Drugs Law.

Original Language Title: LEY DE MEDICAMENTOS.

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1. Decree No. 1008 the Legislative Assembly of the Republic of EL SALVADOR, considering: I.-that in accordance with article 1 of the Constitution of the Republic of El Salvador recognizes the human person as the origin and purpose of the activity of the State, which is organized for the attainment of Justice, the legal security and the common good; Consequently, it is obligation of the State to assure the inhabitants of the Republic, the enjoyment of freedom, health, culture, economic well-being and Social Justice.
II.-that article 69 of the Constitution of the Republic establishes that the State will provide the resources necessary and indispensable for the permanent quality control of chemical, pharmaceutical and veterinary products by means of monitoring bodies.
III. that pursuant to the foregoing it is necessary to create a responsible entity for the permanent quality control of drugs, the manufacture, import, export, distribution, transport, storage, supply, marketing, prescription, dispensing, purchase, promotion, advertising and rational use of medicines.
IV.-therefore, it is necessary to update and strengthen the legal framework regulating drugs.
Therefore, in use of his constitutional powers and at the initiative of the deputies and members Zoila Beatriz jaw Solís, Irma Lourdes palaces Vasquez, Pedrina Rivera Hernandez, Virginia Morataya, Yohalmo Edmundo Cabrera Chacón; of the President of the Republic through the Minister of health and with the support of the deputies Guillermo Francisco Mata Bennet, José Álvaro Cornejo Mena, Carlos Cortez Hernandez, Luis Alberto Corvera Rivas, Blanca Noemi Coto Estrada, Nery Díaz, Antonio Echeverría Veliz, Emma Julia Fabián Hernández, Santiago Flores Alfaro, La Norme Fidelia Ramirios Guevara, Gaspar Armando Portillo Benitez, Benito Lara , Gladys Marina Landaverde walls, Inmar Rolando Reyes, Roberto Lorenzana, Oscar Ernesto Novoa, Guillermo Antonio Olivo Méndez, Mr. Orestes Fredesmán Ortez Andrade, Othon Sigfrido Reyes Morales, Jackeline Noemi Rivera Avalos, David Rodriguez Rivera and Ana Daysi Cruz Villalobos.
DECREES the following: law of drugs 2 title I provisions General Chapter I object, scope and competent authority object article 1.-the present law aims, ensure institutions that ensure accessibility, registration, quality, availability, efficiency and safety of medicines and cosmetics for the population and provide the best price for the user public and private; as well as rational use.
Scope of application article 2.-this law will apply to all public and autonomous institutions included the Salvadoran Social Security Institute and all natural persons and legal private engaged permanent or occasionally to research and development, manufacture, import, export, distribution, transportation, storage, marketing, prescription, dispensing, assessment and information from drugs and cosmetics of therapeutic use.
Creation of the National Directorate of drugs article 3.-create the National Drugs Directorate hereinafter "Address" as an autonomous entity of law and public utility, of a technical nature, of indefinite duration, with full autonomy in the exercise of their functions, both in the financial and administrative and budget; which is the competent authority for the implementation of this law.
Article 4.-the management, will be integrated by delegates: to) the Director, who shall be appointed by the President of the Republic;
(b) Ministry of health);
(c) Ministry of economy;
(d) the Consumer Ombudsman;
e) the Instituto Salvadoreño Social insurance;
(f) Ministry of Finance);
(g) University of El Salvador in its own right; and (h) one elected between the private career allied health universities.

3. an Executive Director who shall be appointed by the members of the direction, it shall have the right to speak but not to vote.
Each member owns, will have their respective alternate with equal rights in the absence of this.
Agreements and resolutions shall be adopted by a simple majority, and in the event of a tie, the Director of the Directorate shall have qualified vote.
The members of the Directorate, will remain as members three years and may be reappointed for one further period.
Article 5.-no member of the address must have direct or indirect relationship with the pharmaceutical industry in the assigned period or in the last five years.
Likewise no member of the staff of the National Directorate of drugs, including the staff of the laboratory of Control of quality and any other dependencies, shall perform the offices of Regent of pharmaceutical establishments, head of quality Control or another in any way intervene in technical, economical, financial, administrative, medical and services hired directly or through third parties including relationships in any of the courses listed directly or through relatives to a third degree of consanguinity and the second degree of affinity in the assigned period or in the last five years.
Article 6.-are powers and duties of the National Directorate of drugs: to) hire people who occupied various posts that ensure the proper functioning of the address;
(b) prepare the draft annual budget for each financial year fiscal revenues and expenditures of the institution and send it to the Ministry of finance so that it be submitted to the Legislative Assembly for approval;
(c) authorize the opening and operation of all types of establishment permanently or occasionally engaged in the activities described in article 2 of this law;
(d) authorize the registration, importation, manufacture and sale of the products regulated by this Act, with the exception of the compounding;
(e) authorize the registration, importation, manufacture and sale of pharmaceutical specialties, vitamin supplements, natural products and other products or substances that provide a therapeutic action made in the country or abroad and which comply with the requirements established in the regulations of this law;
(f) qualify and authorize, prior to publication or broadcasting, the propaganda of all products to be offered to the public as a means of prevention and cure of 4 conditions, promotion or restoring the health, avoiding such propaganda involve exaggeration, omission, inaccuracy or that may lead to consumer deception, mistake or confusion about the origin of the product components or ingredients, the benefits or implications of your case; avoiding such propaganda abuse of good faith and credibility of persons;
(g) approve the work Plan presented by the Director of the Directorate;
(h) develop and propose projects of regulation of this law to the President of the Republic for approval;
(i) manage the resources that are assigned to them;
(j) authorizing the introduction to the country of drugs that institutions or foreign organizations sent out as a donation to institutions established in this law, according to the rules laid down in the respective regulations;
(k) cancel the authorizations granted for the dispensing of specialties, Officinal products and cosmetics, when it is found that they constitute a danger to health;
(l) develop the memory of the year of management work and present it to the Legislative Assembly;
(m) ensure the entire process quality control of medicines;
n) ensure that audits are practice timely and correspond to the periods indicated;
(o) carry out the supervision of the proper performance of the Executive;
(p) in coordination with the Ombudsman's protection the consumer, supervise the selling prices of medicines in the approved establishments in article 2 of this law;
(q) regulating the import and consumption of products covered in the law activities related to drugs and the regulation of narcotic drugs psychotropic and aggregates;
(r) in coordination with the Ministry of health set up the listing of drugs (LOM) compulsory existence in the national health system; This list will be published in the official journal of the Republic and will be updated in the first quarter of each year;
(s) monitor the conditions of storage, distribution, transportation and dispensing of medicaments in approved establishments;
(t) published in the official journal of the Republic and in two largest-circulation during the first month of each year, the list of drugs approved for sale free in any of its modality;

5 u) published in the official journal of the Republic and two largest-circulation list of the establishments which they has suspended or revoked the operating license;
(v) collect fees or rights that it corresponds to collect licenses, authorizations and certifications that extends, as well as the services that pay, which should be determined through a technical study and be subject to approval by the Legislative Assembly;
(w) you will meet and resolve resources of appeal pursuant to article 92 of this law; and (x) ensuring compliance with the present law.

Article 7.-the management will be formed in the following way: to) Executive direction; (b) unit of inspection and control; (c) unit of registration and visa; (d) unit of promotion and publicity; e) unit of quality Control in the Pre and Post registration of medicines; f) unit price; (g) unit of imports, exports and donations of medicines; (h) financial unit; (i) human resources unit; (j) internal audit unit; (k) Narcotics Unit; (l) legal unit; and (m) others deemed necessary by management.
Heritage article 8.-the heritage of the address, will be made by: a) an initial contribution from the General budget of the State concept of founding capital according to the needs of the new institution;
(b) the resources that the State transferred to the beginning of its operations;
(c) transfer of resources which annually shall be entered in the General budget of the State;
(d) the real and personal property and values transferred by the Ministry of health and the Superior Council of public health for the start of its operations and those acquired during its operation to the performance of its functions;
(e) extraordinary contributions granted by the State for any reason;

(6 f) revenue from rights that charge for their registration, pre control services and medicines and publications;
(g) inheritances, legacies and donations national or foreign aimed at the attainment of the objectives of the address; and (h) other income that may be legally obtained.
Resources shall be deposited and kept in a special account, is handled according to the budgetary rules and shall be subject to fiscal controls established under the management and responsibility of the National Directorate of drugs.
Regime applicable tax article 9.-the source of financing of the address will have their origin in those resources which the Ministry of finance must be included in the corresponding budget laws approved in each fiscal year.
Art.10.-the national medicines, will feature an Executive Director who shall be appointed by the Director, by simple majority, from a list of three proposed by the Director of the Directorate.
Faculties and powers of the Director Executive article 11.-the Director shall have the following powers and duties: to) take a public registry for the registration of establishments that are authorized;
b) carry a public register of authorisations for medicinal cosmetics, pharmaceutical chemical products, and other substances that provide therapeutic action;
(c) collaborate with other institutions of the Executive branch in the corresponding fields and respective monitoring bodies, in the preparation of proposals of laws and regulations related to health;
(d) prepare the draft regulations, to agencies and establishments under its control subject and send them to the address for approval;
(e) have a record of every licensed pharmacy responsible for Regents;
f) notify the Attorney General of the Republic of all irregular processes related to the implementation of this law;
(g) impose sanctions and fines, has location, for the violations committed against the provisions of the present law; and (h) other pointing this law.

7. the Executive Director will make use of the attributions and powers mentioned in this previous article technical backstopping by the respective unit.
Requirements of the Director Executive article 12.-to qualify for the position of Executive Director, you must meet the following requirements: to) be Salvadoran;
(b) hold a degree in their respective profession in the health area, conferred by universities legally established in the country or incorporated by the University of El Salvador;
(c) of professional experience;
(d) of conduct and notorious morality;
(e) be more than thirty years of age; and (f) be in the exercise of the rights of citizens and have been in the previous five years.
Chapter II concepts and definitions article 13.-for the object and purpose of this Act, be used the following concepts and definitions: authorization for marketing: legal procedure by which the competent authority authorizes its registration marketing or free distribution of a product evaluation of their quality, safety and efficacy.
Good manufacturing practices: A set of rules and procedures among themselves to ensure that pharmaceutical products retain the identity, purity, concentration, power and safety required during its useful life.
Good storage and transportation practices: set of technical standards that are applied to the deposit, distribution, dispensing and sale of pharmaceutical products in order to guarantee the quality for the life.
Quality control: all measures taken, including the establishment of specifications, sampling, analysis, to ensure that raw materials, intermediate products, packaging materials and finished pharmaceutical products meet the specifications set forth by the compendial standards such as identity, strength, purity and other features.
International Nonproprietary name: Is the name that identifies the substance or active ingredient 8 pharmacist. Each international non-proprietary name is a unique name which is recognized worldwide and of public property. The international non-proprietary name is also known as generic name.
Dispensation: Pharmaceutical professional Act of providing one or more medications to a patient, according to the verification of a prescription by a licensed professional. In this Act the pharmacist advises and orients the patient on the rational and appropriate use of the drug.
Dependent: Staff working in pharmacies duly accredited by the Board of supervision of the profession pharmaceutical companies, and that carries out the dispensation of medicines prescribed by a physician, make sure that the same shall be delivered in concentration, dosage form, and quantity specified, without modifying the active ingredient prescribed, which should be trained and supervised by the Regent.
Drugstore: Is any establishment that operates the import, storage and distribution of pharmaceutical products for the wholesale.
Pharmaceutical equivalents: which contains the same amount of molar of the same pharmaceutical active ingredient, in the same dosage form, comply with comparable standards and if it is intended to be administered by the same route. The pharmaceutical equivalence does not necessarily therapeutic equivalence, as differences in the excipients and the manufacturing process and some other variables that may give rise to differences in the action of the product.
Therapeutic equivalents: Two products are therapeutic equivalents if they are pharmaceutical equivalents and also after administration in the same dose, their effects with respect to efficacy and safety are essentially the same, which is determined by appropriate bioequivalence, pharmacodynamic, clinical or in vitro studies studies. Two therapeutic equivalents are interchangeable.
Pharmaceutical establishments: Understood by pharmaceutical establishment, all kinds of laboratories, drugstores, pharmacies selling drugs, retailers and storage centers and distribution of pharmaceutical products, previous qualification by the competent authority.
Optional: Health professional in the areas of medicine, dentistry and veterinary medicine, legally authorized and registered for the exercise of their profession.
Pharmacovigilance: Refers to activities relating to the detection, assessment, understanding and prevention of adverse reactions or incurred related side effects patients with medications, in order to identify new information about the risks and take measures to its control and prevention.
Pharmacy: Establishment that operates in the acquisition, storage, conservation, compounding, dispensing and sale of medicines, natural products, vitamins and others offering therapeutic action directed at the public in general.
Pharmaceutical form: It is the physical form that is given a drug, which facilitates the dosage of assets or of the principles so that they can exercise their action at the place and time in the patient, such 9 as capsules, tablets, etc.
Magistral formula: Any medicinal product intended for a patient specific, prepared by the pharmacist, or under his direction, according to the technical standards of the pharmaceutical art, in order to comply explicitly an individualized prescription of medicinal substances which includes; This will be dispensed in pharmacy, with the proper information to the patient, without requiring registration for its sale.
Officinal formula: Any medicinal product prepared and guaranteed by a pharmacist, or under his direction, which will be dispensed at the pharmacy, with the proper information to the patient. With the rules established in the official texts will be followed for its elaboration.

Therapeutic form: Document containing the monograph of the active principles of the list of essential drugs used to prevent and cure the diseases prevalent and is aimed at medical professionals who prescribed in the network of public and private establishments.
Quality assurance: broad concept covering all the aspects that individually or collectively influence the quality of the product. They are all applicable measures in order to ensure that pharmaceutical products are of the quality required for their intended use. Quality assurance includes both the good manufacturing practices and other factors, including the design and development of the product.
Quality Control Laboratory: tecnica-normativo line agency, responsible for the quality control of medicines and products covered by this law.
Pharmaceutical laboratory: Pharmaceutical chemical establishment authorized, with facilities designed to perform all operations that involve the manufacture of pharmaceutical products.
Packing material: any material used in the packaging of medicines.
Medication: Substance simple or composed of natural, synthetic or semi-synthetic origin that is therapeutic, prophylactic or diagnostic and occurs in a dose and is suitable for his administration.
Biological medicinal product: Any medicinal product obtained by means of biotechnological processes properly registered, licensed and that they require for their sale the corresponding registration.
Essential medication: Are drugs that have proven efficiency, range of acceptable security, and serve to meet the needs of the greater part of the population health care.
Drugs with cosmetic purposes: any substance or prepared to be put in contact with the different parts of the surface of the human body (epidermis, hair and capillary system, nails, lips and external genital organs) or with the teeth and the mucous membranes mouth, in order exclusive or main clean them, perfuming them, modify their appearance, protect them, keep them in good condition or correct body odours.
Interchangeable generic drug: It is that 10 comparator is therapeutically equivalent to the product and can be exchanged with the comparator in clinical practice.
Generic drug: Those who are registered and used with the International Nonproprietary name of the active ingredient and which proves to be Bioequivalent to the innovative molecule.
Medication Homotoxicologico: Homotoxicologico medications are composed of different substances homeopathically prepared formulations.
Homeopathic medicinal product: Pharmaceutical substance employing microdose of extracts of plants, minerals, animals or mixtures of these therapeutic purposes and which must be marketed prescription prior registration.
Innovative medication: Is one that offers a new molecule for therapeutic purposes and typically corresponds to a new chemical entity, on the basis of its safety, efficacy and quality, provided by the titular lab documentation and is protected by law in a period of time.
Brand generic medicine: generic drug to which is added a commercial name or the name of the laboratory that manufactures it.
OTC drugs: pharmaceutical product registered, licensed and published for sale without a prescription.
Medicines without medical prescription: are qualified as not subject to medical prescription drugs those who go for processes or conditions that do not require a precise diagnosis and whose data toxicological, clinical evaluation or use and route of Administration does not require medical prescription, so these medications can be used for auto health care through its dispensation in the office of Pharmacy by a pharmacist who will inform, you will advise and instruct on proper use.
Leaflets and labelling of medicines that do not require medical prescription shall contain those warnings that suit their nature and, in particular, those aimed at preventing drug abuse.
Prescription: Order signed by legally authorized practitioners, so that one or more pharmaceuticals specified in that are dispensed.
Medical prescription: The public or private delivery, prescription is the document that ensures the establishment of a treatment with medications by prescription from a doctor, dentist, or veterinarian.
Active principle: Any substance or mixture of substances from source natural, human, animal, vegetable, mineral, microbiological, chemical, biogenetic synthetic or semi-synthetic which an effect possessing drug specific, is credited with a proper activity to constitute a medicament.
Natural product: Is that its composition contains active principles, parties obtained directly or through specific procedures of plants, minerals or animals, whose use is enabled and justified by the practice of traditional medicine or scientific studies.

11. promotion: All informative, advertising activities undertaken by manufacturers, distributors, and dispensers in order to induce the prescription, supply, acquisition and the rational use of medicines.
The promotion of drugs, will be oriented to report on their rational use and prevention of their abuse.
Advertising: Means advertising of pharmaceuticals and specialties that is made by any form or means of dissemination, such as: printed advertising, broadcasting, teledifundida, drawn, painted, designed, or disseminated through the internet, audio systems, fixed or mobile as well as the free distribution of samples.
Regent: Pharmaceutical chemical professional duly authorized and registered to practice their profession, responsible for the technical direction of a pharmaceutical establishment.
Registration: It is the technical legal process that ensures that the medicinal product to market meets the requirements of quality, efficacy and safety, which culminates with a health certification for marketing which is issued by the competent authority.
Title II of the drugs chapter I regulated products and classification products regulated article 14.-are subject to the regulations of this law all medicines, cosmetics and substances that provide a therapeutic action made in the country or imported from abroad. Sorting basics article 15.-for the purposes of this Act, drugs are classified: 1) according to their origin: a. drug synthesis or semisynthesis;
b. drugs from medicinal plants;
c. radiopharmaceuticals;
d. homeopathic medicines;
e biotechnological medicines;
f compounding;

12 g. medication blood product;
h. immunological medicinal product;
i. biological drugs.
(2) according to their development: a. innovative medicines;
b. prescription generic and brand medications.
(3) according to the required prescription: a. drug dispensing free;
b. dispensing prescription medications;
c. retained special prescription dispensing medications;
d. drugs of prolonged use.
Chapter II listing official medicines, rational use listing officer of drugs article 16.-in coordination with the Ministry of health, direction will establish the official drug list of compulsory existence in the national health system; This list will be published in the official journal.
Article 17.-in the first quarter of each year will be updated and published the official list of medications. Rational use of medicines Art.18.-La direction national drugs in coordination with the Ministry of health and other government agencies and non-governmental direct actions aimed at continuing and permanent training on drugs, therapeutic and health products to health professionals.
The aforementioned institutions, will direct his performances to implement an agile, efficient and independent system that ensures scientific, objective and up-to-date information for drugs and medical devices to healthcare professionals.

13. the public health administrations shall promote the publication of guides pharmacological or pharmaceutical for use by health professionals.
Health authorities carried out health education programs on drugs aimed at the public in general promoting actions that promote a better understanding of the drugs to improve treatment adherence, avoid risks arising from a misuse and creating awareness among citizens of the economic value of the drug.
Chapter III prescription, dispensing and prescription medical faculty to prescribe Art.19-medicines on prescription may only be prescribed by medical professionals, dentists and veterinary surgeons, enabled for the exercise of the profession and duly registered by the respective authority. Prescribing article 20.-the professionals referred to in the preceding article, shall inform the patient about the therapeutic action, side effects of prescription medicines and will write in the recipe, the brand name and the generic name of the drug. Content essential recipes

Article 21.-all recipe should be in plain text, as a minimum contain the following information: a) the prescriber and the patient identification data;
(b) the drug of choice of the optional;
(c) the generic name of the ingredient;
(d) presentation;
(e) details of the concentration of the drug doses;
f) route of administration;
(g) day of treatment and the amount prescribed in numbers; and (h) place, date, signature and stamp of the prescriber.
In the case of public health institutions, will not apply them regulated in subparagraph (b) of this article.

14 narcotic drugs, psychotropic substances and added article 22.-the prescription of narcotic drugs, psychotropic substances and aggregates will be in special recipes printed and delivered under the responsibility of the direction through the section of narcotic drugs, psychotropic substances and aggregates.
In every single recipe can be prescribed a medication that contains narcotics, psychotropic in the dosage for treatment, indicating the brand of the medication or trade name, generic name, dose, route of administration and amount. Contracting and subcontracting of medical article 23.-it prohibits any recruitment or subcontracting of physicians, dentists and veterinarians, to practice the profession to the interior of the pharmacies in order to prescribe any kind of drugs. * DECLARED unconstitutional dispensing article 24.-the dispensation of drugs, will be in charge of pharmaceutical establishments approved by management, be they public or private, that will be under the responsibility and supervision of a pharmaceutical chemical professional duly authorized by the respective Board of surveillance; and who will remain in the establishment under its responsibility a minimum period determined by the competent authority.
Ban article 25 is prohibited the dispensation and ambulatory marketing of drugs.
Except classified as over-the-counter drugs.
Illegal sale of drugs article 26.-it prohibits the sale of prescription drugs in places not authorized by the National Directorate of drugs.
Except classified as over-the-counter drugs.
Chapter IV distribution and storage agents for distribution and sale article 27.-the distribution and sale of drugs, will be through laboratories, drugstores, pharmacies and people natural, national or foreign duly registered in the specified record, who may be only marketed properly registered products guaranteeing a service of quality and compliance with good practices in force.

15 obligations of the distributors art. 28.-the natural persons or legal responsible for the distribution of medicinal products, shall be obliged: to) to have premises, and equipment fitted with human resources, materials and technicians to ensure proper conservation and distribution of medicines and others that offer therapeutic action, with full guarantee for public health;
b) ensure compliance with General or specific conditions of conservation of medicines, and others that offer therapeutic action throughout the network of distribution through procedures duly authorized by the management;
(c) meet the standards of best practices for storage and distribution; and (d) compliance with other legal obligations or regulations.
Title III authorization and registration chapter I authorization and registration authorization of drugs article 29.-all person natural or legal you can manufacture, import, export, distribute, sell, store, transport, dispense, prescribe, experience or promote drugs, raw materials or medical supplies, prior authorisation of the National Directorate of drugs.
Registration article 30.-the management will take a record of authorized medicinal products, which shall be public and be permanently updated.
The requirements for obtaining the registration shall be entered in its respective rules. Registration of natural products article 31.-the basic requirements for the registration of natural products, vitamins, homeopathic, dietary supplements and nutritional supplements with therapeutic properties, will be regulated by the Directorate. Modification, transmission and extinction article 32.-any modification to the product authorized in the dosage, form pharmaceutical, route of administration and additional presentations, as well as any other modifications and extensions to be introduced, should be subject to new authorization and registration.

16 refusal of the authorisation article 33.-the management may deny authorisation for the marketing of a medicinal product for the following reasons: to) when the benefit ratio is not favourable;
(b) when not sufficiently justify the therapeutic efficacy;
c) when medication declared qualitative and quantitative composition is not as or lack of adequate quality; and (d) when the data and information contained in the documentation of the application for authorization be incorrect or fail to comply with the rules of application in the field.
Validity of the authorisation article 34.-the authorisation of medicines will have a duration of five years and must be renewed, upon assessment of the criteria referred to in the previous article.
The authorisation of a medicinal product shall be expired if, within a period of five years, the holder not to the effective marketing of the same or once authorized, registered and marketed ceases to be effectively in the market for three consecutive years.
De-registration the registration health article 35.-the health of a product may be cancelled: to) when it is confirmed that the product is unsafe and ineffective in evaluating it technically with data from literature or bibliographies recognized internationally, or through notification of international organizations related to the preservation of health, recognized by the health authority;
(b) collected evidence, within the framework of actions of pharmacovigilance and rear control that develops direction, or the information to show that its use and consumption constitute a health hazard;
(c) detect any tampering or falsification in the statements, documents or information submitted by the holder of the registration or the manufacturer of the product when applying for the registration or its amendment;
(d) is detected in the market any information relative to the product, which does not match the documentation approved by the direction;
(e) when is the product manufactured in an establishment other than that was taken into account at the time of authorization health;

(17 f) when it is determined that the manufacturer establishment does not comply with good manufacturing practices;
(g) when having promotion and advertising of a product in breach of the regulations on advertising;
(h) where the holder of the registration, help with the same number of registration, other or other products;
(i) when there is place to the definitive closure of the establishment manufacturer;
(j) when the post registration monitoring framework is detected by that authorised product does not meet the specifications of quality according to the analysis of quality control; and (k) when it has not cancelled the corresponding annuity, as well as the renewal of its license for marketing.
Sanitary authorization of the registration of generic drug whose active ingredient is protected by patent.
Article 36.-to facilitate the access of drugs to the population, the Directorate will authorize the start of the processing of an application for registration of a pharmaceutical product which is protected by a patent.
Initiated the procedure, the applicant can perform activities of import, storage and use of raw materials, as well as studies aimed at obtaining the registration. However, the marketing will be only authorized from the date when the patent expires.
Recorder article 37.-all logger must be professional in chemistry and Pharmacy and must be registered and authorized by the National Directorate of drugs to serve in this role.
Title IV Chapter I Control quality, good practices of manufacture, storage and transport laboratory quality article 38.-the Steering, will feature a laboratory of quality Control that will have the following responsibilities: to) quality prior to registration: 18 1. Analysis of the products that you wish to sell in the country prior to registration;
2. check the identity, purity and power of medicines through the analysis of physical, chemical, microbiological and others that were needed;
3 analysis of the drugs at the request of the persons concerned or at the request of the direction;
4. check and certify the quality of their competition subject to import and export products; and 5. Design the procedures related to the taking of samples for the analysis of products from your competition.
(b) Control of quality Post registration).

The quality Control Laboratory, must be random samplings of drugs, at any time and place to check the quality of the pharmaceutical laboratories, drug stores, storage centers, private pharmacies, hospitals and public and private health facilities, customs and in general in any place of manufacture, storage, distribution, and dispensing.
Certificate of quality Control for the register article 39.-the national pharmaceutical industry or the holders of the authorization for the importation and marketing of medicines, will be required to guarantee the quality of their products by presenting a certificate of quality control properly informed for each lot of production or import. The address may randomly check the veracity of such certification, whose costs will be charged to the holder of the authorization of the registration.
Quality of the raw materials article 40.-the raw materials and supplies imported for the production of medicines, must be accompanied by the corresponding certification of quality issued by the lab of origin. Also you must submit the GMP certificate issued by the competent authority of their country of origin. Certificate of good practices of manufacturing industry pharmaceutical article 41.-La direction, through the best practices unit is responsible for the granting of the certificate of the good manufacturing practices of the laboratories that operate in the country.
The issuance of the certificate will be conditioned to comply with the best practices of 19 articles, determined through monitoring, prior cancellation by the interested party of the respective rights.
The certificate will last three years from their issuance.
Acceptance of certifications from other countries article 42.-in the case of imported drugs, will be accepted the certificate of good manufacturing practices compliance, granted by the competent authority to stakeholders with regard to laboratories foreign manufacturers.
The certificate of pharmaceutical products by the World Health Organization, or good manufacturing practices certificate issued by any other country with which El Salvador has in effect a Treaty of free trade where it is stipulated the reciprocity of certificates of good manufacturing practices will be accepted. Deadline for compliance with best practices of manufacturing and storage article 43.-the subjects regulated in article 2 of this law, have a peremptory period of a year starting from the entry into force thereof, to comply with good manufacturing practices, distribution and storage. Compliance with best practices of distribution and transport article 44.-the management will monitor to ensure a quality system, which includes the requirements for reception, storage, transport and distribution of drugs in the public and private sectors.
Article 45.-the non-compliance findings or breaches will result in the initiation of a sanctioning procedure, in accordance with the present law.
Withdrawal of samples article 46.-to verify the quality of medicines with subsequent to registration, address, through its delegates and inspectors properly identified for this purpose, may withdraw samples of a product according to rules laid down for analysis.
These products will be returned by the manufacturer or distributor to the establishment where the inspection was carried out and the costs generated by their analysis shall bear the national manufacturer or drugstore or another suministrante in representation of the foreign laboratory, in the case of imported drugs. New analysis Article 47.-If the applicant has not been as with the results of the analysis obtained by the 20 laboratory of Control of quality direction for registration as the post register, request a new analysis arguing their disagreements.
In the second analysis confirmed the original result, this will be as definitive.
Article 48.-everything related to the process of drug surveillance, and will be the competence of the Ministry of health.
Chapter II of the visa article 49.-all product that is to be introduced to the country in form of visa, must comply with the following provisions: a) for those that request registration, the invoice must specify the name of the product, presentation, quantity and register of the country of origin;
(b) for those who already have record in the country, the Bill must specify the name of the product, presentation, quantity and registration number assigned by the National Directorate of drugs.
(c) in both cases, the National Directorate of drugs through inspection and control unit, verify the veracity of the information provided and will give the go-ahead for the next step.
Title V establishments pharmaceutical chapter I classification and requirements identification of container Art. 50.-the drug, after the packaging manufacturers, must identify medication using their respective label, which must contain: a) trade name;
Principio Activo (b));
(c) amount of concentration of principle active;
(d) indication, contraindication, warnings;
(e) dose;
(f) date of production and expiry;

21 g) presentation;
(h) manufacture batch number; e i) number.
The requirements for identification of container shall be determined according to the technical standard approved by the direction.
Tagged article 51.-technical labelling requirements that must fill the medication previously qualified and approved by the Directorate, will be fixed in regulations of labeling and advertising, as well as special regulations. Obligations of the producer, importer or supplier Art. 52-all producer, importer or distributor of drugs, previously classified by the direction, should be recorded in the container or packaging, in Spanish: the name or trademark of the product, is a pharmaceutical, concentration, active principle, registration to the address number, expiration date, the composition of the same batch number , manufacturer, as well as incorporating them or instructional attachments, the rules for the use of the first, such as dosage, route of administration, contraindications, warnings, risks of its use, residual toxic effects, and others in accordance with the regulations in force.
Chapter II of the laboratories pharmaceutical obligations special article 53.-without prejudice to the other obligations under the Act, the owner of the pharmaceutical company authorized, must comply with the following: to) the permanent presence of a Regent who has the technical management of the laboratory, if you commit any infringements referred to in this law, you can respond jointly and severally with the owner;
(b) provide staff sufficient and suitable to guarantee the quality of medicinal products pursuant to prescribed in this law;
(c) communicate promptly to address the suspension or cessation of activities;
(d) allow access to the duly accredited personnel to facilities and documentation in order to make inspections, audits or investigations that may be required;

22 e) liable for the obligations that are legally enforceable at the time of its activity and five years after its closure or suspension;
f) guarantee the distribution under the prevailing conditions of medicines, to establishments approved for marketing;
(g) having a laboratory of control that ensures quality in the development of medications, natural products, vitamins and others that offer therapeutic action;
(h) ensure compliance with good manufacturing practices referred to in this law;
(i) verify the proper rotation of inventories;
j) request to the address, the license of importing controlled products;
(k) inform the direction the entry of controlled products;
(l) request to the National Directorate of drugs the destruction of drugs or products controlled, damaged and expired; and (m) registry and control of narcotic drugs, psychotropic substances and aggregates.
Justification for the installation of laboratories article 54.-for the installation of pharmaceutical laboratories, they must justify its activity in scientific technical procedures, proven according to the criteria developed in the good practices of manufacturing of pharmaceutical industry.
These criteria will be updated periodically to the State of the science and technology.
Chapter III of the drugstores obligations of the Regent article 55.-all drugstore has an obligation to tell within your staff with a professional chemical pharmacist on a permanent basis, who will be in addition to the designated responsibilities under this Act, the following: to) the facilities adequate and suitable staffed;
b) monitor the handling of products that are properly registered for marketing;
(c) advise the feasibility studies of market for new products, to its 23 activities are carried out with full guarantees;
(d) maintain reasonable minimum existence of drugs that ensures the supply; and

(e) having the technical team to ensure optimal conditions of medicines, both with respect to its storage, as the transportation of and; in particular, for those that require special conditions for its conservation.
Chapter IV of the pharmacies obligations of the Regent Art. 56-all pharmacy is required to have a professional chemical responsible pharmacist, named Regent, who at all times must ensure compliance with the provisions of this Act, relating to the dispensing and sale of drugs, in addition to the checking feasibility studies of market for new products, ensure that expired products are not sold directly verify the purchase of drugs and that this is carried out with the manufacturer laboratory or authorized drugstore and everything that involves better rational use and control of medicines.
The responsibility of pharmaceutical Regent does not exempt from liability to the owner of the pharmaceutical establishment. Prohibitions Article 57.-is prohibited to the pharmaceutical laboratories, drug stores and pharmacies: to) alter the quality, composition and quantity of drugs, at the time of their manufacture and later;
b) distribute and commercialize medications, natural products, vitamins and others that provide therapeutic action settlements not authorised by the management;
(c) distribute and market drugs that are expired, defective or to put at risk the health and life of consumers;
(d) to supply medicinal products to the public, in the case of drug stores or distributors;
(e) give or offer, directly or through third parties, gifts, gifts, commissions, bonuses, payment in cash or any other type of royalties, direct or indirectly to doctors, dentists, veterinary surgeons, dependents, Regents, employees of public and private institutions or owners of drug stores or pharmacies, for prescribing, dispensing or sale to the public of their drugs in the preferential form;
f) use bullets, vouchers, and gift certificates, as a commercial strategy for the prescription, 24 dispensing or sale to the public, in the preferential form of their medications; as well as any other form of incentive designed to search the prescribing, dispensing or sale to the public in the preferential form of their medications;
(g) sale of drugs coming from donations; and (h) store or distribute pharmaceuticals without registration, altered, fraudulent, expired, or owned by the Ministry of health, the Salvadoran Social Security Institute or other public agency.
Title VI prices chapter I price of medication outside of marketing article 58.-the maximum sale price to the public, shall be determined on the basis to the international reference price by setting different profit margins for innovative or generic drugs manufactured in the country or imported.
The trading margin will be three to five times the international price of reference of each product according to the parameters established by the World Health Organization, and in any case may be greater than the average price of Central America and Panama, this being the maximum sale price to the consumer.
In the establishment of the reference price, the National Directorate of drugs will compare the prices of the drugs at the same level in the chain of distribution of Central America and Panama.
The price of generic drugs, should have cost between 30 to 40 percent less than prices for innovative medicines.
This regulation excludes those drugs approved for sale in any form.
Article 59.-any medicinal product will be printed on their packaging or pack your maximum price for sale to the public, according to the specifications established in the respective regulations and its origin.
The address, in coordination with the Consumer Ombudsman, will be responsible for verifying compliance with approved prices in the domestic market.
Title VII promotion and publicity chapter I 25 promotion and advertising on the promotion and article 60.-La direction national advertising of drugs authorized promotion and publicity, if they meet the following requirements: to) be classified into over-the-counter drugs;
(b) that you have registration in the country;
(c) provide accurate reliable information up to date and capable of checking; and (d) must be oriented to promote the rational use as well as to the prevention of their abuse.
Advertising aimed at professionals article 61.-the information and promotion can be made through written, audiovisual and electronic media or any other technical and scientific information aimed exclusively at professionals of health. For reports or articles funded by a pharmaceutical company or entity related to it, you must specify this fact in the publication.
Article 62.-text and illustrations of advertisements intended for doctors and health professionals must be compatible with the monograph for the medicinal product concerned or any other source of impartial information of analog content.
Prohibition of psychotropic substances article 63.-is prohibited the public promotion of psychotropic medications and narcotics.
Title VIII of the trade external chapter I import authorization import article 64.-Podran import drugs the pharmaceutical laboratories, drug stores, pharmacies or any natural or legal person duly authorized, intended for sale to the public or to the national health system provided they comply with the requirements established in this Act and their respective regulations.
Fiat special article 65.-the management may authorize the importation of drugs to patients when the dominant pathology requires a drug that is not on the national market.

26 established above, the import will be held exclusively for use and consumption of the patient for whom the authorization is requested.
Import of medicines for scientific research article 66.-the importation of medicines intended for scientific research, may be carried out by establishments legally authorized, at the request of the legally established universities through their faculties of medicine, chemistry and pharmacy, prior authorisation of the research protocol by the National Ethics Committee.
Ban Art. 67. is strictly forbidden the import of medicines that do not comply with the requirements specified in this law and other regulations related to the matter.
Chapter II export article 68.-Podran exported medicines that meet the legal requirements in this law. Drugs in transit article 69-the State shall take the necessary measures, to ensure that medicines in transit to a third country, may not be diverted to the national territory, unless the requirements of this Act are met.
Title IX procedure penalties, resources and provisions late chapter I sanctions and resources of the inspections article 70.-corresponds to the direction the inspections necessary to ensure the observance of this law.
Powers of the inspectors Art. 71-unit respective will carry out periodic inspections to all public, private institutions and autonomous object from the scope of application of this law.
The inspectors in the performance of their duties will have free access to the institutions referred to in this article. Establishments shall provide all the necessary facilities for the exercise of the functions of the address inspectors properly identified.

27. obligation of raising Act article 72.-in all inspection practiced at the establishments covered by this Act, the corresponding Act, which must be subscribed by the Regent, or the owner and the inspectors will rise. If you refuse to sign the first two, will sign only the inspector stating that fact. Confiscation of drugs article 73.-where there are expired, damaged, altered, or unregistered pharmaceutical products or there is presumption of anomalies in them, the inspector will lift inventory and will seal them, keeping them out of circulation and supplies products which are necessary for their respective analysis. Products that collect, you will sign the corresponding minutes.
Measures precautionary article 74.-in the case that there are drugs that cause risks to health, direction shall take the following measures of safety within the scope of this law: to) the withdrawal from the market and the prohibition of use of medicines, Officinal preparations and keynote formulas, as well as the suspension of activities, advertising and the provisional closure of establishments facilities or services;
((b) the suspension of processing, prescription, dispensing and supply of medicines in research:) and (c) information to the population using different media, noting the dangers of consumption of the same.

In the event that there is a reasonable presumption that a drug causes harm to health, management will proceed to the temporary suspension of the use and the marketing of that product while the respective quality analysis.
The cost of precautionary measures shall be borne by the natural or legal person which had led to their adoption.
The application of precautionary measures or security, shall be without prejudice to penalties which may be applied, for the same actions or omissions that motivated them.
Infringements article 75.-any natural person or legal that would infringe upon the present law shall be punished administratively by address, without prejudice to the criminal, civil and professional liability incurred.
Classification of the offences 28 article 76.-for purposes of this Act, infringements will qualify as mild, severe and very severe according to the criteria of risks to health, degree of intentionality, severity of the health and social disturbance produced, and recidivism.
Infractions minor article 77.-are breaches mild as follows: to) comply with the provisions of article 21 of this law.
b) refuse to dispense medications without just cause;
(c) hinder the work of inspection by any action or omission that disrupt or delay
Offences serious Art. 78. are violations graves the following: to) not contributing entities, or responsible persons, with data, declarations as well as any information that are required to supply for reasons of health, technical, economic, administrative and financial;
(b) breach by professionals subject to this law the obligation to inform the competent authority, when any knowledge about any evidence of harmful secondary effect caused by a drug;
(c) breach the duty to collaborate with the address in the evaluation and control of drugs;
(d) dispense medications once the period of validity of the recipe in the case of products with retained special recipe;
(e) failure to comply with article 5 related on the incompatibility of the Regent;
(f) to dispense medications without a prescription, when these require medical prescription;
(g) a person who abused his position of authority, takes medications to their own advantage or third parties;
(h) carry out promotion, and advertising of medicinal products not authorized for sale free;
(i) does not verify the identity of the drug before being delivered to the patient;
(j) the recidivism in the Commission of offences classified as mild.
Very serious offences 29 Art.79.-are very serious offences, as follows: to) stop the activities of inspectors duly accredited, in workplaces that are developed, manufactured, distributed and dispense medications;
b) allow, the responsible for the pharmaceutical establishment, providing services of medical consultation, dentistry, nursing and other health professions inside drugstores, pharmacies and medicines sales, as well as the prescription of drugs in such establishments; (* Declared unconstitutional c) prescribe and prepare Officinal preparations and master formulas in breach of the legal requirements;
(d) modified by the owner, without any prior authorization from the conditions of authorisation of the medicinal product;
(e) provide, purchase or sell drugs or medical devices to entities not authorized to carry out such activities;
(f) breach of article 24 of this law governing the dispensation of drugs;
(g) dispensing or supply drugs in establishments other than those authorized;
(h) provide directly or indirectly any kind of incentive, bonuses, discounts banned, bonuses or gifts, carried out by who have interests directly or indirectly in the production, manufacture and marketing of medicines, health care professionals, on the occasion of the prescription, dispensing and administration of them, or to their relatives by consanguinity or affinity, or people who save some kind of verifiable coexistence;
(i) sell drugs of any nature without having obtained the corresponding authorization and registration;
j) dispense drugs regulated over-the-counter special retained;
(k) the manufacture, distribution and sale of counterfeit products;
(l) manufacture, import, export, dispense and distribute drugs without the respective authorization;
(m) not having a laboratory of quality control, which ensures the correct drug development;
(n) failure to comply on the manufacture, import, export and distribution of drugs, with the controls of quality determined by the management;
(o) non-compliance with the requirements on systems acquisition, 30 conservation, preparation of pharmaceutical specialities and dispensing established by the management;
p) increase the maximum sale price determined by the National Directorate of drugs;
(q) distribute or keep the medicines without observing conditions, as well as to sell medications altered, donated, in bad conditions, or with expired expiration date;
r) selling drugs through the internet;
(s) carry out promotion, information or misleading without conform to the conditions laid down in the authorization;
t) breaching security measures on drugs deemed the direction that it can cause serious damage to public health;
(u) obtain fraudulently, any authorization or license to perform activities related to the manufacture, import and distribution of drugs;
v) comply with best practices for manufacturing, storage and transport regulated in article 39 of this law;
w) make the replacement of a drug on the other hand that does not contain the same ingredient;
(x) the recidivism in the Commission of offences classified as serious.
Sanctions article 80.-to those who commit the offences classified in the previous articles, impose them the following administrative sanctions: a) fines;
(b) suspension of the authorization granted by the Directorate;
(c) revocation of the authorization granted by the Directorate; and (d) cancellation of the registration of medicaments, vitamins, natural products and others that offer therapeutic action.
Criteria for the imposition of the sanctions Article 81.-the Directorate, once exhausted due process and having established the responsibility of the offender, shall be imposed according to the severity of the sanction, taking as reference 31 the economic capacity of the offender, the significance to the detriment of the society and the circumstances in which the offence was committed.
Penalty for infringement minor article 82.-the persons subject to this law who commit a minor infraction, shall be punished with a fine of ten to twenty-five urban minimum wages in the sector commerce and services. In the case of the literal (b) of section 77 of this Act, the fine will be imposed on the pharmaceutical establishment.
Penalty for violation Grave article 83.-the persons subject to this law who commit a serious offense, shall be punished: a) in the case of the literal (a), (b), (c), (e), (f), (g), (h), (j) and (i) of article 78 of this law, shall be punished with a fine of twenty-six to fifty urban minimum wages in the sector commerce and services.
(b) in the case of the literal (d) and (l) of article 78 of this law, shall be punished with suspension of the authorization. In the case of the literal (d), the suspension will be with respect to the authorization granted to the pharmaceutical establishment by management.
Sanction for violation very serious article 84.-the persons subject to this law, who commit very serious offence, shall be punished: to) in the case of the literal (a), (f), (g), (k), (l), (p), (r) and (s) article 79 of this law, shall be punished with a fine of one hundred to two hundred urban minimum wages in the sector commerce and services;
(b) in the case of the literal (h), (i), (n) and (or) article 79 of this law, shall be punished with the revocation of the authorization;
(c) in the case of the literal (b), (c), (e), (j), (q) and (v) of article 79 of this law, shall be punished with suspension of the authorization. In the case of subparagraph (j), the suspension will be with respect to the authorization granted to the pharmaceutical establishment by management;
(d) in the case of the literal (d), (m), (t), (u) and (w) of article 79 of this law, shall be punished with the cancellation of the registration.
The authorisation granted is revoked in the event of recidivism.
Procedure administrative 32 article 85.-When you have knowledge by any means the Commission of any of the offences established under this law, the address should start investigations ex officio, by denunciation or by notice.
The direction will open the respective file or informational knowledge, by any means, of having committed any offence against health, ordering in the Act the first steps leading to the fact and those responsible, in any case, testing will be taken preventive measures appropriate in order to protect the health also report to the Attorney General of the Republic.

Article 86.-the complaint will be filed in written form addressed to the National Directorate of drugs and contain as a minimum: a) generals of the complainant, and his Legal representative or proxy if necessary;
b) generals of the respondent, and location in case of ignoring them, be designated as General ignored;
(c) narrative of the facts;
(d) provision of evidence;
e) request in particular;
(f) place to hear notifications; and (g) place, date, and signature of the complainant or who do so at their request.
Admission of the complaint article 87.-within three working days of the complaint, the address will resolve its admission and be prevented in case of not meeting the requirements of the complaint; so within a period of three working days remedy these preventions, under penalty of declared inadmissible.
If prevention is accomplished in the indicated term and cured omissions, will accept the complaint; otherwise it shall declare inadmissible and filed, and can the interested party complaint again on the same facts.
Article 88.-a site once admitted the complaint within a period of five working days will be located to the respondent answer the complaint and exercised its right of defence.
Answer 33 article 89.-the respondent can answer the complaint in the term before indicated, counted from the day following the notification; If the complaint is not answered in such terms shall be answered in the negative and will continue with the process.
End of test article 90.-the informative opens to test for a period of eight working days to receive the testimonial or documentary proof, both parties shall submit, if required by their respective tests.
For other means of proof, the common law rules apply.
Final resolution article 91.-within the period of ten business days the direction will issue the final resolution.
The final resolution shall issue duly motivated in terms of their legal and factual basis, and rating tests based on the rules of healthy criticism.
Review resource article 92.-judicial review properly reasoned, which must be lodged within the three working days counted from the day following its notification shall be admissible against the decision issued by the direction.
Direction will issue the resolution of judicial review within five business days after submitted the appeal.
Chapter II provisions late regulation article 93.-the Executive branch through the National Directorate of drugs will be responsible for drawing up the regulations required for the proper function of the same, which will be submitted for approval by the President of the Republic within a maximum of six months after the entry into force of this.
Repealing Article 94.-repeal of the following legal provisions of the health code: to) the literal g), h), i), k), n), r), s), t), u), x) Art. 14;
((b) d) of article 17;
(c) chapter IX "Registry" of title I;

34 d) the second subparagraph of article 250.
Article 95.-repeal of the following legal provisions of the law of the Superior Council of public health and health professions boards of surveillance: to) the literal g), h), i), k), l), or) article 11.
Article 96.-repeal of the pharmacy Act, promulgated by legislative decree dated 30 June 1927, published in the official journal number 161, volume 103 number of date on July 19, 1927.
Article 97.-when the decrees, laws and regulations make reference to powers granted to the Superior Council of public health or to the boards of surveillance of professions related to health and the Ministry of health, in relation to drugs, means that from the entry into force of this law will be given you to the National Directorate of drugs.
Article 98.-this law, because of its special character, prevail over any other legal provision that counteract it transitional provisions article 99.-the Council Superior of public health and the Ministry of health are empowered to carry out the transfer of assets, consisting of movable property, in favour of the National Directorate of drugs, which are no longer useful for the fulfilment of its purposes under the provisions of this law.
In addition, the Superior Council of public health and the Ministry of health transferred the total number of files and documents that are pharmaceutical, drugs and establishment registration from the entry into force of this Act are administered by the National Directorate of drugs.
Article 100.-staff who will be affected by the entry into force of this law shall be compensated in accordance with the respective laws.
Publication and entry into force article 101.-the present law shall enter into force thirty days after its publication in the official journal.
GIVEN in the blue room of the Legislative Palace: San Salvador, twenty-two days of the month of February in the year two thousand twelve.

Presidential House: San Salvador, to the two days of the month of March of the year two thousand twelve.
PUBLISHED, Carlos Mauricio Funes Cartagena, President of the Republic.
María Isabel Rodríguez VDA. de Sutter, Minister of health.
D. o. No. 43 volume no. 394 date: March 2, 2012.
SV/adar 10-04-2012 36 unconstitutional: * the room constitutional of the Supreme Court of Justice, by judgment No. 33-2012, published in the D. O. No. 206, 405 T., November 5, 2014, declares unconstitutional article 23, since the prohibition of hire or SUBCONTRACT physicians, dentists and VETERINARIANS, to practice the profession to the INTERIOR of the PHARMACIES with the object prescribed drug , VIOLATES THE RIGHT TO WORK AND THE ESSENTIAL CHARACTER OF THE RIGHTS OF WORKERS RECOGNIZED IN THE ARTS. 37 AND 52 INC. 1° CN., RESPECTIVELY, AS WELL AS IN THE ARTS. 23, 65 AND 101 CN.; BECAUSE THE PROHIBITION CONTAINED IN THE CONTESTED PROVISION DOES NOT ONLY AFFECT RIGHTS OF JOB NATURE, BUT ALSO AGAINST D FREEDOM POWER, THE RIGHT TO HEALTH AND FREEDOM OF CONSUMERS; AND ARTICLE 79 LETTER B), FOR THE CONNECTION MATERIAL BREACH THAT REGULATES SUCH PROVISION. (JQ/04/12/14)