"(Artículo 1°.-Introdúcense las siguientes modificaciones en el Código Sanitario: 1) the fourth book shall be replaced by the following:" fourth book of pharmaceuticals, food, cosmetics and use pharmaceuticals article 94-doctor title I will correspond to the Ministry of health to ensure the population's access to drugs or pharmaceutical products of quality, safety and efficacy "" which take place by itself, through its ministerial regional secretariats and agencies that relate to the President of the Republic through.
The Ministry of health shall adopt a national formulary that will contain the list of essential medicines in accordance with their international nonproprietary name, dosage form, dose and intended use, which will be the arsenal need pharmacotherapy for the efficient care of the population, considering their condition of health and diseases prevalent and that it will provide the basis for determining the minimum petitions that must have the establishments of retail sale of pharmaceutical products. Monographs of each medicinal product included in the list will be approved by resolution of the Minister of health.
It will be up to the Central of supply of the national system of health services ensure adequate availability of drugs in the area and referee action that tells the Ministry in this regard.
Article 95.-It refers to pharmaceutical product or medicine any natural, biological, synthetic substance or mixtures of them, originated by synthesis or chemical, biological or biotechnological, processes intended to persons for the purpose of prevention, diagnosis, mitigation, treatment, or cure of diseases or symptoms or regulation of their systems or particular physiological States, including in this concept the elements that accompany his presentation and that goes to his administration.
It is prohibited to manufacture, import, possession, distribution and transfer, to any degree, from medicines adulterated, counterfeit, altered or contaminated. Designated health authorities in article 5 that detect the existence of drugs which are annotated conditions will be empowered to its immediate confiscation, regardless of site or premises which are, without prejudice to the instruction of the relevant health summary and the possible application of sanctions arising from this.
Article 96-Institute of public health of Chile will be the authority in all the national territory of the sanitary control of pharmaceutical products, settlements of the area and supervise compliance with the provisions which are contained in this code and regulations on this matter.
It shall be also to this Institute, ex officio or at the request of part, resolve sanitary inspection system which may be applicable to certain substances or products, in accordance with its characteristics or purpose.
Against the actions and decisions taken by the Director of the Institute in the exercise of its functions in respect of the matters referred to in this code, except for sentences relapses recovery in health summaries of their competence, may bring action for claim to the Minister of health, within a period of five days from the date of notification of the respective resolution.
Through one or more regulations, issued by the President of the Republic through the Ministry of health, health rules that regulate import, internment, export, production, preparation, fractionation, storage, holding, transport, distribution free or onerous title, dispensing, pharmacovigilance, traceability, advertising, promotion or information professional, medical or scientific research of pharmaceutical products in accordance with the provisions of this code, shall be determined.
Regulations issued for that purpose will also contain rules that permit to guarantee the quality of the product in all of the activities outlined above, as appropriate, without prejudice to the responsibility that will fall on the public or private entity that will develop the activity in question, in this matter which you must implement a suitable system for your assurance.
The quality requirements to the product will be determined by your registration, having as reference pharmacopoeias officially recognized in the country, by the corresponding ministerial resolution.
Article 97.-The Institute of public health of Chile shall keep a register of all pharmaceutical products favorably evaluated for effectiveness, safety and quality that should prove and guarantee during the period provided for its use. Any pharmaceutical product may be distributed in the country unless it has been registered.
Pharmaceutical products exclusively intended for export shall be subject to the procedure of registration to be determined by the regulations issued to that effect, whereas its composition, technical specifications, labeled and good manufacturing practices.
The Ministry of health shall be responsible to decide prior to the cancellation of the registration of a drug. For the cancellation of a registration, the Institute shall communicate its holder the report request addressed to the Ministry of health. The Institute may not cancel the registration against a negative ruling of the Ministry in this regard, without prejudice to judicial and administrative resources that come from the holder of the registration or other stakeholders.
Article 98-Products narcotic, psychotropic and other substances that produce similar effects shall be governed by the specific regulations which, in effect, handed down, which will address your health record, import, internment, export, circulation, production, preparation, fractionation, storage, holding, transport, distribution free or onerous title, dispensing or sale, pharmacovigilance and traceability, advertising, promotion or information professional, medical or scientific research and other activities requiring special safeguards all of which is subject to the international treaties and conventions signed and in force in Chile and to the provisions of this code.
When required by the appropriate protection of public health, by Decree of the President of the Republic, issued through the Ministry of health following a report from the Institute of public health of Chile, apply all or some of the regulations referred to in the previous paragraph other substances or products whose use or indiscriminate consumption may generate a risk or harm to the user.
Article 99.-without prejudice to the provisions of article 97, the Institute of health public of Chile may temporarily authorise the distribution, sale or sale and use of pharmaceutical products without prior registration, clinical trials or other research, as also for urgent medicinal purposes derived from situations of shortage or inaccessibility that affect persons considered individually or collectively. However, a research protocol not may develop in unregistered drugs or for new uses in medicines registered without a favourable report from the scientific ethical Committee that corresponds.
In the case of situations like those described in the preceding paragraph, related to drugs whose availability is essential for the development of programs or health plans of public interest that are carried out in the national system of health services, the Central of supply of the national system of health services may request before the Institute the relevant provisional registration which shall be without prejudice to the free marketing of the product by third parties.
Article 100.-The retail of pharmaceutical products can only be made upon presentation of the prescription from the practitioner who prescribed them, except for those drugs that are authorized for direct sale in the respective registration.
Advertising and other activities aimed at informing the consumer a pharmaceutical product only will be permitted with regard to direct selling drugs and in the terms established in the respective registration and in accordance with stated in articles 53 and 54 of this code.
The pharmaceutical product promotion aimed at professionals enabled for your prescription, within the therapeutic utility of the respective registration instructions, may not be through social media aimed at the public in general. Such promotion may include the delivery of medical samples to these professionals in the terms set forth in the respective registers, to be provided gratuitously, to people who use its services.
The donation of pharmaceuticals for advertising and the economic incentives of any kind, which induces to privilege the use of specific product enabled practitioners to prescribe and dispense medications or to dependents of retail establishments and any other person involved in the sale or administration of drugs are prohibited.
Incentive means any payment, gift, service or profit made or delivered to persons mentioned in the preceding paragraph, by pharmaceutical laboratories, drug stores, importers, or distributors of drugs, pharmaceutical establishments in general or those who represent them.
Without prejudice as provided in the preceding subparagraphs, the donation of pharmaceutical products to non-profit health care establishments, will be permitted whenever those are included in the national formulary.
Medications must be submitted in containers which hinder children not assisted intake and not be able to form of sweets, sweets, candy, figures, toys or any other activities that promote their consumption, as determined in the respective regulations.
Article 100 bis.-direct selling medications must be submitted in containers containing the therapeutic indication required for decision to purchase and to ensure proper management, in accordance to what point the regulation on the outside.
Containers must have labels that enable to verify if the content has been manipulated.
Article 101.-The recipe is the private instrument by which the practitioner to prescribe directs a person identified and previously evaluated, as an integral part of the medical Act and therefore the clinical relationship, the use and the conditions of employment of a pharmaceutical product individualized by name of fantasy, and must add, by way of information, the International Nonproprietary name that authorize their Exchange , if any medicines certified Bioequivalent, under the terms of the following paragraph.
If the prescribed medication is of those who must demonstrate bioequivalence according to Supreme Decree founded, the chemical pharmaceutical, at the request of the patient, it will dispense any product which, being Bioequivalent of the prescribed, have demonstrated this requirement in accordance with the requirements contained in the respective Supreme Decree issued through the Ministry of health, which must conform to the regulations of the World Health Organization.
If the prescribed medication is of those that do not require to demonstrate bioequivalence, chemical pharmacist will dispense it according to the prescription.
Will be obliged to retail establishments make available who require the dispensing of a drug, a list of products that must demonstrate bioequivalence according to the decree pointed out above.
It will also obligation of referred sale establishments having a pharmaceutical petition, in the terms indicated in article 94 of the code, which will be approved by resolution of the Minister of health, indicating drugs that must necessarily be made publicly available. This requirement will include all medications that, containing the same active ingredient and dose per dosage form, have demonstrated bioequivalence, all this in accordance with the regulations established through the Ministry of health.
Prescription shall also indicate the period determined for the total treatment time, or repeated periodically, as indicated by the professional who issued it.
Professional recipe should be extended in document graphic or electronic to complying with the requirements and safeguards to be determined by the relevant regulations and it will be delivered to the person requiring it or a third party when that authorized it. The regulation will establish at least the technical elements that prevent or hinder the forgery or the replacement of the recipe, such as the use of forms printed and laminated, barcode or others. If it is handwritten it must extend with letter legible printing. In any case the use of e-prescribing can prevent that the patient can use this instrument in the pharmaceutical establishment freely choose your can always require the recipe in graphic document.
The prescription of the products referred to in article 98 shall be governed by the regulations contained in the specific regulation that is applicable to them.
The recipe and its content, analyses and clinical laboratory tests and health-related services will be reserved and considered sensitive data subject to the provisions of law N ° 19,628.
This article does not preclude that pharmacies can give to know, for statistical purposes, sales of pharmaceutical products of any type, including the name and quantity of them. Any information provided by pharmacies indicate the name of recipes, or the doctors target persons who issued them, or data that can serve to identify them.
Owner, coach and the Assistant of the pharmacy that will expend a drug other than the one indicated in the recipe, contrary to the provisions of this article, shall be punished in accordance with the tenth book.
In cases in which issue electronic prescriptions, this must be entered in an electronic document signed by the authorized optional in this law through advanced electronic signature according to the provisions of law N ° 19.799.
The regulation will establish situations and cases the application of the provisions of subsection may exempt that first, such as rurality, geographic location, technological availability, or other situations of a similar nature.
Title II of foodstuffs article 102.-it means food or food any substance or mixture of substances intended for human consumption, including beverages and ingredients, and additives of such substances.
They are considered to be special food products or preparations intended for particular nutritional purposes drinking, used in the treatment of certain diseases or health conditions, requiring arrangements not parenteral administration, such as the mouth or other and supervision special by the health personnel.
Article 103.-It will be the Ministerial Regional Secretariat of health authorize and supervise, within its territory of competence, the installation of premises earmarked for production, processing, packaging, storage, distribution and sale of food and slaughterhouses and refrigerators, public and private.
It will be also the authority perform, directly or by delegation to appropriate public or private entities or qualified professionals, veterinary inspection of animals benefiting and meats.
Article 104-Food products must respond to its organoleptic characteristics and, in its chemical composition and microbiological characteristics, their markings and designations and regulations.
It prohibits the manufacture, import, possession, distribution and transfer, to any degree, of foodstuffs contaminated, adulterated, counterfeit or altered.
Article 105-The regulations shall determine the characteristics that must gather food or food products intended for human consumption, health conditions which must follow its production, import, internment, processing, container, signage, storage, distribution and sale, special conditions of use, if it is case, the surveillance of specialty foods and other health requirements which establishments must comply means of transport and distribution intended for these purposes.
Title III of the products cosmetics and hygiene products and odorization personal article 106-cosmetic product is any ready it is intended to be applied externally to the human body, for the purpose of beautification, modification of their physical appearance or preservation of normal physical and chemical conditions of the skin and its annexes, which have only local action or to be absorbed into the body lacks systemic effect.
Hygiene products personal or odorificos, those that are applied to the surface of the body or the oral cavity, with the exclusive object to ensure your toiletries or odorization are called.
Article 107.-For their distribution on the national territory, all cosmetic products must have sanitary registration issued by the Institute of public health of Chile.
Article 108-Internment and the production in the country's hygiene and personal odorant products must be notified to the Institute so that this exercise their powers of control with respect to its composition, regarding the use to which they are destined and the facilities in which they arise. Also, establishments that are manufactured, which are installed in the national territory, are subject to the obligation to notify the Institute and subject to its control.
It prohibits the manufacture, import, possession, distribution and transfer, any title, cosmetics, hygiene and personal odorant, adulterated, counterfeit, altered or contaminated.
Article 109-by one or more regulations issued by the President of the Republic through the Ministry of health, health rules governing registration, import, internment, export, production, storage, possession, sale or distribution to any title and advertising of cosmetics, hygiene and personal odorization shall be determined.
Cosmetic products qualifying low-risk Regulation shall apply to reporting and surveillance standards for hygiene and personal odorant products referred to in the preceding article.
Article 110.-It will be up to the Institute of public health of Chile authorize the installation of laboratories that manufacture cosmetics and overseeing its operation, in accordance with the regulations mentioned in the previous article.
Cosmetic production laboratories must be managed technically by a chemical pharmacist and must have a system of independent quality, in charge of another chemical pharmaceutical control.
The development of cosmetic products intended exclusively for export, by or self-employed, must be carried out in approved cosmetic production laboratories and shall be notified to the Institute. Such notification will include the individualization of the exporter, manufacturer and qualitative formula of the product, which should not be made up of ingredients prohibited by the regulations in force.
Title IV of the elements of medical use Article 111.-the instruments, apparatus, devices and other items or items intended for the diagnosis, prevention and treatment of diseases of humans, as well as the replacement or modification of their anatomies and that do not apply to the substances described in articles 95, paragraph first, 102 and 106 shall comply with standards and quality requirements that apply to them according to their nature (, in accordance with the following provisions: a) natural or legal persons who, at any title, manufactured, imported, placed on the market or distribute such elements shall carry out the respective control and certification of its quality of services, institutions, laboratories and establishments with health authorization, issued by the Institute of public health of Chile, in accordance with the provisions of article 7.
The regulation shall establish the conditions of equipment and other resources that must have the facilities, as well as the way in which you will be prompted and grant this authorization. Controlling and certifying entities whose applications are denied or not answered within the time limit referred to in the second paragraph of article 7 may claim against the Minister of health, pursuant to the third subparagraph of article 96.
(b) the Institute of public health of Chile will be the authority of authorizing and overseeing institutions carrying out the concerned control and certification, and must, in the absence of private bodies that develop these tasks, run them by itself.
(c) controls and quality tests to be carried out pursuant to the previous letters are subject to the technical specifications laid down by the Chilean official rules of the National Institute of standards approved by the Ministry of health and, in the absence of these, that approval of the Ministry of health, a proposition of the mentioned Institute and on the basis of the information generated by international agencies or specialized foreign entities.
Natural or legal persons whose instruments, apparatus, devices, articles or items are rejected by the quality control of an authorized entity may claim to the Director of the Institute of public health of Chile. Received the claim, turns to the attention of the entity that objected to the conformity of the element, which must report and remit all the background information in his possession within a period of ten working days counted from the receipt of the communication, to overcome which, even without the report, and requested background, the Director of the Institute will be able to resolve the claim.
(d) Decree founded, issued through the Ministry of health, will be effective the application of the provisions of this article to different kinds or types of instruments, apparatus, devices, articles and items in question, to public health Institute proposal of Chile. The decree will indicate the technical specifications to be fastened quality control, adopted pursuant to point (c)) and the entities who have official approval to run it or the lack of interested in obtaining this authorization.
(e) shall be competent to instruct the health summary and punish violations of these provisions the Regional Ministerial Secretary of health in the territory are committed.
(f) items that are sold or distributed to any degree without the certificate of quality established in this provision shall be forfeited, without prejudice to other measures that can be taken by the health authority.
(g) the customs destination of these elements is subject to the provisions of law No. 18.164 and its use and disposal must be approved by the Institute of public health of Chile.
Certifications will be in charge of the natural or legal persons who request them. "."
(2) replace the sixth book with the following: "book sixth of the settlements in the AREA of health preliminary title article 121-settlements in the area of health are public or private entities that perform or contribute to the implementation of actions of promotion, protection and recovery of health and rehabilitation of sick people."
These establishments will require, for your installation, expansion, modification or transfer, sanitary authorization of the Regional Ministerial Secretary of health for the region in which they are located, which shall be granted prior fulfilment of the technical requirements determined by the regulation, without prejudice to the powers conferred by this code to the Institute of public health of Chile.
Title I of article 122-the health care facilities welfare establishments carrying out health activities to persons require authorization of the Regional Ministerial Secretary of the territory in which they are located and shall be subject to the requirements of installation, operation, and technical direction determined by the regulation governing them in particular, in its condition of closed facilities General or specialized. That regulation will also determine professional requirements shall be anyone with its technical direction.
Article 123-Health authorisation also required open or ambulatory care facilities in which are carried out special procedures for the diagnosis or treatment of diseases requiring special facilities and infrastructure for its realization and eventually of sedation or local anesthesia, all of which must meet the requirements of physical, human resources and technical direction that in your connection provides in relevant regulations.
Establishments that are engaged in alternative or complementary medical practices regulated by Decree will require sanitary authorization, which will be awarded in accordance with the provisions of this regulation.
The exercise of practices not covered in the above form it will be inspected by the health authority and is subject to the prohibitions laid down in articles 53 and 54 and in the fifth book.
Article 124-Establishments that carry out activities aimed at care and body aesthetic embellishment will be controlled by the health authority in order that its operation conforms to the regulations which, in effect, handed down. Without limiting the foregoing, those establishments which, even when they are announced or pursue an aesthetic purpose, using instruments or equipment that affect the human body invasively, generate risk for this, execute maneuvers or operated instruments which penetrate the skin and mucous membranes must have a technical direction in charge of a professional in the area of health, in addition to sanitary authorization prior to its operation.
Title II of the establishments of optics and other elements of article 125.-the medical use will require establishments that manufacture medical elements referred to in article 111 health the Ministerial Regional Secretariat of competent health authorization, which will be awarded after verification of compliance with the requirements and conditions relating to its production, quality control distribution and sale to be determined in regulations that specifically issued for each class or type, according to the health risk that involves their use or destination.
The health authority shall supervise the operation of these establishments in their areas of manufacture, distribution and sale.
Article 126.-Only settlements of optics may manufacture lenses with Dioptric power according to prescriptions that order in the corresponding recipe.
Optical establishments may open premises upon receipt and clearance of prescriptions issued by professionals that are prescribed these lenses, under the technical responsibility of the relevant optics. None of these establishments is allowed the installation of medical consultations or medical technologists.
Authorized the manufacture, sale and delivery, without prescription, from lenses with Dioptric force only spherical and equal in both eyes without correction of astigmatism, destined to correct problems of presbyopia.
The sale or delivery of these lenses should be accompanied by a warning about the desirability of an ophthalmologic evaluation that allows to prevent risks for eye health. Title III of the settlements in the pharmaceutical area article 127-the production of medicines can only be made in pharmaceutical laboratories especially authorized by the Institute of public health of Chile, entity will correspond to which, in addition, supervision and control, all in accordance with conditions to be determined by the regulations.
The technical direction of these establishments will be in charge of a professional chemical pharmacist and, in the case of the manufacture of pharmaceutical products of biological origin, may also correspond to an engineer in biotechnology, a biochemist or a surgeon with specialization in that area.
All laboratory of pharmaceutical production must have independent quality assurance and control systems, different professionals, which must be one of the titles and specializations referred above, as the case may be. These systems shall ensure compliance with the requirements referred to in good practices of manufacturing and laboratory that are approved in their regard by ministerial resolution, depending on the type of productive activity which has been authorized for the establishment.
Pharmaceutical companies running on an exclusive basis stages of conditioning or quality control will be compliance with regulations covering the effect.
Despite the foregoing, pharmacies may be elaborated, without using industrial processes, pharmaceutical preparations in accordance with the indications of who prescribed or to those contained in the approved development standards, as appropriate to the type of prepared magistral or Officinal, on such terms and conditions stating that regulation to the effect is issued.
Master recipes are understood to be authorized to prepare drugs orphan.
Article 128-Import, internment, storage, transport and distribution to any title of drugs and raw materials required for their production may be made by the pharmaceutical companies responsible for the manufacture of medicaments in question and drugstores that have been approved by the Institute of public health of Chile, in accordance with the requirements containing the respective regulation in its regard , and are technically directed by a chemical pharmaceutical.
Without prejudice to the provisions above, storage, transport and distribution of drugs can be made also by deposit establishments authorized by the Institute, prior compliance with the regulatory requirements established for this purpose.
The manufacture, packaging or internment of pharmaceutical products intended exclusively for export, by or self-employed, shall be carried out by authorized laboratories or drugstores, as appropriate. In addition, they must be notified to the Institute, including the individualization of the exporter, manufacturer and the product registration.
Article 129-Pharmacies and pharmaceutical stores be installed independently, with access to public roads, or as a space that is contained within another. A regulation issued by the Ministry of health shall determine the requirements that such establishments must comply to be authorised by the Institute of public health of Chile, as well as the suitability of the professional or technician which, according to each case, pursues its technical direction and hours or shifts that must be offered to ensure adequate availability of drugs in legal holidays and non-working days and at night. For the purpose of fixation of shifts, must consider population data and number of pharmacies, pharmaceutical warehouses and health facilities in the locality concerned.
Pharmacies are health centers, that is, places in which there are sanitary, and such actions, shall cooperate in order to ensure the rational use of medicines in health care. They will be led by a chemical pharmaceutical and demands minimum of medicines will have to contribute to the work of pharmacovigilance.
They may be authorized in those places where there are no established pharmacies mobile pharmacies, which correspond to mobile structures that will be located at places and times authorised expressly by the health authority, facilitating the access of the population to medicines, complying in any case the conditions which in effect set the respective regulation.
In addition, in those places where there are no dispensing of medicines to the public establishments, the Ministry of health contents 14(bis) will provide the necessary measures for its adequate availability, through health facilities.
Only settlements mentioned in this article and in article 129 D shall be entitled to dispense pharmaceuticals, regardless of the condition of sale of these.
Article 129a-pharmacies shall be directed technically by a chemical pharmacist who must be present during all hours of operation of the establishment.
It will be up to these professionals carry out or supervise the adequate dispensation of pharmaceutical products, in accordance with the terms set forth in the recipe, inform personally and tend to its rational use, acquitting queries that users make you. They shall also exercise permanent surveillance of the aspects sanitary technician of the establishment, without prejudice to the responsibility that can fit them in the same administrative operation, which will be entrusted to its dependent staff. In the exercise of its function of dispensing, such professional must, in addition, or supervise the parcelling out of containers of medicines for the delivery of the number of doses required per person, according to the prescription of the competent professional.
By decree issued through the Ministry of health standards for the proper execution of the fractionation, which will include the determination of products of prescription not subject to legal control over which will be carried out, including its pharmaceutical form, the obligation to distribute and dispense them safely, avoiding contamination and errors, and the conditions of delivery container labeling to the acquirer that identify the product will be approved the prescriber and the patient, as well as the indications for their use. These standards will be mandatory for importers, manufacturers and distributors of medicines and pharmacies.
Article 129 B-direct over-the-counter drugs may be available in pharmacies and warehouses pharmaceutical in shelving, shelves, shelves, shelves, dispensers or other similar devices which allow direct access to the public, whereas measures of safeguard to prevent scope and handling by children or infants, all as determined by the regulation issued to regulate the provisions of this article.
For this purpose, the making available to the public must be made in a special and exclusively designed area for this purpose, which should allow its proper conservation and storage.
Pharmacies and pharmaceutical stores that sell over-the-counter drugs direct in accordance with the preceding paragraph, shall also: 1) install Infographics in areas visible to the public, allowing the reading of a warning about the proper use and dosage of medications with condition of direct selling.
(2) keep in a place visible to the public, phone numbers of existing lines free of charge providing toxicological information, whether from public or private services.
The text and format of the graphics, as the information over telephone lines referred to in this article, shall be approved by resolution of the Minister of health.
Article 129 C-drugs may also be sold to the public in pharmaceutical stores, which must be approved in accordance with the regulations issued to that effect, which must include demands for infrastructure, processes and technical qualification of the personnel in charge.
However the operation of pharmacies or private pharmaceutical stores, in communities of less than 10,000 inhabitants and those that are located more than 100 kilometers from another town, the welfare establishments of the town will be authorized to supply pharmaceutical products, foods for medical use and elements of healing and first aid to the public.
Article 129 D-care closed health care facilities and ambulatory care that have flags of minor surgery / procedure rooms may count with pharmacy or first-aid kits that include the drugs needed for the exercise of the actions of health that will take effect within the establishment.
Kits, in accordance with the regulations issued, in other establishments or places of work, taking into consideration its Constitution, organization, isolation or the development of activities or services that involve risks of accidents and health may also be authorized.
The first-aid kits referred to in the preceding subparagraphs may be authorised, in addition, for the dispensing of drugs.
Open and closed health care establishments which incorporate medicines to the benefit of health granted to its members or beneficiaries may provide, by itself or by third parties, service management, fractionation, and delivery of these items.
The professional qualified to prescribe drugs or perform procedures that incorporate them may maintain existence thereof exclusively for his administration and employment in the exercise of its activity, being them prohibited the sale of such products. In any case, is obligation of such professionals keep the products set out in conditions of safety and conservation.
None of the rules laid down in this law may be interpreted in the sense of that authorized the dispensing of medicines in places or venues other than those specified expressly therein or for direct sale on shelves or other areas of direct access to the public.
Article 129 E-Health liability for breach of the rules laid down in this law shall be effective in accordance to the tenth book. "."
(3) repeal article 169.
(4) replace the second paragraph of article 174, by paragraphs following second, third and fourth: "resolutions that establish the infringements and determine the fines will have executive merit and will be effective in accordance with the articles 434 et seq. of the code of Civil procedure.
The above-mentioned offences can be punished, in addition, with the closure of establishments, enclosures, buildings, houses, premises or workplaces where was committed the offence; with the cancellation of the authorization of operation or the granted permissions; with the cessation of works or tasks; with the suspension of the distribution and use of the products concerned, and removal, seizure, destruction or denaturing them, when appropriate.
The foregoing is without prejudice to give effect to the responsibilities which establish other legal bodies with regard to the facts. "."