Legislative Decree 12-30-92 n. 540

Legislative Decree. 30 December 1992, no. 540.
Implementation of directive 92/27/EEC concerning the labeling and package leaflet of medicinal products for human use.
(1) Published in OS n. 7 of the Official Gazette of 11 January 1993.
THE PRESIDENT OF THE REPUBLIC
Having regard to articles 76 and 87 of the Constitution;
Given the art. 15 of the law of 19 December 1992, n. 489, authorizing the Government to implement directive 92/27/EEC of the Council of 31 March 1992;
Given the preliminary resolution of the Council of Ministers, adopted in the meeting of 23 December 1992;
Given the resolution of the Council of Ministers, adopted in the meeting of 30 December 1992;
On the proposal of the Ministers for the coordination of Community policies and for regional affairs and health, in agreement with the Ministers of Foreign Affairs, of Justice and of the Treasury;
Issues the following legislative decree:
Art. 1. Scope of application.
1. This decree governs the labeling and package leaflet of medicinal products for human use subject to marketing authorization pursuant to the legislative decree of 29 May 1991,
no. 178.
2. For the purposes of this decree:
a) name of the medicinal product: that provided for by art. 8, paragraph 2, letter b) of the legislative decree 29 May 1991, n. 178;
b) common name: the international common name recommended by the World Health Organization or, failing that, the commonly used common name;
c) dosage of the medicinal product: the content, in active principle, expressed in quantity per unit of dose, per unit of volume or weight according to the presentation;
d) primary packaging: the container or any other form of packaging which is in direct contact with the medicinal product;
e) outer packaging: the packaging in which the primary conditioning is placed;
f) labelling: the wording written on the outer packaging or on the primary packaging;
g) package leaflet: the leaflet containing information intended for the user and which accompanies the medicinal product.
Art. 2. Labelling.
1. The outer packaging or, failing that, the immediate packaging of any medicinal product must bear the following indications:
a) the name of the medicinal product, followed by the common name if the medicinal product contains a single active ingredient and if its name is an invented name. When various pharmaceutical forms and/or various strengths exist for a medicinal product, the pharmaceutical form and/or strength must appear in the name of the medicinal product; the indication of the dosage can be replaced by the expressions: "adults", "children", "babies";
b) the qualitative and quantitative composition in terms of active ingredients, expressed per unit of administration or, in relation to the pharmaceutical form, for a given volume or weight, through the use of common names;
c) the pharmaceutical form and the content by weight, volume or administration unit;
d) a list of excipients used; if it is an injectable product, a topical preparation or eye drops, all the excipients must always be indicated; in other cases it is possible to limit the indication to certain excipients, in accordance with the provisions of the decree of the Minister of Health, on the basis of the guidelines published by the Commission of the European Communities;
e) the method and, if necessary, the route of administration;
f) the warning “Keep the medicine out of the reach of children”;
g) any special warnings deemed necessary for the medicinal product in question;
h) the month and year of expiry, indicated with words or numbers;
(i) where appropriate, the special precautions to be taken for storing the medicinal product;
l) if necessary, the special precautions to be taken for the disposal of the unused product or waste derived from the product;
m) the name and address of the marketing authorization holder, preceded by the expression "MA Holder:". If the owner resides abroad, the indication of the name and address of the same must be followed by the name and address of the importer;
n) the marketing authorization number, preceded by the initials: “AIC:”;
o) the manufacturing batch number;
p) for self-medication medicines, the therapeutic indications;
q) the supply regime in accordance with the legislative provisions implementing European Community Council directive no. 92/26/EEC and any subsequent amendments;
r) the price of the medicinal product, accompanied, in the case of a product subject to the administered price regime, by the indications pursuant to art. 3 of Legislative Decree 27 January 1992, n. 79;
s) for homeopathic medicines, indication of their homeopathic nature in clear and legible characters (2).
Note (2)
Provision added by art. 1, Legislative Decree 17 March 1995, n. 185, reported at no. E/LVIII.

2. In addition to the indications provided for in paragraph 1, it is lawful to report, subject to ministerial authorisation, the name and address of whoever, on the basis of a specific agreement with the marketing authorization holder, sees to the actual marketing of the product throughout the national territory. These indications, as well as any symbols and emblems relating to the distributor itself, must be smaller in size than the indications, symbols and emblems relating to the marketing authorization holder.
3. The outer packaging or primary packaging may also bear prior authorization
ministerial, signs or pictograms aimed at making some information referred to in paragraph 1 more explicit, as well as other information compatible with the summary of product characteristics, approved pursuant to art. 9, paragraph 5 of the legislative decree 29 May 1991, n. 178, useful for health education, with the exclusion of any element of a promotional nature.
4. The provisions of this article are without prejudice to the provisions in force concerning the labeling of medicinal products included in the therapeutic handbook of the National Health Service and the adoption of systems capable of guaranteeing the authenticity of the products.
Art. 3. Labeling of blister packs and small primary packaging.
1. If contained in an external packaging compliant with the provisions of art. 2, primary packaging that comes in the form of blisters must bear at least the following indications:
a) the name of the medicinal product, in accordance with the provisions of art. 2, letter a);
b) the name of the marketing authorization holder;
c) the expiry date;
d) the manufacturing batch number.
2. The primary conditioning of small dimensions, on which it is impossible to mention the indications referred to in art. 2, must bear at least the following indications:
a) the name of the medicinal product and, if necessary, the strength and route of administration;
b) the expiry date;
c) the manufacturing batch number;
d) the content by weight, by volume or by unit.
3. Primary conditions other than those governed by paragraphs 1 and 2 must bear the indications envisaged by art. 2, paragraph 1, with the exception of those referred to in letters q) and r).
Art. 4. Usable languages; registration requirements.
1. The indications referred to in articles 2 and 3 must be written in Italian, be easily legible and understandable for the public and be indelible.
2. The complementary use of foreign languages is permitted, provided that the indications correspond exactly to the indications given in Italian.
3. The holder of the authorization to place the medicinal product on the market who intends to make use of the faculty provided for in paragraph 2 must give advance notice to the Ministry of Health and keep the sworn translation of the texts in foreign languages at its disposal.
Art. 5. Leaflet.
1. A leaflet intended for the user must be included in the packaging of any medicinal product, except in the case in which all the information required by paragraph 2 appears directly on the outer packaging or on the primary packaging.
2. The leaflet, drawn up in accordance with the summary of the product characteristics, approved pursuant to art. 9, paragraph 5, of the legislative decree 29 May 1991, n. 178, must report, in order
following:
a) the elements specified below for the identification of the medicinal product:
1) the name of the medicinal product according to the provisions of art. 2, letter a);
2) the complete qualitative composition, as well as the quantitative composition in terms of active ingredients, provided using the common names, for each medicinal product presentation;
3) the pharmaceutical form and the content by weight, volume or administration unit, for each presentation of the medicinal product;
4) the pharmacotherapeutic category, or the type of activity, in terms easily understood by the patient;
5) the name and address of the marketing authorization holder and of the manufacturer, as well as the elements indicated in paragraph 2 of the art. 2, under the conditions established therein;
6) the name and address of the manufacturer who carries out the final production operations and those for checking the finished product; if the medicinal product is checked in a plant other than the production one, it is sufficient to indicate the name and address of the person carrying out the checks, preceded by the words "Checked by...";
b) the therapeutic indications;
c) the information that must be known before using the medicine:
1) contraindications;
2) appropriate precautions for use;
3) interactions with other medicines and interactions of any other kind (for example with alcohol, tobacco, food), potentially capable of influencing the action of the medicine;
4) special warnings; in particular, where appropriate, warnings about the possible effects of the treatment on the ability to drive a vehicle or to operate certain machines;
d) the necessary and usual instructions for correct use; in particular:
1) dosage;
2) method and, if necessary, route of administration;
3) frequency of administration, specifying, if necessary, when the medicinal product can or should be administered;
4) duration of the treatment, if it must be limited, in relation to the nature of the product;
5) if necessary, methods of intervention in the event of an overdose (for example: symptoms, urgent interventions);
6) if necessary, conduct to be followed in the event that the administration of one or more doses has been omitted;
7) possible indication of the risk of a withdrawal syndrome;
e) a description of the undesirable effects which may be observed during normal use of the medicinal product, with an indication, if any, of the countermeasures to be taken; in any case, the patient must be expressly invited to communicate any effect to his doctor or pharmacist
unwanted not described in the leaflet;
(f) a postponement of the expiry date appearing on the packaging, accompanied by:
1) a warning against any exceeding of that date;
2) if necessary, the special precautions to be taken for the storage of the medicinal product;
3) where appropriate, a warning regarding particular visible signs of deterioration;
g) the date on which the leaflet was last revised by the Ministry of Health.
3. By way of derogation from paragraph 2, letter b), the Ministry of Health may decide that some therapeutic indications should not appear on the package leaflet when the disclosure of such information could cause serious inconvenience for the patient.
4. The information referred to in paragraph 2, letter c), must take into account the particular situation of certain categories of users, such as children, pregnant or breastfeeding women, the elderly, patients with specific clinical pictures; the information must also draw attention to the excipients the knowledge of which is important for effective and safe use of the medicinal product.
5. The leaflet may contain signs or pictograms aimed at making some information referred to in paragraph 2 more explicit, as well as other information compatible with the summary of the product characteristics, useful for health education, with the exclusion of any element of a promotional nature.
6. The provisions on labeling provided for by art. 4.
7. Compatibly with the characteristics of the product, it is permitted to create a single leaflet for a medicinal product with multiple formulations and dosages.
Art. 6. Presentation of the texts of the labeling and the package leaflet and their modifications.
1. The texts of the external packaging, the primary packaging and the package leaflet of the medicinal product to be attached to the application for marketing authorization pursuant to art. 8, paragraph 3, letter d) of the legislative decree 29 May 1991, n. 178, if they are not presented in the definitive typographic guise, they must faithfully reproduce the models that are intended to be used in the product on the market.
2. Two copies of each of the texts referred to in paragraph 1 and of the summary of the product characteristics referred to in art. 8, paragraph 3, letter d) of the legislative decree 29 May 1991, n. 178, must be presented with stamp duty.
3. The marketing authorization holder of the medicinal product cannot propose changes to the labeling or package leaflet that are incompatible with the summary of product characteristics approved by the Ministry of Health, unless corresponding changes to the summary are simultaneously proposed.
4. The modifications of the label and of the package leaflet compatible with the summary of the characteristics of the product approved by the Ministry of Health can be implemented by the marketing authorization holder, if the aforesaid Ministry has not pronounced itself within 90 days from the submission of the application submitted pursuant to art. 12, paragraph 1, of the legislative decree 29 May 1991, n. 178.
5. Applications for changes to the labelling, the package leaflet and the summary of product characteristics must be accompanied by specimens of printouts compliant with the provisions of paragraph 2.
Art. 7. Compulsory nature of indications.
1. The Ministry of Health cannot approve labels and leaflets of medicinal products for human use containing wordings other than those provided for in this decree, with the exception of those imposed by other legislative or regulatory provisions.
Art. 8. Sanctions.
1. Unless the fact constitutes a crime, if a medicinal product is placed or kept on the market with a label or leaflet different from those approved by the Ministry of Health, or with a label or leaflet not modified according to the provisions issued by the same Ministry, the holder of the marketing authorization is subject to an administrative fine ranging from L. 10,000,000 to Lit 60,000,000.
2. In the case envisaged by paragraph 1, the Minister of Health, with a reasoned provision, notifies the holder of the marketing authorization of the adaptation of the labeling or the package leaflet, establishing a deadline for compliance. In case of non-compliance within the indicated deadline, the Minister of Health can suspend the marketing authorization of the medicinal product until compliance. The suspension is notified to the interested party with an indication of the means of redress envisaged by current legislation and the deadline within which they must be proposed.
Art. 9. Amendments and additions to the regulations on labeling and on the package leaflet.
1. The provisions of articles 2, 3 and 5 may be modified or supplemented by decree of the Minister
health, pursuant to art. 16 of the legislative decree 29 May 1991, n. 178.
2. By decree of the Minister of Health, derogations from the provisions of articles 2 to 6 of this decree may be established for certain categories of products; moreover, provisions may be issued on the labeling and leaflet of hospital packs containing a quantity of product that is multiple of that contained in the packs which are authorized for sale to the public.
Art. 10. Transitional provisions.
1. The texts of the labeling and package leaflet authorized prior to the entry into force of this decree may continue to be used until the marketing authorizations for medicinal products are renewed, without prejudice to the hypothesis of modifications of the texts themselves, at the request of the owner company or following a provision by the Ministry of Health adopted for reasons of public health protection.
2. Starting from 1 January 1994, applications for authorization to place on the market or for the modification or renewal of an already granted authorization cannot be accepted if the labeling and the package leaflet do not comply with the provisions of this decree.
3. The adaptation of the labeling and the leaflet to the provisions of the present decree does not imply the obligation to withdraw from the market the packages complying with the previous provisions, without prejudice to the provisions adopted to protect public health.
Art. 11. Entry into force.
1. This decree enters into force on the sixtieth day following that of its publication in the Official Gazette of the Italian Republic.