

D) Allow at all times, access to its premises and archives to the competent authorities for inspections.

E) To facilitate the performance of its functions the technical director and take care that has the means to do so.

F) Reply of the obligations they become due during the period of its activity, even in case of suspension thereof, and during the five years after its closure.

G) Ensure that the transport of drugs to destination, either distribution entities or services or pharmacies, is done fulfilling both the obligations imposed on the authorization of the same as the rules of proper distribution of medicines.

H) Set as established by the legislation of the autonomous communities promotional activities, advertising and sponsorship made by laboratories.


I) Informing the Ministry of Health, Social Services and Equality units sold drugs to be dispensed in the country, including lot numbers regardless of the final destination.

J) Communicate the suspension or termination of its activities.

2. Pharmaceutical laboratories must meet the standards of good manufacturing practice issued by the Ministry of Health, Social Services and Equality, in accordance with the detailed guidelines on good manufacturing practices of medicines established in the Community framework.

Also, manufacturers and distributors of active substances used as raw materials must meet the standards of good manufacturing of active ingredients and good distribution practices of active ingredients, published by the Ministry of Health, Social Services and Equality. For this purpose, the term "manufacture of active substances used as starting materials' means the complete or partial manufacture or import of an active substance used as raw material, as defined in Article 2 and the various processes dividing up, packaging and presentation prior to its incorporation into a medicinal product, including repackaging and relabeling.

The drugmaker only be used as active ingredients raw materials manufactured in accordance with good manufacturing of active ingredients and distributed in accordance with good distribution practices for active substances. To this end, the drugmaker verify compliance by the manufacturer and distributors of active principles of good manufacturing practice and good distribution practices by conducting audits at the manufacturing facilities and distribution manufacturers and distributors of them. The drugmaker will verify such compliance by itself or, without prejudice to its responsibility in accordance with the provisions of this law, through an entity acting on his behalf under a contract.

3. The drugmaker ensure that the excipients are suitable for use in a drug by identifying practices appropriate manufacturing, with a formal risk assessment carried out in accordance with the applicable guidelines referred to in the good manufacturing of drugs and the established within the Community framework.

4. The pharmaceutical laboratory perform quality checks as appropriate on raw materials, intermediate products and finished product manufacturing in accordance with generally accepted methods and techniques.

5. In order to comply with the provisions of the preceding paragraph, each drugmaker will have a control unit and quality assurance of products, processes and procedures with the authority and responsibility to accept or reject raw, intermediate and final products materials. Processes and manufacturing processes must be validated.

6. Drugmakers and health products must have insurance, guarantee or equivalent financial guarantee to meet any damages health problems arising from drug safety, in the terms legally available.

Article 65. Modification, suspension and revocation of authorization.

1. Any modification of the requirements referred to in paragraphs a) and b) of Article 63.2 or under authorization must be approved by the Spanish Agency for Medicines and Health Products.

2. Replacement of technical director will be communicated to the Spanish Agency for Medicines and Health Products and the competent body of the Autonomous Community.

3. The Spanish Agency for Medicines and Health Products may suspend or revoke the laboratory authorization for a given product category or for all of them, where the requirements and / or obligations under this chapter are not met. It may also suspend or revoke when the laboratory does not meet the good pharmacovigilance practice or perform on time and studies for such purposes, as required by this law.

Article 66. Manufacture by third parties.

1. Pharmaceutical companies may entrust third parties to carry out activities of manufacturing or controls under this Act for drugs, if the following requirements are met:

A) The contracted third party must have the authorization referred to in Article 63 refers


B) The Spanish Agency for Medicines and Health Products must specifically authorize the production by third parties.

2. Exceptionally, when required attention to their patients, hospital pharmacy services and pharmacies may entrust legally authorized by the Spanish Agency for Medicines and Health Products carrying out any stage of production of a specific preparation to an entity or analytical control.
CHAPTER II


Drug distribution

Article 67. Guarantees of accessibility and availability of medicines.

1. The distribution of authorized medicines are made through distribution entities or directly by the holder laboratory marketing authorization thereof.

2. The distribution activity will ensure a quality service, and its priority and essential function supplies to pharmacies and pharmacy services legally allowed in the country.

3. The use of third parties by a laboratory or distribution entity for distribution of drugs should be included in the authorization as a laboratory or distribution entity.

Article 68. Administrative control of wholesale distribution.

1. Wholesale warehouses and stores contract shall be subject to prior authorization of the autonomous community where the store is domiciled. Nevertheless, the store must inform the conduct of its activities to the health authorities of the autonomous communities, not being domiciled such activities are conducted.

The authorization may include distribution entity store activity contract.

2. Without prejudice to the powers of the autonomous communities, the distribution entity and, if applicable, the laboratory holds the marketing authorization shall communicate directly to the Spanish Agency for Medicines and Health Products the beginning of its activities.

3. Notwithstanding the provisions of paragraph 1 drug stores under customs supervision or control shall be subject to prior authorization as drug distribution entity that will be granted by the Spanish Agency for Medicines and Health Products.

Article 69. Requirements operation.

1. Distribution entities and, where appropriate, pharmaceutical laboratories that distribute their products directly be obliged:

A) have premises and equipment incorporating technical personnel, material and to ensure proper conservation and distribution of drugs, with full guarantee for public health.

B) To ensure compliance with the general or specific conditions of conservation of medicines and especially the maintenance of the cold chain throughout the distribution network by standard procedures.

C) to maintain minimum stocks of medicines to ensure proper continuity of supply.

D) To ensure delivery, minimum frequency distributions, permanent means pharmaceutical technical advice and support offices and pharmacy services.

E) To comply guard services and disaster prevention.

F) To have an emergency plan which ensures effective implementation of any recall from the market ordered by the competent health authorities.

G) have implemented an alert system covering all pharmacies in the territory of its scope.

H) To comply with the standards of good distribution practices that have been promoted or authorized by the competent health authorities and cooperate with them to ensure quality pharmaceutical services.

I) the fulfillment of other obligations that are imposed by law or regulation.

2. The Government, with basic character, may establish minimum requirements and conditions of these establishments to ensure the provisions contained in the preceding paragraph. The Government will preserve the right of distribution entity to be supplied by laboratories.

Article 70. Technical Director.

All distribution entities authorized under Article 68 will have a pharmaceutical technical director, whose office is incompatible with other activities involving direct health nature interests to manufacturing or dispensing medications or detrimental appropriate performance of its functions.

The Government will establish the functions of technical director.


Article 71. Intermediation in the distribution of medicinal products for human use.

1. People engaged in tasks of intermediation in the distribution of medicinal products for human use established in Spain must register so prior to the beginning of its activity, in a register that the Spanish Agency for Medicines and Health Products maintained for that purpose, which It will include all data to be fixed by the regulations. The health authorities of the autonomous communities have access to the full details of this record for inspection. This register shall be publicly accessible.

2. People who are engaged in the brokering of medicinal products must fulfill the obligations that come imposed in the current regulations and the specific provisions included in the good practices of distribution of drugs published by the Ministry of Health, Social Services and Equality.
TITLE V


From the health guarantees of foreign trade of drugs

Article 72. Imports.

1. Without prejudice to other legal or regulatory requirements established, may be imported only authorized and registered in the Registry of Drug accordance with the requirements under this law drugs.

2. The distribution of medicines shall comply with the requirements provided for in Title IV. For this purpose the importer may use channels pharmacists legally entitled to do so or constitute prior distribution entity permission granted in accordance with Chapter II of Title IV.

3. The technical director of the importing entity guarantees the conformity of imported lots and answers that each consignment of imported manufacturing has been in Spain a full qualitative analysis, quantitative analysis referred, at least all the active ingredients and other controls that are necessary to ensure quality under the terms of the authorization and registration of the drug.

To this end it shall provide documentation and samples to be determined by regulations to control by the Ministry of Health, Social Services and Equality.

4. The checks referred to in the preceding paragraph shall be deemed made when in the opinion of the Ministry of Health, Social Services and Equality is credited documentarily been made in the home country, with identical requirements to those provided in this law, without prejudice to the obligations membership of the European Union and other international treaties signed by Spain.

5. Imports of 'investigational medicinal products' require prior authorization from the Spanish Agency for Medicines and Health Products.

6. The holder of a drug in Spain may not prevent importation and marketing by third parties whenever they enter the Spanish market with the guarantees established by this law with adjustments by regulation.

7. Natural or legal persons engaged in the importation of drugs, raw materials or medical devices must have, on the same terms as manufacturers, with insurance, guarantee or equivalent financial guarantee to cover any damage to health from problems safety of medicines, according to the regulations available.

Article 73. Exports.

1. May export drugs laboratories and distribution entities that meet the requirements established by law.

2. The export of medicines approved and registered shall be notified by the exporter to the Spanish Agency for Medicines and Health Products in the cases and terms established by regulation.

3. the product shall be no requirement to export the requirements established by this Act for authorization as a medicine in Spain, as regards format or presentation, texts, labeling and characteristics of the packaging, provided that the principles are respected that this law establishes information on security professionals and users.

Article 74. Drugs for the treatment of travelers.

1. Medications accompanying travelers for their own administration or treatment are excluded from the requirements laid down in the previous articles, subject to control measures when such drugs could represent a deviation in amount or destination especially prevention of use unlawful.


2. Public administrations take appropriate measures to prevent the products subject to this law, in transit to a third country, they may be diverted for use in Spain without compliance with the requirements under this Act.

3. According to the provisions of the legislation on protection of health and the fight against doping in sport, athletes, teams or sports groups and foreign directors who represent them are required when entering Spain to participate in a sporting activity, to submit duly completed to the Spanish Agency for Health Protection in Sport forms that may be established, in which the products transported for use are identified, drives them and responsible for their prescription or doctor, in the case of animals participating in sporting events, the veterinarian.
TITLE VI


The registration of pharmaceutical laboratories and registration of manufacturers, importers or distributors of active substances

Article 75. Registration of pharmaceutical laboratories.

1. The Spanish Agency for Medicines and Health Products maintain a record of pharmaceutical laboratories that include all data that are required to provide for compliance with the provisions of this law. This register shall be publicly accessible.

2. It is mandatory enrollment in this record of the initial authorization, and any transmission, modification or termination.

Article 76. Registration of manufacturers, importers or distributors of active substances.

1. The Spanish Agency for Medicines and Health Products maintain a register of manufacturers, importers or distributors of active ingredients that include all data to be fixed by the regulations. The health authorities of the autonomous communities have access to the full details of this record, for the purposes of inspection. The data of this register shall be publicly available.

2. Registration is mandatory in this register prior to the start of the activity of manufacture, importation or distribution and immediate referral of any changes in the data provided can affect the quality, safety or efficacy of the active ingredients. It also annually submitted data will be updated.
TITLE VII


The rational use of medicines for human use
CHAPTER
I

Guarantees of training and independent information and quality for the proper use of medicines and health products

Article 77. Guarantees of public administrations.

1. The competent public authorities in the health and education orders direct their actions to promote the continuous and permanent university and post-university education on medicines, medical devices and therapeutic health professionals.

2. Public health authorities direct their actions to implement an agile, efficient and independent system to ensure the objective of medicines and medical devices healthcare professionals scientific information, current and.

3. Public administrations will direct its actions to promote the creation of own information centers medications and health products through promotion and coordination in the use of resources and information technologies that enable professional health institutions and other entities access to information on such products.

4. Public administrations sanitary promote the publication of pharmacological and / or pharmacotherapy for use of health professional guides.

5. Public health administrations conduct health education programs on drugs that target the general public promoting actions that favor improved awareness of drugs to improve treatment compliance, avoid risks arising from misuse and raise public awareness of the economic value of the drug .

Article 78. Objectivity and quality of information and marketing to health professionals.

1. Information and promotion aimed at health professionals, under control of the health authorities under the terms provided in Article 102.1 of Law 14/1986 of 25 April, General Health, shall be in accordance with the technical and scientific information authorized by the Spanish Agency for Medicines and Health Products and must be rigorous, well-founded and objective and not misleading, in accordance with current legislation and comply with the data sheet.


2. Information and promotion may be made through written, audio or other media, targeted exclusively to health professionals and have scientific. In the case of reports or articles funded by a pharmaceutical company or entity related thereto, it shall specify that fact in the publication.

3. In the case of information distributed by computer or promotion, health authorities can access it for the purposes of inspection.

4. Offers awards, grants, contributions and subsidies meetings, conferences, study tours and similar acts by any person, whether natural or legal, related to the manufacture, processing, distribution, prescription and dispensing of medicines and health products, will be made public in the manner determined by regulation and shall apply only to activities of a scientific nature when recipients are health professionals or bodies associated. Programs, publications and presentations of work meetings, conferences and similar events are to be identified funding source thereof and the funds obtained from each source. The same obligation overtake the means of communication whose path is made public and obtain funds or for publication.

Article 79. The prescription and hospital prescription.

1. Medical, public or private prescription and hospital order dispensing are documents that ensure the establishment of drug treatment by instruction from a doctor, dentist or podiatrist, within their respective powers, only professionals with faculty to prescribe medicinal products subject to medical prescription.

Notwithstanding the foregoing, the nurses independently, may indicate use and authorize the dispensing of those medicinal products not subject to medical prescription and medical devices related to their professional practice, by an order of dispensing. Physical therapists can also indicate use and authorize autonomously, dispensing drugs not subject to medical prescription and medical devices related to the exercise of their profession, by order dispensing.

The Government will regulate the indication, use and authorization of dispensing of certain medicinal products subject to medical prescription by nurses, under the principles of comprehensive health care and continuity of care through the implementation of protocols and guidelines Healthcare and clinical practice, joint development, agreed with collegiate organizations of doctors and nurses and validated by the Directorate General of Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality.

Likewise, the Government will regulate the indication, use and authorization of dispensing of certain medicinal products subject to medical prescription by nurses in the area of ​​both general care and specialized, and shall, with the participation of professional organizations of nurses and medical, general criteria, specific requirements and procedures for the accreditation of these professionals, with effects throughout the territory of the State, in proceedings under this section.

The Ministry of Health, Social Services and Equality, involving the relevant professional organizations, credited with effects throughout the State nurses and physiotherapists for actions foreseen in this article.

2. The pharmacist will dispense those drugs that require prescription. This requirement must be expressly specified in the packaging of the drug.

3. The prescription is valid throughout the national territory and will be published in the official Spanish language of the State and the respective co-official languages ​​in the regions that have it.

4. Prescriptions and hospital dispensing orders shall contain basic identification data prescriber, patient and medication.

5. In prescriptions and hospital orders dispensing, the optional contain appropriate warnings to the pharmacist and the patient, as well as instructions for better treatment follow-through procedures of pharmaceutical care, in order to ensure the achievement of those health goals.


6. The Government may regulate basic character with the provisions of the preceding paragraphs and establish the requirement of other requirements that affect public health or the health system have to be of general application in medical prescriptions or hospital orders.

7. The procedures are subject to prescriptions and medical orders and especially in its processing, comply with the provisions of Article 10 of Law 14/1986 of 25 April.

8. The Government shall determine with basic character the minimum requirements to be met by the extended prescriptions and / or edited on computer support in order to ensure accessibility for all citizens under conditions of effective equality in the whole of Spanish territory, the pharmaceutical services of the National Health System.

's Consent for the processing and transfer of data resulting from the implementation of information systems based on prescription in paper or electronic form, in accordance with the provisions of Articles 7 shall not be required, paragraphs 3 and 6; 8; and 11, paragraph 2.a) of Law 15/1999, of December 13, Protection of Personal Data. Said actions should aim to facilitate medical and pharmaceutical patient care and allow monitoring of pharmaceutical services of the National Health System.

9. The Health Public Administration conducted health education programs for the general population, aimed at highlighting the importance of the prescription as quality assurance and patient safety.

10. The provisions of this Article shall also apply to veterinary prescription, in which case the references to the doctor and dentist construed as references to the vet.

Article 80. Guarantees in drug advertising and medical devices intended for the general public.

1. They may be advertised to the general public medicinal products which satisfy all the requirements listed below:

A) not financed with public funds.

B) That for its composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnosis, prescription or monitoring of treatment, but require the intervention of a pharmacist. This requirement may be waived when vaccination campaigns approved by the competent health authorities are made.

C) do not constitute narcotic or psychotropic substances as defined in international conventions.

2. The advertising of a medicinal product which is advertised to the public, meet the requirements set out in paragraph 1 of this Article; meanwhile, advertising messages must meet the following requirements:

A) it is obvious the advertising nature of the message and is clearly specified that the product is a drug.

B) the name of the drug in question is included, as well as the common name if the product contains only one active substance.

C) all information necessary for correct use of the drug as well as an explicit and clearly visible to carefully read the instructions contained in the leaflet or on the outer packaging, as the case invitation and recommendation included consult the pharmacist about their proper use.

D) Do not include expressions that provide security of healing, or testimony on the virtues of the product or professionals or persons whose reputation can induce consumption.

E) not be used as an advertising argument the fact of obtaining health approval in any country or any other authorization or approval number of appropriate certification issued or controls or analysis that concerns health authorities run under the provisions of this law.

F) Advertising messages of medicines that are issued in audiovisual support must meet the accessibility for people with disabilities established in the legal system for institutional advertising.

3. Advertising of medicinal products not subject to prescription shall not require prior administrative authorization, although the competent health authorities carry out the necessary checks to ensure that advertising content comply with the laws and regulations that apply to them and that are exactly to scientific and technical conditions included in the marketing authorization.


4. The health authorities, for reasons of public health or safety of persons, they may restrict, condition or prohibit the advertising of medicines and medical devices.

5. premiums, gifts, prizes, contests, bonuses or similar as methods linked to the promotion or sale to the public of these drugs are prohibited.

6. In the case of medical devices the possibility of directly or indirectly, to the public at the event that a product is funded by the National Health System advertising is excluded. This advertising ban affects the manufacturers, distributors or trading companies, as well as all those entities that can maintain direct contact with the patient. Also, bonuses, gifts, discounts, prizes, contests, bonuses or similar as methods linked to the promotion or retail of these products are prohibited.

7. May not be advertised to the public for medical devices that are intended to be used or applied exclusively by healthcare professionals.

8. Advertising techniques or medical or surgical procedures associated with the use of specific health products respect the criteria in the advertising of medical devices.

Article 81. Guarantees in advertising products with supposed health properties.

Advertising and commercial promotion of products, materials, substances or methods that beneficial health effects attributed shall be governed by regulations.

Article 82. Rational use of drugs in sport.

The import, export, distribution, marketing, prescription and dispensing of medicines, legally recognized, there shall aim to increase the physical abilities of athletes or modify the results of the competitions in which they participate, should be adjusted in its development and objectives applicable regulations in the field.
CHAPTER II


The rational use of drugs in primary health care
Article 83.
support structures for the rational use of medicines and health products in primary care.

1. Without prejudice to the responsibility that all healthcare professionals have in the rational use of medicines, management structures of primary care services must have units or primary care pharmacy.

2. To contribute to the rational use of medicines services units or primary care pharmacy perform the following functions:

A) Ensure and assume technical responsibility for the acquisition, quality, proper maintenance, coverage needs, custody, preparation of formulations and preparations officinal and dispensing of medicines to be applied within primary care and of those for which special surveillance, monitoring and control is required, as provided in Article 103 of Law 14/1986 of 25 April, General Health and the regulations implementing it.

B) Establish an effective and safe distribution of drugs and medical devices in the centers and structures responsible system.

C) Establish information systems management pharmacotherapy including clinical, effectiveness, safety and efficiency of the use of medicines and provide accurate information and training on drugs and medical devices to healthcare professionals.

D) Develop protocols and formularies to ensure the correct pharmacotherapeutic care to patients, especially regarding drug selection and continuity of treatments and support systems for clinical decision making in drug therapy.

E) Promote coordination between different health pharmacotherapy structures and levels of care and promote clinical research in drug quality and appropriate to the needs of patients, ensuring proper custody and dispensing of products undergoing clinical research.

F) Establish a system for monitoring treatments to patients to help ensure adherence as well as programs that promote safe use of medicines.

G) To promote and participate in programs educating people about drugs, their rational use and prevention of abuse and be part of the commissions related to the rational use of drugs and medical devices.


H) Promote coordination and teamwork and collaboration with hospitals and specialized care services, in order to ensure the quality of pharmaceutical services by following the treatments prescribed by the doctor.

I) To carry out all functions can lead to better use and control of medicines, through collaborative strategies among health professionals in primary care teams.

3. All of the above will also apply for medical devices except in cases where its application impossible by the very nature of the product.
CHAPTER III


The rational use of medicines in the hospital and specialty care
Article 84.
support structures for the rational use of medicines in hospitals.

1. Without prejudice to the responsibility that all healthcare professionals have in the rational use of medicines, hospitals must have services or hospital pharmacy units with the minimum conditions established by this law. Hospitals highest level and those that are determined must have services or units of Clinical Pharmacology.

2. To contribute to the rational use of medicines units or hospital pharmacy services perform the following functions:

A) Ensure and assume technical responsibility for the acquisition, quality, proper maintenance, coverage needs, custody, preparation of formulations and preparations officinal and accurate dispensing of medicines for hospital-acquired and other activities for those treatments extrahospital, as provided in Article 3.6.

B) Establish an effective and safe drug distribution system, take steps to ensure proper administration, store and dispense the products undergoing clinical research and ensure compliance with legislation on drugs or psychoactive substances any other medication requiring special control.

C) Being part of hospital fees that may be useful knowledge for selection and scientific evaluation of medicines and their use.

D) Establish a drug information service for all staff of the hospital, nosocomial pharmacovigilance system, systematic studies of drug use and clinical pharmacokinetic activities.

E) Carry out educational activities on matters within its competence aimed to hospital staff and patients.

F) Perform own research work in collaboration with other units or services and participate in clinical drug trials.

G) Work with the structures of primary and specialty care area in the development of the functions set out in Article 83.

H) To carry out all functions can lead to better use and control of medicines.

I) To participate and coordinate the management of purchases of medicines and medical devices the hospital in order to ensure the efficiency of it.

3. The functions defined in paragraphs c) to h) of the previous section will be developed in collaboration with clinical pharmacology or clinical units and other hospital services.

Article 85. Hospital pharmacy.

1. The hospital pharmacy services will be under the ownership and responsibility of a specialist pharmacist in hospital pharmacy.

2. The health authorities with competencies in pharmaceutical management perform this function in the hospital pharmacy maintaining the following criteria:

A) Setting requirements for proper functioning, in line with established functions.

B) That the actions are performed with the presence and performance of the necessary pharmaceutical or for proper care.

C) Pharmacists in hospital pharmacies must have completed studies of the relevant specialty.

3. Hospitals that do not have pharmaceutical services must apply for authorization to the autonomous communities, if necessary, keep a deposit of medicines under the supervision and control of a pharmacist. The conditions, requirements and performance standards of such deposits will be determined by the competent health authority.
CHAPTER IV


The rational use of medicines in the pharmacy
Article 86.
pharmacies.


1. In the pharmacy, pharmacists, as responsible for dispensing drugs to citizens, ensure compliance with the guidelines established by the attending physician in prescribing and cooperate with him in monitoring the treatment through the pharmaceutical care procedures, helping to ensure their effectiveness and safety. They also participate in the realization of joint activities aimed at the rational use of medicines, in particular through the informed dispensing to the patient. After dispensing the medication may facilitate dosing systems customized to patients who request it, in order to improve compliance in the treatment and the conditions and requirements established by the competent health authorities.

2. The health authorities carry out the management of the pharmacy and should take into account the following criteria:

A) General planning of the pharmacy in order to ensure adequate pharmaceutical care.

B) The presence and performance of the pharmaceutical and inexcusable as a condition for dispensing to the public of medicines requirement, taking into account the number of pharmacists needed depending on the activity of the office.

C) The minimum materials, techniques and media requirements, including accessibility for people with disabilities, established by the Government with basic character to ensure the provision of proper health care, without prejudice to any powers conferred communities autonomous in this area.

3. Pharmacies are required to dispense drugs that are demand both by individuals and by the National Health System in regulatory conditions.

4. For emergency reasons and distance from the pharmacy or other special circumstances applicable in certain establishments may be authorized, exceptionally, creating kits under the conditions prescribed by regulation with basic character, without prejudice to any powers attributed the autonomous communities in this area.

5. Public administrations ensure the continuing education of pharmacists and appropriate qualifications and training of assistants and pharmacy technical assistants.

6. Pharmacies are considered private health facilities, public interest.

Article 87. Prescription drugs and medical devices.

1. Prescription drugs and medical devices in the National Health System will be made in the most appropriate manner for the benefit of patients, while the sustainability of the system is protected.

2. In the National Health System prescriptions drugs included in the system of reference prices or homogeneous groupings not included therein, they shall be made according to the following scheme:

A) For acute conditions, prescription will, in general, by active ingredient.

B) For chronic conditions, the first prescription, corresponding to the establishment of the first treatment will, in general, by active ingredient.

C) For chronic processes whose prescription corresponds to the continuity of treatment, it may be made by trade name, provided that such information is included in the reference price system that is the lowest price in its homogeneous grouping .

3. However, the prescription drug trade name will be possible as long as the principle of greater efficiency in the system and in the case of drugs considered non-replaceable respected.

4. When the prescription is made by active ingredient, the pharmacist will dispense the drug lowest price of its homogeneous grouping and, in the case of equality, the generic drug or drug corresponding biosimilar.

5. In any case, the prescription of a medicament for use in different to those in its data sheet conditions must be authorized by the commission responsible for the therapeutic protocols or equivalent collegial body in each region previously.

Article 88. Information systems to support the prescription.


1. The competent bodies of the autonomous communities will equip their prescribers of a system of electronic prescribing common and interoperable and will allow the recording of information on the number of adjusted to the needs of treatment doses, which subsystems support will be incorporated into the prescription, such as online drug gazetteer; correspondence between active ingredients, medicines available and pathologies in which are indicated; treatment protocols recommended by pathology from health institutions and medical societies, indicating election standards and expected benefits; cost of prescribed and alternative therapeutic choice treatment, according to efficiency criteria; database interactions; database of clinical trials in their province or autonomous region; periodic information online (authorization and withdrawal of drugs and medical devices, alerts and communications relevant to the protection of public health); dissemination of news about drugs, without being strictly alerts will help improve the health status of the population.

2. Support systems to collect prescribing information corresponding to the selected input via reduced, so that the doctor can take into account the economic impact for prescription drugs and health products prices.

3. Systems support the prescription will be managed from the competent bodies autonomous community level. The Inter-Territorial Council of the National Health System will ensure that they are articulated efficiently and help to maintain equity of the health system.

4. The Ministry of Health, Social Services and Equality, in coordination with the autonomous communities, establish treatment protocols of basic character so that the prescription and use of medicinal products that, by their unique characteristics, require special attention and caution in its prescription Eastern and dispensing.

Article 89. Substitution by the pharmacist.

1. The pharmacist will dispense the medicine prescribed by the doctor.

2. Exceptionally, when because of shortages is not available in the pharmacy of prescription medication or attend reasons of urgent necessity in dispensing, the pharmacist can substitute it for the lowest price. In any case, you must have the same composition, dosage form, route of administration and dosage. The pharmacist in any case inform the patient about the substitution and ensure you know the treatment prescribed by the doctor.

3. In these cases, the pharmacist shall note in the appropriate place of the prescription, the drug of the same composition, dosage form, route of administration and dosage dispensed, date, signature and rubric.

4. They shall be exempt from this possibility of substitution drugs that, because of their bioavailability characteristics and narrow therapeutic range, determined by the Ministry of Health, Social Services and Equality.

5. When the prescription is made by trade name, if the medication prescribed has a price higher than the retail price of its homogeneous grouping, the pharmacist will replace the medicine prescribed by the lower price of its homogeneous group and in case of equality, dispense the generic drug.

For biosimilar medicines, according to current regulations specific rules governing the replacement and interchangeability be respected.
CHAPTER V


Traceability of medicines

Article 90. Guarantees of traceability.

1. In order to ensure adequate supplies of the market and establish security guarantees for citizens, laboratories, distribution entities, pharmacies, retail commercial establishments and entities or livestock groups authorized to dispensing veterinary medicines, they are subject to the reporting obligations referred to in this article.

2. Pharmaceutical companies must communicate in terms that are set, by regulation, the Ministry of Health, Social Services and Equality, units of presentations identified batch of drugs and recipient, sold in national territory, and which are subject to return . They shall ensure, in the terms set by regulation, identifying each unit along its route, in accordance with Article 15.4.


3. Distribution entities shall, under the terms statutorily set, to the Autonomous Community in which they have their registered office and the Ministry of Health, Social Services and Equality supplied units and returned, indicating the lot to which they belong and as the recipient, both concerned office or pharmacy services as distribution of other entities, regardless of the Autonomous Community in which situated.

4. Without prejudice to the concerts could subscribe, holders of the pharmacy shall inform the competent body of the Autonomous Community in which they have their scope units dispensed drugs. The competent bodies of the autonomous regions shall send that information to the Ministry of Health, Social Services and Equality, in the terms set by regulation.

5. Pharmacies, retail establishments and commercial entities or persons authorized to dispense veterinary drugs, livestock groups shall, in the terms set by regulation, the Spanish Agency for Medicines and Health Products units of veterinary drugs dispensed.

6. The collection and processing of data under this Article shall comply with current regulations on safety and protection of personal data, in compliance with Law 15/1999 of 13 December on Data Protection Personal character, having considered responsible for their publicly-owned files the General State Administration, the competent health authorities of the autonomous communities and, where appropriate, the corresponding corporate administrations.
TITLE VIII


Public funding of medicines and health products

Article 91. Principle of territorial equality and coordination.

1. The right of all citizens to obtain medications under equal conditions throughout the National Health System, without prejudice to the measures to rationalize the prescription and use of drugs and medical devices that can take autonomous communities exercise its powers.

2. The regulatory provisions of the Government or the Ministry of Health, Social Services and Equality and resolutions issued by the competent Directorate of the Ministry, on financing of medicines and medical devices National Health System, will take effect throughout the Spanish territory from the date they are applicable.

3. The wholesale price of public funding established by the competent organ of the Ministry of Health, Social Services and Equality, for drugs dispensed in pharmacies by an official prescription of the National Health System, may not be modified or bonus, except in the event that it consists of a linear or discount percentage applicable throughout the national territory, subject to the regulations in Article 4.6.

The provisions contained in the preceding paragraph shall also apply to medical devices, once the financing system of prices and margins for such products, including pharmaceutical services in the National Health System regulations developed.

4. Any change in the price of a drug or medical device funded by the National Health System shall take effect on the same date throughout the Spanish territory.

5. Measures to rationalize the prescription and use of drugs and medical devices that can take the regions will not produce differences in the conditions of access to medicines and health products financed by the National Health System, catalog and prices. These rationalization measures will be homogeneous for the entire Spanish territory and will not produce distortions in the single market of drugs and medical devices.

6. The Inter-Territorial Council of the National Health System may agree on general terms of planning, coordination, contracting, procurement and supply of medicines and health products and services structures publicly owned integrated in the National Health System.

Article 92. Procedure for public funding.


1. Public financing of medicines and health products inclusion in pharmaceutical services will be required by the relevant specific resolution of the unit responsible for the Ministry of Health, Social Services and Equality, establishing financing conditions and price in the field of the National System of health.
Similarly
will proceed when a modification of the authorization affecting the content of pharmaceutical services, prior to the placing on the market of the modified product nature occurs, either change affect the indications of the drug, either because without affect them, the Spanish Agency for Medicines and health Products so decides for reasons of public interest or protection of health or safety of persons.

The inclusion of drugs in funding the National Health System is made possible through targeted funding and not indiscriminate taking into account general, objectives and published criteria and specifically the following:

A) gravity, duration and consequences of various diseases to those which are indicated.

B) specific needs of certain groups.

C) social therapeutic and clinical benefit of the drug and the same incremental value taking into account their cost-effectiveness.

D) Rationalization of public spending and budgetary impact pharmaceutical services in the National Health System.

E) Existence of drugs or other therapeutic alternatives for the same conditions at a lower price or lower cost of treatment.

F) Degree of innovation of the drug.

Without prejudice to the provisions of Article 24, and in order to ensure the rational use of medicines and health products, the Ministry of Health, Social Services and Equality reserves singular may refer to the specific conditions of prescribing, dispensing and funding them in the National Health System, of its own motion or proposal of the autonomous communities in the Standing Committee of Pharmacy Interterritorial Council of the National Health System.

In order to guarantee the right of all persons enjoying the status of insured and beneficiary in the system access to pharmaceutical services on an equal basis throughout the National Health System, the autonomous communities may not establish unilaterally reserves specific singular prescription, dispensing and financing of drugs or medical devices.

Nevertheless, within the Standing Committee of Pharmacy Interterritorial Council of the National Health System may be decided except motivated by one or several regions because of their specificities.

2. The Ministry of Health, Social Services and Equality will review the groups, subgroups, categories and / or classes of drugs whose funding is not deemed necessary to cover the basic health needs of the Spanish population. In any case, not be included in the pharmaceutical supply medicinal products not subject to medical prescription, drugs that are not used for the treatment of a clearly defined pathology, nor cosmetics, dietary use, mineral waters, elixirs, toothpaste and other products Similar.
Nor
drugs indicated in the treatment of syndromes and / or symptoms of less serious financed or those who, even having been authorized according to the regulations in force at the time, do not respond to current treatment needs, understanding such a balance unfavorable benefit / risk in the diseases for which they are indicated.

3. The decision to exclude, in whole or in part, or subject to special financing conditions, medicines already included in the pharmaceutical provision of the national health system, be done with the criteria set out in the preceding paragraphs and taking into account the price or cost treatment of comparable existing drugs on the market and orientations of the Inter-Territorial Council of the National Health System.

4. Equivalently shall apply in the case of medical devices which are to be included in the pharmaceutical provision of the national health system and which are granted through official prescription in national territory.


5. The Government shall periodically review and update the list of medicines and medical devices included in the pharmaceutical provision of the national health system, according to the evolution of the criteria for rational, scientific knowledge, the emergence of new drugs greater therapeutic utility or the occurrence of adverse effects that alter the benefit / risk and the criteria in the above paragraphs.

6. Medical devices are to be included in the pharmaceutical provision of the national health system and which are granted through official prescription, in national territory, will the criteria given for drugs. In any case, they must comply with the specifications and proven technical performance that had previously determined the Ministry of Health, Social Services and Equality, taking into account general, objectives and published criteria and in particular the following:

A) gravity, duration and consequences of various diseases for which prove indicated.

B) specific needs of certain groups.

C) Diagnostic value, control, treatment, prevention, alleviation or compensation for a disability.

D) social value of the medical device and incremental clinical benefit of it taking into account their cost-effectiveness.

E) Existence of medical devices and other therapeutic alternatives for the same conditions at a lower price or lower cost of treatment.

7. Regulation procedure will be developed incorporating the pharmaceutical provision of the national health system of medicines, in accordance with Article 14 bearing the initials EFG because of their interchangeability.

8. For the financing decision for new drugs, in addition to the corresponding cost-effectiveness and budget impact will take into account the innovation component, for indisputable therapeutic advances to modify the course of the disease or improve the course of it, the prognosis and therapeutic outcome of the intervention and its contribution to the sustainability of the National health System if, for the same health outcome, positive contribution to GDP.

Article 93. Exclusion of pharmaceutical provision of drugs and medical devices.

1. The body responsible for pharmaceutical services of the Ministry of Health, Social Services and Equality update, reasoned decision, the list of drugs that are excluded from the pharmaceutical services in the National Health System.

2. The motivation for the exclusion will respond to any of the following criteria:

A) The establishment of selected prices.

B) Living together with a non-drug subject to medical prescription with which it shares active ingredient and dose.

C) Consideration of the drug as susceptible to advertise directly to the public in the European Union.

D) the active ingredient have an safety profile and a favorable and well documented through years of experience and extensive use efficiency.

E) it is indicated in the treatment of minor symptoms.

F) fulfill any of the criteria for non-inclusion in public financing enshrined in Article 92.2.

3. Those responsible for products excluded from funding inform the competent body the prices at which they are marketing these medicines. The same obligation extends to variations in prices.

4. In the following entry in the registry of the competent organ of communications to the month preceding paragraph, it shall decide on their agreement or not the proposed prices. In case of disagreement, the court will raise the discrepancy to the Interministerial Committee on Prices of Medicines, which will decide on the issue. Such decision shall be notified by order of the competent body to the applicant.

The collection administrative decision in the preceding paragraph shall be based on reasons of protection of public health, equal access to medicines by patients or potential interests of disadvantaged groups or actual injury.

5. As long as the disagreement remains mentioned in the preceding paragraph, the term of maximum industrial price will remain.

Article 94. Pricing.


1. For the Government to establish the criteria and procedure for the pricing of medicines and recommended medical devices by the National Health Service for both drug dispensing by pharmacy through official prescription, as for drugs on hospital setting, including clinical packaging or dispensed by pharmacy services to patients not admitted.

Be taken into consideration, the mechanisms of return (linear discounted price revision) for innovative medicines.

The Interministerial Committee on Prices of Medicines will consider the cost-effectiveness and budget impact analysis.

2. For marketing a drug in Spanish territory must have transacted will supply the same to the National Health System. This shall, likewise, if substantial changes in the conditions for approval of the drug occur.

3. The Government may regulate the mechanism of pricing of medicines and medical products not subject to medical prescription which are provided in Spanish territory, following a general objective and transparent regime.

4. In any case, holders of marketing authorizations thereof may be marketed drugs dispensed in Spanish territory under the reported prices, meaning the communication of the price to the Ministry of Health, Social Services and Equality, so that the department can object to it on grounds of public interest.

5. Corresponds to the Interministerial Committee on Prices of Medicines under the Ministry of Health, Social Services and Equality, set so motivated and according to objective criteria, prices of funding from the National Health System of drugs and medical devices for which necessary medical prescription, which are provided in Spanish territory. When these same products are found not funded, if they are filled in national territory will operate as provided in paragraph 4.

6. In any case, drugs and medical devices make up your mind to be financed by the National Health System may also be marketed for prescription outside.

7. As a rule, the price of financing by the National Health System will be less than the industrial price of the drug when applied is dispensed out of the National Health System. Pharmaceutical laboratories, distribution entities and pharmacies through the Pharmaceutical Organization Schoolboy, must provide the information that is determined to implement the refund due for the pharmacy to pharmaceutical laboratories and distribution entities in those drugs it is established and which have been dispensed outside the National Health System. The method developed for joint regulation.

8. For decision-making, the Interministerial Committee on Prices of Medicines will consider the reports prepared by the Advisory Committee for Pharmaceutical Service Financing National Health System.

9. Corresponding to the concepts of the distribution and dispensing of medicines and medical devices financial amounts and, where applicable, of deductions applicable to billing them to the National Health System shall be fixed by the Government, with the agreement of the Government Commission for economic Affairs, generally or by groups or sectors, taking into consideration technical criteria of economic and health issues.

10. The Ministry of Health, Social Services and Equality set the selling price to the public of medicines and health products financed by aggregating the permitted industrial price, which is considered a maximum, and margins for the activities of wholesale distribution and dispensing to the public.

Article 95. Advisory Committee for the Financing of the Pharmaceutical Service of the National Health System.

1. The Advisory Committee on Financing the Pharmaceutical Service of the National Health System is the body, scientific-technical, attached to the relevant ministerial body for pharmaceutical services of the Ministry of Health, Social Services and Equality, responsible for providing advice , evaluation and consultation on the relevance, improving and monitoring the economic assessment necessary to support the decisions of the Interministerial Commission on Drug Prices.


2. The Advisory Financing of Pharmaceutical Service of the National Health Committee shall be composed of a maximum of seven members appointed by the person holding the Ministry of Health, Social Services and Equality, among renowned professionals with experience and background accredited pharmacoeconomic evaluation.

3. Also, depending on the issues to be discussed, may attend meetings of the Committee assessors body responsible for drugs and medical devices that have developed assessments of drugs and medical devices under discussion.

4. In any case, the creation and operation of the Advisory Committee for the Financing of the Pharmaceutical Service of the National Health System will be treated with the technical and personal media budget allocated the body to which you are assigned.
Article 96 Review
price.

1. The price set pursuant to Article 94 shall be reviewable on its own initiative or upon request in accordance with the provisions in Articles 102 and following of Law 30/1992 of 26 November on the Legal Regime of Public Administrations and Common Administrative Procedure.

2. Outside the cases referred to in the preceding paragraph, the price of a medicinal product may be modified where required by changes in the economic, technical, health or the assessment of its therapeutic usefulness.

3. The Council of Ministers agreement of the Government Commission for Economic Affairs may revise globally or set the conditions for periodic review of industrial prices or, where applicable, prices of retail, for all or part of medicines and medical devices included in the pharmaceutical provision of the national health system.

4. also for the Council of Ministers, with the agreement of the Government Commission for Economic Affairs, the revision of the financial amounts corresponding to the distribution and dispensing of medicines and medical devices.

5. The drugs excluded from funding from public funds and have not excluded indications thereof, they shall be considered financed by these funds, for the purposes of fixing and revising its price intervened.

6. For the purposes of revisions lower prices parte provided for in paragraph 1 shall be taken into account involving at least a reduction of 10% of the maximum industrial price in authorized for public funding force .

Article 97. Economic information.

1. For the purposes of pricing, pharmaceutical companies must provide the Ministry of Health, Social Services and Equality all information on the technical, economic and financial aspects. The Ministry may carry out checks on the information provided.

2. In the event that the company is integrated in a group performing other activities besides those related to drugs, or develop outside Spain, the Ministry of Health, Social Services and Equality may require the information to help determine the allocation for determine the expenditure concerned to the pharmaceutical activity in Spain.

3. The information under this Article for the General State Administration will be kept confidential.

4. The Ministry of Health, Social Services and Equality rise annually to the Government Commission for Economic Affairs a report on its proceedings on prices.

Article 98. reference price system.

1. Public financing of drugs shall be subject to the system of reference prices. The reference price will be the maximum amount with which drug presentations included in each of the sets to be determined, provided they are prescribed and dispensed with public funds will be financed.


2. The sets include all presentations of funded drugs with the same active ingredient and the same route of administration, among which there will be included in the pharmaceutical provision of the national health system, at least, a presentation of generic or biosimilar, unless the drug or its main active ingredient have been approved with a minimum of ten years in a member State of the European Union, in which case the existence of a generic or biosimilar is not essential to establish a set. The presentations indicated for pediatric treatments, as well as those for drugs hospital setting, including clinical packaging constitute separate sets.

3. The reference price of each set is calculated based on the cost / treatment / day lower drug presentations grouped in it and, in any case, the supply must be ensured to the pharmacy for drugs lower price. Medications may not exceed the reference price of the set to which they belong.

4. the new sets will be established and prices of existing sets will be reviewed annually. However, lower prices of new homogeneous groups will be set automatically in the corresponding Gazetteer, and lower prices of existing ones will be reviewed on a quarterly basis.

5. The Ministry of Health, Social Services and Equality establish a similar pricing system for medical devices.
Article 99. System
selected prices.

1. The Ministry of Health, Social Services and Equality may propose to the Interministerial Committee on Prices of Medicines implementing the system of selected drugs and medical devices bankable prices.

2. To this end, the Ministry of Health, Social Services and Equality prepare a reasoned proposal, according to the criteria set out in this article, which will contain the maximum price applicable in each case selected.

3. Once approved by the Interministerial Committee on Prices of Medicines, the Ministry of Health, Social Services and Equality published the decision by resolution of the head of the pharmaceutical services unit.

4. In the case of medicines reimbursed, the selected system prices apply to medicinal products subject to reference prices, taking into account:

A) The consumption of the whole.

B) The budgetary impact.

C) The existence of at least three drugs in the set.

D) That no risk of shortages occur.

5. In the case of medical devices apply similar criteria.

6. It valued the above criteria, the Ministry of Health, Social Services and Equality, through the body responsible for pharmaceutical services, shall communicate to suppliers the start of a procedure selected price with communication maximum price of funding He proposes to express their intentions.

7. Based on the submissions received, the Ministry of Health, Social Services and Equality prepare the proposal referred to in paragraph 2.

8. Those medications and / or medical devices exceeding the maximum price fundable be excluded from funding by the National Health System.

9. The selected price will be valid for two years during which can not be modified.

10. The selected system will be updated prices for cases in which I not been applied previously, annually, simultaneously updating the reference price system.

11. The application of this system will involve the exclusion of public funding for those presentations that are not selected for the lifetime of the selected price.

12. In any event, the presentations of medicines that are affected by the regulations in this article shall be exempt from that time, the application of deductions regulated in Articles 8, 9 and 10 of Royal Decree-Law 8/2010 of 20 May, extraordinary measures to reduce the public deficit are adopted.

13. Holders of the marketing authorization presentations of medicines and companies offering presentations of medical devices that are finally selected laboratories must make a commitment to ensure adequate supply by express statement to that effect.


14. The price system selected drugs and medical devices, not being funded, they are considered of interest to public health in the terms expressed in the Law 33/2011, of October 4, General Public Health may apply.

15. In this regard, the Ministry of Health, Social Services and Equality for determining the selected price will take into account the special characteristics of distribution and application of these products.

16. It also may extend the pricing system selected by setting a reduced contribution by homogeneous groups.

Article 100. Promotion of competition and competitiveness.

1. To achieve the goals of efficiency and sustainability of the pharmaceutical provision of the national health system administrative and regulatory measures in each financial year considered appropriate to stimulate competition between suppliers of pharmaceutical inputs, resulting in decreases in unit prices will be implemented .

2. Any action limiting competition be considered contrary to the principles of efficiency and sustainability and will be prosecuted ex officio by the competent bodies.

Article 101. Obligations of patients.

1. The Government periodically review the co-payment to be paid by citizens for pharmaceutical services included in the supplementary common portfolio of the National Health System, and assumptions of full financing from public funds.

The review will be published in the "Official Gazette" by order of the person holding the Ministry of Health, Social Services and Equality.

2. Participation in payment may be modulated by the Government with criteria that take into account:

A) The ability to pay.

B) The therapeutic and social utility of medicines or medical devices.

C) The specific needs of certain groups.

D) The severity, duration and consequences of various diseases for which they were given.

E) Rationalization of public spending on pharmaceutical services.

F) Existence of drugs or medical devices already available and others better or equal alternatives for the same conditions.

3. Users will be required to justify their right to the appropriate form of payment when they so required by the medical staff of the National Health System or offices of dispensing pharmacy.

Article 102. Providing users and beneficiaries in outpatient pharmaceutical services.

1. It is understood by outpatient pharmaceutical services which the patient is dispensed by prescription or dispensing hospital order, through offices or pharmacy services.

2. Ambulatory pharmaceutical provision shall be subject to user input.

3. The user input is made at the time of dispensing the drug or medical device.

4. The user input is proportional to the level of income that will be updated at most annually.

5. In general, the percentage of user input follow the following scheme:

A) 60% of PVP for users and beneficiaries whose income is equal to or greater than 100,000 euros in Item general taxable income and savings of the declaration of Income Tax of Individuals.

B) 50% of PVP for people who have the status of active insured and their beneficiaries whose income is less than 18,000 euros and less than 100,000 euros in Item general tax base and saving statement of Income Tax of Individuals.

C) 40% of PVP for people who have the status of active insured and their beneficiaries and are not included in paragraphs a) or b) above.

D) 10% of PVP for people who have the status of insured as Social Security pensioners and their beneficiaries, except for those included in paragraph a).

6. In order to ensure continuity of treatment of chronic and ensure a high level of equity to pensioners patients with long-term treatments, overall rates are subject to contribution ceilings in the following cases:

A) 10% of PVP in the drugs in the ATC groups reduced contribution, with a maximum contribution of 4,24 euros.


B) For people who have the status of insured as Social Security pensioners and their beneficiaries whose income is less than 18,000 euros in Item general tax base and saving tax return Income Individuals or are not included in the following paragraphs c) or d), up to a maximum monthly contribution of 8.23 ​​euros.

C) For people who have the status of insured as Social Security pensioners and their beneficiaries whose income is less than 18,000 euros and less than 100,000 euros in Item general tax base and saving statement of Income Tax of Individuals, up to a maximum monthly contribution of 18.52 euros.

D) For persons holding insured status as Social Security pensioners and their beneficiaries whose income exceeds 100,000 euros in Item general tax base and saving tax return Income Individuals, up to a maximum monthly contribution of 61.75 euros.

7. The amount of contributions in excess of the amounts referred to in the preceding paragraph shall be repaid by the Autonomous Community, with a maximum six months.

8. Contribution shall be exempt from users and beneficiaries belonging to one of the following categories:

A) Affected toxic syndrome and people with disabilities in cases covered by specific legislation.

B) income people receiving social integration.

C) non-contributory pension percipient People.

D) Unemployed people who have lost the right to receive unemployment benefits while their situation subsists.

E) Persons with treatments derived from industrial accidents and occupational diseases.

9. The level of contribution of people falling under the General Mutuality of Civil Servants, the Social Institute of the Armed Forces and the General Judicial Mutual Society will be 30% in general, resultándoles implementing the provisions of paragraph a) of paragraph 6 and in paragraph e) of paragraph 8.

Article 103. Protection of personal data.

1. The National Institute of Social Security or, where appropriate, the Social Marine Institute may process the data contained in the files of the managing entities and common services of the Social Security and entities that collaborate with them that are essential to determine the amount of the contribution of the beneficiaries in the pharmaceutical benefit. Such treatment, which does not require the consent of the person concerned is fully subject to the provisions of Law 15/1999, of December 13, and its implementing provisions.

2. Similarly, and in order to which the preceding paragraph, the competent authority in tax matters may inform the National Institute of Social Security or, where appropriate, the Social Marine Institute, without the consent the person concerned, the data are necessary to determine the required level of income.

Similarly, government bodies that are competent to determine the concurrence of the requirements for exemption from the contribution provided for in Article 102.8 may communicate this fact to the National Institute of Social Security or, if applicable , the Social Marine Institute without the consent.

3. The National Institute of Social Security or, where appropriate, the Social Marine Institute will inform the Ministry of Health, Social Services and Equality and this, in turn, to the other competent health authorities the data on the level of contribution corresponding to each user in accordance with the provisions of the regulations of prescriptions and dispensing orders. In any case, such information shall include information on the specific amount of income.

The data reported in accordance with the provisions of the preceding paragraph shall be processed by the corresponding for the sole purpose of joining the information system of individual health card health administration.

Article 104. Assessment of the prescription.

1. In the area of ​​the National Health System is for government health assessment requirements for areas, areas, therapies, population groups and other circumstances.


2. The Ministry of Health, Social Services and Equality establish coordination mechanisms that reveal the use of medicines and health products, optimize research of its evolution and adopt measures for information and promotion of rational use of medicines and health products and, where appropriate, precautionary and corresponding control measures demand for administrative and criminal liability that might arise.

Article 105. Collaboration between pharmacies and the National Health System.

1. Pharmacies, and health facilities are collaborate for the purposes of this law to ensure the rational use of medicines in primary health care.

2. Irrespective of its obligations under this law and determined in the implementing regulations, the pharmacy may be subject to consultation in the National Health System, according to the general system of administrative contracts and in accordance with the criteria Article 92.6 general concerns.

Article 106. Management information on pharmaceutical provision of the national health system.

1. In order to carry out the actions necessary for the evaluation of prescription and political general pharmaceutical, the competent public authorities provide aggregate information or disaggregated on the consumption of drugs both prescription and at the level of hospitals and any other areas included within of pharmaceutical services of the National Health System. At a minimum, this information is presented on a monthly basis; It will be provided from the Ministries responsible for the autonomous communities to the Ministry of Health, Social Services and Equality, which will make the corresponding aggregation and clearance before publication.

2. The resulting aggregated information processing recipes National Health System, including the Mutuality of Officials of the Civil Administration, the General Mutuality Judicial and Social Institute of the Armed Forces, is public domain, always safeguarding the confidentiality of health care and trade data for individualized companies. Its management corresponds to the health services of the autonomous communities in its territory and the State Administration set information in the National Health System.

The provisions of the preceding paragraph shall also apply to the information on purchases of medicines and health products made through the corresponding pharmacy services for hospitals in the National Health System.

3. The resulting aggregated information processing recipes referred to the preceding paragraph will be treated and sent in electronic form by the agencies responsible for it.

The Government, by royal decree, establish the procedure for submission of information to the authorities responsible for the management of pharmaceutical services so as to allow applying to the monthly bill from each pharmacy for prescriptions of Use human manufactured industrially from public funds of autonomous communities and the National Institute of Health Management, MUFACE, ISFAS and MUGEJU, a joint scale applicable deduction on margins.

4. The information referred to in this article will be provided on a monthly basis and will be referred to a period not exceeding three years immediately preceding the date on which it is provided months.

Article 107. Fundamentals of information systems for the control of pharmaceutical services.

1. State intervention in medicines and health products financed by the National Health System requires the full disposal of solid information on the consumption of health inputs subject to such information. To this end, both the Ministry of Health, Social Services and Equality and the competent departments of the autonomous communities and, where appropriate, the suppliers and their bodies professional representation, provide the following information on the trafficking and consumption of the same :

A) Billing of official prescriptions of the National Health System monthly, dispensed by pharmacies and aggregated by province and autonomous community.


B) Data acquisition services for pharmaceutical and health centers or social services of the National Health System and, where appropriate, fertilizers medicines and medical devices, at least monthly and aggregation level by province and community autonomous.

2. The General Mutuality of Civil State officials, the General Mutuality Judicial and Social Institute of the Armed Forces provide the same type of information, with the specific qualifications of care modalities that are proper.

3. Drugs dispensed by pharmacists and health services centers or social services of the National Health System Outpatient will be collected in a specific application.

4. Computer processing to which the preceding paragraph may be extended to other medicines and medical products for hospital use only to the Interministerial Commission on Drug Prices deems appropriate to apply a unique safeguards regime.
TITLE IX



Penalties CHAPTER
I
Inspection and precautionary measures


Article 108. Inspection.

1. It corresponds to the health authorities in the scope of its powers conducting the necessary measures to ensure compliance with the provisions of this law inspections.

2. The General Administration of the State conducting the inspection function in the following cases:

A) In the case of the necessary actions for timely clearances or records that, according to this law, correspond to the General State Administration.

B) In any case, in the case of inspections to be carried out on the territory of the autonomous communities that do not hold executive powers of legislation pharmaceutical or there Were not received the corresponding transfers.

C) In the case of medicines, products or articles intended for foreign trade or the use or consumption could affect public safety.

3. The staff at the service of public administrations to develop inspection functions, when exercising those functions and prove their identity, shall be authorized to:

A) enter freely and without notice, at any time, in any facility or establishment subject to this law.

B) Carry out the tests, investigations or examinations necessary to verify compliance with this law and the regulations issued for its development.

C) take or remove samples, in order to check compliance with the provisions of this law and the provisions for development.

D) To carry out all necessary actions are in order to comply with inspection functions develop.

Article 109. Precautionary measures.

1. In the event that there is or there is an imminent and serious health risk is reasonably suspected health authorities may take the following precautionary measures in the scope of this law:

A) The quarantine, the withdrawal from the market and prohibition of drug use, magisterial formulas and officinal preparations and the suspension of activities, advertising and provisional closure of establishments, facilities or services.

The quarantine will immediately blocking in the pharmaceutical facility where they are or they are destined, if transport not completed, by the time it is determined or until further order by their responsible.

B) The suspension of processing, prescribing, dispensing and supply of medicines and health products research.

C) The limitation, prohibition, suspension or subject to special conditions of manufacture, importation, marketing, export, advertising, commissioning or use of health products, cosmetics or personal care products, as well as commissioning quarantine, withdrawal and recovery of such products.

2. The duration of the measures in the preceding paragraph, which are specified for each case, without prejudice to any subsequent extensions agreed by reasoned resolutions refers not exceed what the situation requires immediate and serious risk that justified it.

3. The Spanish Agency for Medicines and Health Products shall be informed immediately by the health authority which adopted the injunction.

4. The precautionary measures the Spanish Agency for Medicines and Health Products will know by appropriate means and with appropriate speed for each case, health services, responsible entities or the general public, as appropriate.


5. The cost of precautionary measures shall be borne by the natural or legal person that had led to its adoption.
CHAPTER II

Offences and penalties


Article 110. General Provisions.

1. Infringements on medicinal products, medical devices, cosmetics and personal care products will be subject to appropriate administrative sanctions upon instruction appropriate proceedings, without prejudice to any civil, criminal or other order which can occur responsibilities.

2. Instruction criminal case before the courts suspend the processing of sanctioning administrative proceedings that had been initiated by the same facts and, where appropriate, the effectiveness of administrative acts of imposition of sanction. Administrative measures have been taken to safeguard the health and safety of persons will remain in the judicial authority to rule on them.

3. In any case a double penalty for the same acts and according to the same protected public interests will prevail, although other responsibilities required to be deducted from other concurrent events or violations.

4. With regard to the penalty system and not provided for by this law shall apply the provisions of Title IX of Law 30/1992 of 26 November.

Article 111. Violations in medicines.

1. Violations are classified as minor, serious and very serious according to criteria of health risks, amount of the eventual benefit obtained, severity of health and social alteration produced, generalization of the offense and recidivism.

2. They constitute administrative offenses and shall be penalized under the terms provided in Article 114, offenses are classified below:

A) Minor offenses:
1st
not provide, entities or persons responsible, data, statements and any information they are required to provide for economic, administrative and financial health reasons techniques.

2nd Breaching the duty to collaborate with the health administration in the evaluation and control of drugs.

3.ª not have the obligation to do so, access to the Spanish Royal Pharmacopoeia and the National Formulary establishments.

4.ª not provide, pharmaceutical companies, health practitioners practicing that request the data sheet of drugs before they are marketed.
5th
advertising Perform master formulas or officinal preparations.

6th Breaching the requirements for conducting medical examination, set the rules of the competent health authorities in the management of pharmaceutical services.

7.ª not properly complete the information and warnings that must contain standardized recipes.

8th Dispense drugs after the period of validity of the recipe.

9th Perform replacement of a drug, where it is possible, in breach of the requirements of this law.

10th disobey any requirements, obligations or prohibitions in this law and implementing provisions so that, on the basis of the criteria referred to in this article, such breaches deserve the classification of mild or appropriate qualification as faults serious or very serious.
11th
not include in the packaging of medication information in Braille for proper identification by the blind and visually impaired, in accordance with Article 15.5.

B) Serious offenses:
1st
not perform in the development, manufacture, import, export and distribution of drugs or active ingredients, the quality controls required by health legislation or breach the detailed guidelines on good manufacturing practice or good distribution practices established within the Community framework or make manufacturing processes or control through procedures not validated.
2nd
develop, manufacture, import, export, distribute or dispense medicines by natural or legal persons without the required authorization.

3rd Hinder the inspection work by any act or omission that disrupt or delay it.

4th individually prepare vaccines and allergens in establishments other than those authorized.

5th Prescribing and preparing lectures and officinal formulas prepared in breach of the legal requirements.

6th
Change by the owner, without prior authorization or notification, as appropriate, any of the conditions for approval of the drug.

7.ª not available, a pharmaceutical company or entity distribution, technical director or other staff required in each case.

8th Breaching, technical and other staff, the obligations incumbent upon their positions.

9th Breaching, the sponsor or investigator of a clinical trial, the obligations for each of them in the current legislation, when due to the fact the criteria referred to in this article does not deserve the rating as very serious.

10th Breaching, the promoter of clinical trials, the time limits communication to health authorities for serious and unexpected adverse reactions occurring in a clinical trial.

Facilitate 11th, the Ethics Committee for Clinical Research or health authorities, information and / or documentation related to a clinical trial, untruthful or result in inaccurate conclusions.

12th Breaching, the promoter, the obligation to publish the results of a clinical trial as set out in Article 62.
13th
Act, members of the Clinical Research Ethics Committee without complying with the requirements legally established or operating without being accredited.

14th Breaching, pharmaceutical laboratories, distribution entities or health personnel, the duty of pharmacovigilance.

15th refuse to dispense drugs without just cause.

16th Dispense medicinal products not subject to medical prescription, cases where it is required.

17th Supply, acquire or sell drugs not authorized to perform such activities entities.

18th Acting, health professionals involved in the cycle of prescription, dispensing and administration and provided they are in office, acting medical business delegates, representatives, commission agents or informers drug laboratories.
Breaching
19th meetings, health workers, the duty to ensure the confidentiality and privacy of patients in the processing of prescriptions and medical orders.

20.ª Run, pharmaceutical services and pharmacies, without the presence and performance of the responsible pharmacist.

21st Breaching, the pharmacy, the demands made by billing the National Health Service of the products covered by this law.
Defrauding
22nd, pharmacies, the National Health System or the beneficiary thereof in connection with the billing and collection of official prescriptions.

23rd Dispense or supply medicines in establishments other than those authorized.
24th
not adjust drug prices as determined by the Administration.
Replace
25th in dispensing drugs, contravening the provisions of Article 89

26th restrict freedom of the user in choosing the pharmacy by any act or omission.
27th
directly or indirectly offer any incentives, bonuses, discounts prohibited, premiums or gifts, made by a person having direct or indirect interest in the production, manufacture and marketing of medicines, healthcare professionals, during prescribing, dispensing and administering them, or their relatives and people in their coexistence.
28th
OK, healthcare professionals, during the prescription, dispensing and administration of drugs under the National Health System, or their relatives and people in their coexistence, any incentives, rebates, discounts prohibited, premiums or gifts made by a person having direct or indirect interest in the production, manufacture and marketing of medicines.

29th pharmaceutical laboratories not communicate to the Ministry of Health, Social Services and Equality units sold drugs to be dispensed in the country.
30th
No distribution entities report to the health authorities of the autonomous communities which have their registered office and the Ministry of Health, Social Services and Equality, units supplied to pharmacies or pharmacy services who reside in national territory and, where appropriate, to other distribution entities, regardless of the Autonomous Region in the latter situated.
31th
not communicate pharmacies dispensed drug information that this law concerns.


32nd Provide or hide entities or persons responsible, data, statements or information are required to furnish competent health authorities so that are not truthful or lead to inaccurate conclusions, in order to obtain it some benefit, whether economic or of any other nature.

33rd Breaching, people who engage in brokering medicinal products, the requirements of current legislation and best practices in drug distribution.

34th Breaching, the manufacturer of the drugs, the obligations of carriers used in the manufacture of drugs.

35th Conduct, by the holder of the laboratory authorization or the holder of a distribution authorization, activities that do not conform to it.

36th Breaching, pharmacies and pharmacy, legally established in terms of user input in the pharmaceutical provision of the national health system.

37th pharmacy Perform any act that induces the user to purchase a larger amount of drugs in the pharmaceutical provision of the national health system that truly needed or demanded by the latter.

C) Very serious offenses:

1st Place in the drug market of any nature without having obtained the necessary health authorization.

2nd manufacture, import, export, brokering, distributing, dispensing and selling counterfeit drugs. This offense also apply in the event that this sale takes place at a distance.

3rd Breaching, the holder of the authorization, the obligation to submit periodic safety reports
Prepare 4th
nostrums.
5th
Import and Export blood, fluids, human tissues and glands and their components and derivatives without prior authorization.

6th clinical trials without prior administrative authorization.

7.ª clinical trials without the consent of the trial subject or, where appropriate, their legal representative, or the breach, by the researcher, the duty of information on the clinical trial who participates as subject thereof.

8.ª not communicate, the sponsor of a clinical trial, health authorities adverse reactions occurring in its development or periodic safety reports.

9th Breaching, the sponsor or investigator of a clinical trial, the obligations for each of them in the legislation when it involves prejudice to the rights, safety and welfare of subjects.

10th Distribute or keep drugs without observing the requirements, as well as to sell drugs altered, or in poor condition, when it is pointed out, past the expiry date.

11th Sell drugs at home or through the Internet or other telematic or indirect means, contrary to the provisions of this law or breach of the provisions governing such selling arrangement.
Breaching 12th
distribution entities and pharmacies their legal obligations and, in particular, do not have adequate stocks of drugs for the normal delivery of its activities or services.
Breaching 13th
distribution entities and pharmacies their legal obligations and, in particular, have no minimum stocks of medicines for emergency situations or disasters, resulting in cases required.

14th Develop, manufacture, import, export, distribute, market, prescribing and dispensing products, preparations, substances or combinations thereof, whether presented as drugs without being legally recognized as such.

15th Breaching the obligation to take out insurance, guarantee or equivalent financial guarantee in the cases required by this law.

16th Conduct promotion, information or unauthorized advertising or without such activities comply with the provisions of this law or general legislation on advertising medicines.
Make
17th promotion, advertising or information for the public of products or preparations for medicinal purposes, even if the product itself does not make explicit reference to those purposes, including medicinal substances and combinations thereof, which are not authorized as medicaments.

Offer 18th premiums, gifts, prizes, contests, bonuses, discounts or the like as methods linked to the promotion or retail of products covered by this law.


19th meetings Breaching the precautionary and definitive measures on drugs that the health authorities agree on serious grounds of public health.

20.ª not meet the requirements and conditions required by regulations on advertising and sales promotion of products, materials, substances, energy or methods that beneficial health effects attributed.

21st Cesar supply of a medicinal product by the marketing authorization holder, in the case where attend for health reasons or health interest, as in the case of therapeutic lagoon originate either in the market in general or in the pharmaceutical provision of the national health system.

22nd distribute drugs outside the country for which there are supply problems with welfare impact.

23rd Conduct, by pharmacies, drug distribution activities to other pharmacies, authorized distribution agencies, or other entities, institutions or individuals without authorization for distribution activity or the conducting drug shipments outside the national territory.

24th Dispense, sell or market returned or given drugs by patients or the general public to the pharmacy.

25th Breaching, the holder of the marketing authorization, its obligation to adequately supplied market, adequately and continued to enable compliance with the requirements legally established in the field of pharmaceutical services of the National Health System ensure supply to pharmacies and pharmacy services drugs on homogeneous groupings, lower price and lower price.

26th Prevent the performance of accredited inspectors in centers which produce, manufacture, distribute and dispense medicines.

3. The commission of an offense, preceded by two other grade immediately below or equal sanctioned firm within a year prior to the commission, increase from mild to severe, serious or very serious, such infringement.

Article 112. Infractions concerning medical devices.

1. Violations are classified as minor, serious and very serious according to criteria of health risk, amount of the eventual benefit obtained, severity of health and social alteration produced, generalization of the offense and recidivism.

2. They constitute administrative offenses and shall be penalized under the terms provided in Article 114 behaviors that typify below:

A) Minor offenses:
1st
not provide, entities or persons responsible, data, statements and any information they are required to provide health reasons for economic, technical, administrative and financial.

2nd Breaching the duty to collaborate with the health authorities in the assessment, monitoring and control of medical devices.

3rd Hinder the inspection work by any act or omission that disrupt or delay it.

4th Present at fairs, exhibitions and demonstrations products unfit for the placing on the market or service without the appropriate indication of non-compliance or inability to commissioning.

5.ª not available to the patient maintain the planned declaration for products as not inform you about it or give it to your requirement.

6.ª not identify as such products intended solely for export.

7th disobey any requirements, obligations or prohibitions established in the applicable regulations, on the basis of the criteria referred to in this article, deserve the classification of mild or if not relevant qualification as serious or very serious.

B) Serious offenses:
1st
not provide the patient and / or may not include in your medical record the required information about the product that you have received or implantation card when this has been established, and not send the card to the supplier or the national registry has been arranged.

2nd Fabricate, assemble and sterilize products on national territory without prior medical license system operation, and import medical devices without prior establishment license.

3rd Fabricate, assemble, spay or import products without respecting the requirements or without complying with the conditions under which the operating license was granted.

4th Breaching the technical manager the obligations incumbent responsible.


5th Commercialize medical devices without "CE marking" given where required, use any other markings that could lead to confusion with the "CE mark", and place the "CE mark" in products in different conditions established, except as provided in the infringement 5th letter c) of this section.

6.ª not keep available to the competent authorities and by the time appointed the required documentation and refusing to provide such documentation to the health authorities.

7th Breaching the duty of marketing communication in the products in which such communication is required, as well as communicate the modifications produced or cessation of marketing.

8th Breaching the duty of responsible communication established in Spain if the disclosure is required as well as communicate the changes produced.

9th Breaching the manufacturer, authorized representative, importer or distributor obligations relating to the identification of agents that precede them or follow them in the marketing chain.

10th Breaching the importer or the distributor's obligations to ensure that the products have followed the procedures appropriate conformity assessment has been prepared and the required documentation.

11th Distribute or sell products on an outpatient basis or in establishments that have not been duly communicated or authorized, or who do not have the technical or qualified professional concerned.

12th distribute, install, maintain and use products without observing the requirements, and altered to sell medical devices in poor condition or has been exceeded the period of validity.

13th Distribute implantable devices without providing the corresponding card implementation when it is mandatory, and not to the treatment because such cards.

14th Sell health products to the public in cases not permitted and without the required prescription cases where it is required, except as provided for in the infringement 7th, letter c) of this section.

15th conduct clinical research without complying with the procedures and conditions provided except as provided for in 8th and 9th infringements of the letter c) of this section.

16th Run incorrectly notified body actions assigned to it without having implications for the safety of certified products.

17th Refusing to facilitate notified the documentation requested by the Ministry of Health, Social Services and Equality to verify compliance with its requirements and obligations body.

18th Breaching the manufacturer, authorized representative, importer or distributor duty of reporting of adverse incidents and security actions Surveillance System Health Products and refusing to modify or suspend actions in the conditions required by the health authority.

19th meetings Breaching the duty to notify during clinical investigations of the required circumstances.

20.ª Prevent the performance of inspectors duly accredited in establishments that manufacture, store, distribute, sell or use medical devices.

21st Violating the principle of confidentiality regarding patient information and products who are required to maintain it.
22nd
Put into service in Spain products that are not included in the labeling and instructions for using the data and information required, at least in Spanish.

23rd Breaching the requirements and conditions relating to advertising and promotion of medical devices.

24th Make advertising to the public of the products in which it is not permitted except as provided for in the infringement 12th letter c) of this section.
25th
Offer, give or promise bonuses, pecuniary advantages or benefits in kind to any other qualified health professionals or relating to the use or prescription of medical devices, as well as their relatives and people in their coexistence. Also request them or accept them.
Use a professional
26th products under conditions and for uses other than those specified by the manufacturer, or by unqualified personnel or properly trained.
Use in patients
27th products that have not satisfied the procedures of conformity assessment applicable to them.

28th Refusing to dispense medical devices without just cause.


29th Acting, health professionals involved in the cycle of prescription, dispensing and administration and provided they are in office, acting medical business delegates, representatives, commission agents or informers of medical laboratories.

30th Fabricate as medical devices without the corresponding prescription written by a physician.

31th Breaching the health professional duty of reporting of adverse incidents Surveillance System Health Products.

32nd Breaching, pharmacies and pharmacy, legally established in terms of user input in the pharmaceutical provision of the national health system.

C) Very serious offenses:

1st Putting on the market and / or service products that do not meet the essential requirements that apply to them.

2nd Place on the market and / or service products that have not satisfied the procedures of conformity assessment or who have not made the statements, if any, are applicable thereto.

3rd market and / or put into service products that endanger the health or safety of patients, users or, where appropriate, third parties.

4th Install and / or improperly maintaining products so as to compromise the health or safety of patients, users or, where appropriate, third parties.

5th unduly Use "CE marking" in non-conforming products or which have not satisfied the assessment procedures corresponding compliance, as well as products that do not have the status of medical devices.

6th Breaching the duty of implementing the measures and actions necessary to reduce or eliminate health risks caused by products and the measures and actions ordered by the health authorities.

7th Sell products to the public for genetic diagnosis.

8th conduct clinical research in breach of its obligations under current legislation, when detrimental to the rights, safety and welfare of patients.

9th conduct clinical research without the consent of the subject thereof or, where appropriate, of his representative or by the researcher breach the duty of information on clinical research who participates as a subject of the same.
10th
Use by a professional products under conditions and for uses other than those specified by the manufacturer, or by unqualified personnel or properly trained, threatening the health and safety of people.
11th
Run incorrectly notified body, the activities entrusted to it, when it is damaged safety of certified products, as well as continue to certify after removal of the corresponding description.

12th Make advertising to the public of products for genetic diagnosis.

13th falsify medical devices, as well as falsifying the documents of conformity.

14th Breaching, the utility company, its obligation to adequately supplied market, adequately and continued to enable compliance with the requirements legally established on the provision with medical devices National Health System and ensure catering.

15th Any act of the pharmacy to induce the user to acquire more medical devices within the pharmaceutical provision of the national health system that truly needed or demanded by the latter.

Article 113. Offences relating to cosmetic products and personal care products.

1. Violations are classified as minor, serious and very serious according to criteria of health risk, amount of the eventual benefit obtained, severity of health and social alteration produced, generalization of the offense and recidivism.

2. They constitute administrative offenses and shall be penalized under the terms provided in Article 114 behaviors that typify below:

A) Minor offenses:

1st Hinder the inspection work by any act or omission that disrupt or delay it.

2nd Breaching the duty to cooperate with the competent health authorities in the assessment, monitoring and control of cosmetics.

3rd disobey any requirements, obligations or prohibitions set forth in the applicable legislation, when due to the criteria referred to in this article, such breaches deserve the classification of mild, or not appropriate qualification as serious or very serious misconduct.

B) Serious offenses:


1st Commercialize as if they were cosmetic products which do not conform to the definition of such established in current legislation, or by the place of application aimed, either by their purpose.

2nd Commercialize as if they were cosmetics products for the prevention, diagnosis and treatment of diseases, as well as those intended to be ingested, inhaled, injected or implanted in the human body or protection against contamination or infection microorganisms, fungi or parasites.

3rd Commercialize substances or mixtures are presented as cosmetics without complying with the applicable regulations.

4.ª not provide the competent authority the information that is required to supply the person responsible, and the lack of communication of any modification of the initial information necessary to communicate.

5.ª not provide the competent health authorities the information requested of them on substances for which there is doubt regarding their safety, as well as any other information required by those authorities for market control .

6th The mismatch between the details required the labeling of products and the information provided to the competent authority.

7th Commercialize cosmetics labeling omitted any mention required or not expressed in the language and / or in the terms established.
8th
Use in the labeling, marketing and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other symbol or not, to imply that these products have characteristics or functions They lacking and make claims that violate the established common criteria.

9th cosmetics that confusing with food, medicines, medical devices, biocides or other products, or referring to the treatment of diseases.

10th Commercialize cosmetics without making the safety assessment provided for in the regulation or without having done under the conditions set.

11th Perform activities manufacture of cosmetic products or some of its phases, such as control, packaging or labeling, on national territory, or import of cosmetics from non-EU countries without a technician with appropriate qualifications as to specific rules.

12th manufacture or import cosmetic products, or relocate, expand or substantially modify activities and facilities without having submitted the declaration responsible for compliance with requirements for such activities.
13th
manufacture or import cosmetic products without complying with the conditions expressed in the declaration of responsibility, and develop cosmetic products without observing the principles of good manufacturing practice.

14th Breaching the technical manager and other personnel obligations incumbent upon their positions.

15th Breaching the responsible person or the distributor's obligations to bring into conformity nonconforming products and refuse to implement the measures ordered by the health authorities for this purpose.

16th Breaching the responsible person or the distributor obligations relating to the identification of agents that precede them or follow them in the marketing chain.

17th Breaching the responsible person or the distributor's obligations to ensure that the products they sell comply with the requirements established in the regulations.

18th Breaching the duty to notify the person responsible or distributor to serious health authorities undesirable effects, the risks posed by the products and corrective measures taken.

19th meetings Prevent the performance of inspectors duly accredited in establishments that manufacture, store, distribute, sell or use cosmetics.

20.ª Provide consumers cosmetics intended for internal or intended to be presented at trade fairs, exhibitions or demonstrations and whose introduction in Spanish territory has been authorized solely for that purpose studies.

21st Distribute cosmetics without observing the requirements, as well as to sell cosmetic products altered, in poor condition or has been exceeded the minimum durability date, as appropriate.

22nd
not keep available to the competent health authorities any / s of the information / n in the file of product information, or express them in Spanish, where required is established.

23rd not provide the public by the person responsible for the information that is mandatory according to the regulation.

24th place on the market cosmetic products manufactured in facilities that have not been responsible declaration.

C) Very serious offenses:
1st
marketing of cosmetic products or products presented as cosmetics that harm human health when applied under normal or reasonably foreseeable conditions of use, or where not warn consumers of the risks that could foreseeably derived from normal use by instructions, warnings and appropriate indications.
2nd
marketing of cosmetic products including:

1st Substances banned for use in cosmetics.

2nd substances in concentrations above and / or in different conditions established for use in cosmetics.

3rd dyes, preservatives or other UV filters authorized for use in cosmetics, or in higher concentrations and / or under different conditions than those established.

4.º Substances classified as carcinogenic, mutagenic or toxic to reproduction outside the conditions laid down in the rules of cosmetics.

3rd Commercialize cosmetics that do not comply with the requirements set on animal experimentation.

4th Distorting information to be provided to the health authority and distort responsible for compliance with requirements for carrying out manufacturing activities and import declaration.
Breaching the duty
5th implementation of the measures and actions necessary to eliminate health risks caused by cosmetics, as well as the measures and actions ordered by the health authorities.

6th Develop cosmetic products in poor technical and health conditions affecting safety.

7th Fabricate, bring to market or sell counterfeit goods.

3. The provisions of the preceding paragraphs shall apply to personal care products when the object of the offense applicable to such products.

In any case they shall be considered very serious infringements:

A) Commercialize personal care products without the mandatory sanitary authorization.

B) Develop personal care products in poor technical and health conditions affecting safety.

C) marketing personal care products that harm human health when applied under normal or reasonably foreseeable conditions of use, or where consumers of the risks that could foreseeably result from normal use will not notice through instructions, warnings and appropriate indications.

4. The commission of an offense, preceded by two other degree or less immediately committed and sanctioned firm within a year prior to the commission, increase from mild to severe, serious or very serious, such infringement.

Article 114. Penalties.

1. Offenses concerning drugs shall be punished with fine in accordance with the provisions of Article 111 by applying a graduation minimum, average and maximum at each level of offense, based on negligence and intent of the subject offender, fraud, collusion, failure to comply with previous warnings, turnover of the company, number of people affected, harm caused, profits because of the infringement, permanent or transitory risk and recidivism by commission within a year of more than one offense of the same nature when this has been declared by a final decision:

A) Minor offenses:

Minimum Grade: Up to 6,000 euros.

Middle Grade: From 6,001 to 18,000 euros.

Maximum Grade: From 18,001 to 30,000 euros.

B) Serious offenses:

Minimum Grade: From 30,001 to 60,000 euros.

Middle Grade: From 60,001 to 78,000 euros.

Maximum Grade: From 78,001 to 90,000 euros.

C) Very serious offenses:

Minimum Grade: From 90,001 to 300,000 euros.

Middle Grade: From 300,001 to 600,000 euros.

Maximum Grade: From 600,001 to 1,000,000 euros and may exceed that amount up to five times the value of the goods or services covered by the infringement.


However, in the case of infringements of veterinary drugs, the penalty will only be imposed on the maximum degree when the offending action has produced direct damage or caused a serious and direct risk to public health or safety food.

2. Notwithstanding the fine to be levied in accordance with the provisions of the preceding paragraph, the drug infringements will be sanctioned with the confiscation, in favor of the Treasury, the illicit profit obtained as a result of the commission of the offense. The resolution of the Directors shall determine for this purpose an amount of illicit benefit obtained.

3. Notwithstanding the fine to be levied in accordance with paragraph one of this article, the very serious infringement on medicinal products, contained in section 23 paragraph c) of section 111.2, may result in disqualification from office pharmacy dispensing prescriptions involved National Health System for a minimum period of 3 months and up to 1 year.

4. The penalties for the commission of serious and very serious infringements will be published in the appropriate official gazette once they acquire steadfastness.

5. It is for the exercise of sanctioning powers to the central government or the regions that hold the inspection function, according to the regulations in Article 108.

6. In addition, in cases of very serious infringements may be agreed by the Council of Ministers or by the competent bodies of the autonomous communities corresponding implementing legislation on pharmaceuticals, the temporary closure of the establishment, facility or service for maximum period of five years. In such a case, it shall apply the provisions of Article 53 of Law 31/1995 of 8 November on Prevention of Occupational Risks.

7. The provisions of the preceding paragraphs will apply to infringements on health and cosmetic products in accordance with the provisions of Articles 112 and 113.

However, in the case of infringements of health and cosmetic products, the penalty will only be imposed in its maximum degree when the offending action has produced direct damage or caused a serious and direct risk to public health.

Article 115. Other measures.

1. They will not have character sanction decommissioning and closure of establishments, facilities or services that do not have prior authorization or mandatory health records, or suspend its operation until the defects are remedied or the requirements for reasons of health are met, hygiene or safety.

2. The authority to resolve appropriate file may agree to the confiscation of damaged products and medicines, expired, unauthorized or potentially pose health risks.

3. Transportation costs, distribution or destruction of products and medicines as well as derivatives of the suspension, closure and closure of establishments, facilities or services identified in the preceding paragraphs shall be borne by the offender.

Article 116. Prescription.

1. Very serious infringements shall lapse after five years, two years severe and mild year; in the same terms shall prescribe penalties.

2. The limitation period for infringements begin from the day the offense was committed.

Interrupts prescription initiation, with the knowledge of the person concerned, of disciplinary proceedings, the limitation period resumed if the disciplinary proceedings were paralyzed for more than a month for reasons not attributable to the accused.

3. The limitation period of sanctions begin to run from the day following that on which the decision becomes final for which the penalty is imposed.

Interrupts prescription initiation, with knowledge of the subject, the execution procedure, returning to the period of time if that is paralyzed for more than a month for reasons not attributable to the offender.
TITLE X


From the injunction

Article 117. Prior request to exercise the injunction.

1. When advertising medicinal products for human use, medical devices or products with supposed health properties is contrary to this law, its implementing provisions or the Law 14/1986 of 25 April, affecting the collective interests or diffuse consumers and users may request their cessation:


A) The Spanish Agency of Consumer Affairs, Food Safety and Nutrition and bodies or entities of the autonomous communities and local authorities competent in the field of consumer protection.

B) Consumer associations and users who meet the requirements set out in the revised text of the General Law for the Protection of Consumers and Users and other complementary laws, approved by Royal Decree 1/2007 of 16 November, or, where appropriate, in the regional legislation on consumer protection.

C) entities from other Member States of the European Union that referred to in Article 118.

D) Holders of a right or a legitimate interest.

2. The application shall be in manner that allows reliable record of its date of receipt and their content.

3. Cessation may be requested from the beginning to the end of advertising. the action may also be exercised to prohibit performing a behavior when it is completed at the time of bringing proceedings, if there is sufficient evidence to make its reiteration fear immediately.

4. Within fifteen days of receipt of the request, the requested notify the requesting irrefutably its willingness to cease advertising activity and effectively proceed to such cessation.

5. In cases of silence or negative, or when it had not occurred cessation, the applicant, prior justification of having made the request for an injunction, you may exercise the action described in the following article.

6. The request and the will to cease, or, where appropriate, refusal to cease advertising activity, shall be communicated to the competent health authority control drug advertising.

Article 118. Action cessation.

1. You can exercise the injunction against the following acts, if they are contrary to this law, its implementing rules or the Law 14/1986 of 25 April, and is detrimental to collective or diffuse interests of consumers and users: | ||
A) Conducts on advertising of medicinal products for human use, in which case the action may be exercised without submitting the request referred to in Article 117, which will have a facultative nature.

B) Conducts on advertising of medical devices or products alleged health properties, after the mandatory filing of the application referred to in Article 117.

2. The injunction is aimed at obtaining a judgment ordering the defendant to cease the conduct contrary to the standards listed in the preceding paragraph and to prohibit its future repetition. the action may also be exercised to prohibit performing a behavior when it is completed at the time of bringing proceedings, if there is sufficient evidence to make its reiteration fear immediately.

Shall be notified to the competent health authority control drug advertising both the filing of the action, as the sentence, if any, is issued.

3. They will be entitled to exercise the injunction:

A) The Spanish Agency of Consumer Affairs, Food Safety and Nutrition and bodies or entities of the autonomous communities and local corporations.

B) Consumer associations and users who meet the requirements set out in the revised text of the General Law for the Protection of Consumers and Users, or, where appropriate, in the regional legislation consumer protection .

C) The Prosecutor.

D) entities other Member States of the European Union established for the protection of collective interests and diffuse interests of consumers that are enabled by inclusion in the list published for that purpose in the "Official Journal of the European Union".

Judges and courts accept this list as proof of the capacity of the qualified entity to be part, subject to examine whether the purpose of it and the interests involved legitimize the exercise of the action.

E) holders of a right or legitimate interest.

All institutions referred to in this article may make themselves known in other processes promoted by any of them, if they consider appropriate for the defense of the interests they represent.
TITLE XI



Rates
Article 119. Creation, regulations and territory.


1. the fee for the provision of services and performance of activities of the General State Administration for medicines, health products, cosmetics and personal care products is created.

2. The tax regulated in this title shall be governed by the provisions of this law, failing that, by Law 8/1989 of 13 April on Public Fees and Prices, and implementing regulations.

3. This fee will apply throughout the national territory in accordance with the provisions of Article 124, and without prejudice to the powers vested in the autonomous communities.
Article 120. Taxable
.

The taxable event of the rate of the benefit or execution, by the competent bodies of the General State Administration, services or activities that Article 123 relating to legally recognized medicines, medical devices, cosmetics concerns and personal care products, pharmaceutical laboratories and distribution entities.

Article 121. Exemptions.

1. Shall be exempt from the provision of services or carrying out activities relating to the manufacture of "orphan drugs" to which Article 3.3 refers.

2. Be exempt services and activities for changes in the packaging material which have as their object to enforce printing Braille language, according to the provisions of Article 15.5.

3. They will be exempt from the fee services and activities related to advanced therapy medicinal products that are to be performed by entities of public nature within the National Health System as well as those not intended for the marketing of such products.

4. They will be partially exempt from paying the fee modifications or variations of authorizations granted by the Spanish Agency for Medicines and Health Products arising necessarily when the approval by regulatory standard, a new general regulation. The rate will be reduced by 95% of the amount established in each case.

5. They shall be exempt partially payment of the fee holders of marketing authorizations authorized medicinal products when, for reasons of health interest, the Spanish Agency for Medicines and Health Products and the European Commission urge modification. The rate will be reduced by ninety five percent of the amount established in each case.

6. veterinary medicinal products intended only for minor species or minor uses an exemption of 70% of those for marketing authorizations to line extensions for minor species or minor uses of already approved drugs to larger species, at rates will apply the amendments to the marketing authorization, scientific advice, products undergoing clinical research veterinary medicine, veterinary clinical trials, renewal of the authorization, presentation of simple annual declaration of intent marketing and periodic reports safety, veterinary drugs authorized by national procedure , mutual recognition or decentralized. It shall not apply to procedures for transfer of ownership and / or representative of the owner.

7. They will be partially exempt from paying the fee scientific advice on drugs to include only questions related to the pediatric development. The rate will be reduced by 95% of the amount established in each case.

Article 122. Taxable person.

Shall be liable rate natural or legal persons requesting the provision of services or performance of the activities that constitute the taxable event.

Article 123. Amount.

1. The amount of each euro rate will be:

Group I. Medicinal products for human use.




epigraph





Description





euros














Evaluation, Authorization and registration of new drugs














1.1





Fee for the evaluation, authorization and registration of a new drug for human use (authorization dossier submitted under Article 17 except that referred to in Article 17.3).





20734.46






1.2






Fee for the evaluation, authorization and registration of a new generic drug for human use (authorization dossier submitted pursuant to Article 17.3).





8434.22






1.3





Fee for the evaluation, authorization and registration of a new medicinal gas.





8434.22














Transfer of ownership of a medicinal product for human use














1.4





Fee for the procedure of transfer of ownership of the authorization of a medicinal product for human use, or modification of the representative of the holder.





704.55














Evaluation, authorization and registration of a variation of a medicinal product for human use














1.5





Fee for the procedure for amending the authorization of a medicinal product for human use, described as "more important" type II.





7122.25






1.6





Fee for the procedure for amending the authorization of a medicinal product for human use, classified as type IB.





1249.22






1.7





Fee for the procedure for amending the authorization of a medicinal product for human use, classified as type IA (IA type including immediate notification).





724.42














Procedures for renewal of the marketing authorization














1.8





Fee for the renewal procedure for the authorization of a medicinal product for human use.





2342.71














annual maintenance fee of authorized medicinal














1.9





simple annual rate of an already authorized medicinal product for human use.





373.70














Fees for parallel imports














1.10





Fee for the authorization procedure for the "parallel importation" of a drug for human use.





905.45






1.11





Fee for the procedure for amending the authorization for the "parallel importation" of a drug for human use.





366.49






1.12





Fee for the renewal procedure of authorization for the "parallel importation" of a drug for human use.





366.49






1.13





Import notification fee.





359.04














Fees for batch release of vaccines, blood products and bulk














1.14





Fee for issuing European certificate of lot release for vaccines and blood products for human use when analyzing a drug batch is required.





1212.00






1.15





Fee for batch release of blood products and vaccines according to Articles 41.4 and 43.3 of Royal Decree 1345/2007, of October 11 :.


















(A) each individual application.





101.00













(B) between 6 and 10 applications / year (per year).





505.00












(C) between 11 and 40 applications / year (per year).





1515.00












(D) between 41 and 160 applications / year (per year).





3535.00












(E) for more than 160 applications / year (per year).





5050.00






1.16





Fee for the European certificate issuing batch release for vaccines and blood products for human use when analyzing a bulk is required (bulk).





339.36














Fee for the evaluation of pharmaceutical innovations














1.17





Fee for the review of an application for a declaration of medical innovation of therapeutic interest.





984.04














Rate applicable to exports














1.18





Export authorizations, to intra-Community and third countries, narcotics and psychotropic drugs.





171,70














other














1.19





Rate for the actions envisaged in Article 124.6.





366.49






1.20





Fee for booking a vacancy to act as Reference Member State in a decentralized procedure or mutual recognition.





757.50





Group II. Drug allergens.




epigraph





Description





euros














Evaluation, authorization and registration of a new allergen medicinal product for diagnostic use














2.1





Fee for the National Procedure.





860.93














Transfer of ownership of an allergen for diagnostic use drug














2.2





Fee for the procedure of transfer of ownership of the authorization of an allergen medicine for diagnostic use.





472.46














Evaluation, authorization and registration of a variation of an allergen for diagnostic use drug














2.3





Fee for the procedure for amending the authorization of an allergen for diagnostic use drug, described as "more important" type II.





502.74






2.4





Fee for the procedure for amending the authorization of an allergen medicine for diagnostic use, defined as type IB.





88.19






2.5





Fee for the procedure for amending the authorization an allergen medicine for diagnostic use, qualified type IA (IA type including immediate notification).





51.14














Procedures for renewal of the marketing authorization














2.6






Fee for the renewal procedure of authorization of an allergen medicine for diagnostic use.





307.38














annual maintenance fee of authorized medicines allergens














2.7





simple annual rate of an allergen for diagnostic use drug already approved.





373.70














Fee for release of bulk














2.8





Fee for authorization bulks.





614.77





Group III. Herbal medicines.




epigraph





Description





euros














Evaluation, authorization and registration of a new traditional herbal medicine (MTP)














3.1





Fee for a national simplified procedure.





2186.94














Evaluation, authorization and registration of a variation of a traditional herbal medicine (MTP)














3.2





Fee for the procedure for amending the authorization traditional herbal medicine (MTP).





338,98














Evaluation, authorization and registration of a new drug for human use herbal by using well established














3.3





Fee for the National Procedure, except section 3.1.





8434.22














Transfer of ownership of herbal medicines














3.4





Fee for the procedure of transfer of ownership of the authorization of a traditional herbal medicine (MTP) or herbal medicine approved by well established use.





704.55














Evaluation, authorization and registration of a variation of a herbal medicine














3.5





Fee for the procedure for amending the authorization of a medicinal product for human use herbal, described as "more important" type II.





1249.22






3.6





Fee for the procedure for amending the authorization of a medicinal product for human use herbal, classified as type IB.





557.67






3.7





Fee for the procedure for amending the authorization of a medicinal product for human use herbal qualified type IA (IA type including immediate notification).





317.85














Procedures for renewal of the marketing authorization














3.8





Fee for the procedure for renewal of the authorization of a traditional herbal medicine (MTP).





307.38






3.9





Fee for the renewal procedure of authorization for a medicinal herbal authorized by well-established use.





1522.95















annual maintenance fees authorized herbal medicinal plants














3.10





simple annual rate of traditional medicine and authorized herbal (MTP).





373.70






3.11





simple annual rate of herbal medicine approved by well established use.





373.70





Group IV. Homeopathic medicines for human and veterinary use.




epigraph





Description





euros














Evaluation, authorization and registration of a new homeopathic medicinal product without approved therapeutic indication




















Fee for a national simplified procedure:












4.1





A single strain.





569.69






4.2





Between two and five strains.





745.85






4.3





Over six strains.





932.32














Evaluation, authorization and registration of a variation of a homeopathic medicinal product without approved therapeutic indication














4.4





Fee for the procedure for amending the authorization of a homeopathic medicinal product without approved therapeutic indication.





329.01














Evaluation, authorization and registration of a new homeopathic medicine approved therapeutic indication














4.5





Fee for the National Procedure.





8434.22














Transfer of ownership of a homeopathic medicine with or without approved therapeutic indication














4.6





Fee for the procedure of transfer of ownership of the authorization of a homeopathic medicine with or without approved therapeutic indication, or by modifying the representative of the holder.





704.55














Evaluation, authorization and registration of a variation of a homeopathic medicine approved therapeutic indication














4.7





Fee for the procedure for amending the authorization of a homeopathic medicine approved therapeutic indication, described as "more important" type II.





1249.22






4.8





Fee for the procedure for amending the authorization of a homeopathic medicine approved therapeutic indication, classified as type IB.





557.67






4.9





Fee for the procedure for amending the authorization of a homeopathic medicine approved therapeutic indication, qualified type IA (IA type including immediate notification).





317.85














Renewal Procedures marketing authorization














4.10





Fee for the renewal procedure for the authorization of a homeopathic medicinal product without approved therapeutic indication.






307.38






4.11





Fee for the renewal procedure of authorization of a homeopathic medicine approved therapeutic indication.





1522.95














annual maintenance fees authorized homeopathic medicines














4.12





simple annual rate of a homeopathic medicinal product without approved therapeutic indications already authorized.





90.90






4.13





simple annual rate of a homeopathic medicinal products for human use approved therapeutic indication already authorized.





373.70





V. Clinical Research Group.




epigraph





Description





euros






5.1





Fee for an assessment procedure of the first clinical trial with drugs not approved in a country belonging to the International Conference on Harmonization (ICH) with active substances or combinations of active substances not authorized in Spain.





4242.00






5.2





Fee for the procedure:


















a) authorization of a clinical trial with an authorized in a country belonging to the International Conference on Harmonization (ICH), other than Spain medicine.





404.00






b) authorization of clinical trials unauthorized in any country of the International Conference on Harmonization (ICH), after the first clinical trial included under 5.1 drugs.






c) authorization of a clinical trial with the characteristics listed in section 5.1 in the case of a repetition of the application for authorization when the result of the first application was not a waiver or authorization of the trial.






d) authorization of an unauthorized change in a country belonging to the International Conference on Harmonization (ICH) authorized in Spain active clinical trial of a drug.






5.3





Fee for the procedure:


















a) authorization of a clinical trial with medicines authorized and registered in Spain, regardless of the specific labeling of these for testing.





112.30






b) authorization of a clinical trial whose promoter is a researcher or group of researchers in a Pharmacy Service is responsible for developing or mask investigational medicinal products.






5.4





Qualification procedure as a product under clinical investigation of unauthorized veterinary medicine in Spain.





278.17






5.5





Fee for veterinary clinical trial procedure.





112.30





Group VI. pharmaceutical companies, manufacturers, importers or distributors of active substances and other entities that develop activities with drugs or active ingredients.




epigraph





Description





euros






6.1





Authorization procedure for opening a pharmaceutical laboratory.





5916.36






6.2





Procedure for amending the authorization of a pharmaceutical laboratory for minor changes in it.





329.01






6.3a)






Procedure for amending the authorization of a pharmaceutical laboratory for major changes in same when the inspection activities do not include inspection visit.





3896.36






6.3.b)





Procedure for amending the authorization of a pharmaceutical laboratory for major changes in same when the inspection activities include inspection visit.





5916.36






6.4.a)





individualized tax inspection, except in cases of complaint or request for a representative association of users or consumers, at the national level.





5004.97






6.4.b)





individualized tax inspection, except in cases of complaint or at the request of a representative association of users or consumers, in third countries.





10908.00






6.4.c)





individualized inspection activities in third countries, not mandatory, at his request.





20200.00






6.5





Authorization procedure for manufacturing drugs approved in other countries and not registered in Spain.





643.22






6.6





Authorization procedure for exceptional production by third parties of medicinal products for human use and / or veterinarian.





329.01






6.7





Authorization procedure and / or certification under control drug warehouses or customs supervision.





1313.00






6.8





Authorization resolution crop plants that can be used for the manufacture of drugs and psychotropic drugs.





606,00






6.9





Initial registration, notification mandatory annual update modifications or registration of manufacturers, importers or distributors of active ingredients.





808,00






6.10





Registration of persons engaged in intermediation in the distribution of medicinal products for human use.





252.50





Group VII. Certifications and reports.




epigraph





Description





euros






7.1





Fee for the issuance of a certificate.





141.86






7.2





Fee for scientific advice for drugs that include multidisciplinary questions about (a) quality, safety and clinical development, or (b) quality and clinical development, or (c) safety and clinical development, or (d) pre-referral advice of a record .





4224.39






7.3





Fee for scientific advice for drugs that include questions on (a) clinical development, or (b) quality and safety, or (c) the quality and bioequivalence studies for generic drugs.





3061.44






7.4





Fee for scientific advice for drugs that include questions on (a) quality, or (b) security, or (c) bioequivalence studies for generic drugs.





2022.74






7.5





Fee for advice tracking assumptions included under 7.2.





2022.74






7.6





Fee for advice tracking assumptions included under 7.3.





1530.73






7.7





Fee for advice tracking assumptions included under 7.4.





984.04







7.8





Advisory fee for the classification of variations not classified according to Article 5 and for grouping of variations, according to Article 7 of Regulation (EC) No 1234/2008 of the European Commission.





492.01






7.9





Fee for scientific advice on medicinal products for pediatric use in any of the cases included in previous sections.





205.01






7.10





scientific / technical facilities on the design and manufacturing processes in accordance with good manufacturing advice.





492.01





Group VIII. health products, cosmetics and personal care products.




epigraph





Description





euros






8.1





Special declaration procedure cosmetics.





487.90






8.2





Registration procedure and individual authorization for products for personal care and disinfectants.





487.90






8.3





Registration procedure and registration of medical devices.





101.00






8.4





Modification procedure and validation of products for personal care and disinfectants.





170.02






8.5





Procedure for issuing a certificate.





147.82






8.6





Testing procedure and control activity responsible for the manufacture of cosmetics and personal care statement.





717.08






8.7





Testing procedure and control activity responsible for the import of cosmetics and personal care statement.





369.63






8.8





Testing procedure and control responsible for changes in the activity of manufacture of cosmetics and personal care statement.





369.63






8.9





Verification procedure and control of responsible activity modifications import of cosmetics and personal care statement.





170.02






8.10





individualized tax inspection for verification of the declaration of responsibility.





717.08






8.11





Authorization procedure confidentiality of cosmetic ingredients.





487.90






8.12





Prelicensing procedure operation of sanitary products and disinfectants: manufacturing establishment, grouping.





717.08






8.13





Prelicensing procedure operation of sanitary products and disinfectants: import establishment.





369.63






8.14





Procedure for amendment of the operating license of establishments of health products and disinfectants in terms of its location: establishment manufacturing group.





717.08






8.15





Procedure for amendment of the operating license of establishments of health products and disinfectants in terms of its location: import establishment.





369.63






8.16






Procedure for amendment of the operating license of establishments of health and disinfectants.





170.02






8.17





Revalidation procedure license health facilities and disinfectants: manufacturing establishment.





517.47






8.18





Revalidation procedure license health facilities and disinfectants: import establishment.





317.88






8.19





Authorization of clinical investigations of medical devices.





808,00






8.20





Evaluation report of active ingredient incorporated in a medical device.





1478.50






8.21





Dossier evaluation certification "CE marking" of medical devices belonging to the same family full quality assurance system.





2460.36






8.22





Dossier evaluation certification "CE marking" of medical devices by "EC" type examination combined with quality assurance of production, "EC" verification or guarantee of product quality.





887.10






8.23





Dossier evaluation certification "CE marking" of medical devices belonging to the same family, "EC" declaration of conformity combined with quality assurance of production, "EC" verification or guarantee of product quality.





739.27






8.24





Product verification and product lots.





230.17






8.25





Dossier evaluation certification "CE marking" of medical devices by "EC" design examination.





1626.37






8.26





Initial audit under full quality assurance system.





3232.00






8.27





Initial audit in accordance with quality assurance in production.





2686.60






8.28





Initial audit in accordance with product quality assurance.





2154.33






8.29





Follow-up audits and certification extension.





2154.33






8.30





Local supplementary audits and repetition.





1077.67






8.31





Modifying administrative data certification "CE marking".





147.82






8.32





Extensions certifications "CE marking".





147.82






8.33





Modification procedure medical devices.





60.60





Group IX. veterinary drugs.




epigraph





Description





euros






9.1





Application fee for marketing authorization of a veterinary medicinal product, except for applications referred to in Article 17.3.





10367.22






9.2





Application fee for marketing authorization for a generic veterinary medicinal product (dossier submitted pursuant to Article 17.3).





4217.10






9.3






Fee for the procedure of transfer of ownership of the authorization of a veterinary medicinal product, or by modifying the representative of the holder.





704.55






9.4





Fee for the procedure for amending the authorization of a veterinary medicinal product, described as "more important" type II.





3561.13






9.5





Fee for the procedure for amending the authorization of a veterinary drug, defined as type IB.





1224.72






9.6





Fee for the procedure for amending the authorization of a veterinary medicinal qualified type IA (including immediate notification type IA).





724.42






9.7





Fee for the renewal procedure for the authorization of a veterinary medicinal product.





2342.71






9.8





Fee simple annual declaration of intent to market a veterinary medicinal product already authorized.





120.20






9.9





Fee for the authorization procedure for the "parallel importation" of a veterinary medicinal product.





738.93






9.10





Fee for evaluation of safety semiannual periodic report of a veterinary drug, whether or not registered the drug in Spain.





382,71






9.11





Fee for evaluating periodic report annual safety of a veterinary drug, whether or not registered the drug in Spain.





757.84






9.12





Fee for evaluation or three-year periodic report more than three years of a veterinary drug safety, whether or not registered the drug in Spain.





2273.52






9.13





Fee for issuing European certificate of official batch release for immunological veterinary medicinal products under Article 81 of Directive 2001/82 / EC.





339.36






9.14





Fee for issuing European certificate of official batch release for immunological veterinary medicinal products under Article 82 of Directive 2001/82 / EC.





1212.00






9.15





Fee for booking a vacancy Spain to act as Reference Member State in a decentralized procedure or mutual recognition.





404.00





Group X. Procedures funding from public funds and pricing of medical devices.




epigraph





Description





euros






10.1





Procedure for inclusion of a health product pharmaceutical services of the National Health System.





347.90






10.2





Procedure of exclusion of a medical device in the pharmaceutical provision of the national health system.





347.90





2. For the purposes of the preceding paragraph shall mean the second line extension and subsequent applications for authorization and registration of other dosage forms, routes of administration and concentration of an already authorized and registered medicine.

The amount of the rate of line extensions will be seventy percent of the first authorization of the drug.

In the case of veterinary medicines, will be considered line extension the extension of authorization to new target species always concerned with producing species.


Line will be an extension of those amendments requiring the submission of a new application for authorization, according to the European standard governing the authorization of medicinal modifications granted by the competent authority of a Member State.

The provisions of the preceding paragraphs regarding line extensions applies also when the drug is not yet approved and are presented in parallel extensions of a parent application.

For the purposes of the fee described in sections 8.1 and 8.21, is considered to:

A) "cosmetic product under special declaration", who, upon the authorization of the Spanish Agency for Medicines and Health Products, includes in its composition dyes, preservatives and ultraviolet filters, not included among the substances admitted as components of cosmetic products.

B) 'family of medical devices ", the set of medical devices, belonging to the same category, are intended for identical or similar healthcare applications.

3. The amount of fees for services and activities of the General State Administration for medicines, health products, cosmetics and personal care products, in accordance with the provisions of the Law 8/1989, of April 13, may modified by the Law on State Budget.

4. When the evaluation and control of a drug or medical device requires action abroad or exceptional costs, the fees will be assessed on the actual cost of the service that is the assumption that determines its demand.
Also
costs of travel, accommodation and trials resulting from the actions envisaged in sections 6.1, 6.4 a), b) and c will be settled on the actual cost of the service), 8.22, 8.24, 8.26, 8.27, 8.28, 8.29 , 8.30 and 10.1.

5. When in the authorization procedure and registration of a medicinal product for human or veterinary use, which corresponds to the fees provided for in sections 1.1, 1.2, 1.3, 1.5, 9.1, 9.2 and 9.4, the request is rejected the validation phase, will proceed to the return of seventy percent of the total amount of the fee.

For the purposes of the provisions of this Act, the term validation action of an administrative nature, developed with the purpose of verifying that the application meets all the requirements necessary to perform the service or execution of administrative activity .

6. The amendments to the authorization of a drug, arising from a decision of the European Commission and activities that do not involve scientific assessment by the Spanish Agency for Medicines and Health Products bear the rate provided in section 1.19.

In cases of group of independent change Type IA, these being the same or different, involving several drugs belonging to the same owner and wherever they occur simultaneously and in a single application form in accordance with Article 7 Regulation (EC) No 1234/2008 of the Commission of 24 November 2008 concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicines, will accrue for each the same types of modifications a primary rate and reduced rates for the other amendments.

When a modification affects different drugs of the same holder, and that involve a single scientific assessment, the second and subsequent bear the fee provided for in section 1.19.

When different changes occur in the marketing authorization of a medicinal product, the total amount of the awards may not exceed the rate provided for the authorization procedure and registration in the Register on the type of drug involved.

In the case of a group of independent changes affecting the same drug and provided all occur at the same time and in a single application form, in accordance with Article 7 of Regulation (EC) No 1234/2008 of the European Commission, a fee for each of the requested changes will be required.


The rate corresponding to the section 7.2, 'Fee for scientific advice for drugs that include multidisciplinary questions about (a) quality, safety and clinical development, or (b) quality and clinical development, or (c) safety and clinical development, or (d) pre-referral advice from a file 'shall be reduced by 25% for scientific advice including questions about development only clinical efficacy; or pre-clinical quality and safety; or quality and bioequivalence.

7. Rates decentralized procedures for medicinal products for human or veterinary use, resulting in a national authorization in which Spain acting as Reference Member State (performance of sections 1.1, 1.2, 1.3, 1.5, 1.6, 1.7, 1.8, 3.1 , 3.3, 3.5, 3.6, 3.7, 4.1, 4.2, 4.3, 4.5, 4.7, 4.8, 4.9, 9.1, 9.2, 9.4, 9.5, 9.6 and 9.7) will increase by 25% on the value of the corresponding fee.

In the mutual recognition procedures for medicinal products for human or veterinary use in which Spain acting as Reference Member State one third of the full reference rate (performance of sections 1.1, 1.2, 1.3, 3.1 will be paid, 3.3, 4.1, 4.2, 4.3, 4.5, 9.1 and 9.2).

The rate of under 1.20, which applies to any medicinal product for human use, including special medication, be deducted from the total amount paid in the appropriate case the applicant submits an application relating to a decentralized procedure or mutual recognition, Spain acting as reference member State.
Also heading
rate of 9.15, which applies to any veterinary medicinal product shall be deducted from the total amount paid in the appropriate case the applicant submits an application relating to a decentralized procedure or mutual recognition, Spain acting as reference member State.

Article 124. Accrual.

The rate shall be paid when the application that initiates the file, please log entry of the Spanish Agency for Medicines and Health Products and the Ministry of Health, Social Services and Equality, according to their respective competence, at which time the service or performing administrative activity starts.

Article 125. Payment.

1. Payment of the fee shall be in accordance with the provisions of Law 8/1989 of 13 April, Law 58/2003, of 17 December, General Tax and other rules.

The payment of the fees referred to in this law is preferably performed by means or electronic means, in accordance with the provisions of Law 11/2007 of 22 June, on Electronic Access to Public Services.

2. No one who is not accompanied by proof of payment of the applicable fee request is processed.

3. When, paid the fee, the Administration can not process the corresponding procedure for reasons not attributable to the taxpayer because the return of the same will be eighty percent of the amount.

4. Paid the fee, the taxpayer must submit an application within ten days after admission.

5. Tax collection rates regulated by this law corresponds in voluntary means, the Ministry of Health, Social Services and Equality and the Spanish Agency for Medicines and Health Products, according to their respective competence.

6. The Spanish Agency for Medicines and Medical Devices may be used to obtain the effectiveness of their debits nature of public law, administrative enforcement procedure, provided that such debts are in executive period. The Spanish Agency for Medicines and Health Products may agree with the State Tax Administration Agency collection management of its public revenue in the form provided by the General Collection Regulations, approved by Royal Decree 939/2005 of 29 July.

Article 126. Cases of refunding of fees.
Proceed
return fee income, in addition to the cases referred to in Article 221 of Law 58/2003 of 17 December, when the rate paid, the taxpayer fails to submit the request for the service or conducting corresponding activity within ten days of admission laid down in Article 125.4, whenever for reasons not attributable to the taxpayer, accredited reliably. This refund will be eighty percent of the amount.

First additional provision. Guaranteed supply of medicines and health products and coordination of availability of fluids and other elements.


1. In order to develop and promote the necessary activities in supplies of drugs and medical devices and coordinate adequate availability of blood and other fluids, glands and human tissues and their components and necessary for healthcare products, the Ministry of Health, Social services and Equality, in addition to the missions entrusted by this law, shall perform the following functions:

A) Ensure the medication reservoir psychoactive substance in accordance with the provisions of international treaties.

B) To authorize the import of foreign medication and urgent unauthorized in Spain.

C) Maintain a state strategic reservoir of medicines and medical devices for emergencies and disasters.

D) Making the purchase and distribution of drugs and medical devices for international cooperation programs.

E) Coordinate the provision of vaccines, drugs and other health products whose acquisition campaigns and joint distribution is decided by various health authorities.

F) To promote the manufacture and marketing of "orphan drugs".

2. Also exercise the coordination of trade and transport of blood and other fluids, human tissues and glands and their components and derivatives.

Second additional provision. Law enforcement to health services of the Armed Forces.

The application of the criteria and standards set forth in this law to health services of the armed forces shall be determined by regulation a joint proposal by the ministries concerned.

Third additional provision. Law Enforcement medical devices, cosmetics and personal care products.

1. In accordance with the provisions of this law shall be determined by regulation the conditions and requirements that meet the medical devices manufacture, import, clinical research, distribution, marketing, commissioning, dispensing and use, as well as the respective administrative procedures of according to the provisions of the regulations of the European Union.

2. The provisions of the preceding paragraph shall also apply, in what appropriate products and personal care cosmetics.

3. The activities of manufacture and importation of cosmetics and personal care products undergo the regime responsible declaration, governed by Article 71a of Law 30/1992 of 26 November. This sworn statement must be filed with the Spanish Agency for Medicines and Health Products. The presentation of the responsible declaration will allow the start of activities, without prejudice to the subsequent verification by the Spanish Agency for Medicines and Health Products, through documentary verification and, if necessary, inspection of the elements and circumstances revealed by the interested in responsible declaration.

4. They will accrue the necessary fees to cover the costs of checking the responsible declaration and inspection that is necessary, where appropriate.

Fourth additional provision. Deposit of drugs in prisons.

Prisons may request the competent authority in each case permission to hold a deposit of medicines for assistance to internally under the supervision and control of a pharmacist authorized hospital pharmacy services of the National Health System more close.

Fifth additional provision. Procedure for the total or partial exclusion of drugs in the pharmaceutical provision of the national health system.

The Government by royal decree on the report of the Inter-Territorial Council of the National Health System, shall determine the form, requirements and conditions of application of the criteria in Article 92 and determine the total or partial exclusion of groups, subgroups, categories or classes of drugs funding from public funds.

Sixth additional provision. Contributions by volume of sales to the National Health System.


1. Individuals, business groups and legal entities not integrated into them engaged in Spain in the manufacture, import or supply the National Health System medicines and / or medical devices, publicly funded, are dispensed in offices pharmacy through official prescription or order dispensing the national Health System, in national territory, be paid on a quarterly basis the amounts resulting from applying on its quarterly sales volume through said prescription or order dispensing the percentages referred on the following scale:




PVL quarterly sales





Contribution percentage






from





until






0.00





3,000,000.00





1.5






3,000,000.01





Henceforth





2.0





In the event that the total sales volume of medicines and health products to the National Health System is, in annual current terms, less than the previous year, the government may revise the above percentages of contribution.

The amounts resulting from the application of the previous scale will be disenfranchised depending on the valuation of companies under the Profarma program according to the following percentages:

A) Not Rated: 0.00.

B) Acceptable: 5%.

C) Good: 10%.

D) Very good: 15%.

E) Excellent: 25%.

Those classified in the Profarma program as very good or excellent companies, participating in R & D consortia or temporary associations made for this purpose with other companies established in Spain and R & D public and private, for research basic and preclinical relevance through specific and specific projects, may benefit from additional netted from ten percent of the contribution.

The minoraciones that may affect these returns will take effect from the last resolution of Profarma program.

Business groups sent to the Ministry of Health, Social Services and Equality, during the month of January of each calendar year, the companies integrated into them. If the composition of a business group is changed in the course of the year, the communication will take place during the month in which the change has taken place. For the purposes of the above, it is considered to belong to the same group companies which constitute a decision unit, under the terms of Article 4 of Law 24/1988 of 28 July, on the Securities Market.

2. The Ministry of Health, Social Services and Equality, based on the provisions of the preceding paragraph and sales for the current year, communicate the amount to be paid to each manufacturer, importer or affected offeror and the payment period of that amount . In the first installment of the following year will be made, where appropriate, the adjustment of quarterly liquidations, assuming they have incorporated the record data not taken into account in the aforementioned partial settlements.

3. The amounts to be paid will go towards research in the field of biomedicine, sufficient to finance the needs of clinical research carried out amount, through the sectoral initiative research in biomedicine and health sciences, thus entering in the case of Carlos III Health Institute. The remaining funds will go to the development of policies for health cohesion, training programs for medical practitioners, dentists, pharmacists and nurses, as well as health education programs for the population to promote the rational use of medicines, according to the distribution determined by the Ministry of Health, Social Services and Equality, the report of the Inter-Territorial Council of the National Health System, thus entering the Treasury.

Seventh additional provision. Preservation of organs for transplantation.

Solutions for preserving organs for transplantation, shall be governed, as far as applicable to them, as provided in this law for drugs.

Eighth additional provision. Advertised drugs.

The price set in the container of medicinal products which are subject to the advertising provided for in Article 80 it shall be considered as maximum retail price. The maximum discount applicable regulations shall be established by the pharmacy.


Ninth additional provision. Genetically modified organisms.

Activities contained use and deliberate release of genetically modified organisms that are incorporated or can be incorporated into medicinal products for human or veterinary use it are subject to the provisions of Law 9/2003 of 25 April, which establishes the legal regime for the contained use, voluntary release and commercialization of genetically modified organisms and its implementing regulations.

Tenth additional provision. Participation of the autonomous communities and mutuals officials in decision-making procedures for medicines and medical devices.

The autonomous communities and officials Mutual participate in the terms established by regulation, in the Governing Council of the Spanish Agency for Medicines and Health Products, as a collegiate management body of the organism. The Agency will be assisted by independent experts of recognized scientific prestige proposed by the autonomous communities.

The Ministry of Health, Social Services and Equality provide a report to all regions and Mutual officials at each meeting of the Standing Committee of Pharmacy Interterritorial Council of the National Health System, identifying the name of the drug and medical devices that have been authorized by the Spanish Agency for medicines and Health products since the last meeting of the Council and the price of those drugs and medical devices that have been included in the financing of the National Health System.

Eleventh additional provision. Quality assurance, safety and efficacy of pharmaceutical products and the protection of patients.

The authorities, in the exercise of its powers, ensure compliance with the provisions of this law, in order to ensure the quality, safety and efficacy of pharmaceutical products and the protection of patients. In particular, they shall ensure, through its inspection and control functions, compliance with the requirements of the pharmaceutical legislation.

Twelfth additional provision. Placement or delivery of medical devices as by a physician.

The placement or delivery of medical devices as by a physician, in the exercise of their professional duties, shall not be considered dispensing, marketing, sales, distribution, supply or placing on the market thereof, for the purpose articles 4.1 and 111. in any case, the practitioner must separate their fees manufacturing costs.

Thirteenth additional provision. Information lower prices of homogeneous groups of drugs and medical devices.

1. For the purposes of applying the assumptions dispensing and replacement of Articles 88 and 90, respectively, the Directorate General of Basic Services Portfolio of the National Health System and Pharmacy, Ministry of Health, Social Services and Equality publish on its website, by the Gazetteer of pharmaceutical products of the National Health System, information on homogeneous groupings of presentations of medicines and medical devices requiring outpatient for official dispensing prescription or order dispensing.

The information about lower prices will be updated on the first business day of each month and published on the website of the Ministry of Health, Social Services and Equality.

2. In each homogeneous group of medicines presentations of medicines financed by the / the same / s first / active s / s regarding dose, content, dosage form or group of dosage form, and route of administration that can be be integrated exchange object dispensing.

Homogeneous groups of drugs integrated exclusively for drug and its licenses with the same price will differentiate the reference medicine.

3. Also, in each homogeneous grouping of medical devices will be integrated, whenever possible, presentations financed, bearing the same characteristics, type, size and content and being classified according to the groups listed in Annexes I and II of Royal Decree 9 / 1996 of 15 January, by which the selection of effects and accessories regulates funding with funds from the Social Security or state funds earmarked for health and rate of supply and dispensing outpatient, can be exchanged in dispensing.


4. If the variations in the prices of medicines or medical devices and so advice and agreement of the Standing Committee of Pharmacy Interterritorial Council of the National Health System, said Directorate General may update the information of lower prices, affecting if any such update to all groups, or groups deemed relevant, and incorporate new groups, and establish deadlines for coexistence price and return of stocks, presentations of medicines and medical devices that have voluntarily reduced price depending on the retail price of each group, being able to authorize such a reduction is made without changing the national code.

For information purposes updates the information of lower prices will be included in the List of pharmaceutical products of the National Health System, the periods ended as the case had been established.

Fourteenth additional provision. Exception of the legal regime provided for in Article 43.1 of Law 30/1992 of 26 November.

1. Without prejudice to the procedures listed in ninth twentieth additional provision of Law 14/2000 of 29 December on Fiscal, Administrative and Social Order, corresponding to the exception provided in Article 43.1 of Law 30/1992 Measures, of November 26, they are understood to include that exception, the following:

A) Authorization and major modifications of pharmaceutical laboratories.

B) Authorization for import, export and manufacture of unregistered medicines.

C) Exceptional authorization of export of medicines for humanitarian donations.

D) Statement of medical innovation of therapeutic interest.

E) Authorization, modification and renewal of the parallel importation of drugs.

F) Authorization of drugs decentralized procedure between States of the European Union.

2. The procedure for registration and approval of medical devices not included in the scope of Royal Decree 1616/2009, of 26 October, by which the active implantable medical devices are regulated, and Royal Decree 1591/2009, of 16 October, by which medical devices contained in the twenty-ninth additional provision of Law 14/2000 of 29 December regulating, is excluded from the exemption provided in Article 43.1 of Law 30/1992, 26 of November.

Fifteenth additional provision. Renewal of authorizations of medicines.

A drugs whose authorization has been renewed after the entry into force of Law 29/2006 of July 26, they will apply, after that renewal, current regulations regarding the periodic safety update reports .

Sixteenth additional provision. Application of system pricing in health products authorized prior to the entry into force of Law 29/2006 of 26 July.
Medical devices
previously authorized the entry into force of Law 29/2006 of July 26, will have a maximum wholesale price resulting from the application of the price system regulated in this law, starting from the corresponding PVP and discounting marketing margins.

First transitional provision. Data exclusivity periods applicable to applications for authorization submitted before 1 November 2005.

Periods of data exclusivity for the reference medicines which had submitted a request for authorization before 1 November 2005 shall be those prevailing prior to the entry into force of Law 29/2006 of July 26.

Second transitional provision. Conflict of interests.

Without prejudice to compliance with the provisions of this law and, in particular Article 4 pharmacists in practice with pharmacy in retail business establishment, entities or livestock groups or services hospital pharmacy and other care structures, the entry into force of Law 29/2006 of July 26, have a direct interest in authorized pharmaceutical laboratories, may maintain those interests until the expiry of the authorization or transfer of the laboratory.


Also related pharmacists in the previous paragraph that part or that may become part of cooperatives with a minimum of 20 cooperatives or corporations with a minimum of 100 shareholders or members, formed in both cases exclusively by cited pharmaceutical and existing at the entry into force of Law 29/2006, of July 26, may participate in them until its dissolution, provided it does not involve a potential conflict of interest.

Third transitory provision. Transitional arrangements for automatic identification of each drug unit along its route.

As is not statutorily set the mechanism that allows automatic identification of each drug unit along its route, in accordance with Article 90, pharmaceutical laboratories and distribution entities shall promptly inform the Ministry of Health, Social Services and Equality, under the terms established by the Ministry by order, batch data and the number of sold or supplied units and which are subject to refund in national territory, specifying the recipient, both in the case of pharmacies or pharmacy services or other distribution entities.

First final provision. competential title.

This law is issued under the following competence titles of state:

1. The preliminary title; Titles I; II, except for Article 38; III; IV, except Articles 67 to 70 of Chapter II; V; SAW; Articles 77.2, 78, 80-82, 84 and 87 to 90 of Title VII; Articles 93 to 99 of Title VIII; and IX; additional provisions first, second, seventh, eighth, thirteenth, fifteenth and sixteenth and transitional provisions, have the status of legislation on pharmaceutical products and are issued under Article 149.1.16 of the Constitution.

2. Articles 38, 67 to 70, 77.1, 3, 4 and 5, 79, 83, 85, 86, 100 and 104-107 and the third additional provisions, fourth, ninth to twelfth and fourteenth, have the status of basic legislation and They are issued under Article 149.1.16 of the Constitution, which grants the State exclusive competence on bases and overall coordination of health.

3. Articles 91, 92 and 101-103, as well as additional provisions fifth and sixth, they are issued under Article 149.1.17.ª of the Constitution, which grants the State exclusive competence in economic system of Social Security .

4. Title X is issued under Article 149.1.6.ª of the Constitution, which grants the State exclusive jurisdiction in matters of procedural law.

5. Title XI is issued under Article 149.1.14.ª of the Constitution, which grants the State exclusive competence of the Treasury General.

Second final provision. policy development.

The Government is authorized, in the scope of its powers, to approve the rules and regulations for the implementation and development of this law.