Ministerial Decree 6/23/81
DECREE 23 June 1981.
Regulation of scientific information on drugs.
THE MINISTER OF HEALTH
Given the art. 31 of the law of 23 December 1978, n. 833, on the establishment of the National Health Service, which delegates to the Ministry of Health the task of preparing a multi-year program for scientific information on drugs, also aimed at health education initiatives, and of dictating rules for the regulation of the scientific information service itself and the activity of scientific representatives;
Considering that, pending the general regulation of drugs pursuant to art. 29 of the aforementioned law of 23 December 1978, n. 833, it appears necessary to establish norms to regulate scientific information and the activity of scientific representatives;
Having regard to the opinion of the National Health Council, expressed in the session of 6 March 1980, in which the establishment of a committee for the preparation of the multi-year program for scientific information on drugs is envisaged;
Having therefore considered the need to lay down provisions of a general nature governing the scientific information service on medicinal products for human use, in order to periodically inform healthcare professionals of the characteristics and properties of medicinal products, in order to ensure their use according to the appropriate indications and dosages;
Examine the further findings acquired in the records;
Decrees:
Article 1.
The activity of scientific information on medicines for human use must be inspired by the principles contained in the law of 23 December 1978, n. 833, on the establishment of the National Health Service, and be aimed at ensuring the correct use of the drugs themselves, also with reference to the need to contain the relative consumption.
The informative material sent to healthcare professionals and the material used by scientific reps in the exercise of their activity must refer exclusively to the texts of the publications approved by the Ministry of Health and to the documentation on the basis of which the authorization was granted.
The informative material referred to in the previous paragraph must in any case be accompanied by the technical data sheet referred to in the following art. 4. The same must correspond to the following requirements:
a) the data relating to the pharmacological and clinical characteristics of the product must be reported in
scientifically documented form, with the citation of the relevant bibliographic sources.
Particular emphasis must be given to the part relating to contraindications, warnings and effects
collateral, the text of which must correspond to that approved by the Ministry of Health for the sheets
illustrative;
b) the texts must comply (when there is correspondence) with the most accredited international monographs on drugs (WHO reports, PDRs and monographs on FDA generics);
c) the texts must not contain any graphic element (drawings, diagrams, figures, etc.) or statements (titles, statements, slogans), which is not strictly adherent to the technical content of the product and does not correspond to scientific symbolisms. In any case, allegories dictated by promotional intent must be avoided.
Article 2.
Without prejudice to the provisions of the second paragraph of this article, the provisions of the previous article also apply to information material included in scientific publications or journals.
When the sole purpose of the advertisement is to recall the name of a medicinal product, only the following information must be provided:
I) Name of the specialty.
The international non-proprietary name recommended by the Organization should be used.
world health care, whenever it exists. This common denomination must be
ed immediately after the invented name and must be equally legible.
II) Name of the person responsible for placing on the market and, if applicable, of the manufacturer.
It is not permitted to publish texts of scientific information relating to drugs in publications
which are not exclusively technical-scientific in nature.
Article 3.
The material used in any case for the scientific information of medicinal products must be sent in copies to the Ministry of Health - General Directorate of the Pharmaceutical Service, before being sent, delivered or illustrated to persons authorized to prescribe, supply or administer medicines.
The Ministry of Health can order the cessation of the distribution and publication of information material that does not comply with the information and documentation acquired in the documents during the marketing authorization of the medicinal product or after its introduction on the market.
Article 4.
Pharmaceutical companies will have to submit, together with the application for authorization to place medicinal products on the market, also a technical file which must be attached to all scientific information texts they intend to use.
The technical sheet must include:
1) name of the specialty;
2) international non-proprietary name of each active ingredient, recommended by the Organization
world health organization;
3) pharmacological data; pharmacological properties, fate of the drug (pharmacokinetics);
4) clinical information:
4.1) therapeutic indications;
4.2) contraindications;
4.3) side effects (frequency and severity);
4.4) special precautions for use (in case of pregnancy, breastfeeding, etc.);
4.5) warnings (risk of habituation, addiction, etc.);
4 6) drug interactions and incompatibilities;
4.7) dosage and method of administration;
4.8) dosage (symptoms, emergency measures, antidotes);
5) pharmaceutical information:
5.1) qualitative and quantitative composition of active ingredients;
5.2) excipients;
5.3) pharmaceutical forms and related prices;
5.4) name or company name and domicile or registered office of the manufacturer.
Article 5.
Scientific congresses and conferences on drugs must comply with criteria of a strictly technical nature and the subjects dealt with must be devoid of promotional and advertising intentions.
Scientific information activities, carried out side by side with the congresses themselves, must be conducted in harmony with the provisions of this decree.
Pharmaceutical companies and other institutions responsible for organizing meetings are
required to communicate in advance to the Ministry of Health - Directorate General of the Pharmaceutical Service, the news concerning the congresses and conferences referred to in the first paragraph (theme, organisation, place and date).
For meetings of health professionals organized locally, the communication referred to in the previous paragraph must be made to the territorially competent local health unit, which will notify the Ministry of Health.
Article 6.
Technical-scientific information on medicines must be brought to all healthcare professionals interested in the relative pharmaceutical prescription, on the basis of their own competence.
While waiting for the matter to be regulated in compliance with art. 29, letter g), of the law of 23 December 1978, n. 833, starting from the entry into force of this decree and without prejudice to the factual situations existing on that date, scientific representatives must have a university degree in biomedical or chemical-pharmaceutical disciplines (medicine, veterinary medicine, biological sciences, organic or biological chemistry, pharmacy, chemistry and pharmaceutical technology) or a high school diploma, supplemented by adequate training or professional qualifications, such as, for example, attendance of the training course held pursuant to the following seventh paragraph.
Pharmaceutical companies must send, within six months of the entry into force of this decree, the Ministry of Health - Directorate General of the Pharmaceutical Service, the list of names of the respective information officers on drugs, with an indication of the qualification and residence, as well as the type of relationship with the company.
Subsequently, any variation of the specified elements must be promptly communicated to the aforementioned Ministry.
Pharmaceutical companies will have to give their scientific representatives adequate specific professional training, suitable for providing healthcare professionals with all the information necessary to highlight the nature, quality, any contraindications and side effects of the drugs.
The Ministry of Health will take care of promoting, organizing, supervising and supervising initiatives aimed at updating and professional enrichment of scientific representatives, which can also be carried out by the regions.
Each training and refresher course must be communicated in advance to the Ministry of Health, which provides the indications and guidelines intended to give homogeneity to the initiatives, on the basis of the criteria established by the committee referred to in art. 9.
The Ministry of Health will take care of the regular sending of its information bulletin on medicines to scientific representatives.
The employment relationship of the scientific informant finds its discipline in the related collective bargaining between the categories involved.
Considering, however, the effects of the informant's activity within the National Health Service, the establishment of a full-time and subordinate employment relationship is to be considered qualifying.
Article 7.
Samples can only be sent to persons authorized to prescribe medicinal products, in order to make known the characteristics of the medicinal product and its preparation in its prescriptive capacity, for the first two years from the date of issue of the marketing authorization or from the date of inclusion in the National Therapeutic Formulary, under the following conditions:
1) absolute identity between the sample and the medicinal product, even if in a smaller package than that authorized, provided that it is therapeutically suitable;
2) indication "free sample - not to be sold" or other similar mention to be reported on the external and internal label and, indelibly, on the punch or stamp showing the price.
After two years from the above dates, a written request from the addressee is also required, dated e
signed by the same on his recipe book.
The requirement referred to in point 1) above as well as the obligation of a written request do not apply to pharmaceutical preparations intended for clinical trials carried out in university institutes and hospitals. In such cases, however, the samples must still be provided via the hospital pharmacy.
Article 8.
For the purpose of collecting the data necessary for the fulfillment of the ministerial decree of 20 March 1930, published in the Official Gazette of the Italian Republic no. 83 of 25 March 1980, the Ministry of Health will take care of sending doctors, through the local health units, a suitable quantity of forms, compliant with the model attached to this decree, for the collection of data on the use of drugs.
Doctors, within the framework of the collaboration envisaged by current legislation for the implementation of the national health service, will fill in the forms every time they register toxic, secondary or unexpected effects, both local and general, consequent or in any case correlated with the use of drugs.
The companies that hold the marketing authorizations for medicinal products are required to collect the aforementioned forms from doctors, also through scientific representatives.
Doctors will also be able to send copies of the forms directly to the Ministry of Health Directorate General of the Pharmaceutical Service.
Article 9.
In order to prepare the programs referred to in the fourth paragraph of art. 31 of the law of 23 December 1973, n. 833, as well as to establish the criteria that the Ministry must follow in providing indications and guidelines for the training and refresher courses referred to in the seventh paragraph of the previous art. 6, a special committee is set up at the Ministry of Health consisting of:
the director general of the Pharmaceutical Service, president;
a doctor designated by the National Federation of Medical Associations;
a pharmacist designated by the Federation of Italian Pharmacists;
three officials of the Ministry of Health with a qualification no lower than top manager;
three researchers from the Higher Institute of Health;
three experts designated by the Minister of Health among university professors of biomedical disciplines o
chemical-pharmaceutical;
three experts designated by the regions;
three scientific representatives designated by the most representative trade union organisations
of workers in the pharmaceutical industry;
three experts designated by the pharmaceutical industry trade association.
An official in the managerial career of the Ministry of Health exercises the functions of secretary.
The attendance fee referred to in the decree of the President of the Republic no. 5 of 11 January 1956 and subsequent amendments will not be paid to the members of the committee and to the secretary.
Par. 530.
The related expense will be charged to the cap. 1093 of the forecast of the Ministry of Health.
Taking into account the resolutions of the committee and having consulted the National Health Council, the Ministry of Health issues special provisions which pharmaceutical companies must comply with in the exercise of their information activity, and coordinates the information activity of the structures of the National Health Service.
Article 10.
The ascertained non-compliance with the provisions of the previous articles is evaluated for the purposes of the
the possible revocation of the registration of the medicinal product concerned, in relation to the provisions of art. 27, no. 1), 2) and 3), of the regulation approved with royal decree 3 March 1927, n. 478, without prejudice, in any case, to the provisions of art. 175 of the consolidated text of health laws, approved with royal decree 27 July 1934, n.1265.
Scientific representatives are required to collaborate with the Ministry of Health, also with suggestions or indications, in order to ensure the correct and optimal performance of information on drugs.
Article 11.
This decree enters into force from the date of publication in the Official Gazette of the Italian Republic.
Rome, June 23, 1981
The Minister: Aniasi