JOHN CARLOS I

KING OF SPAIN

To all who present it and understand it.

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

EXPLANATORY STATEMENT

Ordering drugs is a universally felt need. The World Health Organisation has repeatedly urged the Member States to establish and implement a policy of scale in relation to medicinal products. This organization has been developing in this field, for several decades, normative functions, advising and exchange of information that for its magnitude and quality constitute an unavoidable reference point. Incorporating their fruits and results to the benefit of the health of the Spanish and contributing our capabilities to the international solidarity circuit that the WHO assumes, requires legal and institutional improvements.

the European Economic Community, for its part, has since 1965 developed an intense activity in the harmonization of the right of directives and recommendations concerning medicinal products with measures which involve the crystallization of all a Western tradition in defence of the interests of patients and consumers. Evidence of this is the numerous Directives already enacted on the basis of the health conditions required for the marketing of proprietary medicinal products and Community procedures for the harmonization of national decisions. (a) the cooperation mechanisms established for the monitoring of adverse reactions and the exchange of information when the safety of the sick is at stake, as well as the recent socio-economic provisions oriented towards the unification of the European market.

Over the past 25 years almost all developed countries have enacted their drug laws. Two generations of drug laws can be talked about, a first, until the 1960s, it demands security, but it does not claim demonstration of effectiveness. After 1962, the Talidomide catastrophe introduces a fundamental change and allows to speak of a second generation of laws that demand safety and proven efficacy with controlled clinical trials. In the United States in that year the Kefauver-Harris amendments to the Food, Drugs and Cosmetics Act are approved. In 1964 they also altered their legislation Norway and Sweden. England passes their law in 1968. Switzerland arrives at the Intercantonal Convention in 1971, Germany promulgates its law in 1976. Austria, Belgium and Greece do so in 1983. Japan has also introduced legislative amendments on several occasions since 1961. Now, perhaps, we are facing a third generation of drug laws: The concern has shifted from the requirements that the product has to meet to the conditions for its rational use.

Our Constitution already contains the cornerstones in which to support the relaunch of Spain's participation in this global dynamic by establishing in its article 43 the right to health protection and to indicate how exclusive competence of the State in its Article 149.1.16, the competence and responsibility of the legislation on pharmaceutical products.

According to the mentioned international trends and commitments and with the constitutional mandate, the Law of the Medication seeks, in the first term, to propel the progress of health care by providing institutional support firm to a determined effort to take advantage of the benefits and reduce the risks that the drugs are susceptible to provide. In the last 80 years, the drugs have achieved memorable successes in the prevention and fight against pain and disease. Scourges that since ancient afflict Humanity as smallpox have been erased from the face of the Earth to mention but an example to which many others could be added. In reality a large part of the medical or surgical acts and procedures include a medication treatment. The benefits of medicines are not only expressed in terms of lives saved and suffering avoided, but also in terms of sick time and hospitalization shortened, as well as in very important economic savings from the function (a) replacement of the following in relation to less effective preceding therapies.

These spectacular benefits should not make us disparage, however, the adverse reactions that can be presented and that exemplifies the tragedy of Talidomide. The abuse of medicinal products whose rational use is beneficial may lead to serious health problems, for example, irreversible renal or hepatic inadequacies. There is also the under-utilisation of medicines, however, available.

This Standard also wants to promote new technologies by enhancing the indissoluble union between drugs and scientific and technological development, to which new perspectives are opening today. It is no coincidence that the first biotechnological products of general consumption are medicines. In Spain, the Plan for the Promotion of Research in the Pharmaceutical Industry, integrated in the National Plan of Pharmaceutical Research and Development, should be supported by legislation of the drug that will organize the admission of products in order to benefit the patients as soon as possible and the investments made in their discovery can be recovered without delay.

The pharmaceutical industry needs a stable legal framework that constitutes its strategic reference and that this Law comes to crystallize. It is an industry with a future for which public health control mechanisms, which regulate their access to the market with new products and influence their research activities and the process of competition, are vital. The Spanish market for medicines is the eighth world market and the companies established in Spain have aggregate volumes of production, employment and foreign trade and carry out an effort of research and technological development that make this one of the most dynamic sectors of the national economy.

On the other hand, productive structures are undergoing major transformations: acquisition and concentration of companies, mergers, participation in capital, and the creation of new companies.

The primary objective of the Law is to contribute to the existence of safe, effective and quality medicines, correctly identified and with appropriate information. To achieve this, it sets:

A) The principle of public intervention, by subjecting the marketing of medicinal products to health authorisation and prior registration which are of a constitutive nature to these effects and which determines that the medicinal products are legally recognised and non-clandestine.

B) A closed list of legal drug categories.

C) The conditions to which drug research should be adjusted, especially in people.

D) The criteria that should govern the evaluation process, prior to authorization, of the specialty pharmaceutical to verify that it can be placed on the market:

(a) High technical level, guaranteed with the realization and signature by qualified experts of the studies and protocols; definition of correct laboratory and clinical procedures and standards of correct manufacturing.

b) Safe, effective, quality, correctly identified product with appropriate and up-to-date information in accordance with technical progress, which is guaranteed with analytical, pharmacological, toxicological and clinical studies, quality, designations, labelling, packaging, technical information and package leaflet and the authorisation of five-year validity, all in accordance with the Community Directives.

c) Enterprise with capacity, guaranteed with timely authorization.

d) Responsible, agile, neutral, rigorous, true and flexible administrative action, secured with the allocation of powers to a specialised body; a detailed procedure, licences and standardised technical sheets; organized in a register and informatised and with singularities when they are required by the circumstances of the product.

E) The Law also regulates the conditions of manufacture and foreign traffic with instruments such as the Spanish Royal Pharmacopoeia, the National Form and the Rules of Good Manufacturing.

F) The public intervention system continues once the drug is made available to healthcare professionals and the public. The surveillance of adverse reactions is regulated, ratifying the duty to declare them and giving the basic rules of operation of the Spanish Pharmacovigilance System as an integral element of the plans and programs carried out by the different Public administrations and healthcare professionals on one side and on the pharmaceutical industry of another.

G) Also establishes the review of medications to adjust the already available to the requirements of the Law.

This provision primarily pursues health objectives, but also involves economic and business objectives. A rigorous, agile and neutral evaluation mechanism is essential for business development by ensuring market access, fast and without discrimination between companies. It also promotes more efficient research and technological development by priming relevant therapeutic products. It maintains the powers of the Administration for the direct intervention of the prices of proprietary medicinal products, justified by the presence of very important market failures. It also includes the precise precepts to enable a policy of promoting market transparency: it facilitates, in its technical aspects, the conclusion of competitive competitions as methods of purchase by hospitals; use of international common names to facilitate the use of generic medicines; regulates the ability of the pharmacist to replace, for legitimate reasons, trade marks relating to equal products and control Advertising administrative that contributes to the transparency of the market.

The provision of medicines by the National Health System at reasonable prices and with a tight public expenditure is made possible through selective and non-indiscriminate public funding (already established by the General Law of Health) and a selective contribution of the sick.

In order to achieve these objectives and in the context of commitments to match the requirements of the Community, the Law starts the process of harmonization with the relevant Directives or medicinal products, which will be supplemented by the regulatory provisions to be enacted in the development of such regulations.

The Law has been structured by distributing its content in Titles and Chapters.

The First Title, relating to General Provisions, comprises only five articles. The first article is part of the consideration that they are the subject of regulation by this Law, not only the medicinal products for human and veterinary use, but also the medical devices that are used for therapeutic, preventive or It is a fact that, as a result of this, it is not possible to apply the rules, criteria and own requirements for the purposes of achieving the same purpose as the law itself. they are intended for medicines.

On the other hand, this article first completes the scope of the Law, pointing out that it is also the subject of regulation by the law of all those persons who participate in the circulation of these products, that the legal regulation of medicinal products cannot be understood without the correlative regulation of natural or legal persons involved in an important part of the process, by virtue of which medicinal products produce their efficacy.

The second article, for its part, comes to frame the content of the Law in the various competing titles that converge in this matter, with a scrupulous respect for the Constitution and the different levels of competition. which are held by the Autonomous Communities.

In this framework, it is necessary to take into account the fact that, in terms of state competition, pharmaceutical products meet several different legal titles, although they operate with different intensity in the various titles in which the Law is structured.

With a prevailing character, the state competence is collected, on the one hand, in the exclusive competence conferred on the State by Article 149.1.16. of the Constitution, when the "legislation on the subject" is reserved exclusively to the State. "pharmaceutical products", and from another, the competence that the same precept also attributes to the State to establish "the bases and general coordination of health".

For their part, the state funding of the drugs is justified in the exclusive competence that the State corresponds to determine the economic regime of the Social Security.

In addition to these specific titles, other aspects of this Law connect with other competences than the State reserves the article 149.1 of the Constitution: it is the case of the import and export of the products In the case of pharmaceutical products, which are covered by the State competition in the field of external trade: the promotion of scientific and technical research in the field of medicinal products: or state competition in the field of economic planning, This law designs for the pharmaceutical industry and, in particular, in terms of administrative intervention of the prices of the medicinal products.

All this, as has already been indicated, regardless of the differences that the Statutes of Autonomy present in terms of the competences assumed by the Autonomous Communities in the matters governed by this Law.

On the basis of these considerations, the second article states that the provisions of the Law are pharmaceutical legislation, and as such exclusive competence of the State, both for its establishment in this Law and for the future promulgation of other laws or regulations, and which others have the consideration of basic standards or general coordination of health, or of rules relating to the economic regime of Social Security, without making further details on the other concurrent ratings, which would be explicit.

Finally, Articles 3, 4 and 5 are devoted to the obligation of supply and supply and to establish, without prejudice to the incompatibilities already established for the exercise of public activities, the incompatibilities professionals in this field, as well as the obligation of information among the Public Administrations, for the purposes of safeguarding the health and public safety and proper functioning of this Law.

The Second Title, which is generally initialled as medicinal products and expressly qualified as pharmaceutical legislation, is divided into several chapters, dedicated, respectively, to regulating the drugs and their classes, the assessment, authorisation, registration and conditions for dispensing of proprietary medicinal products, the health requirements of other medicinal products, special medicinal products, pharmacopoeia and quality control and pharmacovigilance.

The First Chapter states what are the legally recognized drugs and their definitions for the purposes of the Act.

The Second Chapter regulates an essential part of all pharmaceutical legislation, such as the evaluation, authorization and registration of proprietary medicinal products.

By means of Articles 9 to 34, the Law regulates in the first term all the process, requirements and guarantees required for the granting of the authorization of the medicinal products, establishing the guarantees of safety, non-toxicity or tolerance, efficiency, quality, purity and stability, identification and information to be met for the relevant authorisation. This is set out as a singularized and successive process which culminates with an express pronouncement of the state body in which it decides not only whether the product should be authorised as a medicinal product but also other extremes such as the funding or its advertising specialty condition.

This last end is dealt with in its entirety in this Chapter because of its inescapably linked nature to the authorization procedure, which makes the information and advertising regime of the advertising pharmaceutical specialties cannot be dissociated from the authorisation and registration process, as it is in this process that the requirements that can be configured as such are to be assessed and it is precisely the verification or verification between the data in the Register and the content of the advertising message which determines the possibility of such authorisation advertising.

The Fourth Chapter is dedicated to special medicines, regulating through different sections, biological drugs, those of human origin, narcotic drugs and psychotropic drugs, those of medicinal plants, radiopharmaceuticals, homeopathic medicinal products and veterinary medicinal products. The latter are subject to regulation in accordance with Community rules. Accordingly, the Law regulates these products on the basis of the configuration and the nature of the medicinal product granted to them by the Community legislation and which, consequently, requires their regulation in a Law on the Medicines, taking into account, by another part, its possible impact on the human being, indirectly, through the consumption of food.

The last two Chapters-Fifth and Sixth-of this Title Second address, respectively, the Pharmacopoeia, as a code of rules to be respected, and pharmacovigilance, in its double aspect of collection and communication of the information on adverse drug reactions.

The Third Title is dedicated to clinical trials with a legal treatment of these that aims to combine the two factors that converge in this field: the need for its existence as a necessary mechanism for the advances (a) scientists and the obligation to respect the fundamental rights of those who are subject to clinical trials. Given the nature of this activity, the law accurately regulates the administrative intervention in clinical trials, requiring its express authorisation on a case-by-case basis, after evaluation of all the personal, material and material elements. research.

The Fourth Title of the Law consists of two chapters dedicated to pharmaceutical laboratories and wholesale warehouses.

The First Chapter is set out in the law as regulations under the jurisdiction of pharmaceutical legislation, since the authorization of a pharmaceutical laboratory could not be understood as dissociated or as a independent act of the authorization of the proprietary medicinal product itself, since the authorization of the same is conditioned, among other things, by the assessment, verification and analysis of all the human equipment, material and technical of the the laboratory which, therefore, is integrated as a whole in the process of authorization of the specialty. The Second Chapter, dedicated to the Wholesale Warehouses, is conceived as basic regulations in order to ensure a homogeneous content of these establishments, granting special relief to the figure of the Technical Director, given the health importance which has the handling of pharmaceutical products at this stage of their distribution.

Title V, which is also considered as pharmaceutical legislation, regulates in full compliance with Community legislation, health guarantees for the external trade in medicinal products.

According to the latest guidance of the most modern drug laws, the Law devotes the entire Title Sixth to the establishment of a set of rules and principles on the rational use of medicines. Given the extent, and to some extent, heterogeneity of what is established in this Title, its precepts participate and are sometimes a reflection of the state competence on pharmaceutical legislation, while others are qualified as normative. (a) basic health, or as rules relating to the economic system of social security, bearing in mind that, as regards the rational use of medicinal products, the conditions of basic equality in the right to protection of the health as proclaimed in Article 43 of the Constitution.

For the proper understanding of this Title and its content, it is necessary to take into account that under the generic name "rational use of medicines", a concept recently enshrined by the WHO, is included in the (i) the whole range of activities which are intended not only for adequate use by the potential patient of the medicinal product but also, and above all, for regulatory measures such as training and information, conditions, establishments, forms and instruments of supply to both the public and the attention centres health and forms of possible public funding for medicinal products. It is, in short, a set of measures and matters of unavoidable regulation in a legal standard on medicinal products, and which, although disparate and different, may nevertheless be grouped under the heading given to this Title by virtue of the rational use an ultimate end to which, regardless of others, they all respond.

To achieve this objective, the Law, based on the consideration that it is a basic principle of primary health care to have structures of technical support for the participation and collaboration of the healthcare professionals, adequately trained in the rational use of medicines:

A) It establishes the principle of the empowerment of programs of university and continuous training of Pharmacology and Clinical Pharmacy, as well as the development of an adequate system of information of medications.

B) Regulates the principles of medical prescriptions.

C) Imposes the rules that should govern information and promotion aimed at healthcare professionals.

D) Impresses the introduction of improvements in primary, specialized, and hospital care.

The Title Seventh of the Law, through Advisory Commissions, the participation of health professionals from the National Health System, Research and Development and Teaching in the evaluation and control of the (i) medicinal products in accordance with the guidance already provided for in the General Law on Health and in harmony with the countries of the European Economic Community which have a high tradition in this type of participation and coordination necessary to protect the neutrality of decisions and the use of resources.

The Law dedicates its last three Titles to the intervention of drug prices, the sanctioning regime and the fees.

The Law, at last, aims to provide Spanish society with an institutional instrument that allows it to confidently hope that the problems related to drugs are addressed by how many social agents are involved in its management (pharmaceutical industry, healthcare professionals, public authorities, citizens themselves) in the perspective of improving health care.

TITLE FIRST

General provisions

Article 1. Scope of the Law.

1. The Law regulates, in the field of competences corresponding to the State, the manufacture, production, quality control, circulation, distribution, price regime, marketing, information and advertising, import, export, storage, prescription, dispensing, evaluation, authorisation and registration of medicinal products for human and veterinary use, as well as the management of their rational use and the intervention of narcotic drugs and psychotropic substances. The regulation also extends to the substances, excipients and materials used for their manufacture, preparation or packaging.

2. It also regulates the action of natural or legal persons as they intervene in the industrial or commercial circulation of medicinal products or who, by their professional qualifications, can guarantee, control, prescribe or dispense them.

3. Equally and within the scope of the competences that correspond to the State, this Law regulates the principles, norms, criteria and basic demands on the efficacy, safety and quality of Sanitary and Personal Hygiene Products.

Art. 2. Legislation on pharmaceutical products and basic regulation.

1. The provisions of Title 1, Second, except Article 50, Third, Fourth, except Chapter II, Fifth, Articles 84.2 and 86 of Title VI, Titles Seventh, Eighth, Ninth, Tenth and Additional Provisions First, Second and Fourth and all Transitional Provisions, as well as development standards, have the status of legislation on pharmaceutical products in accordance with the provisions of Article 149.1.16. of the Constitution.

Likewise, under the terms of Article 149.1.1. and 17. of the Constitution, on the regulation of the basic conditions that guarantee the equality of all Spaniards and the economic regime of social security, the provisions of the Articles 94, 95 and Additional Disposition Seventh is the exclusive competence of the State and the Development Provisions are State-owned.

2. The provisions of Articles 50, 77 to 80, 84.1, 3, 4, 5 and 6, 85, 88, 89, 90, 93, 96, 97, and 98, Additional Third and Additional Provision, as well as the express references to the basic regulations to be made by the Government, have the status of a basic rule within the meaning of Article 149.1.1. and 16. of the Constitution on the basis and general coordination of health.

3. Articles 87, 91 and 92 shall apply throughout the national territory in the absence of specific regulation by those Autonomous Communities with regulatory competence in the field of pharmaceutical management.

Art. 3. Obligation to supply and supply.

1. The laboratories, importers, wholesalers, pharmacy offices, pharmacy services of hospitals, health centers and other health care structures are obliged to supply or to dispense the medicines requested in the legal and regulatory conditions established.

2. Those responsible for the production, distribution, sale and supply of medicinal products shall respect the principle of continuity in the provision of service to the community.

3. The prescription and dispensing of medicinal products must be in accordance with the basic criteria of rational use laid down in this Law.

4. It is prohibited to sell at home and any type of indirect sale to the public of medicinal products, without prejudice to the distribution, distribution or supply to the legally authorized entities for dispensing to the public.

5. The custody, conservation and dispensing of medicinal products for human use shall be:

-To the pharmacy offices open to the legally authorized public.

-To the pharmacy services of hospitals, Health Centers and Primary Care structures in cases and under conditions to be established in accordance with Article 103 (1) of the General Law of Health.

Art. 4. Professional incompatibilities.

1. Without prejudice to the incompatibilities laid down for the exercise of public activities, the clinical practice of medical, dental and veterinary medicine shall be incompatible with any kind of direct economic interest derived from the manufacture, manufacture and marketing of medicinal products and medical devices.

2. Likewise, the professional practice of the pharmacist in the office of pharmacy or in a hospital pharmacy service and other care structures shall be incompatible with any kind of direct economic interests of the laboratories. pharmacists.

3. The clinical practice of medicine, dentistry and veterinary medicine shall be incompatible with the ownership of the pharmacy office.

4. Membership of the National Drug Evaluation Commission or the Ethical Committees of Clinical Research shall be incompatible with any class of interests arising from the manufacture and sale of medicinal products and medical devices.

Art. 5. Reporting obligations among public administrations.

For the purpose of safeguarding health and public safety requirements, Public Administrations are obliged to communicate how much data, actions or information is derived from the exercise of their competencies and results necessary for the proper functioning of this law.

TITLE SECOND

Of the drugs

CHAPTER FIRST

Of the medications recognized by the Law and its classes

Art. 6. Legally recognised medicinal products.

1. Only those legally recognised as such and listed below shall be:

a) The proprietary medicinal products.

b) The master formulas.

c) Official formulae or formulas.

d) Prefabricated drugs.

2. They shall have the legal treatment of medicinal products for the purposes of the application of this Law and of their general control substances or combinations of substances specially qualified as "clinical research products" authorised for their use. use in clinical trials or for animal research.

3. It is for the Ministry of Health and Consumer Affairs to decide on the allocation of the medicinal product to certain substances or products.

4. Secret remedies are prohibited.

5. It is mandatory to declare to the health authority all known characteristics of the medicinal products.

Art. 7. Prohibited activities.

1. The production, manufacture, import, export, distribution, marketing, prescription and supply of products or preparations which are to be presented as medicinal products and which are not legally recognised shall give rise to the Sanctions provided for in Chapter II of Title Ninth of this Law, regardless of the precautionary measures that proceed.

2. It is expressly prohibited:

(a) The direct or indirect offer of any incentive, premiums or gifts, by those who have direct or indirect interests in the production, manufacture and marketing of medicinal products to professionals Health care providers involved in the cycle of prescribing, dispensing and administration, or their relatives and people of their coexistence.

b) The performance of these same professionals, provided that they are in exercise, with the functions of medical visit delegates, representatives, commission agents or agents of the specialty laboratories pharmaceutical.

c) Advertising of formal formulas and formal preparations.

Art. 8. Definitions.

For the purposes of this Law:

1. 'medicinal product' means any medicinal substance and its associations or combinations intended for use in humans or animals provided with properties to prevent, diagnose, treat, alleviate or cure diseases or diseases; or to affect body functions or mental state. Medicinal substances or their combinations which may be administered to humans or animals for any of these purposes are also considered as medicinal products, even if they are offered without explicit reference to them.

2. 'Medicinal substance' means any matter, whatever its origin-human, animal, plant, chemical or other-to which an appropriate activity is attributed to constitute a medicinal product.

3. 'Excipient' means a matter which, in the form of galenic forms, is added to medicinal substances or to their associations to serve as a vehicle, to enable them to be prepared and stable, to modify their organoleptic properties or to determine the physico-chemical properties of the medicinal product and its bioavailability.

4. 'Raw material' means any substance-active or inactive-used in the manufacture of a medicinal product, whether unchanged, modified or removed during the course of the process.

5. 'Gallic form or pharmaceutical form' means the individual provision to which medicinal substances and excipients are adapted to constitute a medicinal product.

6. 'pharmaceutical specification' means the medicinal product of composition and defined information, in the form of a pharmaceutical form and dosage, prepared for immediate medicinal use, prepared and conditioned for dispensing to the public, with a name, packaging, packaging and uniform labelling for which the State Administration grants health authorisation and enrolls in the Register of proprietary medicinal products.

7. 'Prefabricated medicinal product' means a medicinal product which does not comply with the definition of a medicinal product and which is marketed in a pharmacetic form which may be used without the need for industrial treatment and to which the State Administration Grant health authorization c enrol in the corresponding Register.

8. 'intermediate product' means a product intended for further industrial processing by an approved manufacturer.

9. 'Master formula' means a medicinal product intended for an individual patient, prepared by the pharmacist, or under his/her address, to expressly complete a detailed optional prescription of the medicinal substances which it includes, according to the technical and scientific standards of pharmaceutical art, dispensed in its pharmacy or pharmaceutical service and with due information to the user in the terms provided for in Article 35.4.

10. "Prepared or formal formula": a medicinal product prepared and guaranteed by a pharmacist or under his/her address, dispensed in his pharmacy or pharmaceutical service, listed and described by the National Form, intended for delivery direct to the sick to whom the pharmacy or pharmaceutical service is supplied.

11. 'clinical research phase product' means a product intended only to be used by experts qualified by their scientific training and experience for research in humans or animals on their safety and efficacy.

12. 'sanitary product' means any instrument, device, equipment, material or other article, including accessories and software which are involved in the proper functioning of the device, intended by the manufacturer to be used in human beings, alone or in combination with others, for:

-Diagnosis, prevention, control, treatment, or relief of a disease or injury.

-Research, replacement or modification of the anatomy or a physiological process.

-Regulation of a conception.

Whose main action is not achieved by pharmacological, chemical or immunological means, or by metabolism, but whose function such means may be present.

13. 'Personal hygiene product' means a product which, directly applied to the skin or healthy mucosa, is intended to combat the growth of micro-organisms, as well as to prevent or remove ectoparasites from the human body or to eliminate risks The invention relates to the use of therapeutic prostheses that are applied to the human

.

CHAPTER SECOND

From assessment, authorization, registration, and dispensing conditions for proprietary medicinal products

Art. 9. Authorization and registration.

1. No medicinal product shall be regarded as a medicinal product, nor may it be placed on the market as such without the prior health authorization of the State Administration and the simultaneous registration in the Register of Pharmaceutical Specialties.

2. Any modification, transmission and termination of the authorization of proprietary medicinal products shall be recorded in the Register of Proprietary Medicinal Products which, for these purposes, shall be in the same manner as the registration, constitutive character.

3. Public authorities may not acquire proprietary medicinal products authorised in Spain for their health services under conditions other than those laid down in the Register of Proprietary Medicinal Products, except for express authorization and justified by the Ministry of Health and Consumer Affairs.

Art. 10. Conditions for the authorisation of proprietary medicinal products.

1. Health authorization shall be granted to a medicinal product if it satisfies the following conditions:

a) Be safe, that is, when under normal conditions of use it does not produce toxic or undesirable effects disproportionate to the benefit it seeks.

b) Be effective in the therapeutic indications for which it is offered.

c) Reach the minimum quality and purity requirements to be established.

d) Be correctly identified and accompanied by accurate information.

2. The holder of the authorisation or, where appropriate, the manufacturer must have the material and personal means, the organisation and the operational capacity sufficient for its proper manufacture.

3. The effectiveness and safety or non-toxicity of points (a) and (b) of paragraph 1 of this Article shall be assessed in their reciprocal relationship and taking into account the state of the science and the particular destination of the medicinal product concerned.

Art. 11. General assurance of the assessment.

1. Studies, data and information submitted with the application for authorization of a proprietary medicinal product to justify compliance with the conditions and guarantees referred to in this Chapter must have been prepared and endorsed with his signature by experts with sufficient technical and professional qualifications.

2. Studies and analyses of proprietary medicinal products shall be in accordance with established good laboratory and clinical practice.

3. Packaging, packaging and labelling of proprietary medicinal products shall ensure their prompt and unambiguous identification, perfect preservation and reasonably expected accidents.

Art. 12. Safety guarantees, no toxicity or tolerance.

1. The medicinal products and medicinal products which comprise them shall be the subject of toxicological studies to ensure their safety under normal conditions of use and which shall be in relation to the intended duration of the treatment.

2. These studies shall include studies of acute and chronic toxicity, teratogenic tests, embryotoxicity, fertility, mutagenesis tests and, where necessary, carcinogenesis and, in general, those other than those considered necessary for a correct assessment of the safety and tolerance of a medicinal product under normal conditions of use and depending on the duration of treatment.

3. The excipients of the medicinal products, with the exclusions and limitations that they may have, will be regulated in accordance with the provisions of this Law.

Art. 13. Guarantees of effectiveness.

1. Studies must be available in animals whose results demonstrate the pharmacological actions produced by the medicinal product or substances of the medicinal product and its destination in the body. In any case, the Community and national provisions on the protection of animals used for scientific purposes shall be respected.

2. Such studies shall reproduce the effects of different doses of the substance and also include one or more control groups not treated or treated with a reference product.

3. Pharmacologic studies in animals should not be limited exclusively to the effects related to the indications of the medicinal substance, but shall necessarily include information on the effects of their application.

4. The efficacy of the medicinal products for each of their indications should be established in an appropriate manner, by means of the prior conduct of sufficiently qualified clinical trials.

Art. 14. Guarantees of quality, purity and stability.

1. Every pharmaceutical specialty must have its qualitative and quantitative composition perfectly established. Alternatively, in the case of substances such as biological substances where this is not possible, their preparation procedures should be reproducible.

2. In each case, defined procedures for chemical, physico-chemical, biological or microbiological analysis, as appropriate, must exist and be used by the manufacturer, and the accuracy limits of those methods should be known, so as to establish accuracy. of this composition and the uniformity of the preparation.

3. The permissible limits of quantitative variability in the composition of the specialty shall be established in accordance with the provisions of this Law.

4. Similarly, established quality control methods must be carried out by the manufacturer, with reference to raw materials, intermediates, bulk and end products by the manufacturer, as well as packaging, labelling and packaging material, in their case.

5. The manufacturing process of the specialty must conform to uniform and detailed guidelines, according to the Good Manufacturing Standards. In the case of biological substances, the different stages of manufacture shall be suitably validated so that the purity and maintenance of the properties of the substances can be accurately assessed.

6. In each case, the Laboratory responsible shall carry out galenic tests to ensure the stability and conservation conditions of the specialty.

7. The Ministry of Health and Consumer Affairs shall establish the type of checks required of the manufacturer to ensure the quality of the raw materials, intermediate products, manufacturing process and final product for the purposes of the authorization and (a) registration, with the continued use of such controls for the duration of production and/or marketing of the medicinal product. Quality control procedures shall be modified in accordance with the progress of the technique.

8. The Administration shall carry out periodic checks on the quality of the proprietary medicinal products available on the market, raw materials and intermediate products, as well as the packaging material and storage conditions, transport and sales.

Art. 15. Identification guarantees: Spanish official denominations.

1. A Spanish official name (D.O.E.) shall be assigned to each medicinal substance by the Ministry of Health and Consumer Affairs, with the prior report of the Royal Academies of Pharmacy and other bodies of accredited scientific solvency that are deemed appropriate. The D.O.E. shall be compulsory for use, without prejudice to the fact that it may also be expressed in the official languages of the Autonomous Communities.

2. The D.O.E. shall be as close as possible, as close as possible, to the linguistic needs, to the international common names established by the World Health Organization.

3. The Ministry of Health and Consumer Affairs shall publish a list of substances authorised in Spain

the D.O.E.

4. The D.O.E. of medicinal substances shall be in the public domain.

5. They may not be registered as marks for distinguishing medicinal products from official Spanish designations or international common names or other names which may be confused with each other.

The Health Administrations shall promote, on their own initiative, the necessary actions to declare the nullity of a mark that has been registered in the Registry of Industrial Property in violation of this prohibition.

6. Public bodies, provided they mention medicinal substances, must use the D.O.E., if they exist, or, in their absence, the international common name or, in the absence thereof, the usual or scientific name.

7. The provisions of the preceding number shall apply to all cases where the composition of a medicinal product or medicinal product must appear, either on the packaging, packaging, technical information, package leaflet or on the packaging, packaging, packaging, packaging, advertising material.

8. The Ministry of Health and Consumer Affairs will promote the dissemination of the official Spanish names of medicinal products among health professionals.

Art. 16. Identification guarantees: Name of the proprietary medicinal products.

1. A proprietary medicinal product may be designated with a name of fancy or trade mark or with a Spanish official name and, failing that, with a common or scientific name already attached to a trade mark, already in the name of the holder of the authorization or manufacturer.

2. The name of the proprietary medicinal product, where it is a trade mark or a name of fancy, shall not be confused with a Spanish Official Denomination or International Denomination or mislead the therapeutic or the nature of the craft.

3. In packaging, packaging and labels, as well as in the advertising of a medicinal product containing only a medicinal substance, it must necessarily appear, together with the trade mark or fancy name in legible characters, the Official Spanish name or, failing that, the International Common Name or the usual or scientific common name of that substance.

4. In any case, the technical statement and the package leaflet shall include the Spanish Official Name, clearly highlighted, of the medicinal substances containing the medicinal product or, failing that, the International Denomination or the usual or scientific common name.

Art. 17. Guarantees, identification: Declaration of the composition.

1. The complete exact qualitative and quantitative composition, including not only medicinal substances, shall be included in the application for health authorization and in the technical fiche of the proprietary medicinal products. but also all the excipients and the solvents, even if the latter disappear in the manufacturing process.

2. Packaging, packaging, labelling and package leaflets shall be included in the conditions governing the qualitative and quantitative composition, including medicinal substances and also the excipients whose knowledge is suitable for proper administration and use of the medicinal product.

Art. 18. National code of medicinal products.

The Ministry of Health and Consumer Affairs will establish a National Drug Code of general application that facilitates its early identification, including by mechanical or computer means, and may require that its numbers or keys appear in packaging, packaging, labelling, prospectuses, technical sheets and information and advertising material relating to medicinal products.

Art. 19. Guarantees of Information: Technical document, labelling and package leaflet.

1. The holder of the proprietary medicinal product shall provide sufficient written information on his identification, indications and precautions to be observed in his employment. The texts shall be presented at least in the official Spanish language of the State.

2. Such written information shall consist of the packaging, packaging, package leaflet and the technical information sheet with the extent and details of each of these elements according to their nature and which shall be regulated by the Ministry of Health and Consumer Affairs.

3. The particulars of the specialty, the holder of the authorization and the manufacturer, where appropriate, the route of administration, the quantity contained, the price, the batch number of the manufacture, the date of expiry, the precautions to be taken, shall be included in the packaging and packaging. conservation, dispensing conditions and other data that are regulated as determined.

4. The package leaflet shall provide patients with sufficient information on the identification of the specialty and its holder and instructions for administration, use and storage, as well as on adverse effects, interactions, contraindications and other data to be determined on a regulated basis in order to promote the correct use and observance of the prescribed treatment, as well as the measures to be taken in the event of intoxication.

5. The technical information sheet shall summarise the essential scientific information on the medicinal product concerned and shall be disseminated to the doctors and pharmacists in exercise and, where appropriate, to the veterinary surgeons in question, by the holder of the authorization, prior to the marketing of the proprietary medicinal product.

The technical information sheet shall be in conformity with a uniform format and shall contain sufficient data on the identification of the specialty and its holder, as well as information requiring correct therapeutic and pharmaceutical care, agreement with the studies that support their authorisation. The technical information sheet shall be accompanied by an updated information on the price of the specialty and, where possible, the cost estimate of the treatment.

6. The package leaflet shall contain only information that is corcernent to the pharmaceutical specialty to which it relates. The fiche may also contain information from other dosages or routes of administration of the same medicinal product.

7. The information in the package leaflet and the technical information sheet, in particular for indications, contraindications, adverse effects and particular precautions for use, shall be consistent with the results of the pharmacological studies and (a) clinical trials referred to in Articles 12 and 13 and with the present state of scientific knowledge. They shall also reflect the experience gained with the proprietary medicinal product since its placing on the market.

8. The statements they contain will, in any case, be supported by scientific studies and will not be disorienting to healthcare professionals or the public.

9. The texts and other characteristics of the information sheet, labelling and package leaflet are part of the authorization of the proprietary medicinal products and must be authorized by the Ministry of Health and Consumer Affairs. Their amendments shall also require prior authorisation.

10. The registered trade mark name or generic name, if applicable, shall be printed on the packaging or, failing that, on the packaging in braile, the conditions for compliance with this requirement being laid down by the Government.

Art. 20. Guarantees in the prevention of accidents.

1. Medicinal products shall be developed and presented in such a way as to ensure the reasonable prevention of accidents, especially in relation to children and persons with diminished capacity.

2. In particular, it shall be ensured that the proprietary medicinal products are provided with safety closures or sufficiently open-proof materials, quick and easy identification procedures, and that the colours and flavours are avoided unnecessarily. attractions.

3. In addition, the packages shall bear, where appropriate, any sealing device which ensures the user that the medicinal product maintains the composition, quality and quantity of the product packaged by the manufacturer.

4. Public Administrations shall carry out information campaigns on warnings and precautions to be observed with the remains of unused medicinal products, and may, in the event of obvious risks, be collected.

Art. 21. Processing.

1. In accordance with the provisions of this Law, the Government shall regulate the procedure for obtaining authorization and registration in the Register of Proprietary Medicinal Products, incorporating the formalities and deadlines which the Economic Community The European Union will establish by virtue of Community arminisation.

2. The Ministry of Health and Consumer Affairs may require the applicant to provide supporting documentation, studies, data or information. This requirement will be interrupted by the time marked for the granting, until it is addressed, without prejudice to the provisions of Article 99 of the Law of Administrative Procedure.

3. In the assessment procedure, the Ministry of Health and Consumer Affairs may require the advice and advice of qualified experts from the scientific and professional world.

4. In the authorization procedure, the pharmaceutical specialty, its raw materials, intermediate products and other components may be subject to examination by the National Centre for Pharmacobiology, which, in the absence of the necessary means or power comply with the deadlines set, you must go to another national or foreign laboratory. They shall carry out the tests and experimental checks necessary to give an opinion on whether the specialities comply with the guarantees of quality, purity, stability and other guarantees.

5. The dossier, as a whole, shall be submitted to the opinion of the National Commission for the Evaluation of Medicinal Products, to which the applicant may appear in defence of his application.

6. The transmission of the health authorisation of proprietary medicinal products and any changes affecting the authorised specialities shall be regulated.

Art. 22. Authorizations subject to reservations.

1. The Ministry of Health and Consumer Affairs may, for objective health reasons, subject to special reservations the authorization of proprietary medicinal products which so require by their nature or characteristics.

2. In particular, the validity of the authorisation may be limited to a specified and reviewable period, depending on the results obtained with the use of the medicinal product, which is assessed after the appropriate studies.

3. The restriction on the use of hospital use in the pharmaceutical sector may also be limited, requiring a hospital diagnosis or requiring the prescription by specialist doctors.

4. The authorisation for the production and distribution of free samples shall be exceptional and shall comply with the conditions laid down in regulation.

In any case, free samples of pharmaceutical specialties that have narcotic drugs or psychotropic substances or that cause dependency and those other than the Ministry of Health and Consumer Affairs will determine.

Art. 23. Refusal of authorization.

The authorization of a pharmaceutical specialty will be denied, motivated, for the following reasons:

(a) When your study is deduced that, under normal conditions of employment, it may be harmful or unsafe.

b) When lacking therapeutic efficacy.

c) Where their therapeutic efficacy or safety has not been sufficiently tested by the applicant, without prejudice to the conditional authorisations provided for in the previous Article.

d) When you do not have the declared quantitative or qualitative composition.

e) When its composition is not sufficiently stable under normal conditions of use.

(f) Where the application is not filed in a regulatory manner or the particulars and information of the documentation to accompany it do not comply with the requirements of the Law, or are not completed within the period laid down in Article 71 of the Law of Administrative Procedure, provided that the mandatory requirement has been made in this respect.

g) When methods, controls, facilities used for manufacturing, preparation, packaging or preservation are not suitable for maintaining their identity, potency and purity.

(h) Where studies and investigations that are submitted in support of the application are incomplete, insufficient or imperfect to demonstrate the safety, efficacy and quality of the medicinal product.

i) When studies, data and information have not been performed or are not signed by technicians with the qualifications to mark the Law.

(j) Where requested by a person who does not meet the requirements of Article 10.2 or where the manufacturer does not have the authorization provided for in Article 70 or the authorization issued under the law of the Economic Community European by a member country.

Art. 24. Temporary validity.

1. The authorization of proprietary medicinal products shall be temporary, but may be renewed every five years, at the request of the holder if there are no health reasons against, after updating-if appropriate-the technical documentation. The updating of the technical documentation shall be in accordance with the criteria and guarantees of this Law in the cases and in the form established by the Ministry of Health and Consumer Affairs.

2. The holder of an authorization shall make an annual declaration to the Ministry of Health and Consumer Affairs of the intention to place the market on the market; his failure to comply may lead to the termination of the authorization, subject to a file, with a hearing of the interested.

3. The Health Administration of the State shall, for reasons of health concern, take appropriate measures for the survival or rehabilitation of a medicinal product.

Art. 25. Regime change.

For reasons of public interest or for the protection of the health or safety of persons, the Ministry of Health and Consumer Affairs may amend and restrict the conditions for the authorisation of a medicinal product relating to its composition, indications or information on adverse reactions, or to establish any of the reservations provided for in Article 22.

Art. 26. Suspension and revocation.

The authorization will be temporarily suspended or definitively revoked by the Ministry of Health and Consumer Affairs in the following cases:

(a) Where the medicinal product is harmful or unsafe under normal conditions of use.

b) When the pharmaceutical specialty turns out to be non-therapeutically effective.

(c) Where the pharmaceutical specialty does not have the authorised quantitative or qualitative composition or when the guarantees of quality, purity and stability are not met.

(d) Where the quality controls referred to in Articles 14 and 71 are not implemented.

e) When the manufacturing laboratory does not comply with Good Manufacturing Practices and/or Good Laboratory Practice.

(f) Where it is shown that the data and information contained in the documentation of the application for authorisation as provided for in Article 21 are incorrect or false or have not been adapted in accordance with the provided for in Articles 33 and 71.

g) When it is demonstrated that studies, data and information have not been carried out or are not signed by experts with sufficient technical and professional qualifications.

(h) When, after warning, the rules laid down for the satisfaction of the identification and information guarantees provided for in Article 19 continue to be violated.

i) When, for any other cause, pose a foreseeable risk to the health or safety of people or animals.

Art. 27. Procedure for modification, suspension or revocation.

1. The measures provided for in the two preceding articles shall be agreed upon prior examination of the file with the person concerned. The National Pharmacovigilance Commission in cases (a), (b) and (i) and the National Pharmacobiology Centre in cases (c) and (d) of the previous Article shall be issued with a mandatory but non-binding opinion.

2. The suspension and revocation referred to in the preceding paragraph shall, in accordance with the provisions laid down therein, lead to the corresponding inspection and inspection carried out by the Ministry of Health and Consumer Affairs or the Communities. Autononomes, where they have competence in the field of legislation on pharmaceutical products.

Art. 28. Publication.

Proprietary medicinal products and their suspensions, revocations and cancellations will be published in the "Official State Gazette" when they are firm.

Art. 29. Simplified procedures for medicinal products sufficiently known by the health authority.

1. In the case of medicinal products already known and sufficiently experienced in such a way that their effectiveness, safety of use and adverse reactions are already known and in the scientific literature, the Ministry of Health and Consumer Affairs may require a short documentation that exempts compliance with any of the requirements cited in previous articles.

2. It may also provide for a simplified procedure where the application for authorization relates to a proprietary medicinal product of composition and indexation similar to another already authorised under the provisions of this Law and for the effectiveness and The health authority has due knowledge.

3. In the above cases, the applicant may be exempted in particular from the presentation of the results of the pharmacological, toxicological and clinical studies or replace them with bibliographic documentation.

4. The provisions of this Article shall not apply to the products or categories of biological products which are regulated by regulation.

Art. 30. Fixed dose associations.

In the case of medicinal substances associated with fixed doses, the presentation of evidence that the specialty offers advantages over the isolated use of each of its components will be required.

Art. 31. Dispensing of medications.

1. As a general rule, medicines will only be dispensed with prescription.

The Ministry of Health and Consumer Affairs will establish the minimum requirements, characteristics and validity of prescriptions and hospital orders.

2. The Ministry of Health and Consumer Affairs shall lay down special requirements for the prescription and dispensing of narcotic drugs, psychotropic drugs and others which, by their nature, require them or for particular treatments.

3. The conditions for the fractionated supply of prefabricated medicinal products may be laid down.

4. Proprietary medicinal products which do not require optional prescription may be authorised in order to be dispensed and used, provided that:

-Vayan for pathologies that do not need accurate diagnosis.

-From the data of its toxicological, clinical or use assessment and route of administration, the need for prescription prescription is not removed in order to avoid direct or indirect risks to people's health.

5. The Ministry of Health and Consumer Affairs shall determine the proprietary medicinal products which may be the subject of advertising where they satisfy at least the following requirements:

(a) Do not go to the prevention or cure of pathologies requiring the diagnosis or prescription, as well as to those other pathologies that the mentioned Ministry determines.

b) Stated for the prevention, relief, or treatment of syndromes or minor symptoms.

(c) Be formulated with the medicinal substances expressly established by the Ministry of Health and Consumer Affairs on a positive list, which shall be regularly updated.

d) Hayan demonstrated, with extensive experience, to be safe and effective for the corresponding therapeutic indication.

e) In its application, the paremeral or any other injection route may not be used.

(f) Subject to the conditions and advertising criteria laid down in the corresponding authorisation by the Ministry of Health and Consumer Affairs for each pharmaceutical specialty.

6. For their authorisation, advertising messages for proprietary medicinal products must meet the following requirements:

(a) Adjusting to the conditions and requirements contained in the Register of the proprietary medicinal product concerned and as provided for in paragraph 5 (f) of this Article.

b) Contain the identifying data and recommendations to be determined by the Ministry of Health and Consumer Affairs to promote their rational use, to prevent their abuse and to prevent the risks arising from the normal use of the same.

c) Not to include expressions that provide healing security, nor testimonials about the virtues of the product, nor testimonials from professionals or people who, because of their notoriety, can induce consumption.

(d) Not to use as an advertising argument the fact that they have obtained health authorization in any country or any other authorization, number of sanitary registration or certification to be issued, or controls or the analysis that it is the responsibility of the health authorities to carry out in accordance with the provisions of this Law.

7. The authorization referred to in the preceding paragraph shall be granted by the Ministry of Health and Consumer Affairs when it relates to campaigns promoted in means of dissemination of a higher level than that of an Autonomous Community or when it is carried out in the field of a Community without implementing powers for the legislation of pharmaceutical products.

8. The packaging, packaging, labelling and package leaflets of specialities which do not require medical prescription shall contain such warnings as may be appropriate to their nature and, in particular, to prevent their misuse and the risks arising from their use. normal of the same.

9. Health administrations may, for reasons of public health or safety, limit, condition or prohibit the advertising of medicinal products.

10. Premiums, gifts, rebates, prizes, contests or the like are prohibited as methods related to the promotion or sale to the public of the products regulated in this Law.

11. Proprietary medicinal products for which the public is intended to be advertised in any form shall not be publicly funded.

Art. 32. Confidentiality.

The content of the authorization files for proprietary medicinal products shall be confidential, without prejudice to the information necessary for inspection activities.

Art. 33. Updating the case.

1. The holder of the authorization of a proprietary medicinal product must keep the file provided to obtain it, incorporating to it how much data, reports or technological modifications impose the advances of the science and the correct manufacturing and control procedures.

2. Granted the authorization of a proprietary medicinal product, the holder must take into account in relation to the methods of control the advances of the technique and the progress of the science and to introduce the necessary modifications so that the specialty is controlled according to generally accepted scientific methods. These amendments shall be approved by the Ministry of Health and Consumer Affairs.

3. The Ministry of Health and Consumer Affairs or the Autonomous Communities which have competence in the field of legislation on pharmaceutical products may require the manufacturer of a speciality at any time to justify the carrying out the checks on quality, purity, stability, power and other checks provided for in the authorisation and registration of that authority.

Art. 34. Medicinal products of high therapeutic interest.

1. The Government, in order to ensure the supply of "medicinal products without commercial interest", may adopt special measures in relation to its manufacture, economic, fiscal and distribution and dispensing arrangements.

2. For the purposes of the preceding paragraph and of the provisions of Article 115, 'medicinal products without commercial interest' means those which are necessary for certain treatment of pictures or pathologies with a low incidence, there is no or insufficient supply on the domestic market.

THIRD CHAPTER

Health requirements for other medicines

Art. 35. Requirements of the magistal formulas.

1. The master formulas will be prepared with substances of action and indication legally recognized in Spain, according to the article 55.5 of the prcrent Law and according to the guidelines of the National Form.

2. The master formulas shall be drawn up in the offices of pharmacy and legally established pharmaceutical services which have the necessary means for their preparation in accordance with the requirements laid down in the National Form.

3. In the preparation of master formulas the Standards of Good Manufacturing and Quality Control will be observed.

4. The master formulae shall be accompanied by the name of the pharmacist who prepares them and of sufficient information to ensure proper identification and preservation, as well as their safe use.

5. For the masterful formulation of substances or medicinal products not authorised in Spain, the arrangements provided for in Article 37 shall be required.

Art. 36. Requirements for official preparations.

Official preparations must meet the following conditions:

a) Be listed and described by the National Form.

b) Meet the rules of the Spanish Royal Pharmacopoeia.

c) Be prepared and guaranteed by a pharmacist from the pharmacy office, or from the pharmaceutical service that disfigured them.

(d) They must necessarily be presented and dispensed under generic terms and under no circumstances under commercial trade mark.

e) Official preparations shall be accompanied by the name of the pharmacist who prepares them and of sufficient information to ensure proper identification and preservation, as well as their safe use.

Art. 37. Requirements for foreign medicines without Spanish authorisation.

It is up to the Ministry of Health and Consumer to authorize the importation of medicines legally marketed in a foreign country and not authorized in Spain. This import shall be authorised where it is essential for the treatment or diagnosis of specific pathologies.

Art. 38. Authorisation of products in clinical research phase.

1. No "clinical research product" may be applied to persons if a resolution of the Ministry of Health and Consumer Affairs has not previously been referred to as such and lists the specific indications that may be clinical research.

2. The qualification shall be awarded only when the pre-clinical tests necessary to establish the pharmacological and toxicological profile of the product which guarantee its fitness for clinical research have been carried out.

3. Once a product has been placed on a product, the above qualification may be carried out with it and with reference to the indications referred to therein, the clinical trials that are requested if they are in accordance with the provisions of the Third Title of this Law.

4. A medicinal product may not be investigated in persons other than, in the course of a clinical trial, where the provisions of Title III of this Law are complied with, in the case of evidence of therapeutic indications other than the authorised, new dosages or, in general, different conditions for which it is authorised.

5. Exceptionally, the Ministry of Health and Consumer Affairs may grant authorisation, subject to the conditions laid down therein, for the prescription and application of 'clinical research products' to patients not included in a trial. clinical, when the physician under his sole responsibility and with the express consent of the patient, considers it indispensable to treat them with them and to justify to the health authority the reasons why he decides such treatment.

CHAPTER FOURTH

Special medicines

First Section: Biological Medicines

Art. 39. For vaccines and other biological medicinal products.

1. Vaccines and biological products which may be used as medicinal products shall be subject to the arrangements for proprietary medicinal products with the particularities provided for in this Law or which are established in accordance with their nature and own application features.

2. The individual preparation of vaccines and allergens for a single patient shall be exempt from the provisions of the preceding paragraph, which may only be carried out in establishments which fulfil the particularities which they regulate. by the Ministry of Health and Consumer Affairs.

3. In the case of biological products, where necessary in the interest of public health, the Ministry of Health and Consumer Affairs may subject to prior authorization each batch of finished product and condition the placing on the market of such products. conformity. It may also subject to prior authorization the materials of origin, intermediate products and bulk products and make their use in the manufacture conditional on their conformity. These checks shall be deemed to have been carried out in the case of the Ministry of Health and Consumer Affairs, which is documented in the country of origin, with the same requirements as those laid down in this Law and provided that they are maintained the original product conditions.

Section Two: Medicines of human origin

Art. 40. Medicinal products derived from the blood, plasma and other fluids, glands and human tissues.

1. Blood, plasma and other fluids, glands and human tissues, when used for therapeutic purposes, shall be considered as medicinal products and subject to the arrangements provided for in this Law with the specific characteristics of the products. establish regulations according to their nature and characteristics.

2. The blood, plasma and its derivatives and other fluids, glands and human tissues shall, in any case, be from donors identified and obtained in approved centres. Precise measures to prevent the transmission of infectious diseases shall be taken.

3. Importation and authorization as medicinal products for medicinal products derived from blood and plasma may be refused or revoked where such medicinal products do not originate from altruistic donations made in blood banks or centres of plamapheresis, located in the member countries of the EEC that meet due guarantees.

4. Authorization as medicinal products for medicinal products derived from blood and plasma may be subject to the presentation by the applicant of documentation showing that the price of the medicinal product does not include an illegitimate benefit on the blood donated selflessly.

Healthcare Administrations will promote altruistic blood donations as well as the development of the production and use of blood products from these donations.

Third Section: Narcotic drugs and psychotropic drugs

Art. 41. Narcotic drugs and psychotropic substances.

Narcotic drugs included in the "Single Convention on Narcotic Drugs" and psychotropic substances included in the "Convention on Psychotropic Substances" and the medicinal products containing them, governed by this Law and by its special legislation.

Section 4: Medicinal Plant Medicines

Art. 42. General conditions.

1. Plants and mixtures thereof and preparations obtained from plants in the form of extracts, lyophilisates, distillates, tinctures, cofoundations or any other galenic preparation which is presented with therapeutic, diagnostic or preventive use follow the rules of the rules of procedure, formal preparations or proprietary medicinal products, as appropriate and with the specific features which they regulate.

2. The Ministry of Health and Consumer Affairs shall establish a list of plants for which the sale to the public shall be restricted or prohibited by reason of their toxicity.

3. Plants traditionally regarded as medicinal products may be freely sold to the public and offered without reference to therapeutic, diagnostic or preventive properties, and their street sale is prohibited.

Fifth Section: Veterinary Medicines

Art. 43. General conditions and definitions.

1. The veterinary medicinal products are applicable to all the general criteria and requirements laid down in this Law, with the specific features incorporated in this section or which may be available and which will be exercised by the Ministry. Agriculture, Fisheries and Food in agreement with the Ministry of Health and Consumer Affairs, without prejudice to the powers of the Autonomous Communities.

2. For the purposes of this Act, recognised medicinal products shall also be considered:

Drug premix for feed: veterinary medicinal product, prepared to be incorporated into a feed.

Masterways intended for animals: they shall be those prescribed by a veterinarian and intended for an individual animal or a small number of animals on a particular holding, under the direct care of the animal. optional, and prepared by a pharmacist or at your address in your pharmacy office.

Intermediate product: a product that incorporates a drug premix, used in the preparation of a medicated feed.

3. They are medicated feed, all of which I think has incorporated some drug premix.

Art. 44. Authorization and registration.

1. Proprietary medicinal products and medicinal products for veterinary use, as well as medicated premixtures in order to be manufactured and marketed, will need to be authorized and registered in the Register of Proprietary Medicinal Products. In the case of medicinal products already known and sufficiently experienced in such a way that their effectiveness, safety of use and adverse reactions are already known and in the literature, the Ministry of Health and Consumer Affairs may establish an abbreviated documentation that exempts some of the requirements outlined in this Law.

2. A special scheme may be established, which exempts from any of the requirements laid down in this Law, for the authorization and marketing of veterinary medicinal products intended exclusively for aquarium fish, small rodents and animals not intended for human consumption, provided that the said medicinal products do not require veterinary checks and the necessary measures are taken to prevent their use for other animals. Under no circumstances will this regime catch up with narcotic drugs or psychotropic drugs.

3. The authorization shall be granted by the State Administration prior to the mandatory report of the National Commission for the Evaluation of Veterinary Medicinal Products, which shall be binding when, for reasons of public health, it is negative or proposed limitations, prohibitions, requirements or requirements for use.

4. The necessary inspections in the process of authorization of veterinary medicinal products and of their manufacturers or for the manufacture by third parties shall be carried out by the competent services of the State Administration.

Art. 45. Guarantees, security, effectiveness and identification.

1. Veterinary medicinal products shall be the subject of further studies and tests to ensure their safety, which shall be taken into account:

(a) That when food producing animals intended for human consumption are given to animals, the appropriate waiting time should be known to eliminate the risks to persons derived from residues or metabolites of those.

(b) The impact on the persons handling them, mainly for products intended for mixing with feed.

c) Influences on the environment, when it can result in residual action through waste products.

d) Dealing with biological products and, in particular vaccines, epizootic repercussions.

2. As a guarantee of effectiveness, studies and trials must also be carried out on the animals for which the medicinal product is intended.

3. In addition to the provisions laid down in Articles 17 and 19, the indication that the medicinal product concerned is a veterinary medicinal product and the withdrawal period shall be indicated on the packaging and packaging and on the information accompanying the medicinal product. food-producing animals.

Art. 46. Grounds for refusal, suspension or revocation.

1. In addition to those provided for in Articles 23 and 26 of this Law, they shall also cause grounds for refusal, suspension or revocation of the authorisation of a veterinary medicinal product, if:

a) The indicated timeout is not sufficiently justified.

(b) The use of the product in question is expressly prohibited or subject to public health concerns.

c) Dealing with biological products, reasons for epizootic order do not advise their use.

2. The suspension and revocation referred to in the preceding paragraph shall, in accordance with the provisions laid down therein, lead to the corresponding inspection and control measures carried out by the State Administration or by the Autonomous Communities. where they have competence for enforcement in the field of pharmaceutical legislation.

3. Decisions to refuse, suspend or revoke the authorisation of a veterinary medicinal product shall be reasoned and shall be adopted on the basis of a report from the National Veterinary Medicinal Products Commission.

Art. 47. Animal research.

The conduct of trials in food-producing animals for human consumption will require the prior qualification of "products in the research phase" and the specific authorisation of the State Administration prior to the National Committee for the Evaluation of Veterinary Medicinal Products. Such authorisation shall include all measures taken to avoid any risk to the health of the person or the environment.

Art. 48. Manufacturing entities.

1. The authorization of the laboratories manufacturers of medicinal products for veterinary use and the precept for the manufacture by third parties, will be granted by the Administration of the State following the guidelines provided for in Title IV of this Law.

2. The production of intermediate products and medicated feed may be carried out only on the basis of medicated premixtures with the authorisation provided for in Article 44 and by authorised entities specifically for that purpose.

Art. 49. Veterinary prescription.

1. Only the following veterinary medicinal products shall be required to comply with the prescription requirement by a veterinarian for their supply to the public:

(a) Subject to official use limitations, for reasons of public health or animal health.

(b) For its residual effect on food of animal origin, it is necessary to monitor the use of the food in order to observe the corresponding waiting time.

c) Use may present risks to animals or indirectly, a potential danger to public health, or cause disruption to the persons who apply them.

(d) Destinations for treatments of pathological processes that require an accurate, prior diagnosis, or that may be used to derive repercussions that hinder or interfere with subsequent diagnostic or therapeutic actions.

e) Masterways intended for animals.

(f) Those containing narcotic drugs or psychotropic substances in accordance with their specific legislation.

2. The Government shall establish the relationship of active substances whose dispensing shall require the prescription of a veterinarian by prescription in accordance with the criteria laid down in the preceding paragraph.

Art. 50. Dispensing of veterinary medicinal products.

The Government will develop the dispensing of veterinary medicinal products on a basic basis according to the following criteria:

1. The supply to the public of pre-manufactured medicinal products, proprietary medicinal products, masterways and veterinary official preparations shall be carried out exclusively by:

-The legally established pharmacy offices will also be the only ones authorized for the elaboration of formal formulas and formal preparations.

-entities or livestock groups for the exclusive use of their members, authorised under conditions to be established on the basis of the carrying out of animal health programmes and which have pharmaceutical services and veterinarians.

-The retail establishments authorised under the conditions to be established provided that they have pharmaceutical services responsible for the custody, supply and control of use of these medicinal products.

2. For reasons of urgency and remoteness of pharmacy offices, veterinary medicinal products may be used under conditions to be determined.

3. The animal feed and livestock farming industries may directly acquire the medicated premixtures and intermediate products intended for the preparation of medicated feed.

Section Sixth: Radiopharmaceuticals

Art. 51. Definitions.

For the purposes of this Law:

-Radiopharmaceutical: any product that when prepared for use for therapeutic or diagnostic purposes contains one or more radionuclides (radioactive isotopes).

-Generator: any system that incorporates a radionuclide (radionuclide parent) that in its disintegration originates another radionuclide (radionuclide son) that will be used as an integral part of a radiopharmaceutical.

-Reactive equipment: any industrial preparation that must be combined with the radionuclide to obtain the final radiopharmaceutical.

-Precursor: any industrially produced radionuclide for the radioactive marking of other substances prior to administration.

Art. 52. Manufacturing.

1. Without prejudice to any other obligations arising from a legal or regulatory provision, industrial manufacturing and the authorisation and registration of generators, reactive equipment, precursors and radiopharmaceuticals shall require prior authorisation. of the Ministry of Health and Consumer Affairs, granted in accordance with the general principles of this Law and in accordance with the requirements and procedures to be established.

2. The authorization provided for in the preceding paragraph shall not be required for the extemporaneous preparation of a radiopharmaceutical, per person qualified for application in a legally empowered institution or institution, if it is carried out exclusively from of generators, reactive equipment and authorised precursors and in accordance with the manufacturer's instructions.

Art. 53.

The provisions of this Law will not affect legal measures on the protection against radiation of persons undergoing medical examinations or treatments or for the protection of public health and workers.

Seventh Section: Homeopathic Products

Art. 54. Homeopathic medicines.

Homeopathic products prepared industrially and marketed with therapeutic indication will be subjected to sludge the effects to the regime of medicines provided for in this Law.

CHAPTER QUINTO

Pharmacopoeia and quality control

Art. 55. Real Pharmacopoeia Española and National Form.

1. The Spanish Royal Pharmacopoeia is the code to be respected to ensure the uniformity of the nature, quality, composition and richness of medicinal substances and excipients.

2. The Pharmacopoeia shall include monographs conveniently ordered and coded with the characters of the medicinal substances, excipients, test methods and analyses to be used to ensure their quality, the preparation procedures, sterilisation, preservation and conditioning. Monographs are minimum requirements for compliance.

3. Any raw material presented under a scientific or common name of the Pharmacopoeia in force must be in response to the specifications of the Pharmacopoeia.

4. The Spanish Royal Pharmacopoeia will be constituted by the peculiar Spanish monographs and those contained in the European Pharmacopoeia of the Council of Europe. The WHO International Pharmacopoeia will have an extra character. For substances manufactured in countries belonging to the European Communities, the European Pharmacopoeia shall be governed by the monograph of the European Pharmacopoeia and, failing that, that of a third country.

The Ministry of Health and Consumer Affairs will be able to put in place concrete monographs of foreign drugs.

5. The National Form shall contain the standard forms and the official preparations recognised as medicinal products, their categories, indications and raw materials involved in their composition or preparation, as well as the rules of correct preparation and control of those.

6. The Spanish Royal Pharmacopoeia and the National Form will be updated periodically.

7. The Spanish Royal Pharmacopoeia and the National Form, as well as their additions and corrections, will be approved, after the National Commission of the Spanish Royal Pharmacopoeia, by the Ministry of Health and Consumer Affairs that will announce in the " Bulletin Official of the State ' publication and shall establish the date of its entry into force. The Ministry will carry out its official edition.

8. The offices of pharmacy, pharmaceutical services, distribution entities and laboratories for the manufacture of proprietary medicinal products must have an updated copy of the Spanish Royal Pharmacopoeia and the National Form.

Art. 56. Quality control by the health authority.

1. The Ministry of Health and Consumer Affairs and the Autonomous Communities with implementing powers, in the field of legislation on pharmaceutical products, may establish quality control programmes for medicinal products to verify compliance with the requirements laid down in Article 1 (1) of Regulation (EC) the conditions of the authorisation and of the other conditions of application.

Within the Interterritorial Council of the National Health System, criteria for the coordination of these programs may be agreed with reference to the extent, intensity and frequency of the controls to be carried out.

2. Without prejudice to their own responsibility all health authorities and professionals and manufacturers and distributors are obliged to collaborate diligently in these programs and to communicate to the Health Authorities the anomalies of which have knowledge.

3. The Carlos III Health Institute in accordance with its regulatory standards may provide standards and reference preparations for the control of medicinal substances. Such patterns must have been calibrated with international patterns when they exist.

4. Where there is an international standard or international reference preparation, the activity of medicinal substances shall be expressed in international units.

CHAPTER SIXTH

Pharmacovigilance

Art. 57. Obligation to declare.

1. Healthcare professionals have a duty to communicate promptly to the health authorities or specialised centres that they designate, the unexpected or toxic effects on people or public health that may have been caused by the medicines.

2. Manufacturers and holders of health authorisations for medicinal products are also required to declare to the State Administration and to the Autonomous Communities that they have powers of enforcement in respect of pharmaceutical products. unexpected or toxic effects of which they have knowledge and which may have been caused by the medicinal products they manufacture, or market.

Art. 58. Spanish pharmacovigilance system.

1. The Spanish pharmacovigilance system, which will be coordinated by the Ministry of Health and Consumer Affairs, will integrate the activities carried out by the Sanitary Administrations to collect and develop information on adverse drug reactions.

2. The Ministry of Health and Consumer Affairs shall assess the information received directly or through other programmes and integrate it into the international pharmacovigilance programmes.

3. In the Spanish Pharmacovigilance System, doctors, veterinarians, pharmacists, nurses and other healthcare professionals will be required to collaborate.

4. The health authorities may suspend those pharmacovigilance programmes in which serious defects in the collection of data and the processing of the information obtained are assessed. Such suspension shall require the prior favourable report of the National Pharmacovigilance Commission.

5. The data obtained from the pharmacovigilance programmes shall not be global and defining, as long as they are not assessed, together with the data available, by the National Pharmacovigilance Commission.

6. The National Pharmacovigilance Commission shall be constituted with representatives of the Sanitary Administrations and qualified experts designated by them.

THIRD TITLE

From clinical trials

ONLY CHAPTER

Art. 59. Definition.

For the purposes of this Law, a clinical trial means any experimental evaluation of a substance or medicine, through its administration or application to human beings, oriented towards one of the following purposes:

a) To demonstrate its pharmacodynamic effects or to collect data concerning its absorption, distribution, metabolism and excretion in the human organism.

b) Establish their effectiveness for a given therapeutic, prophylactic or diagnostic indication.

c) Know the profile of your adverse reactions and establish your security.

Art. 60. Respect for ethical postulates.

All tests shall be subject to the administrative authorisation provided for in Article 65 and the following requirements shall be complied with:

1. No clinical trial may be initiated as long as sufficient scientific data and in particular pharmacological and toxicological tests on animals are not available to ensure that the risks involved in the person in question are admissible.

2. Clinical trials must be conducted in conditions of respect for the fundamental rights of the person and the ethical postulates affecting the biomedical research in which human beings are affected, following these effects. contained in the Helsinki declaration and successive declarations to update those postulates.

3. A clinical trial may be initiated only if there is a reasonable doubt about the efficacy and safety of the therapeutic modifications it includes.

4. Consent shall be made freely expressed, preferably in writing, or in the absence of witnesses, of the person in whom the test is to be carried out after being instructed by the health care professional responsible for the research on the nature, importance, extent and risks of the test and have understood the information.

5. In the case of clinical trials with no particular therapeutic interest for the subject of experimentation, consent shall always be in writing.

6. The instruction and the exposure of the scope and risks of the test, as well as the consent referred to in the previous two paragraphs shall be made before and shall be granted by the legal representative in the case of persons who cannot issue it. freely.

It will also be necessary for the representation of the representative if his conditions allow him to understand the nature, importance, scope and risks of the test.

7. The consideration that has been agreed upon by the voluntary submission to the experience will be perceived in any case, although it will be reduced equally according to the participation of the subject in the experimentation in the event that it desists.

Art. 61. Revocation of consent.

The subject participant in a clinical trial or his/her representative may at all times revoke his/her consent without cause.

Art. 62. Test assurance.

1. The initiation of a clinical trial 'with products in the clinical research phase' or for new indications of medicinal products already authorised or where there is no therapeutic interest for the subject of the test may only be performed if the test has been (a) a insurance covering the damages which, as a result of the damage, may result for the person to whom it is to be carried out.

2. Where, for all circumstances, the insurance does not cover the damage entirely, it shall be jointly and severally liable, even if it is not the fault, the sponsor of the test, the principal investigator of the test and the head of the hospital or centre where he/she is has been carried out, with the burden of proof. Neither the administrative authorisation nor the report of the Ethical Committee shall exempt them from liability.

3. It is presumed, unless proof to the contrary, that the damage affecting the health of the person subject to the test, during the course of the test and in the year following its completion, has occurred as a result of the test. However, upon completion of the year, the subject of the test is obliged to test the damage and nexus between the test and the damage produced.

Art. 63. Promoter, monitor and principal investigator.

1. The clinical trial promoter is the natural or legal person who has an interest in carrying out the clinical trial, signs the application for authorisation addressed to the Ethical Committee or the Ministry of Health and Consumer Affairs and takes responsibility for it.

2. A clinical trial monitor the trained professional with the necessary clinical competence chosen by the promoter who is responsible for the direct follow-up of the test. It serves as a link between the promoter and the principal investigator, when they do not participate in the same person.

3. It is the principal investigator who directs the practical implementation of the test and signature in union of the promoter the application, corresponding with him. The condition of the promoter and the principal investigator may be on the same natural person.

Only a sufficiently qualified healthcare professional to assess the response to the substance or medicinal product under study may act as a principal investigator.

In any case, human clinical trials must be conducted under the supervision of a physician with the necessary clinical competence.

Art. 64. Ethical Committees of Clinical Research.

1. No clinical trial may be conducted without prior report of an Ethical Clinical Research Committee, independent of the promoters and researchers and duly accredited by the competent Health Authority to report to the Ministry of Health and Consumer Affairs.

2. The Committee shall weigh the methodological, ethical and legal aspects of the proposed protocol, as well as the risk balance and anticipated benefits of the test.

3. The Ethics Committees shall be composed of at least one interdisciplinary team consisting of doctors, hospital pharmacists, clinical pharmacologists, nursing staff and persons outside the health professions, of which at least one will be jurist.

Art. 65. Administrative intervention.

1. Clinical trials with "products in the clinical investigation phase", or with medicinal products already authorised for new therapeutic indications, when they are to be carried out in Spain, will be subject to a prior authorisation regime. Ministry of Health and Consumer Affairs. This authorisation shall, where appropriate, be produced in a unit of act with the qualification provided for in Article 38.

When a clinical trial has been authorised for the authorisation of other tests, the indications provided for in the authorisation as a 'clinical research product' may be subject to a procedure with requirements. simplified. To this end, it may be established that such tests are authorised if the Ministry of Health and Consumer Affairs does not refuse them within 60 days.

2. Clinical trials with medicinal products registered in Spain as proprietary medicinal products for new dosages or in general, for conditions other than those that were authorised, will require a report from the Ethical Committee of Clinical Research. of the place, who will transfer the documentation to the Ministry of Health and Consumer Affairs.

Such tests shall be deemed to be authorised if the Ministry does not refuse authorisation within 60 days.

3. For the granting of the clinical trial authorisation, it shall be assessed:

-The technical and professional qualification of the healthcare personnel involved in the trial.

-The conditions of the center in which the test is proposed.

The Ministry of Health and Consumer Affairs may limit the conduct of particularly complex clinical trials to certain hospitals or research centres. Clinical trials without therapeutic interest for the subject may only be carried out in research centres which authorise, for each test, the Ministry of Health and Consumer Affairs, where appropriate, report from the Health Administration of the center.

-The proposed research protocol.

4. The authorisation of clinical trials shall decide on the extremes referred to in the previous paragraph and shall set the time limit and the temporary conditions for its completion.

5. The Ministry of Health and Consumer Affairs may at any time interrupt the conduct of a clinical trial or require the introduction of amendments to its protocol, in the following cases:

a) if the Act is violated,

b) if the conditions of your authorization are altered,

(c) the ethical principles set out in Article 60 are not met,

d) to protect test subjects or,

e) in defense of public health.

6. The Health Administrations will have inspection powers in the field of clinical trials, being able to investigate even the individual clinical histories of the test subjects, always keeping their character confidential. They shall also be able to perform the precautionary interruption of the test for any of the causes mentioned in the previous point, immediately communicating it to the Ministry of Health and Consumer Affairs.

7. The Health Administrations shall ensure compliance with the standards of "Good Clinical Practice".

8. The principal investigator of a test shall immediately notify the Ethics Committee, the monitor, the sponsor and the Ministry of Health and Consumer Affairs, without prejudice to the communication to the corresponding Autonomous Communities, any significant adverse reaction observed.

9. The favourable or unfavourable results of each clinical trial, whether or not it comes to an end as well as if the research is abandoned, should be communicated to the Ministry of Health and Consumer Affairs, without prejudice to the communication to the Autonomous Communities. corresponding.

Art. 66. Test procedure.

1. The clinical trial method shall be such that the assessment of the results obtained with the application of the test substance or medicinal product is controlled by comparison with the best reference standard, in order to ensure their objectivity, except for exceptions imposed by the nature of their own investigation.

2. The performance of the test shall in any case be adjusted to the content of the protocol, in accordance with which the authorisation has been granted.

Art. 67. Financing of the test.

The Ethics Committees may require complete information on the sources and the amount of the trial funding and the distribution of expenses (reimbursement of expenses to patients, payments for special analyses or technical assistance, purchase of equipment, payments due to hospitals or to the centres in which the investigation is carried out for the use of their resources, incentives and others.

Art. 68. Common requirements for clinical trials in the National Health System.

1. The Centers, Services. Establishments and health professionals shall participate in the conduct of Clinical Trials in accordance with the common requirements and financing conditions to be regulated by the competent Sanitary Administrations for each of the Health.

2. The Interterritorial Council of the National Health System may agree general principles of coordination with respect to the provisions of the preceding paragraph.

Art. 69. Publications.

1. The publication of the authorised clinical trials shall be carried out in scientific journals and with an indication of the Ethical Committee which informed them.

2. Where studies and research work on medicinal products for the scientific community are made public, the funds obtained by the author shall be recorded by or for the purpose of the research and the source of funding.

TITLE FOURTH

From drug manufacturers and distributors

CHAPTER FIRST

From pharmaceutical laboratories

Art. 70. Authorization and requirements.

1. For the purposes of this Law, natural or legal persons engaged in the manufacture of proprietary medicinal products or any of the processes which it may understand, including packaging, packaging and presentation for the sale must be authorized in advance by the Ministry of Health and Consumer Affairs. This authorization and its extinction will be published in the "Official State Gazette".

2. In order to obtain the authorisation of a pharmaceutical laboratory, the applicant shall meet the following requirements:

a) Detailed the pharmaceutical forms you intend to manufacture, as well as the place, establishment or laboratory of manufacture and control.

b) Dispose of adequate and adequate local, technical and control equipment for proper manufacturing, control and conservation that meets legal requirements.

c) Dispose of a responsible Technical Director, a manufacturing officer and a quality control officer. The latter two shall in any case be under the authority of the Technical Director.

When it comes to laboratories that manufacture small quantities or simple products, they may incorporate the control function to the Technical Director, but the manufacturing address must correspond to another person.

3. The Ministry of Health and Consumer Affairs shall grant the relevant authorisation only after verifying that the required legal requirements are met.

4. The authorisation shall be granted within a period to be determined by regulation. Such time limit shall be interrupted if the Administration requires the applicant to provide additional information until it satisfies it.

Art. 71. Obligations of the holder of the pharmaceutical laboratory authorisation.

1. Without prejudice to any other obligations arising from a statutory or regulatory provision, the holder of the authorisation shall comply with the following obligations:

(a) Dispose of sufficient personnel and with the technical qualification necessary to ensure the quality of the products manufactured and the execution of the controls carried out in accordance with the provisions of the Law.

b) Not to supply authorized specialties more than in accordance with current legislation.

c) Having continuously supplied the market with the registered products, with the possibility of suspending such supply only after having the corresponding authorization by the Ministry of Health and Consumer Affairs.

d) Communicate the suspension or cessation of its activities.

e) Allow, at all times, access to your premises and files to the competent authorities for inspections.

f) Facilitate the performance of their duties to the Technical Director and ensure that they have the necessary means to do so.

g) Respond to the obligations that are required for them during the time of their activity and five years after the closure or suspension.

(h) To ensure that the transport of the medicinal products to destination, either to wholesale warehouses or to services or pharmacy offices, is carried out in compliance with the obligations imposed on them.

2. The manufacturer of a proprietary medicinal product shall carry out the checks on quality, purity, stability, power and other controls on the raw materials, the intermediate products of manufacture and the finished product in accordance with the methods and generally accepted techniques.

3. For the purposes of the previous paragraph, each manufacturing establishment of proprietary medicinal products shall have a unit of control and quality assurance of the products, processes and procedures with the authority and responsibility of accept or reject raw materials, intermediates and end products. Manufacturing processes and procedures shall be validated.

Art. 72. Rules of correct manufacturing.

The holders of a pharmaceutical laboratory authorization must comply with the Good Manufacturing Standards promulgated by the Ministry of Health and Consumer Affairs, as well as the Good Laboratory Practice. These standards will be regularly adapted to the state of science and technology.

Art. 73. Modification, suspension and revocation of the authorization.

1. Any amendment to the requirements referred to in points (a) and (b) of Article 70 or the subject of the authorisation shall be approved in advance by the Ministry of Health and Consumer Affairs.

2. The replacement of the Technical Director shall be communicated to the Register of Proprietary Medicinal Products and to the corresponding Health Department of the Autonomous Community.

3. The Ministry of Health and Consumer Affairs may suspend or revoke the laboratory authorisation for a particular category of products or for all products, where the requirements of Article 70 are not met.

4. The Ministry of Health and Consumer Affairs may also, without prejudice to any other measures, suspend the manufacture of proprietary medicinal products or suspend or revoke the manufacturing authorization itself if the obligations are not met. set in this Chapter.

Art. 74. Unified registration of pharmaceutical laboratories.

1. The State Health Administration shall maintain a unified registry of pharmaceutical laboratories that will centralize all data that it is required to provide for compliance with the provisions of this Law.

2. Registration of the initial authorization as well as of any transmission, modification or extinction is mandatory.

Art. 75. Technical Director.

1. The technician referred to in Article 70 shall meet the following conditions:

a) Have a degree in pharmacy or other higher degree equally qualified according to the current regulations.

b) Have professional experience in manufacturing and control of proprietary medicinal products to be determined.

2. This charge shall be incompatible with other health-type activities which involve direct interests with the distribution or dispensing of medicinal products or which are detrimental to the exact performance of their duties.

3. The Technical Director shall take care of:

(a) That each batch of proprietary medicinal products has been manufactured, controlled and preserved in accordance with the Law and in accordance with the terms of the authorization of the relevant pharmaceutical specialty.

(b) that each batch of manufacture complies with the above conditions by formalising its security through the appropriate documents and records, which must be kept up to date and at the disposal of the accredited inspectors, at least two years after the expiry date.

4. Where the Technical Director fails to fulfil his obligations, he shall be subject to a penalty file and may be suspended, in serious cases, in his duties since the opening of his duties, without prejudice to the other responsibilities required.

The responsibility of the Technical Director does not, under any circumstances, exclude corporate responsibility.

Art. 76. Manufacture by third parties.

1. Manufacturers of proprietary medicinal products may entrust to third parties the performance of manufacturing activities or controls provided for in this Law for proprietary medicinal products if the following requirements are met:

(a) Count the third-party contractor with the health authorisation of the manufacturer of proprietary medicinal products referred to in Article 70.

b) Get from the Ministry of Health and Consumer specific authorization for third-party manufacturing.

2. Exceptionally, and when it is necessary to care for its patients, the Hospital Pharmacy and Pharmacy Offices may entrust to an entity legally authorized by the Ministry of Health and Consumer Affairs, the performance of any the production stage of a particular preparation or its analytical control.

CHAPTER SECOND

From the wholesale stores

Art. 77.

To facilitate the distribution of proprietary medicinal products and medicinal substances intended to constitute a medicinal product from the manufacturing laboratories and the importers to the pharmacy offices and pharmacy services Legally authorised, the mediation of the wholesale warehouses may be used.

Art. 78. Wholesale distribution.

1. Stores of wholesale distribution of pharmaceutical products and medicinal substances to legally authorized offices and pharmacy services shall have the authorization of the Autonomous Community where they are domiciled and perform their activities.

2. The Ministry of Health and Consumer Affairs will maintain and publish a permanently updated catalogue of wholesale warehouses.

Art. 79. Operational requirements.

1. Without prejudice to any other obligations arising out of legal or regulatory provision, wholesale warehouses shall be obliged to:

(a) To have facilities sufficiently equipped with personal, material and technical means for their mission to be verified with full guarantee for public health.

b) To maintain minimum stocks of medicinal products to ensure continuity of supply.

c) To ensure compliance with the general or particular conditions for the preservation of medicinal products and in particular the maintenance of the cold chain throughout the distribution network through procedures normalised.

d) To meet guard and disaster prevention services.

2. The basic requirements and conditions of these establishments may be laid down by the Government on a basic basis in order to ensure the forecasts contained in point 1.

Artliqui 80. Technical Director.

1. Authorized wholesale warehouses shall have a Technical Technical Director whose position shall be incompatible with other activities of a health nature which involve direct interests in the manufacture or supply of medicinal products or which are in detriment of the exact performance of their functions.

The following are technical director functions:

(a) Ensure compliance with the provisions of health order relating to wholesale warehouses and their operations.

b) Analyze the raw materials that are fractionated and ensure their quality and purity.

c) Care that the storage and packaging of medicinal substances and the packaging of proprietary medicinal products are carried out in due course and guarantee their legitimacy of origin.

d) Verify health conditions for the transport, entry and exit of medicines and substances.

e) Monitor compliance with special legislation on narcotic drugs and psychotropic substances and require appropriate measures to be taken.

2. On the basis of a certain amount of professional activity, the Government shall establish, on a basic basis, the need for additional pharmacists, in addition to the Technical Director, for a wholesale pharmaceutical distribution warehouse.

TITLE FIFTH

From the health guarantees of the foreign trade of medicines

Art. 81. Imports.

1. Without prejudice to other legal or regulatory requirements laid down, only medicinal products which are wholly or wholly disposed of for sale to the public may be imported where those products are authorised and registered in the Registration of Proprietary Medicinal Products in accordance with the requirements laid down in this Law.

2. The distribution of the proprietary medicinal products referred to in the preceding paragraph shall be in accordance with the requirements laid down in Title IV of this Law. To this end, the importer may use the pharmaceutical channels which are legally authorized to do so or to constitute a pharmaceutical distributor after the corresponding authorization granted in accordance with Chapter II of Title IV of the Law.

3. The Technical Director of the distribution entity shall ensure the conformity of the imported lots and replies that each batch of imported manufacture has been the subject of a full qualitative analysis in Spain of a quantitative analysis referred to above. at least to all medicinal substances and other controls which are necessary to ensure their quality in accordance with the terms of the authorisation and registration of the proprietary medicinal product.

For this purpose, the documentation and samples that are regulated for inspection by the Ministry of Health and Consumer Affairs shall be provided.

4. The checks referred to in the previous paragraph shall be deemed to have been carried out in the case of the Ministry of Health and Consumer Affairs, which is documented in the country of origin, with the same requirements as those provided for in this Law, without prejudice to the obligations arising from the accession to the EEC and other international treaties concluded by Spain.

5. The importation of "products in the clinical investigation phase" shall require prior authorisation from the Ministry of Health and Consumer Affairs.

6. The holder of a proprietary medicinal product in Spain may not prevent its importation and marketing by third parties provided that they introduce it into the Spanish market with the guarantees established by this Law with the adaptations that it regulates are determined.

Art. 82. Exports.

1. They may export proprietary medicinal products to wholesale laboratories and warehouses which comply with the legally established requirements.

2. Exports of proprietary medicinal products authorised and registered in the Register shall be notified by the exporter to the Ministry of Health and Consumer Affairs in the cases and terms which are determined.

3. The export of any other medicinal product which is not a proprietary medicinal product shall be authorised by the Ministry of Health and Consumer Affairs and shall be deemed to be granted if the latter does not object within one month.

4. The authorization referred to in the preceding paragraph shall be granted when the product complies with the health requirements laid down in Title II of this Law.

5. The product shall not be required to export the requirements laid down in this Law for the authorisation of pharmaceutical specialty in Spain, in respect of format or presentation, texts, labelling and packaging characteristics, provided that respect the principles that this law provides for guarantee information to professionals and users.

Art. 83.

1. Medicinal products accompanying travellers for their own medicinal products shall be excluded from the requirements laid down in the preceding Articles, without prejudice to control measures where such medicinal products may represent a deviation by its value or destination.

2. Public administrations shall take appropriate measures to prevent the products covered by this Law, which are in transit to a third country, from being diverted for use in Spain without complying with the requirements laid down in this Directive. Law.

TITLE SIXTH

The rational use of medicines

CHAPTER FIRST

From training and information about medicines and prescription

Art. 84. Actions of the Public Administrations.

1. The Public Administrations responsible for health and education orders will direct their actions to promote the continuous and permanent university and post-university training on medicines from healthcare professionals. In particular the promotion of pharmacology and clinical pharmacy.

2. Public health authorities shall direct their actions to provide scientific and objective information on medicinal products to healthcare professionals, which may relate not only to the content of the technical information sheet referred to in the Article 19 but also the pharmacological, toxicological and clinical studies on which the marketing authorisation was based.

3. The Public Administrations shall direct their actions to promote the establishment of information centres for own medicines or in hospitals, in scientific societies, in professional schools and other public or private entities.

4. The Health Administrations, with the advice of the National Commission for the National Use of Medicinal Products, will take the necessary measures to ensure that in the specialized and primary care structures, the selection and Scientific assessment of medicinal products and their use through the Commissions of Pharmacy and Therapeutics or any other equivalent means.

5. Health Public Administrations shall carry out health education programmes on medicinal products for the general public.

6. Public Health Administrations will promote the publication of Pharmacological Guides for the use of healthcare professionals.

Art. 85. Recipe.

1. The prescription, as a document that endorses the prescription and valid prescription for the entire national territory, shall be published in the official language of the State without prejudice to the official languages of each Autonomous Community.

2. Prescriptions and hospital orders for dispensing must contain the basic data for identification of prescribers, patients and medications.

3. In the prescriptions and orders, the optional will include the relevant warnings for the pharmacist and instructions for the best observance of the treatment.

4. The Government may, on a basic basis, regulate the provisions of the above numbers and lay down the requirement for other requirements which, in order to affect public health or the health system, must be applied in general to prescriptions or orders. hospital.

5. The procedures for the submission of prescriptions and medical orders and, in particular, in their processing, shall comply with the provisions of Article 10 of the General Health Law.

CHAPTER SECOND

From information and promotion of medicines to healthcare professionals

Art. 86. Information and promotion addressed to healthcare professionals.

1. The information and promotion directed to healthcare professionals, under administrative control by the Sanitary Administrations in the terms provided for in Article 102.1 of the General Law of Health, must be in accordance with the data contained in the Register of Proprietary Medicinal Products of the Ministry of Health and Consumer Affairs and must be rigorous, well-founded and objective and not mislead, in accordance with the legislation in force, and conform to the technical information sheet.

2. The means of information and promotion used as support, whether written, audiovisual or otherwise, shall be basically scientific in character and shall be aimed and distributed exclusively to healthcare professionals.

3. In the case of information or promotion distributed by computer means, the Sanitary Administrations may access them for inspection purposes.

4. Prizes, scholarships, contributions and grants to meetings, congresses, study trips and events, similar donated by any person related to the manufacture, manufacture, distribution and dispensing of medicinal products will be applied exclusively for activities of a scientific nature where the addressees are clinical practitioners or the entities in which they are associated.

In the publications of meetings, meetings, conferences and similar events, the funds obtained for their implementation and source of funding will be included.

The same obligation will reach the media by whose way they are made public and which will obtain funds for or for publication.

THIRD CHAPTER

From the rational use of drugs in primary health care

Art. 87. Functions to ensure the rational use of the drug in primary care.

The following are considered functions that ensure the rational use of drugs in primary health care:

a) Elaboration of pharmacotherapeutic protocols and guidelines.

b) Transmission of medicines to healthcare professionals.

c) Information about medication for patients, monitoring of treatments and pharmacovigilance.

d) Collaboration with hospitals, and specialized care services.

e) Impulse and participation in the education of the population on drugs, their rational use and the prevention of their abuse.

f) The custody and proper preservation of the medications in your care.

g) The dispensing of medicinal products to patients by a pharmacist or under his supervision, with full professional responsibility and in accordance with the prescription, or according to the guidance of the scientific and pharmaceutical art in the Case of authorised non-prescription, informing them, advising and instructing them on their correct use.

h) Elaboration and dispensing of formal and formal formulae, guaranteeing their quality in accordance with the provisions of this Law.

Art. 88. Pharmacy offices.

1. Health administrations with competence in the field of pharmaceutical management shall carry out the management of pharmacy offices, having regard to the following criteria:

a) General planning of pharmacy offices in order to ensure adequate pharmaceutical assistance.

b) The presence and professional performance of the pharmacist is a condition and inexcusable requirement for the dispensing of medication.

(c) The minimum material, technical and sufficient means required by the Government to ensure the provision of proper health care, without prejudice to the powers of the attributed the Autonomous Communities in this field.

d) Pharmacy offices are required to dispense medicines that are required by individuals and the National Health System under established regulatory conditions.

2. On the basis of a certain amount of professional activity, the need for additional pharmacists, in addition to the holder or substitute where appropriate, shall be established by the office of pharmacy, in accordance with the powers conferred on it. have the Autonomous Communities attributed to them in this field.

3. For reasons of emergency and remoteness of the office of pharmacy or other special circumstances in certain establishments, the creation of kits may be authorized, exceptionally, under the conditions governing the establishment of determine on a basic basis, without prejudice to the powers conferred on the Autonomous Communities in this field.

4. The Public Administrations shall ensure the continued training of pharmacists and the appropriate certification and training of the Technical Assistance and Assistants of Pharmacy.

Art. 89. DDOE prescription.

In cases where the prescriber indicates in the recipe simply a Spanish official name, the pharmacist will dispense, if any, a pharmaceutical specialty of those authorized under such a name. And if you don't have it, a low conventional denomination to your professional criteria.

Art. 90. Replacement by the pharmacist.

1. Where the medicinal product is not available for legitimate reasons at the office of pharmacy or a prescribed conventional name, the pharmacist may, with the knowledge and conformity of the person concerned, replace it with a name generic or other proprietary medicinal product having the same composition, pharmaceutical form, route of administration and dosage.

Also, if the prescriber identifies the specialty in the prescription by a generic name, it may be replaced by another authorized under the same name.

2. In such cases, the pharmacist will write to the back of the prescription the specialty that he disfigured, the date, his signature and his rubric.

3. Those specialties which, by reason of their characteristics of bioavailability and narrow therapeutic range, shall be determined by the Ministry of Health and Consumer Affairs shall be exempted from this possibility.

CHAPTER FOURTH

The rational use of medications in hospital and specialty care

Art. 91. 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 units of hospital pharmacy according to the minimum established by this Law. Hospitals at the highest level and those that are determined must have services or units of Clinical Pharmacology.

2. In order to achieve the rational use of medicinal products, hospital pharmacy units or services shall perform the following functions:

(a) Ensure and assume the technical responsibility of the acquisition, quality, correct conservation, coverage of the needs, custody, preparation of master formulas or official preparations and dispensation of the precise medicines for intra-hospital activities and for those other, for extra-hospital treatment, requiring particular surveillance, supervision and control.

b) Establish an effective and safe distribution system for medicinal products, take measures to ensure proper administration, safeguard and dispense products in the clinical investigation phase and ensure compliance with legislation on narcotic drugs and psychotropic substances or any other medicinal product requiring special control.

(c) Forming part of the hospital commissions in which their knowledge for the scientific selection and evaluation of the medicinal products and their use can be useful.

d) Establish a drug information service for all hospital staff, an intra-hospital pharmacovigilance system, systematic studies of drug use, and pharmacokinetic activities clinic.

e) Conduct educational activities on issues of their competence to the hospital's healthcare personnel and patients.

f) To carry out own research work or in collaboration with other units or services and to participate in clinical trials with medicinal products.

g) Collaborate with the Primary and Specialized Care structures of the area in the development of the functions identified in Article 87.

h) Performing as many functions as possible in better use and control of medications.

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

Art. 92. Hospital pharmacy.

1. Hospitals with 100 or more beds will have Hospital Pharmacy Service under the ownership and responsibility of a hospital pharmacy specialist pharmacist.

2. Depending on the volume, activities and type of hospital, the need for additional pharmacists in the hospital pharmacy will be regulated.

3. Health administrations with competence in pharmaceutical management will perform such a function in the hospital pharmacy while maintaining the following criteria:

a) Setting requirements for proper operation, in line with established functions.

b) That the actions be performed with the presence and professional performance of the pharmacists or pharmacists needed for proper assistance.

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

4. Hospitals with less than 100 beds that do not wish to establish pharmaceutical services will be able to request authorization from the Autonomous Communities to maintain a drug depot under the supervision and control of a pharmacist. The conditions, requirements and operating rules for such deposits shall be determined by the competent Health Authority.

CHAPTER QUINTO

The rational use of drugs in the national health system

Art. 93. Principle of territorial equality and coordinated procedure.

1. The right of all to obtain medicinal products under conditions of equality throughout the national territory within the National Health System is recognized, without prejudice to measures to rationalize the use of medicinal products that may be adopted Autonomous Communities in the exercise of their powers.

2. The drugs will be dispensed by the pharmacy offices and pharmaceutical services of the hospitals, health centers and primary care structures, in accordance with Article 103 of the General Health Law.

3. The Interterritorial Council of the National Health System may agree on the general conditions for the planning, coordination, procurement, procurement and supply of medicines in the National Health System.

Art. 94. Procedure for public funding.

1. At the time of authorization and registration of a proprietary medicinal product, it shall be decided, in addition, if it is included, modality in its case, or is excluded from the pharmaceutical provision of Social Security, from funds of this or to state funds affected by the Health.

General, objective and published criteria will be taken into account and in particular the following:

a) Severity, duration and sequelae of the various pathologies.

b) Needs of certain collectives.

c) Therapeutic and social utility of the drug.

d) Limitation of! public expenditure intended for pharmaceutical provision.

e) Existence of drugs already available and other alternatives better or equal for the same conditions at lower price or lower cost of treatment.

2. Medicinal products for which the indications are symptomatic or for minor syndromes, as well as the total or partial exclusions, determined by the Member State, may not be financed by Social Security funds or State resources. Government of groups, sub-groups, categories or classes of medicinal products or medical devices, the public funding of which is not justified or is not deemed necessary. Products for cosmetic use, dietetic, mineral waters, elixirs, dentifrics, advertising and other similar products shall be considered to be excluded for this purpose.

3. The decision to exclude, in whole or in part, or subject to special financing conditions, medicinal products or medical devices already included in the provision of social security shall be made with the criteria laid down in the preceding points and Taking into account the price of the similar existing on the market and the guidelines of the Interterritorial Council of the National Health System and previous report of the National Commission for the National Use of Medicinal Products.

4. The equivalent shall be carried out in the case of medical devices.

5. The Government shall periodically review and update the list of medicinal products and medical devices included in the pharmaceutical provision of social security, in accordance with the available budgetary resources and the development of the criteria rational use, scientific knowledge and the criteria included in the previous numbers.

Art. 95. Patients ' obligations.

1. According to the General Health Law, by means of Royal Decree, prior to the report of the Interterritorial Council of the National Health System, the government will periodically regulate, when financing from the funds provided for in paragraph 1 of the Previous article, the assumptions in which the administration of medicines and medical devices will be free, as well as the participation in the payment to satisfy by the sick for the medicines and sanitary products that the System provides National of Health.

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

a) The ability to pay.

b) The therapeutic and social usefulness of medicines.

c) The needs of certain collectives.

d) The severity, duration, and sequelae of the different pathologies.

e) The limits of the budgetary forecasts affected by the pharmaceutical provision.

3. Users shall be required to justify their right to the provision when required by the medical staff of the National Health System or the dispensing pharmacies.

Art. 96. Assessment of the prescription.

In the field of the National Health System, the Health Administration is responsible for evaluating the prescriptions for areas, zones, therapies, population groups, and other circumstances. The Ministry of Health and Consumer Affairs shall establish coordination mechanisms to optimize the investigation of its causes and to adopt the precautionary and control measures corresponding to the requirements of administrative and administrative responsibilities. penalties to occur.

Art. 97. Pharmaceutical collaboration-National Health System.

1. Pharmacy offices, such as healthcare facilities, will collaborate for the purposes of this Law to ensure the rational use of drugs in primary health care.

2. Regardless of the obligations established in this Law and those that are regulated, the offices of pharmacy may be the object of consultation in the National Health System, according to the General System of Contracting Administrative and in accordance with the general criteria referred to in Article 93.3.

Art. 98. Aggregated information.

The aggregated information resulting from the processing of the prescriptions of the National Health System is in the public domain, always saving the confidentiality of health care and commercial business data individualised, as well as statistical secrecy. Its management corresponds to the Health Services of the Autonomous Communities in its territorial scope and the State in the aggregated information of the National Health System.

TITLE SEVENTH

From the Advisory Commissions

Art. 99. Participation.

1. All qualified persons who provide their services in the National Health System or the Public System of Scientific Research and Technological Development have the right to participate and the duty to collaborate with the Administration. Health in the assessment and control of medicines.

2. The Health Administration of the State shall be assisted by multidisciplinary consultative commissions composed of experts appointed by their relevant professional, scientific and health merits, as well as, where appropriate, representatives of the consumers and users, whose constitution, composition and procedure of action will be determined in a regulatory manner.

TITLE EIGHTH

From the intervention of drug prices

Art. 100. Fixing the starting price.

1. The Government, by Royal Decree, on a proposal of the Ministries of Economy and Finance, Industry and Energy and of Health and Consumption and with the agreement of the Commission Delegation of the Government for Economic Affairs, will establish the general system of fixation of the industrial prices of proprietary medicinal products, which will meet objective and verifiable criteria.

Likewise, the Government, on a proposal from the Ministry of Health and Consumer Affairs, and the agreement of the Government Delegation for Economic Affairs, will establish, on a national basis, the price regime for services. corresponding to the distribution and supply of proprietary medicinal products, in general or by groups or sectors, taking into account the costs of the corresponding services, services and arrangements.

2. The Ministry of Health and Consumer Affairs, pursuant to the first subparagraph of the preceding paragraph, shall establish the maximum industrial price on a national basis for each pharmaceutical specialty by authorizing it and entering it into the Record.

3. The Ministry of Health and Consumer Affairs shall establish the Price of Sale to the Public of the proprietary medicinal products through the aggregation of the Industrial Price and the concepts corresponding to the marketing. The Price of Sale to the Public shall be entered in the copies thereof.

4. The industrial prices of the proprietary medicinal products shall be free in those specific products, classes of products or therapeutic groups to be determined by the Government for competition or other social and health interests. they advise, without prejudice to the administrative intervention deemed necessary.

Art. 101. Characteristics of the pricing.

1. The decision setting the price may set a time limit for its validity not less than one year.

2. The fixed price shall be reviewable on its own initiative or at the request of a party where changes in economic, technical or social circumstances require it.

Art. 102. Economic information.

1. In order for the price intervention to achieve its objectives, manufacturers must provide the Ministry of Health and Consumer with sufficient 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 into a group that carries out other activities, in addition to those related to medicines, or develops them outside Spain, the State Administration may require the information to be disclosed by the company. imputation to determine the costs involved in the pharmaceutical activity in Spain.

3. The information provided by this article will be reserved for the State Administration.

Art. 103. Competent bodies.

The Government's Delegation for Economic Affairs, on a proposal from the Ministries of Economy and Finance, Industry and Energy, and Health and Consumer Affairs, will approve the General Plan for the intervention of the exercise. The Ministry of Health and Consumer Affairs will annually raise a memory of its actions in this field to the Government's Delegation for Economic Affairs.

The Government's Delegation for Economic Affairs will be able to agree annually on products or groups of products of high therapeutic interest that may be subject to individualized price review by the Government. Ministry of Health and Consumer Affairs.

Art. 104. Price revision.

The short-term reviews of the prices of the proprietary medicinal products will be carried out in accordance with the procedure established by the Government.

TITLE NINTH

Sanctioning Regime

CHAPTER FIRST

Inspection and precautionary measures

Art. 105. Inspection.

1. It is up to the Sanitary Administrations in the field of their competence to carry out the necessary inspections to ensure compliance with the provisions of this Law.

2. It is up to the State Administration to carry out the inspection function in the following cases.

(a) In the case of the necessary actions for the appropriate authorizations or records which, according to this Law, correspond to the State Administration.

(b) In any case, in the case of inspections to be carried out in the territory of the Autonomous Communities which do not have powers of implementation of the legislation of pharmaceutical products.

(c) In the case of medicinal products, products or articles intended for external trade or the use or consumption of which may affect public safety.

3. Personnel serving the Public Administrations who carry out the inspection functions, when exercising such functions and, crediting their identity, shall be authorised to:

a) Enter freely and without prior notification, at any time, throughout the center or establishment subject to this Law.

b) Proceed with the necessary tests, investigations, or examinations to check compliance with this Law and the rules that are required for its development.

c) Take or take samples, in order to check compliance with the provisions of this Law and the provisions for its development.

d) Perform as many performances as accurate in order to fulfill the inspection functions they develop.

Art. 106. Precautionary measures.

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

(a) Quarantine, withdrawal from the market and prohibition of the use of proprietary medicinal products, prefab medicinal products, formal formulae and official preparations, as well as the suspension of activities, advertising and the provisional closure of establishments, centres or services.

The quarantine shall mean the immediate blockade of the pharmaceutical establishment in which they are located or to which they are intended, in the case of transport not completed, for the time to be determined or until new order, in charge of their responsible.

(b) The suspension of the manufacture, prescription, supply and supply of products in clinical research or for animal research.

2. The duration of the measures referred to in the preceding paragraph, which shall be fixed for each case, without prejudice to successive extensions agreed upon by reasoned decisions, shall not exceed what is required by the situation of imminent and serious risk which the justified.

3. The State Administration shall be informed immediately by the health authority which adopted the precautionary measure.

4. Precautionary measures shall be made known by appropriate means and with the appropriate speed to each case, to health services, responsible entities or general public, as appropriate.

CHAPTER SECOND

Violations and penalties

Art. 107. General provisions.

1. The offences relating to medicinal products shall be subject to the appropriate administrative penalties, subject to the instruction of the appropriate file, without prejudice to any civil, criminal or other order which may be held.

2. The criminal proceedings before the Courts of Justice shall suspend the processing of the administrative file of penalties which has been initiated by the same facts and, where appropriate, the effectiveness of the administrative acts of taxation of sanction. The administrative measures that would have been taken to safeguard the health and safety of persons shall be maintained as long as the judicial authority decides on them.

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

Art. 108. lnfractions.

1. The infringements shall be classified as minor, serious and very serious in the light of the health risk criteria, the amount of the possible benefit obtained, the degree of intentionality, the seriousness of the health and social change produced, the generalisation of the violation and recidivism.

2. They shall constitute administrative misconduct and shall be sanctioned in accordance with the terms set out in the following

:

a) Mild infractions:

1. The modification by the holder of the authorization of any of the conditions on which the authorization was granted.

2. It is not the responsibility of the entities or persons responsible for the data that they are required to provide for health, technical, economic reasons. administrative and financial.

3. The lack of a copy of the Spanish Royal Pharmacopoeia and the National Form in the establishments obliged to do so.

4. Do not count the distribution and dispensing entities with the stocks of suitable medicines for the normal performance of their activities or services, as well as not having the minimum stocks established.

5. Do not have minimum stocks of medicines for emergency supplies or disasters, in cases that are obliged to do so.

6. ª Hinder the inspector's work by any action or omission that disturbs or delays the work.

7. Dispense Medications after the prescription is valid.

8. Do not correctly fill in the data and warnings that must contain the normalized recipes.

9. Perform the replacement of a pharmaceutical specialty, in cases where this is possible, in breach of the requirements established for this purpose.

10. Do not provide health practitioners with the technical tab for proprietary medicinal products before they are placed on the market.

11. Modify the texts of the technical tab, package leaflet and labelling without the necessary authorization.

12. Conduct advertising of master formulas or official preparations.

13. Incompliance with the duty to collaborate with the Health Administration in the evaluation and control of medications.

14. Do not adjust the prices of the proprietary medicinal products to that determined by the Administration.

15. The failure to comply with the requirements, obligations or prohibitions laid down in this Law and provisions that develop that, by reason of the criteria referred to in this article, they deserve the qualification of mild or not This applies to their rating as serious or very serious faults.

16. The direct or indirect offer of any incentive, premiums or gifts made, by whom it has direct or indirect interests in the production, manufacture and marketing of medicinal products to the healthcare professionals involved in the cycle of prescribing, dipensation and administration, or their relatives and people of their co-existence.

b) Serious infractions:

1. The manufacture, manufacture, import, export and distribution of medicinal products by natural or legal persons who do not have the required authorization.

2. Not to be carried out in the manufacture, manufacture, import, export and distribution of medicinal products for quality controls required by health legislation or to carry out manufacturing or control processes by means of procedures not validated.

3. The operation of an entity engaged in the manufacture, manufacture and distribution of medicinal products without the existence of a technical director, as well as the rest of the staff required in each case.

4. The operation of Pharmacy Services and Pharmacy Offices without the presence and professional performance of the responsible pharmacist.

5. Incompliance of the Technical Director and other personnel with the obligations of their positions.

6. To prevent the performance of duly accredited inspectors in the centres where medicinal products are manufactured, manufactured, distributed and dispensed.

7. The preparation of formal formulas and formal preparations in breach of established legal requirements.

8. Distribute or keep the medicines without observing the conditions required, as well as put on sale altered medicines, in poor conditions or, when the time has been stated, the term of validity.

9. Use in persons or animals for slaughter of any product in the research phase without prior to the declaration that qualifies as such.

10. Perform clinical trials without prior administrative authorization.

11. The non-compliance by manufacturers, importers and holders of the authorisation of medicinal products with the obligation to communicate to the health authorities the adverse effects of the medicinal products.

12. Failure by the Health Care Personnel of Pharmacovigilance.

13. The individualized preparation of vaccines and allergens in establishments other than those authorised.

14. Dispense Medications in establishments other than those authorized.

15. The refusal to dispense medication without justified cause and the non-prescription dispensing of medications that are subject to this prescription.

16. The substitution in the dispensing of proprietary medicinal products in violation of the provisions of Article 90 of this Law.

17. Any act or omission aimed at coarking the freedom of the user in the choice of the pharmacy office.

18. Incompliance by health personnel with the duty to ensure the confidentiality and privacy of patients in the processing of prescriptions and medical orders.

19. Conduct promotion, information or advertising of unauthorised medicinal products or without complying with the conditions laid down in the marketing authorization, as provided for in this Law and general legislation on advertising.

20. The performance of healthcare professionals involved in the cycle of prescribing, dispensing and administration, provided that they are in exercise, with the functions of medical visit delegates, representatives, commission, or Reporting agents for the laboratories for proprietary medicinal products.

21. The recidivism in the commission of minor infractions, as well as the commission of any of the violations qualified as minor when the circumstances provided for in paragraph 1 of this article are in serious form.

c) Very severe infractions:

1. The manufacture, manufacture, import, export, distribution, marketing, prescription and dispensing of products or preparations that are presented as medicinal products without being legally recognized.

2. The placing on the market of medicinal products without having obtained the prescriptive health authorization.

3. The import and export of blood, fluids, glands and human tissues and their components and derivatives without prior authorization.

4. Incompliance with precautionary and definitive measures on medicinal products to be agreed by the competent health authorities for serious public health reasons.

5. The recidivism in the commission of serious faults in the last five years.

6. Conduct clinical trials without adjusting to the content of the protocols on the basis of which the authorisations have been granted: either, without the consent of the person subject to the authorisation or, where appropriate, of his/her representative, or a substantial breach of the duty of information on the clinical trial in which you participate as a subject.

7. The preparation of secret remedies.

8. The offering of premium, gifts, prizes, contests or the like as methods linked to the promotion or sale to the public of the products regulated in this Law.

9. The recidivism in the commission of serious infractions, as well as the commission of some of the violations qualified as serious when the circumstances provided for in paragraph 1 of this article occur in a serious way.

Art. 109. Penalties.

1. The offences relating to medicinal products shall be sanctioned in accordance with Article 108, applying a minimum, average and maximum degree of graduation to each level of infringement, in the light of the negligence and intentionality of the individual. infringer, fraud or connivance, failure to comply with previous warnings, company turnover, number of persons affected, injury caused, profits made on account of the infringement and permanence and transience of the risks:

a) Mild infractions:

Minimum degree: Up to 100,000 pesetas.

Average Grade: From 100,001 to 300,000 pesetas.

Maximum degree: From 300,001 to 500,000 pesetas.

b) Serious infractions:

Minimum Grade: From 500,001 to 1.150,000 pesetas.

Average Grade: From 1.150,001 to 1,800,000 pesetas.

Maximum degree: From 1,800,001 to 2,500,000, being able to exceed that amount up to five times the value of the products or services that are the object of the infringement.

c) Very severe infractions:

Minimum Grade: From 2,500,001 to 35,000,000 pesetas.

Average Grade: From 35,000,001 to 67,500,000 pesetas.

Maximum degree: From 67,500,001 to 100,000,000, being able to exceed that amount up to five times the value of the products or services that are the object of the infringement.

2. Without prejudice to the fine to be imposed in accordance with the provisions of the preceding paragraph, the infringements in the field of medicinal products shall be sanctioned by the committee, in favour of the public treasury, of the unlawful benefit obtained as a result of the perpetration of the infringement. The resolution of the Administration shall determine for these purposes the amount of the illicit benefit obtained.

3. It is for the exercise of the power of sanctioning the Administration of the State or the Autonomous Communities that hold the function inspector, in accordance with the provisions of Article 105 of this Law.

4. In addition, in the case of very serious infringements, the Council of Ministers or the competent bodies of the Autonomous Communities to which the implementation of the legislation on pharmaceutical products corresponds, may be closed. temporary establishment, installation or service for a maximum period of five years. In such a case, the provisions of Article 39 of Law 8/1988 of 7 April on Infractions and Sanctions of Social Order will apply.

5. The amounts mentioned above may be reviewed and updated regularly by the Government, by means of Royal Decree, taking into account the variation of the Consumer Price Index.

Art. 110. Other measures.

1. The closure and closure of establishments, facilities or services which do not have the prior authorisations or health records required, or the suspension of their operation until the defects are remedied, shall not be of a sanction. or meet the requirements for health, hygiene or safety reasons.

2. The authority to which the file is to be resolved may agree, as a sanction, for the use of damaged, expired, unauthorised products and medicinal products which may pose a risk to health.

3. The costs of transport, distribution or destruction of the products and medicinal products referred to in the preceding paragraph shall be on behalf of the infringer.

Art. 111. Prescription and expiration.

1. The offences referred to in this Law shall be deemed to be minor in the year, qualified as serious, at two years of age, and qualified as very serious, at the age of five. The term of the prescription shall begin to run from the day on which the offence was committed and shall be interrupted from the moment the proceedings are directed against the alleged infringer.

2. The action to pursue the infringements shall lapse where the existence of an infringement and the proceedings for clarification of the facts have been completed, one year after the competent authority has been terminated without the competent authority have ordered the initiation of the appropriate procedure.

Art. 112.

Before the withdrawal of the market and the definitive prohibitions on use, resulting from a sanctioning dossier, the Ministry of Health and Consumer Affairs shall hear the opinion of the National Pharmacovigilance Commission or of the Carlos III Health Institute, as appropriate, and give an audience to the stakeholders.

TITLE TENTH

Rate

Art. 113. Creation, regulation and territorial scope.

1. The fee for the provision of services and the performance of the activities of the State Administration in the field of medicinal products is hereby established.

2. The tax paid in this title shall be governed by the provisions of this Law, in its absence, by the Law on Public Fees and Prices and other applicable legal provisions, as well as by the regulatory norms that are dictated in its development.

3. This fee shall apply throughout the national territory in accordance with the provisions of Article 118 of this Law, and without prejudice to the powers of the Autonomous Communities.

Art. 114. Taxable fact.

1. The taxable fact of the levy is the provision or performance by the competent authorities of the State Administration of the services or activities referred to in Article 117 relating to proprietary medicinal products and other medicines, medical devices, cosmetics and personal hygiene products, manufacturing laboratories and wholesale distributors.

2. For the purposes of this levy, the consideration of cosmetic products subject to a special declaration is that which, subject to the authorization of the Ministry of Health and Consumer Affairs, includes colouring agents, preservatives or Ultraviolet filters, not included among the substances admitted as components of cosmetic products.

Art. 115. Exemptions.

1. The provision of services or activities relating to the manufacture of "medicinal products without commercial interest" referred to in Article 34 of this Law shall be exempt.

Art. 116. Taxable person.

1. The taxable person shall be the natural or legal persons applying for the provision of the services or the performance of the activities which constitute the taxable event.

Art. 117. Amount.

1. The amount of the fee shall be:

	Amount - Pesetas
	I. Pharmaceutical Specialties
1.1. Pharmaceutical laboratory opening and transmission authorization	68,130
1.2. Revalidation and modification of the pharmaceutical laboratory license	17.035
1.3. Pharmaceutical lab home move	68,130
1.4. Granting marketing authorization and registration to the pharmaceutical specialty register:
-New specialty based on medicinal substance or associations that are new to the company	255.510
-Transmission of a pharmaceutical specialty of previous record	45.420
-Modification of a previous record specialty, provided that it affects the active substances, the therapeutic indication, the basic information of the technical tab, the dosage or the pharmaceutical form of the craft	170,340
-Modifying a previous record craft, when referring to the rest of the information on the tab (a) technical, modification of the excipient or composition of the speciality which does not affect the substances Medicinal products and the extension of the authorized packaging types without altering their composition and dosage	28,380
-Special entitlements for widely known medications and whose application refers to the assumptions contained in this Law	56,780
1.5. Authorization of clinical or animal trials and authorization of "investigational product"	28.390
1.6. Revalidation of pharmaceutical specialties	54.970
1.7. Issuing certifications and annual convalidations	5,680
	Group II. Medicinal plants
2.1. Authorization to open and transmit laboratories	34,070
2.2. Recording and transmitting medicinal plants:
-New registration that is new to the Company	12.775
-Transmission of previous record medicinal plants	2.270
-Previous Record Medicinal Plant Modification	8.515
	2.3. Laboratory facilities and home transfers	1,700
2.4. Issuing certifications	1,700
	Group III. Sanitary products, cosmetics and personal hygiene
3.1. Cosmetic Special Statement	34,070
3.2. Individualized registration and authorization for personal hygiene products	34,070
3.3. Registration, enrollment and approval of Healthcare products	34,070
3.4. Clinical implant health record	56,780
3.5. Revalidation and validation of Personal Hygiene and Healthcare Products	11.355
3.6. Issuing certifications	1,700
	Group IV. Inspections practiced at part
4.1. Individual inspecting actions at the request of a party, except in the case of a complaint or at the request of a representative user or consumer association	28.390
4.2. Issuing certifications	1,700

2. The amount of the Fee for the services and activities of the State Administration in the field of Medicines, as provided for in the Law on Public Fees and Prices, may be modified by Royal Decree.

3. Where the assessment and control of a medicinal product or medical device requires action abroad or exceptional costs, the corresponding fees shall be settled on the actual cost of the service in which the taxable event consists.

Art. 118. Accrual.

The rate shall be due at the time the service is initiated or the administrative activity is carried out. Where the High Rate of the issue of documents, the application initiating the file shall become due to the time of submission.

Art. 119. Payment.

1. The payment of the fee shall be effected by means of the use of timbrated effects or, when regulated, in cash, the amount of the fee being paid to the Treasury.

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

ADDITIONAL PROVISIONS

First.

1. In order to develop and promote the necessary activities in the field of supplies of medicinal products and medical devices and to coordinate the adequate availability of blood and other fluids, glands and human tissues and their components and their components As required for health care, the Ministry of Health and Consumer Affairs, in addition to the tasks assigned to it by the Law, shall carry out the following tasks:

(a) Ensure the deposit of narcotic substances in accordance with the provisions of the International Treaties.

b) Authorize the importation of foreign and urgent non-authorized medication in Spain.

c) Maintain a strategic state deposit of medicines and medical devices for emergencies and catastrophes.

d) Conduct the procurement and distribution of medicines and medical devices for international cooperation programmes.

e) Coordinate the supply of vaccines, medicines and other products for health campaigns, the acquisition and distribution of which is decided by the different Sanitary Administrations.

f) Promote the manufacture and marketing of "medicines without commercial interest".

2. It shall also exercise the coordination of exchanges and the transport of blood and other fluids, glands and human tissues and their constituents and derivatives.

Second.

The application of the criteria and rules established in this Law to the Health Services of the Armed Forces will be determined in accordance with the joint proposal of the Ministries concerned.

Third.

1. The scheme provided for in Chapter V of Title VI for the rational use of medicinal products in the National Health System, with the exception of Article 93.2, shall also apply to medical devices with the characteristics of rules are determined.

2. The Government shall establish the criteria and systems for the coordination of clinical research on medical devices, health-related technologies or any other medical devices.

You may also determine health products, cosmetics, body hygiene products, in vitro diagnostics or technologies whose clinical investigation and use, if any, are to be authorized, approved or certified by the State, in view of its particular risk or importance to health.

Fourth.

The preparation and marketing of homeopathic products without therapeutic indication shall be regulated by their specific regulations.

Fifth.

Correctional facilities may request from the competent administration in each case authorization to maintain a deposit of medications for the care of the inmates, under the supervision and control of a pharmaceutical company. licensed pharmaceutical services of prison hospitals.

Sixth.

Article 47.5 of the General Health Law is amended, which will be worded as follows:

" An Advisory Committee is set up, linked to the Interterritorial Council of the National Health System referred to in the previous paragraphs, consisting of the same number of representatives of the business organizations and more representative trade unions and those of the consumer and user associations which the Consumers and Users Council proposes for this purpose and, in all the above, by representatives of the public administrations. present in the Interterritorial Council, designated by the Council. "

Seventh.

The Government by Royal Decree, after report of the Interterritorial Council of the National Health System, will establish the form, requirements and conditions of application of the criteria contained in Article 94 and will determine the total or partial exclusions of the groups, sub-groups, categories or classes of medicinal products excluded from the funding from Social Security funds or State funds affected by the Health.

The entry into force of this Royal Decree will be repealed, in accordance with the provisions of Article 94, Articles 105, 106 and 107 of the General Law on Social Security.

TRANSIENT PROVISIONS

First.

The characteristics and criteria of the Adequation Plan of the pharmaceutical specialties authorized and registered in the registry to the entry into force of this Law will be determined, which must be reviewed progressively, in the aspects that correspond to the provisions of this Law.

Second.

As long as the National Form is approved and published, the elaboration of formal formulas and formal preparations regulated in Articles 35 and 36 shall be in accordance with the general principles laid down in this Law and the rules currently accepted techniques and scientists.

Third.

Within one year, since the entry into force of this Law, pharmacy offices, pharmaceutical services, distribution entities and pharmaceutical specialty laboratories will have a copy of the Pharmacopoeia. European.

Fourth.

In the six-month period, the holders of manufacturing authorizations shall regularise these in accordance with the provisions of Article 70 of this Law.

Fifth.

1. The activities of handling, storage, placing on the market, prescription and dispensing of medicinal plants and their preparations for the provisions laid down in Title II, Chapter IV, Section 4 shall be adapted within two years. Fourth, of this Law.

2. The preparations of medicinal plants currently registered in the special register of medicinal plants will be progressively revised to adapt them to the requirements of the Second Title, Chapter IV, Section 4, of this Law.

Sixth.

Pharmacists in professional practice with a pharmacy office or in a hospital pharmacy service and other care structures, which at the entry into force of this Law have direct economic interests in laboratories Authorised pharmacists may maintain those interests until the authorisation or transfer of the laboratory is extinguished.

Seventh.

As long as the Spanish Royal Pharmacopoeia is not published, the European Pharmacopoeia will be official.

REPEAL PROVISION

The provisions of this Law and, in particular,

provisions of this Law are repealed.

(a) The Ordinance for the exercise of the profession of pharmacy approved by Rea! Decree of 18 April 1860.

b) Base 16-Pharmaceutical Services-of the Law of Bases for the Organization of National Health of 25 November 1944.

(c) Law of 17 July 1947 on incompatibilities in Companies producing or distributing Proprietary Medicinal Products.

FINAL DISPOSITION

The Government is authorized to approve regulations and standards for the implementation and development of this Law.

Therefore,

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

Madrid, 20 December 1990.

JOHN CARLOS R.

The President of the Government,

FELIPE GONZÁLEZ MARQUEZ