Law 23-12-78 n. 833 (art. 29-31)
LAW 23 December 1978, n. 833
(in Ordinary Supplement to the Official Gazette No. 360 of 28 December 1978).
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Article 6
(State powers)
The administrative functions concerning:
a) international relations and international, maritime, air and border prophylaxis, also in veterinary matters; health assistance to Italian citizens abroad and assistance in Italy to foreigners and stateless persons, within the limits and under the conditions established by international commitments, making use of existing health facilities;
b) the prophylaxis of infectious and diffusive diseases, for which compulsory vaccination or quarantine measures are imposed, as well as interventions against epidemics and epizootic diseases;
c) the production, registration, research, experimentation, trade and information concerning chemical products used in medicine, pharmaceutical preparations, galenic preparations, medicinal specialties, vaccines, cellular and viral immunomodulators, serums, anatoxins and similar products, blood derivatives, health and medical-surgical aids and similar products also for veterinary use;
d) the cultivation, production, manufacture, use, wholesale trade, export, import, transit, purchase, sale and possession of narcotic or psychotropic substances, except for the attributions already conferred to the Regions by law 22 December 1975, n. 685;
e) the production, registration and trade of dietetic products, baby foods and cosmetics;
f) the listing and determination of the methods of use of the additives and dyes permitted in the processing of food and drink and in the production of objects for personal and domestic use, the determination of the hygienic-sanitary characteristics of the materials and containers intended to contain and preserve foodstuffs and drinks, as well as of objects intended in any case to come into contact with foodstuffs;
g) the standards of industrial products;
h) the determination of quality and wholesomeness indices of food and food beverages;
i) the production, registration, trade and use of chemical substances and forms of energy capable of altering the biological and ecological balance;
k) health checks on the production of thermoelectric and nuclear energy and on the production, trade and use of radioactive substances;
l) the removal of body parts, their use and the transplantation of organs limited to the functions referred to in the law of 2 December 1975, n. 644;
m) the general regulation of work and production for the purpose of preventing accidents at work and occupational diseases;
n) the approval of machinery, systems and personal protective equipment;
o) the Higher Institute of Health, according to the provisions of the law of 7 August 1973, n. 519, and to the present law;
p) the Higher Institute for the prevention and safety of the workplace according to the rules established by this law;
q) the establishment of the requirements for determining the professional profiles of health professionals; the general provisions for the duration and conclusion of the courses; the determination of the necessary requirements for admission to schools, as well as the requirements for the exercise of the auxiliary medical and health professions;
r) the recognition and equalization of healthcare services pre-established in Italy and abroad by healthcare operators for the purposes of admission to the competitions and as a title in the competitions themselves;
s) professional orders and colleges;
t) recognition of the therapeutic properties of mineral and thermal waters and advertising relating to their use for health purposes;
u) the identification of infectious and diffusive diseases of livestock for which, throughout the national territory, there is an obligation to slaughter and, if necessary, the destruction of infected animals or animals suspected of infection or contamination the determination of the mandatory interventions in the field of zooprophylaxis the prescriptions concerning the use of active ingredients, additives and mineral and chemical-industrial substances in products intended for zootechnical feed, as well as those relating to the production and marketing of the latter products;
v) the military medical organization;
z) the health services established for the Armed Forces and the Police Forces, for the Corps of custodial officers and for the National Fire Brigade Corps, as well as the services of the Autonomous State Railway Company relating to the technical-health assessment of the conditions of employees.
Article 14
(Local health units)
The territorial area of activity of each health unit2 is delimited on the basis of population groups usually between 50,000 and 200,000 inhabitants, taking into account the geomorphological and socio-economic characteristics of the area.
In the case of areas with a particularly concentrated population and also in order to allow the coincidence with a tea! appropriate municipality, higher limits are permitted or, in narrower circumstances,
Within the scope of its duties, the health unit provides in particular for:
a) health education;
b) environmental hygiene;
c) the individual and collective prevention of physical and mental illnesses;
d) maternal and child health protection, diatric assistant and the protection of the right to conscious and responsible procreation;
e) hygiene and school medicine in public and private educational institutions of all levels;
f) occupational hygiene and medicine, as well as the prevention of accidents at work and occupational diseases;
g) sports medicine and the health protection of sports activities;
h) general medical and nursing assistance, at home and outpatient;
i) medical-specialist and nursing assistance, outpatient and at home, for physical and mental illnesses;
1) hospital assistance for physical and mental illnesses
m) to rehabilitation;
n) pharmaceutical assistance and supervision of pharmacies;
o) the hygiene of the production, processing, distribution and trade of food and beverages;
p) prophylaxis and veterinary police, veterinary surveillance inspection of animals intended for human consumption, slaughtering and processing plants, food of animal origin, zootechnical feed and diseases transmissible from animals to humans, animal reproduction, breeding and health, veterinary medicines;
q) checks, certifications and any other medico-legal service due to the national health service, with the exception of those relating to the services referred to in letter z) of article 6.
Article 29.
(Discipline of drugs).
The production and distribution of drugs must be regulated according to criteria consistent with the objectives of the national health service, with the social function of the drug and with the prevailing public purpose of production.
The following rules are laid down by state law:
a) for the regulation of the authorization for the production and placing on the market of medicines, for quality controls and for directing pharmaceutical production towards the purposes of the national health service;
b) for the scheduled review of the authorizations already granted for medicinal products in accordance with the rules established for this purpose by the directives of the European Economic Community;
c) for the regulation of drug prices, through a correct methodology for the evaluation of costs;
d) for the identification of the authorized aids and for the definition of the modalities of the clinical trial prior to the marketing authorization;
e) for the patentability of drugs;
f) to define the characteristics and regulate the placing on the market of over-the-counter medicines;
g) for the regulation of the scientific information service on medicines and the activity of scientific representatives;
h) for the revision and periodic publication of the official pharmacopoeia of the Italian Republic, in harmony with the rules established by the European pharmacopoeia pursuant to the law of 22 October 1973, n.752.
Article 30.
(Pharmaceutical Handbook).
The Minister of Health, having consulted the National Health Council, approves with his own decree the therapeutic handbook of the national health service, subject to a proposal from a committee composed of:
by the Minister of Health, who presides over it;
by the director general of the pharmaceutical service of the Ministry of Health;
by the director of the Higher Institute of Health;
by the directors of the pharmacology and drug chemistry laboratories of the Higher Institute of Health;
by seven experts designated by the Minister of Health, chosen among university professors of pharmacology, of
pharmaceutical chemistry or related subjects, pathology or clinical medicine and between doctors and pharmacists
employees or affiliated with the structures of the national health service;
by a representative of the Ministry of Industry, Commerce and Handicrafts;
by two experts in health economics designated by the Minister of Health on a proposal from the Council
national research;
by five experts in the field designated by the regions.
They are chosen by the President of the Council of Ministers from among the experts designated, one each from the regions, and as regards the Trentino-Alto Adige region, one from the province of Trento and one from the province of Bolzano.
The committee referred to in the previous paragraph is appointed by decree of the President of the Council of Ministers, on the proposal of the Minister of Health, and is renewed every three years.
The therapeutic formulary of the national health service must comply with the principles of efficacy
therapeutics, the cheapness of the product, the simplicity and clarity in the classification and the exclusion of over-the-counter products.
The Minister of Health shall update the therapeutic handbook by 31 December of each year with the procedure referred to in the first paragraph.
Until the approval of the therapeutic handbook of the national health service referred to in this article, the handbook referred to in art. 9 of the decree-law 8 July 1974, n. 264, converted, with amendments, into law 17 August 1974, n. 386.
Article 31.
(Advertising and scientific information on drugs).
The national health service is responsible for providing scientific information on drugs and for monitoring the scientific information activity of companies that hold authorizations to market drugs.
Any form of propaganda and advertising to the public of medicines subject to the obligation of presentation of a medical prescription and in any case of those contained in the therapeutic handbook approved pursuant to article 30 is prohibited.
Until the entry into force of the new general regulation of drugs pursuant to art. 29, the Minister of Health determines with his own decree the limits and methods for the publicity and publicity of drugs other than those indicated in the previous paragraph, taking into account the objectives of health education referred to in the following paragraph and the relevant directives of the European Economic Community.
The Minister of Health, having consulted the National Health Council, having seen the proposals of the regions, taking into account the Community directives and having evaluated the observations and proposals that will arrive from the Higher Institute of Health and from university and research institutes, as well as from the pharmaceutical industry, prepares a multi-year program for scientific information on drugs, also aimed at health education initiatives and lays down rules for the regulation of the aforementioned service and the activity of scientific representatives.
Within the framework of the program referred to in the previous paragraph, the local health units and companies referred to in the first paragraph, in compliance with their own competences, carry out scientific information under the control of the Ministry of Health.
The program for scientific information must also provide for the limits and methods for supplying free samples of medicines to surgeons.
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