Laws, regulations in force, sentences

The figure of the Scientific Representative of the drug found its first normative reference in the Italian legislation in the Consolidated Text of the Health Laws (Royal Decree of 27 July 1934, n. 1265, published in the Official Gazette of 9 August 1934, n. 186);

On August 5, 1978 the law was promulgated Law n.484 which lays the foundations for a regulation on scientific information and the advertising of medicines which was then regulated in the subsequent regulation which took place with the law n.833 of 1978, which establishes the SSN, which in art. 29 says that a State law must be implemented “la regulation of the scientific information service on medicines and of the activity of scientific representatives”, 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 the production of the drugs themselves. In addition to the art. 31 states that "the national health service is responsible for providing scientific information on drugs and for monitoring the scientific information activity of the companies that hold authorizations to place drugs on the market". Several Ministerial Decrees followed which indicated the rules from
follow for scientific information.

Several decades later, the European Commission drew up a series of Directives which concerned the homogenization of the provisions of the law, in the field of scientific information, applied in the individual countries making up the Community (Directive n. 92/28 EEC, transposed in Italy with the Legislative Decree 30 December 1992, n. 541, outlined – among other things – the professional figure in question);

subsequent legislative measures have regulated the figure of the Scientific Pharmaceutical Representative (ISF). In particular, Legislative Decree 24 April 2006, n. 219, atarticle 122 ("Requirements and activities of scientific representatives"), has reformulated the content of the activity of scientific representatives by establishing, among other things, the subjective requirements that allow the exercise of the profession of scientific representative, i.e. the obligation for every pharmaceutical company to communicate to the Italian Medicines Agency (AIFA), within the month of January of each year, the list of Scientific Representatives employed during the previous year, with an indication of the educational qualification and the type of employment contract with the pharmaceutical company;

LThe activity of Scientific Representative takes the form of visits by the latter to doctors in outpatient clinics, studios, hospitals, with the aim of illustrating the composition, technological characteristics, therapeutic efficacy, contraindications, methods of use and the optimal dosage of new drugs or those whose use is now consolidated;

The fundamental task of the Pharmaceutical Representatives is, therefore, to contribute to constantly updating the medical profession of the assigned work area on the scientific and therapeutic contents of the entrusted drugs, within the context of the registered therapeutic indications. In essence, doctors can have, precisely through the interview with the scientific rep, a useful update to carry out their profession even better from a therapeutic point of view;

It is worth recalling here that, often improperly, the professional figure of the Scientific Pharmaceutical Representative is associated with that of the commercial agent, from which – instead – it profoundly differs, since there is no contractual promotion activity in the proper sense. In this sense, the judge seised has ruled on several occasions (Civil Cassation, Labor Section, 10.23.2001, n. 13027; Court of Cassation on 07.19.2004, sentence n. 13389, and Court of Cassation on 06.01.2004 , judgment no. 10507; Court of Cassation sentence 15 September 2014 n. 19394; Court of Appeal of Rome, Labor Section, on 03.27.2006; Court of Naples, Labor Section, on 01.31.2006);

as for the need for a more precise legislative discipline of the profession of the Scientific Pharmaceutical Representative, both in the XIV legislature (Senate act n. 404, approved on 25 September 2002, and Chamber Act no. 3204, approved on 23 February 2005), and in the 16th legislature (AS 3237), Parliament - while not concluding the legislative process - dealt with the matter. During the XVII Legislature, a bill was presented to the Senate of the Republic (S613) on the "New regulation of pharmaceutical scientific information activities and establishment of the register of drug scientific representatives". In the XVIII legislature a new bill was presented: Act Chamber 2077 "Provisions for the recognition of the healthcare profession as drug sales representative and for the establishment of the relative professional register“. The articles of the Bills intend to bring about the necessary regulation in a very particular sector such as that of the activity of scientific-pharmaceutical information with the institution of theRegister of scientific representatives of the drug.

Community legislation:


REGIONAL LAWS and REGULATIONS

The guidelines of the "Regional regulation of scientific information on drugs" have been introduced pursuant toart. 48 paragraphs 21, 22, 23, 24 of the Law 24.11.2003 n. 326, approve the 13.01.005 by the Conference of the Presidents of the Regions and Autonomous Provinces . Definitely approved on Thursday April 20, 2006 by the Conference of Regions and Autonomous Provinces.

Based on this they resolved:

Autonomous Province of Bolzano  (p. 25)- Removed from the Province of Bolzano

Edit 2015 Law_Scientific-information-in-Trento (Autonomous Province of Trento)

Valle d'Aosta Region

Veneto region – 'Medical-scientific information' working group in the Veneto Region. Reconstitution – DGR 1634 del 22.12.2023 Regolamentazione

Marche Region - DGR 598/09

Molise region  BURM 03.16.2007 no. 7 First part - 993 - Annex A 994

Puglia region. ISF regulation

Campania region. ISF regulation. LAW_8_DEL_27-06-2011 – Hospitals of the Hills. Regulations for Medical-Scientific Information on Drugs – AOU St. John of God and Ruggi d'Aragona: Regulation on ISF

Lazio Region.-Indications regarding scientific information on drugs – ISF San Camillo Regulatory Resolution

Lombardy region – ISF Regulation Policlinico San Matteo Pavia –  Pio Albergo Trivulzio Regulation_informators_pharmaceuticals_July_2019-2

Liguria region: Art. 61 Regional Law 7 December 2006, n. 41 Scientific information (Settlement then not carried out)

Region.basilicata.Reg.ISF – DGR 30 luglio 2008

Calabria Region ISF regulation. Calabria. REGULATION OF THE REGIONAL COUNCIL 29 June 2006 - Law: Calabria Region Register of Scientific Representatives of drugs and parapharmaceuticals – Disposizioni attuative e regolamento del Registro Regionale degli ISF

Umbria Region: DGR no. 1022 dated 17/7/03

Tuscany region Annex B -  TAR on legitimacy of the GRToscana resolution – AO Careggi regulations – Policies of IS AUSL 11 Empoli, Local health authority regulation 11 EmpoliScientific information regulation AUSL Toscana Nord Ovest ISf access request – AUSL Tpscana North West ISF PRESENCE REGISTER – North West Tuscany – PisaRegulation of the scientific information of the drug RA 35

Sicily Region 2003 – Sicily Region 2006 – Sicily Circular ISF-19302-of-4-3-2019 – ASP 8 Syracuse Stakeholder Reg – Regulations for Scientific Information ARNAS Civico – Di Cristina – Benfratelli

Sardinia Region –  Application attachment – Sardinia Region DGR New ISF Regulation

Region of Sardinia Modifications Attachment to GR Resolution no. 37/34 OF 30.7.2009

Piedmont Region regulation_isf  – ASL CN2 – Access regulation ISF ASO San Luigi Orbassano (TO)

Emilia-Romagna.dgr-2309-2016 Scientific Information Regulation

Emilia Romagna region. Directives on the subject of scientific drug information – Regulation for the access of scientific representatives within the Rizzoli Orthopedic Institute – Bologna S.Orsola-"Provisions on technical-scientific information" – Meetings between doctors and ISF: the Ospedale Maggiore of Parma sets new rules (The module) – Reggio Emilia regulationReg. ER Annex 1 - Parma AUSL regulation on the scientific information of medicines – Modena Regulations for the Scientific Information of Drugs and DM-IVD – def (MO: Product presentation request form)

 ISF Emilia Romagna Regulation Application 20.01.20 

Local health unit of Viterbo. Scientific Information Regulation

ISF San Camillo Regulatory Resolution

Scientific Information Regional Regulations (summary table)

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ANAC.SSN Code of Conduct Guidelines. (see page 10, bottom of page)

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JUDGMENTS

Activity of medical-scientific informant: does it differ from the activity of the agent?

The activity of the medicines propagandist (also called scientific propagandist or medical-scientific informant), which can take place both in the context of the self-employment relationship and in that of the subordinate employment relationship, consists in persuading the potential customers of the opportunity of the purchase, informing it of the product and its characteristics, but without promoting (if not entirely marginally) the conclusion of contracts. The activity of the agent differs from the aforesaid activity, who, in the context of an obligation not of means but of result, must also achieve the promotion of the conclusion of contracts, since his remuneration is directly connected to these and commensurate.

Civil cassation section lav., 16/04/2021, n.10158


Straining damage. It is wrong to consider the scientific representative to be subjected to marketing management and commercial reasons

Damage from straining, the company must compensate the scientific rep. It is wrong to consider being subjected to marketing management and for commercial reasons compliant with the professionalism of the scientific representative

Cassation Ordinance 33428 Year 2022


Scientific informant of the drug: layoffs at zero hours

The provision of zero-hour layoffs for an employee with the role of scientific sales representative of the drug is illegitimate if, as part of the trade union consultation procedure, the company has formalized the need to abolish a product line on which it is assigned the employee concerned to the suspension, only to then proceed to a mere reorganization of its product lines also through the unification of several business units into other pre-existing or newly established ones, as this reorganization cannot be equated to a real suppression.

Court of Appeal Rome section lav., 24/07/2019, n.2459


Periodic information visits to hospitals

The paper forms for monitoring the use of medicinal products temporarily replacing those prepared by the Administration on institutional sites due to a malfunction of the IT system in charge, where they contain information on medicinal products, have been used by scientific representatives during visits information periodicals at hospitals and are different from those originally authorized by AIFA - albeit marginally for the purpose of assessing the characteristics of the drug - must be considered fully subject to the discipline set out in articles 113 ff. legislative decree no. 219/2006 (Drug Code), relating to the advertising of medicines.

Court of Milan section I, 11/13/2019, n.10325


Paper cards for monitoring the use of medicines

The paper forms for monitoring the use of medicinal products temporarily replacing those prepared by the Administration on institutional sites due to a malfunction of the IT system in charge, where they contain information on medicinal products, have been used by scientific representatives during visits information periodicals at hospitals and are different from those originally authorized by AIFA - albeit marginally for the purpose of assessing the characteristics of the drug - must be considered fully subject to the discipline set out in articles 113 ff. legislative decree no. 219/2006 (Drug Code), relating to the advertising of medicines.

Court of Milan section I, 11/13/2019, n.10325


Qualification of the employment relationship

The nomen juris that the parties attribute to the employment relationship is not decisive for its legal qualification. The will of the contracting parties constitutes a point of reference in the judge's assessment, from which he can deviate in the face of multiple and univocal indices that bring out a different reality from that described in the contract. The clause providing for a minimum remuneration in favor of the worker is compatible with the business procurement contract.

Court of Appeal Milan section lav., 03/15/2017, n.1281


Medical-scientific informant: just cause for dismissal

There is just cause for dismissal when the trust in the correct performance of the duties entrusted to the employee is irreversibly compromised (in this case the employee was a medical-scientific informant and never carried out visits and interviews with doctors, contrary to what was declared by the himself) constituting a superficial and irresponsible attitude in the execution of the tasks entrusted to him and constitutes a serious breach of the obligations incumbent on him.

Castrovillari Court section work, 11/30/2016


Scientific informant activity of the drug

The scientific information activity of the drug can well be carried out both by agents and by employees of the pharmaceutical company, since what is relevant, in order to qualify a relationship as employment, is the proof of the effective subjection of the informant to the management and control power by the company, while the mere fact that the agent must conform his activity, among other things, to the prescriptions of the drug code, in itself does not disqualify to suggest that the contract of agency is not legitimate.

Court of Milan section work, 12/30/2015


Prescribing drugs in exchange for fees paid by the informant

A family doctor who has prescribed drugs not on the basis of the actual therapeutic needs of the patients, but in exchange of fees paid to him by the informant, by issuing false prescriptions, then delivered directly by the informant to some pharmacists aware of the corruptive act, who thus disposed of the stocks present in the pharmacy, on the basis of the explicit agreement that the doctor would have prescribed precisely those drugs.

Corte Conti, (Apulia) section reg. jurisdiction, 04/30/2015, n.258


Scientific informant of the drug: is it subordinate work?

The qualification of subordinate worker must be recognized to the drug sales representative who, in carrying out his activity, reports his work to an area manager and does not, on the other hand, carry out any business procurement activity, typical of the agent, and this regardless of the formal qualification of the relationship - such as an agency contract - agreed by the parties.

Civil cassation section lav., 09/15/2014, n.19394


False scientific informant and crime of receiving stolen goods

The existence of the fraud necessary to integrate the crime of receiving stolen goods pursuant to art. 648 of the Criminal Code in the conduct of a person who has carried out intermediation activities between a carrier of medicinal products and a false scientific representative in the context of a dense network of illicit relationships aimed at the sale of drugs proceeding from theft outside the legal channels, an activity demonstrated by the seizure of correspondence and informal accounting represented by lists of drugs and price lists suitable for proving the stability of the criminal group, as well as awareness of the illegality of the commercial triangle.

Court of Cassation, Section 2, Criminal Law, sentence, 29 May 2014, n. 22159


Scientific informant transfer of the drug

The transfer of a scientific representative of the drug to another area is legitimate where there are proven organizational and production reasons suitable to support the assignment to the employee of a different area from the one initially covered, it being understood that the judicial control of the technical, organizational and production reasons that legitimize the transfer must be aimed at ascertaining the correspondence between the provision adopted by the employer and the typical purposes of the company but, finding a precise limit in the principle of freedom of private economic initiative guaranteed by art. 41 cost., cannot be expanded to include the merit of the choice made by the entrepreneur. A choice which, in the event of an employee's transfer, does not necessarily have to assume the character of inevitability, it being sufficient that the transfer gives rise to one of the possible choices, all reasonable, that the employer can adopt on a technical, organizational and production level.

Civil cassation section work, 10/25/2013, no. 24189


Corporate dependency: concept

The notion of "company dependency to which the worker is employed", useful for the purpose of establishing territorial jurisdiction pursuant to art. 413 cpc, must be understood in a broad sense, being therefore able to include also the residence of the worker, when he carries out his work activity in that place, using a set of company equipment intended for work activity.

(In this case, the Supreme Court recognized a real corporate dependency in the home of the worker, scientific informant of the drug, where he carried out his work using tools intended for corporate activity, such as a computer connected to the company, a printer and the ADSL line).

Civil cassation section work, 11/24/2011, no. 24823


The performance of the work performance

For the purposes of territorial jurisdiction in labor disputes, the notion of "employment" to which the worker has been or is employed - referred to in art. 413, paragraph 2, cpc, for the hypothesis of the private employment relationship – must be interpreted in accordance with the principle of equality sanctioned by art. 3, cost., taking into account, as terms of comparison, the criterion of domicile (provided for by the following paragraph 4 for agency and quasi-subordination relationships) and the criterion of the place of work (provided for by paragraph 5 of the same provision for of public work), and, therefore, also including the employee's home which is configured as an elementary termination of the company, consisting of a minimum of company assets necessary for the performance of the job (such as, in this case, the computer, the forms, the advertising material as well as the "samples" of medicines used by the same employee for the performance, in a subordinate position, of the activity of scientific informant of the medicine).

Court of Bari section work, 06/23/2009


Organization of meeting with scientific representatives of the drug

It falls within the organizational power of each Local Health Authority to identify suitable premises and time slots within which to allow meetings with drug sales representatives within its own structures, above all where it is the regional body of the health service that sets the minimum requirements, in turn, within the criteria and principles of state legislation.

TAR Catanzaro, (Calabria) section I, 10/07/2007, n.977


Scientific congresses and conferences

The deductibility of expenses for congresses and scientific meetings exists when the requirement of a purpose of significant scientific interest really exists or between group visits in meetings in a strictly local context, with the presentation of a scientific representative to a small audience of doctors with an illustration of the characteristics of the product. (1)

(1) – The dispute between the parties concerned the classification of the so-called mini-meetings between scientific congresses and conferences, the deductibility of the related expenses can only exist when the requirement of a purpose of significant scientific interest exists, or between group visits to strictly local meetings, with presentation, by a scientific representative to a small audience of doctors, of the product with illustrations of its characteristics. The office did not dispute the nature and manner of these meetings. The judges, referring to the sentence of the Cassation 25053/06 and to the Agency's 20 September 2002 n. 170586, recognized the deductibility of these expenses. In relation to the qualification of the expenses incurred by pharmaceutical companies, all expenses aimed at making a drug known to the medical profession are to be considered advertising expenses, also through the organization of short-term meetings and meetings and with the participation of a limited number of specialists. While other expenses generally aimed at promoting the image of the pharmaceutical company are not advertising expenses, but entertainment expenses. On the basis of this principle, gifts and presents, dinners and lunches at the end of meetings lasting a few hours constitute an expense inherent in the business activity, but in terms of enhancing the image of the company as a whole, and not of advertising the products (Cassation 25053/06).

Lazio Regional Tax Commission, Section 5, Sentence, 12 April 2007, n. 54


Scientific representative of the drug: trial period

The reference of the collective contractual provision, according to which the probationary period of drug sales representatives who have provided their activity with this qualification for at least two years in other companies is three months, is to be understood in terms of activity performed in the scope of the qualification envisaged by the same national collective labor agreement and cannot also include an autonomous collaboration previously carried out.

In the indication of the duties of scientific informant of the drug, the reference to the precise organizational position regulated by the National Collective Labor Agreement is unequivocal and therefore to the description in the same National Collective Labor Agreement of the profile in the organizational position of reference.

The absence of the burden of motivation and the discretion of motivation which meets the only limit of the circumvention of mandatory rules for the hiring of protected categories or for discriminatory dismissal is finally reaffirmed by the sentence of the Constitutional court n. 541 of 4 December 2000.

Court of Appeal, Milan, Sentence, 23 January 2001


Membership CCNL application

The Court of Vicenza established that the national collective labor agreement for industry employees must be applied in the company at a national level by Filctem, Femca, Uiltec with the industrial representative organization: i.e. the trade union and employer organizations of the most representative sector in the national territory.

Vicenza Court Sentence CCNL - Sentence 23 March 2022


Related news: Cassation. New Ordinance: The ISF is not a commercial agent because it does not sell medicines. With comment by the lawyer

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TRANSPORT AND STORAGE OF DRUGS

You see: Fedaisf. Rules for the ISF for the storage and transport of medicinal samples.

DETENTION OF EXPIRED DRUGS
edited by Marco Perelli Ercolini

Doctors' offices are full of medicines and sometimes even expired drugs, abandoned on some shelf or in desk drawers.

Sometimes inspections in doctor's surgeries have highlighted these expired drugs and the official has drawn up the criminal complaint in relation to article 173 of the Consolidated text of health laws which provides that medicinal products for which the validity period has expired are considered faulty and imperfect and to article 443 of the penal code according to which anyone who holds for trade, places on the market or administers faulty or imperfect medicinal products is punishable.
Therefore, a report to doctors is useful for greater attention in the conservation, in their studies, of medicines, including samples of medicines even if, as reaffirmed in the recent sentence of the Court of Rome - judge Cappiello sentence number 10601/2005, for the purposes of acknowledgment of criminal liability the effective destination for trade or administration is necessary: mere detention for administration must be considered excluded from the category of punishable conduct given the non-application by analogy of the incriminating provision.
For any disposal, the current legislation that regulates the disposal of expired medicines (CER code 180109) is regulated by Presidential Decree 254/2003 which in article 2, paragraph h, point 1a and possibly 1b, classifies them as medical waste which require special management systems.
The subsequent art. 4 refers to Legislative Decree 22/1997 (Ronchi) for the management of all waste and therefore also for expired medicines.
The Ronchi Decree classifies them, pursuant to art. 7, as special waste and therefore subject to the relative obligations (Loading and unloading registers, Forms for transport and notification to the Waste Cadastre; articles 11, 12 and 15 of Legislative Decree 22/ 97).
As far as disposal is concerned, the Presidential Decree 254/200314, paragraph 1, prescribes disposal in incineration plants.

However, the standard does not specify whether the incineration must be carried out in plants other than those for urban waste, so it is presumable that the same plants can be used.
Particular attention should be paid to cytotoxic and cytostatic drugs, considered hazardous medical waste with chemical risk and classified with CER code 180108 and for narcotic drugs to be disposed of according to the procedures established by the Presidential Decree 309/1990 (through the Asl Pharmaceutical Service).

Presidential Decree 15-07-2003, n. 254, Article 2

Art. 2 – Definitions
1. For the purposes of this regulation:
a) medical waste: the waste listed by way of example, in Annexes I and II of this regulation, which derive from public and private structures, identified in accordance with legislative decree 30 December 1992, n. 502, and subsequent amendments, which carry out medical and veterinary activities of prevention, diagnosis, treatment, rehabilitation and research and provide the services referred to in the law of 23 December 1978, n. 833 ;
b) non-hazardous medical waste: medical waste that is not included among the dangerous waste referred to in legislative decree no. 22 ;
c) hazardous medical waste not at infectious risk medical waste listed by way of example in Annex II of this regulation, included among the hazardous waste marked with an asterisk "*" in Annex A of the directive of the Ministry of the Environment and Protection of the territory on 9 April 2002;
d) hazardous medical waste with infectious risk the following medical waste identified by items 18.01.03 and 18.02.02 in Annex A of the aforementioned directive dated 9 April 2002:
1) all waste that comes from infectious isolation environments in which there is a risk of airborne biological transmission, as well as from environments where patients in infectious isolation stay affected by pathologies caused by group 4 biological agents, referred to in Annex XI of the decree legislative September 19, 1994, n. 626, and subsequent modifications;
2) waste listed by way of example in Annex I of this regulation which has at least one of the following characteristics:
2a) come from infectious isolation environments and have come into contact with any biological liquid secreted or excreted by isolated patients;
2b) are contaminated by:
2b1) blood or other body fluids which contain blood in such quantity as to make it visible;
2b2) faeces or urine, in the event that a pathology transmissible through such excretions is clinically recognized by the doctor treating the patient;
2b3) seminal fluid, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, or amniotic fluid;
3) waste from veterinary activities, which:
3a) are contaminated by pathogenic agents for humans or animals;
3b) have come into contact with any secreted or excreted biological liquid for which the competent veterinary surgeon has identified a risk of pathology transmissible through such liquids;
e) waste from exhumation and exhumation: the following waste consisting of parts, components, accessories and residues contained in the boxes used for inhumation or entombment:
1) planks and remains of the coffins used for the burial;
2) religious symbols, feet, ornaments and means of moving the case (for example handles);
3) leftovers of clothing, padding and the like;
4) non-mortal remains of biodegradable elements inserted in the hood;
5) metal remains of chests (e.g. zinc, lead);
f) waste deriving from other cemetery activities: the following waste deriving from cemetery activities:
1) stone materials, aggregates from cemetery construction works, excavated earth, demolition and the like;
2) other metallic or non-metallic objects removed before cremation, burial or inhumation;
g) medical waste assimilated to urban waste: the following medical waste, if not included among those referred to in letters c) and d), subject to the legal regime and methods of management of urban waste:
1) waste deriving from the preparation of meals from the kitchens of health facilities;
2) waste deriving from catering activities and meal residues deriving from the hospitalization wards of health facilities, excluding those deriving from patients suffering from infectious diseases for which a pathology is clinically recognized by the doctor who treats them transmissible through such residues;
3) glass, paper, cardboard, plastic, metals, packaging in general, bulky materials to be delivered to the ordinary separate collection circuits, as well as other non-hazardous waste which in terms of quality and quantity are assimilated to urban waste pursuant to article 21, paragraph 2, letter g), of the legislative decree 5 February 1997, n. 22 ;
4) the garbage;
5) disposable clothing and sheets and those which the holder intends to get rid of;
6) waste from gardening activities carried out in health facilities;
7) orthopedic plaster casts and bandages, sanitary towels, including those contaminated with blood, excluding those of infectious patients, pediatric diapers and diapers, containers and bags used for urine;
8) medical waste with only an infectious risk subjected to a sterilization process carried out pursuant to letter m), provided that the disposal takes place in incineration plants for urban waste. Disposal in landfills is subject to the conditions set out in article 11, paragraph 1, letter c). In the event of disposal, by incineration or disposal in landfills, outside the optimal territorial area, the collection and transport of this waste is not subject to property rights;
h) medical waste requiring particular management systems: the following categories of medical waste:
1a) expired or unusable drugs;
1b) cytotoxic and cytostatic medicines for human or veterinary use and visibly contaminated materials that are generated by their handling and use;
2) unrecognizable organs and anatomical parts referred to in point 3 of Annex I to this Regulation;
3) small experimental animals referred to in point 3 of Annex I to this Regulation;
4) narcotics and other psychotropic substances;
i) special waste, produced outside health facilities, which in terms of risk is similar to hazardous waste with infectious risk, special waste, referred to in legislative decree 5 February 1997, n. 22, produced outside health facilities, with the characteristics referred to in article 2, paragraph 1, letter d), such as, for example, those produced in food, water or cosmetics microbiological analysis laboratories, in blood products, beauty salons and the like. Sanitary towels are excluded;
l) disinfection: drastic reduction of the microbial load carried out with the use of disinfectant substances;
m) sterilisation: reduction of the microbial load such as to guarantee a SAL (Sterility Assurance Level) of no less than 10-6. Sterilization is carried out according to UNI 10384/94, first part, by means of a procedure which also includes shredding and drying for the purpose of making the treatment non-recognisable and more effective, as well as reducing the volume and weight of the waste itself. Only hazardous medical waste with an infectious risk only can be sterilised. Efficacy is checked according to Annex III of this Regulation. The sterilization of infectious risk medical waste is an option that can be exercised for the purpose of simplifying the waste management methods;
n) sterilizers: equipment dedicated exclusively to the sterilization of hazardous medical waste with an infectious risk. The effectiveness of the sterilization procedure and the methods for demonstrating it are established by the UNI 10384/94 standard, first part, on the basis of the validation tests established therein.
Presidential Decree 07-15-2003, n. 254, Article 4

Art. 4 – Management of medical waste, waste from exhumations and exhumations and waste from other cemetery activities.
1. Without prejudice to the provisions of the following articles, the activities of temporary storage, collection, transport, recovery, disposal, intermediation and trade of medical waste, waste from exhumations and exhumations and waste from other cemetery activities apply, in relation the classification of such waste as urban, assimilated to urban, special, hazardous and non-hazardous, the regulatory and technical standards implementing the legislative decree 5 February 1997, n. 22, which govern waste management.
2. In the event that the activity of the healthcare personnel of the public and private structures that provide the services referred to in law no. 833 of 1978, and to the legislative decree n. 502 of 1992, and subsequent amendments, is carried out outside the same, the same structures are considered the place of production of medical waste, pursuant to article 58, paragraph 7-ter, of legislative decree n. 22 of 1997. The transfer of such waste from the place where the service is provided to the healthcare facility takes place under the responsibility of the healthcare operator who provided the service, in good time to ensure compliance with the terms set out in Article 8.
3. Medical waste, with the exception of waste assimilated to urban waste, produced at the decentralized outpatient clinics of the reference healthcare company are also considered to be produced at the reference healthcare facilities.
4. For the purpose of simplifying procedures and containing healthcare costs, to encourage the disposal of sterilized healthcare waste in incineration plants with energy recovery and to ensure the healthcare waste management service at the best market conditions, the regions and the autonomous provinces of Trento and Bolzano can stipulate program agreements among themselves, with the health structures and doctors affiliated with them and with the private subjects concerned.
5. The Regions, according to criteria agreed between the State and the Regions pursuant to the Legislative Decree of 28 August 1997, n. 281, establish systems for monitoring and analyzing costs and their adequacy in relation to the management and disposal of medical waste and transmit, annually, also in computer form, for the purpose of their processing, the data resulting from these activities to the Observatory on waste which, subsequently, communicates them to the Ministries of the environment and the protection of the territory and health. The monitoring system, set up by the regions, can establish the minimum objectives for the recovery of the waste produced that the healthcare facilities are required to achieve.
Presidential Decree 07-15-2003, n. 254, Article 14

Art. 14 – Categories of medical waste that require particular management and disposal systems
1. The waste referred to in article 2, paragraph 1, letter h), must be disposed of in incineration plants. Pending the transposition of Directive 2000/76/EC, the disposal of antiblastic chemotherapy can take place in incineration plants already authorized for hazardous medical waste with an infectious risk.
2. The waste referred to in article 2, paragraph 1, letter h), numbers 2) and 3), must be managed in the same way as hazardous medical waste with an infectious risk.
3. The narcotic substances and other psychotropic substances referred to in article 2, paragraph 1, letter h), number 4), must be sent for disposal in authorized incineration plants pursuant to legislative decree no. 22. Temporary storage, transport and storage are exclusively governed by the decree of the President of the Republic of 9 October 1990, n. 309 .
Legislative decree 02/05/1997, n. 22

Article 7 - (Classification)
1. For the purposes of implementing this decree, waste is classified, according to its origin, as urban waste and special waste, and, according to its dangerous characteristics, as hazardous waste and non-hazardous waste.
2. They are municipal waste:
a) domestic waste, including bulky waste, from premises and places used for residential purposes;
b) non-hazardous waste from premises and places used for uses other than those referred to in letter a), assimilated to urban waste in terms of quality and quantity, pursuant to article 21, paragraph 2, letter g);
c) waste from street sweeping;
d) waste of any nature or origin, lying on public roads and areas or on private roads and areas in any case subject to public use or on seashores and lakes and on the banks of watercourses;
e) vegetable waste from green areas, such as gardens, parks and cemetery areas;
f) waste from exhumations and exhumations, as well as other waste from cemetery activities other than those referred to in letters b), c) and e).
3. They are special waste:
a) waste from agricultural and agro-industrial activities;
b) waste deriving from demolition and construction activities, as well as hazardous waste deriving from excavation activities; [1] c) waste from industrial processes, without prejudice to the provisions of article 8, paragraph 1, letter f-quater); [2] d) waste from craftsmanship;
e) waste from commercial activities;
f) waste from service activities;
g) waste deriving from waste recovery and disposal activities, sludge produced from drinking water purification and other water treatments and from waste water purification and fume abatement;
h) waste deriving from healthcare activities;
i) deteriorated and obsolete machinery and equipment;
l) end-of-life motor vehicles, trailers and the like and their parts;
l-bis) fuel derived from waste. [3] 4. Non-household waste specified in the list in Annex D on the basis of Annexes G, H and I [4] is hazardous.
Legislative decree 02/05/1997, n. 22

Art. 11 – (Register of waste)
1. Within one hundred and twenty days from the date of entry into force of this decree, the Minister of the Environment, having heard the Permanent Conference for relations between the State, the Regions and the autonomous provinces of Trento and Bolzano referred to in article 12 of the law 23 August 1988, no. 400, provides with its own decree for the reorganization of the Waste Registry established pursuant to article 3 of the decree-law of 9 September 1988, n. 397, converted with amendments, by law 9 November 1988, n. 475, and subsequent amendments, in order to ensure a complete and constantly updated information framework, also for the purposes of planning the related management activities, on the basis of the data collection system relating to waste management pursuant to the law of 25 January 1994, no. 70, using the nomenclature provided for in the European Waste Catalog established by decision of the Commission of the European Communities of 20 December 1993, published in the Official Journal of the European Communities n. 5 of 7 January 1994.
2. The Land Registry is divided into a national section, which is based in Rome at the National Agency for the Protection of the Environment (ANPA) and in regional sections or those of the autonomous provinces at the corresponding regional agencies and autonomous provinces for the protection of the environment (ARPA) and, where such Agencies are not yet established, at the Region.
3. Anyone who carries out waste collection and transport activities on a professional basis, including waste traders and intermediaries, or carries out waste recovery and disposal operations, as well as companies and bodies that produce dangerous waste and companies and the entities that produce non-hazardous waste referred to in article 7, paragraph 3, letters c), d) and g), are required to communicate annually in the manner prescribed by the law of 25 January 1994, n. 70 the quantities and qualitative characteristics of the waste involved in the aforementioned activities. Agricultural entrepreneurs referred to in article 2135 of the civil code with an annual turnover not exceeding fifteen million lire and, limited to the production of non-hazardous waste, small artisan entrepreneurs referred to in article 2083 of the code are exempt from this obligation civilians who have no more than three employees. In the event that the waste producers confer the same to the public collection service, the communication is made by the service manager limited to the quantity conferred [1].
4. The municipalities, or their consortia or mountain communities or special companies for the purpose of disposing of urban and similar waste, communicate annually in accordance with the procedures set out in the law of 25 January 1994, n. 70, the following information relating to the previous year:
a) the quantity of municipal waste collected in its territory;
b) the subjects who have provided for waste management, specifying the operations carried out, the types and quantities of waste managed by each one;
c) management costs and technical and financial depreciation of investments for waste management activities, as well as the proceeds of the tariff referred to in article 49;
d) data relating to differentiated waste collection.
5. The Regional and Provincial Sections and the Autonomous Provinces of the Land Registry process the data and subsequently transmit it to the National Section within 30 days of receipt, pursuant to article 2, paragraph 2, of the law of 25 January 1994, n. 70, of the information referred to in paragraphs 3 and 4. ANPA processes the data, highlighting the types and quantities of waste produced, collected, transported, recovered and disposed of, as well as the disposal and recovery plants in operation, and ensures advertising.
6. Until the decree referred to in paragraph 1 is issued, the provisions in force on the subject continue to apply.
7. The reorganization of the Cadastre referred to in paragraphs 1 and 2 must not entail further and additional charges for the State budget.

Note:
1 Paragraph modified by art. 1, paragraphs 13, 14 and 15, Legislative Decree 8 November 1997, n. 389 and, subsequently, by art. 1, paragraph 16, Law 9 December 1998, n. 426.

Art. 12 – (Loading and unloading registers)
1. The persons referred to in article 11, paragraph 3, are obliged to keep a register of loading and unloading, with numbered sheets and endorsed by the Registry Office, on which they must write down the information on the qualitative and quantitative characteristics of waste, to be used for the purposes of annual communication to the Land Registry. Annotations must be made.
a) for producers, at least within a week of the production of the waste and its unloading;
b) for subjects who collect and transport at least within a week of carrying out the transport;
c) for merchants and intermediaries at least within a week of carrying out the relative transaction;
d) for subjects who carry out recovery and disposal operations within twenty-four hours of taking charge of the waste [1].
2. The register kept by establishments and companies that carry out waste disposal and recovery activities must also contain:
a) the origin, quantity, characteristics and specific destination of the waste;
b) the date of loading and unloading of the waste and the means of transport used;
c) the method of treatment used.
3. Records are kept at each waste production, storage, recovery and disposal plant as well as at the headquarters of the companies that carry out collection and transport activities, and at the headquarters of traders and intermediaries. The integrated registers with the waste transport forms are kept for five years from the date of the last registration, with the exception of the registers relating to landfill waste disposal operations, which must be kept indefinitely and at the end of the activity they must be handed over to the authority that issued the permit [2].
3-bis. The loading and unloading registers relating to the waste produced by the maintenance activities of the networks and widespread users carried out by public and private subjects holding special or exclusive rights pursuant to directive 93/38/EC implemented with the legislative decree of 17 March 1995, no. 158, which install and manage, directly or through contractors, networks and systems for the provision of supplies and services of public interest, can be kept, within the province where the activity is carried out, at the organizational coordination offices or other equivalent center communicated in advance to the same province [3].
4. Subjects whose annual production of waste does not exceed 5 tons of non-hazardous waste and one ton of hazardous waste can fulfill the obligation of keeping waste loading and unloading registers also through the relevant trade organizations or their service companies which take steps to record the data provided on a monthly basis, keeping a copy of the data transmitted at the company headquarters [4].
5. The information contained in the register is made available at any time to the supervisory authority which requests it.
6. Pending the identification of the uniform loading and unloading register model and any replacement documents, as well as the methods for keeping them, the provisions in force governing the aforementioned methods for keeping the registers continue to apply [5].
6-bis. The consortia referred to in articles 40, 41, 47 and 48 of the present decree and the consortia referred to in article 9-quinquies of the decree-law of 9 September 1988, n. 397, converted, with modifications, by law 9 November 1988, n. 475, and in article 11 of the legislative decree 27 January 1992, n. 95. [6]

Note:
1 Paragraph modified by art. 1, paragraphs 16 and 17, Legislative Decree 8 November 1997, n. 389, starting from the day of its publication.
2 Paragraph modified by art. 1, paragraphs 18 and 19, Legislative Decree 8 November 1997, n. 389, starting from the day of its publication.
3 Paragraph inserted by art. 1, paragraph 20, Legislative Decree 8 November 1997, n. 389, starting from the day of its publication.
4 Paragraph modified by art. 1, paragraph 21, Legislative Decree 8 November 1997, n. 389, starting from the day of its publication.
5 Paragraph modified by art. 1, paragraph 22, Legislative Decree 8 November 1997, n. 389, starting from the day of its publication.
6 Paragraph added by art. 23, paragraph 1, lett. c), Law July 31, 2002, n. 179.

Article 15 - (Transportation of waste)
1. During transport carried out by bodies or companies, the waste is accompanied by an identification form which must contain, in particular, the following data:
a) name and address of the producer and holder;
b) origin, type and quantity of waste;
c) destination plant;
d) date and route of routing;
e) name and address of the consignee [1].
2. The identification form referred to in paragraph 1 must be drawn up in four copies, completed, dated and signed by the holder of the waste, and countersigned by the transporter. One copy of the form must remain with the holder, and the other three, countersigned and dated on arrival by the recipient, are acquired by the recipient and two by the carrier, who sends one to the holder. Copies of the form must be kept for five years.
3. During collection and transport, hazardous waste must be packaged and labeled in compliance with current legislation on the matter.
4. The provisions referred to in paragraph 1 do not apply to the transport of urban waste carried out by the subject who manages the public service nor to the transport of waste which does not exceed the quantity of thirty kilograms per day or thirty liters per day carried out by the producer of the waste themselves [2].
5. The uniform model of identification form referred to in paragraph 1 is adopted within sixty days of the date of entry into force of this decree.
5-bis. The identification forms referred to in paragraph 1 must be numbered and authenticated by the registry office or by the chambers of commerce, industry, handicrafts and agriculture, and must be noted in the VAT-purchase register. The validation of the aforementioned identification forms is free and is not subject to any right or taxation [3]

You see: Fedaisf. Rules for the ISF for the storage and transport of medicinal samples.

 

 

 

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco