Act No. 138 / 2002 Coll.
Act amending Act No. 40 / 1995 Coll., on the regulation of advertising and amending and supplementing Act No. 468 / 1991 Coll., on the operation of radio and television broadcasting, as amended, as amended, and Act No. 79 / 1997 Coll., on medicinal products and on the modification and addition of certain related acts, as amended
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Effective from 01.06.2002
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138
THE LAW
of 15 March 2002
amending Act No. 40 / 1995 Coll., on the regulation of advertising and amending and supplementing Act No. 468 / 1991 Coll., on the operation of radio and television broadcasting, as amended, as amended, and Act No. 79 / 1997 Coll., on medicinal products and amending and supplementing certain related acts, as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the Advertising Regulation Act
Act No. 40 / 1995 Coll., on the regulation of advertising and amending and supplementing Act No. 468 / 1991 Coll., on the operation of radio and television broadcasting, as amended, as amended, Act No. 258 / 2000 Coll., Act No. 231 / 2001 Coll. and Act No. 256 / 2001 Coll., is amended as follows:
(1) Paragraph 1, including footnotes 1 to 4, reads as follows:
(1) Advertising means the notification, demonstration or other presentation of, in particular, communication media aimed at promoting business activity, in particular the promotion of the consumption or sale of goods, the construction, rental or sale of real estate, the sale or use of rights or obligations, the promotion of the provision of services, the promotion of trade marks, (1) unless otherwise specified.
(2) Communication media disseminating advertising means means enabling the transmission of advertising, in particular periodical press 2) and non-periodical publications, 3) radio and television broadcasting, audiovisual production, 4) computer networks, audiovisual works, posters and leaflets.
(3) Sponsorship means the contribution provided to promote the production or sale of goods, the provision of services or other performance of the sponsor. A sponsor shall mean a legal or natural person who provides such a contribution for that purpose.
(4) For the purposes of this Act, the procuring entity (hereinafter referred to as the contracting entity) is a legal or natural person who has ordered advertising with another legal or natural person.
(5) For the purposes of this Act, an advertising processor (hereinafter referred to as "processor") is a legal or natural person who has processed advertising for himself or for another legal or natural person.
(6) For the purposes of this Act, the propagator (the propagator) is a legal or natural person who publishes advertising.
(7) The provisions of this Act apply to sponsorship, unless otherwise specified.
1) § 1 of Act No. 137 / 1995 Coll., on Trade Marks.
2) § 3 (a) of Act No. 46 / 2000 Coll., on Rights and Obligations in the Issue of Periodic Printing and on the Amendment of Certain Other Laws (Press Act).
3) § 1 of Act No. 37 / 1995 Coll., on Non-Periodic Publications.
4) Paragraph 1 (1) (c) of Act No. 273 / 1993 Coll., on certain conditions for the production, dissemination and archiving of audiovisual works, amending and supplementing certain laws and certain other regulations. "
(2) Paragraph 2, including footnotes 5) to 7) reads as follows:
(1) It shall be prohibited to:
(a) advertising of goods, services or other performances or values the sale, supply or dissemination of which is contrary to the law;
(b) advertising based on subliminal perception. For the purposes of this Act, such advertising shall mean advertising which would affect the subconscious of a natural person without being knowingly perceived by that person,
(c) misleading advertising, 5)
(d) advertising hidden. For the purposes of this Act, such advertising means advertising which makes it difficult to distinguish between advertising, in particular because it is not labelled as advertising,
(e) the dissemination of unsolicited advertising where it leads to expenditure by the addressee or where it harasses the addressee.
(2) Comparative advertisements (6) are admissible under the conditions laid down by this law and by specific legislation. 7)
(3) Advertising must not be contrary to good morals, in particular shall not contain any discrimination on grounds of race, sex or nationality, or challenge religious or national sentiments, threaten in a generally unacceptable manner morality, reduce human dignity, contain elements of pornography, violence or those using the motive of fear. Advertising must not challenge political beliefs.
(4) Advertising must not promote behaviour detrimental to health or to the safety of persons or property as well as behaviour detrimental to environmental interests.
(5) Advertising distributed together with another communication must be clearly distinguishable and appropriately separated from other communications.
5) § 45 of Act No. 513 / 1991 Coll., Commercial Code.
6) Article 50a (1) of Act No. 513 / 1991 Coll., as amended by Act No. 370 / 2000 Coll.
7) § 50a paragraphs 2 and 3 of Act No. 513 / 1991 Coll., as amended. '
3. the following Sections 2a to 2c are inserted after Section 2, including the title and footnotes No 8) and 9:
Comparative advertising for medicinal products intended for human use (hereinafter referred to as "medicinal products for human use '), medical devices (8) or healthcare is permitted, subject to the conditions laid down by special legislation7), if targeted at or provided by persons authorised to prescribe such medicinal products or medical devices (9) (hereinafter referred to as" experts').
Advertising indicating a specific offer
The advertising indicating the special offer shall indicate clearly and unambiguously the date on which the tender ends, or indicate that the special offer is valid until the stocks of the goods offered are exhausted. If the special offer has not yet started to work, the advertising must also indicate the date on which the special price or other special conditions will apply.
Advertising may not in respect of persons under the age of 18:
(a) promote behaviour threatening their health, psychological or moral development;
(b) recommend to purchase goods or services using their inexperience or credibility;
(c) to encourage their parents or legal representatives or other persons to buy goods or services;
(d) to use their special trust in their parents or legal representatives or other persons;
(e) it is inappropriate to show them in dangerous situations.
8) Paragraph 2 of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws.
9) Act No. 20 / 1966 Coll., on the Care of People's Health, as amended. Act No. 160 / 1992 Coll., on Health Care in Non-State Medical Devices, as amended. Act No. 79 / 1997 Coll., on medicinal products and on amendments and additions to certain related laws, as amended. '
4. Article 3, including the title and footnotes No 10) and 11) shall read as follows:
Tobacco products
(1) Advertising of tobacco products 10) must not
(a) be aimed at persons under the age of 18, in particular by using elements, motives, means or actions which are intended or free to distribute articles related to the use of tobacco products which would be attractive to persons under the age of 18;
(b) represent persons under the age of 18; only persons who are or appear to be over 25 years of age may be shown in advertising for such products,
(c) be placed in print media intended for persons under the age of 18;
(d) be placed on large posters at a distance of less than 300 m from schools, 11) children's playgrounds and similar facilities, mainly intended for minors; for the purposes of this Act, large-area posters shall mean posters with a surface area of more than 10 m2;
(e) encourage smoking with words of imperative shape or by displaying scenes where people smoke or hold cigarettes, packs of cigarettes or other tobacco products or smoking equipment.
(2) Advertising of tobacco products must contain a clear warning of the following: "The Ministry of Health warns: smoking causes cancer." The text of the warning shall be given on a white background arranged along the lower edge of the advertising area in the range of at least 20% of the area. The text shall be printed in black, in bold, so as to reach a total height of at least 80% of the height of the white background. The height of the health warning font shall be at least the same as that of the introductory phrase font.
10) Paragraph 2 (v) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 306 / 2000 Coll.
11) Act No. 29 / 1984 Coll., on the System of Primary Schools, Secondary Schools and Higher Vocational Schools (Education Act), as amended. Act No. 564 / 1990 Coll., on State Administration and Self-Government in Education, as amended. '
5. Paragraph 4, including the title and footnote 12, reads:
Alcoholic beverages
Advertising of alcoholic beverages 12) must not
(a) encourage non-moderate use of alcoholic beverages, or, negative or ironically, assess abstinence or restraint;
(b) be targeted at persons under the age of 18, in particular those persons or persons who, as under the age of 18, are not allowed to look for, display, while drinking alcoholic beverages or to benefit from the elements, means or actions which address persons under the age of 18;
(c) combine alcohol consumption with increased performance or be used in connection with driving;
(d) to give the impression that alcohol consumption contributes to social or sexual success;
(e) claim that alcohol in the beverage has therapeutic properties or encouraging or comforting effects, or that it is a means of solving personal problems;
(f) emphasize the alcoholic strength as a positive characteristic of the drink.
12) Paragraph 1 (2) of Act No. 37 / 1989 Coll., on Protection against Alcoholism and Other Toxicomanities. '
6. Article 5, including the title and footnotes No 13) to 15) reads as follows:
Human medicinal products
(1) All information, persuasion or incentives intended to promote the prescription, supply, sale, supply or consumption of medicinal products for human use shall also be considered as advertising for medicinal products for human use. They shall also be regarded as advertising:
(a) visits by sales representatives of medicinal products for human use to persons authorised to prescribe, supply or supply them;
(b) the supply of samples of medicinal products for human use;
(c) support for the prescription, supply and sale of medicinal products for human use by means of a gift, consumer competition and offer or promise of any benefit or financial or material remuneration;
(d) sponsoring meetings attended by experts;
(e) sponsorship of scientific congresses involving experts and reimbursement of travel and accommodation costs associated with their participation.
(2) The provisions of this Act do not apply to:
(a) labelling of medicinal products for human use and package leaflet according to specific legislation, 13)
(b) correspondence necessary to answer specific questions on a particular medicinal product for human use and any accompanying materials of a non-advertising nature;
(c) sales catalogues and price lists, unless they contain a description of the properties of medicinal products for human use, as well as notification, notification and information concerning, for example, changes in the packaging, warnings against adverse effects of the medicinal product for human use;
(d) data on human health or diseases, if they contain no reference, whether or not indirect, to the medicinal product for human use.
(3) Only a medicinal product authorised under a specific legislation may be the subject of advertising. 14)
(4) Any information contained in the advertising of a medicinal product for human use must correspond to the information provided in the summary of data (15).
(5) Advertising of a medicinal product for human use must promote its rational use by objective presentation of the medicinal product without exaggerating its properties.
13) Act No. 79 / 1997 Coll., as amended. Decree No. 473 / 2000 Coll., laying down the details of the marketing authorisation, its amendments, extensions, the determination of the mode of dispensing the medicinal product, the method of notification and evaluation of the adverse effects of the medicinal product and the manner and extent of notification of the use of the non-authorised medicinal product.
14) Act No. 79 / 1997 Coll., as amended.
15) § 2 (13) of Act No. 79 / 1997 Coll. '.
7. The following Sections 5a to 5f are inserted after Section 5, including the headings and footnotes 16 to 26:
Advertising of medicinal products for human use to the general public
(1) The object of advertising to the general public may be medicinal products for human use which, according to their composition and purpose, are adapted and designed to be used without diagnosis, prescription or treatment by a physician, or at the advice of a pharmacist.
(2) The object of advertising aimed at the general public must not be:
(a) medicinal products for human use only subject to medical prescription,
(b) medicinal products containing narcotic drugs or psychotropic substances, 16)
(c) medicinal products for human use for which efficacy has not been assessed in the context of the marketing authorisation procedure.
(3) Advertising to the general public must not contain references to indications of serious diseases; tuberculosis, sexually transmitted diseases, other serious infectious diseases, cancer and other cancer diseases, chronic insomnia, diabetes and other metabolic diseases are considered to be such diseases; the provisions of paragraph 2 (a) and (b) and of this paragraph shall not apply to vaccination operations approved by the Ministry of Health.
(4) The provision of samples of medicinal products for human use to the general public shall be prohibited.
(5) Advertising aimed at the general public must:
(a) be formulated to show that the product is a medicinal product for human use;
(b) contain the name of the medicinal product for human use as specified in the marketing authorisation. If the medicinal product for human use contains only one active substance, the advertising must also contain its general name,
(c) contain the information necessary for the proper use of the medicinal product for human use;
(d) contain a clear, well-read invitation to read the package leaflet carefully in the case of printed advertising.
(6) Advertising aimed at the general public must not:
(a) to give the impression that medical advice, medical intervention or treatment are not necessary, in particular by offering a diagnosis or by offering a remote treatment,
(b) indicate that the effects of administration of the medicinal product for human use are guaranteed, are not associated with adverse reactions or are better or equivalent to those of another treatment or other medicinal product for human use,
(c) indicate that the use of a medicinal product for human use will improve the health of the person taking it;
(d) indicate that non-use of a medicinal product for human use may adversely affect the health status of persons, except for vaccination operations approved by the Ministry of Health,
(e) be targeted exclusively at persons under the age of 15;
(f) recommend a medicinal product for human use, with reference to the recommendations of scientists, health professionals or persons who are not, but who are (for example, actors), and who, because of their actual or anticipated social status, could support the consumption of medicines;
(g) indicate that the medicinal product for human use is a food or cosmetic product or other consumer goods,
(h) indicate that the safety or efficacy of a medicinal product for human use is guaranteed only by its natural origin;
(i) a description or detailed description of the particular course of a particular case, leading to a possible misdiagnosis;
(j) to point out in an inappropriate, excessive or misleading way the possibility of recovery;
(k) use an inappropriate, excessive or misleading representation of changes in the human body caused by illness or injury or the action of a medicinal product for human use on the human body or parts thereof;
(l) indicate that the medicinal product for human use is authorised.
(7) Advertising may contain only the name of a medicinal product for human use where it is a sole reminder of such a product.
Advertising of medicinal products for human use
(1) Advertising of medicinal products for human use to professionals can only be disseminated by means of means of communication intended primarily for such professionals (for example, non-periodic publications, specialist periodicals, professional audiovisual programmes).
(2) The advertising referred to in paragraph 1 shall include:
(a) accurate, up-to-date, verifiable and sufficiently complete data enabling experts to establish their own opinion on the therapeutic value of a medicinal product for human use. Data taken from professional publications or from professional printing must be reproduced accurately and their source must be given,
(b) basic information according to the approved summary of product characteristics, including the date of approval or the last revision;
(c) information on the method of dispensing the medicinal product for human use under the marketing authorisation;
(d) information on the method of reimbursement by public health insurance.
(3) A sales representative (17) must, at each visit carried out for the purpose of advertising a medicinal product for human use, provide the visited expert with a summary of the particulars of each medicinal product for human use which is the subject of the advertisement and with information on how to cover such medicinal products for human use.
(4) In the context of advertising for medicinal products for human use targeting professionals, it shall be prohibited to offer, promise or provide gifts or other benefits, unless they are of negligible value and relate to professional activities carried out by them.
(5) The scope of the free entertainment provided to promote sales must be proportionate, taking into account the main purpose of the meeting, and must not be extended to persons other than experts. In such a case, they shall not be subject to the prohibition laid down in paragraph 4.
(6) Experts shall neither seek nor receive the benefits prohibited under paragraph 4 in relation to advertising of medicinal products for human use or which are contrary to paragraph 5.
(7) Samples of medicinal products for human use may only be provided to persons authorised to prescribe or issue them in a limited quantity of the smallest authorised packaging available on the market, bearing the words "Unsold sample 'or" Free sample'. Products containing narcotic and psychotropic substances (16) must not be supplied. Samples of medicinal products for human use may be provided only at the written request of the person authorised to prescribe and issue them, which is signed and on which the date of issue is issued.
(8) The advertising referred to in paragraph 1 may contain only the name of a medicinal product for human use where it is a sole reminder of such a product.
Medical devices
(1) All information, persuasion or incentives intended to promote the prescription, distribution, sale or supply of medical devices are also considered as advertising for medical devices (8). They shall also be regarded as advertising:
(a) visits by sales agents for advertising on medical devices by persons authorised to prescribe, distribute, issue or sell medical devices;
(b) the provision of samples of medical devices;
(c) support for the prescription, supply or sale of medical devices by means of gifts, competitions, offers or promises of any benefit or financial or material remuneration for persons authorised to prescribe, distribute, issue or sell medical devices;
(d) sponsoring meetings attended by persons entitled to prescribe, distribute, issue or sell medical devices;
(e) sponsoring scientific congresses with the participation of persons authorised to prescribe, distribute, issue or sell medical devices, as well as their participation in related travel and accommodation costs.
(2) Only a medical device which meets the requirements for placing on the market under specific legislation may be the subject of advertising. 18) Only the manufacturer or importer of a particular medical device may be the contracting authority for advertising on a medical device.
(3) Advertising of a medical device must include:
(a) information showing that the product is a medical device;
(b) the name and designation of the medical device in accordance with the name and designation in the declaration of conformity 19) issued to that medical device;
(c) the intended purpose of the use of a medical device which complies with the intended purpose of the use referred to in the instructions for use (19).
(4) The sponsoring of television and radio programmes by legal or natural persons whose activity involves the production, distribution, supply or sale of medical devices may include the promotion of a business firm, name or surname or symbol of that person, but the promotion of a particular medical device, the issue of which is solely related to the prescription of a doctor or which is covered fully or to a certain extent by public health insurance. 20)
(5) Where a medical device which does not comply with a specific legislation is used for the purpose of demonstrating a medical device, 18) the medical device must be visibly marked in such a way as to make it clear that it will not be placed on the market, such as the sign "Unsold sample '.
(6) Medical devices may not be the object of advertising to the general public,
(a) the supply of which is subject to medical prescription,
(b) which can only be supplied by health care establishments, social care establishments and, where appropriate, healthcare professionals, 21)
(c) the use of which users may only carry out in connection with treatment or control by a doctor.
(7) Advertising of medical devices to the general public must include a clear, well-readable call for careful reading of the instructions for use and, where appropriate, consultation with the expert in the case of printed advertising.
(8) Advertising of medical devices intended for general public
(a) to give the impression that the mere use of a medical device can be affected by the state of health and therefore no professional medical care is required;
(b) give the impression that no side effects may occur when a medical device is used in accordance with its intended purpose;
(c) be directed exclusively or principally at persons under the age of 15;
(d) attribute to the medical device effects which are not verifiable;
(e) indicate that the effect of a medical device is equal to or greater than that of another medical device;
(f) a description or detailed description of a particular case to lead to a possible misdiagnosis.
(9) Advertising of medical devices to persons authorised to prescribe, distribute, supply or sell medical devices can only be disseminated by means of means of communication intended primarily for such persons (for example, non-periodic publications, specialised periodicals, professional audiovisual programmes) and must contain sufficient, verifiable and objective data to enable persons authorised to prescribe, distribute, issue or sell medical devices to form an opinion on the therapeutic benefits of a particular medical device.
Food and infant formulae
Advertising of foodstuffs 22) must not mislead in particular:
(a) as regards the characteristics of foodstuffs, their characteristics, composition, quantity, durability, origin or origin and the method of processing or manufacture;
(b) as regards the assignment of effects or characteristics not declared by food;
(c) giving the impression that foodstuffs have specific characteristics when, in fact, those characteristics have all similar food characteristics;
(d) giving food the ability to prevent, treat or treat human diseases or to refer to such abilities; This does not apply to mineral waters and to foodstuffs intended under specific legislation23) for particular nutritional uses.
(1) Advertising of infant formulae (24) must contain only scientific and material data, may only be provided in infant care publications and scientific publications and must not lead to the conclusion that infant formulae are equivalent to or better than maternal milk.
(2) Advertising which is capable of encouraging the general public to buy infant formulae, in particular by dispensing samples, special exposure, discount or special advantage, shall be prohibited in stores.
(3) Producers and sellers of infant formulae are prohibited from passing on to the public free of charge or with discount products, samples or gifts to promote sales. The prohibition in the first sentence shall also apply to the supply of products with a discount, samples or other promotional gifts to pregnant women, mothers and members of their families in public; the prohibition under the first sentence shall not apply to gifts or provision with a discount on medical, charitable or humanitarian institutions for their internal use or for distribution outside such institutions and organisations.
(1) Advertising of infant formulae and sequests25)
(a) they must contain the necessary information on the correct use of the product and must not act against breast-feeding;
(b) it shall not contain a term such as "humanised" or "maternised" or similar term which gives the impression that natural breast-feeding is fully replaced.
(2) Advertising of infant formulae
(a) it must contain a clear text: "Important warning" indicating the priority of breastfeeding and recommending that the product should be used only on advice from independent experts in the field of medicine, nutrition or medicines or other professionals involved in the care of infants and young children;
(b) it must not contain a representation of the infant or any other picture or claim which could idealise the replacement of breast milk. However, it may contain a graphical representation for easy identification of the product and for illustration of the method of preparation.
(3) Advertising of infant formulae and follow-on formulae, aimed at pregnant women and mothers of young children, must always contain clear information provided in specific legislation. 26)
16) § 2 (a) of Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws.
17) § 652 of Act No. 513 / 1991 Coll., as amended by Act No. 370 / 2000 Coll.
18) Article 13 of Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended by Act No. 71 / 2000 Coll.
19) For example, Act No. 22 / 1997 Coll., as amended, Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Decree No. 336 / 2001 Coll., and Decree No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices, as amended by Decree No. 337 / 2001 Coll.
20) Paragraph 15 (5) and (6) of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws.
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Regulation Information
| Citation | Act No. 138 / 2002 Coll., amending Act No. 40 / 1995 Coll., on the regulation of advertising and amending and supplementing Act No. 468 / 1991 Coll., on the operation of radio and television broadcasting, as amended, as amended, and Act No. 79 / 1997 Coll., on medicinal products and on the modification and addition of certain related acts, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.04.2002 |
|---|---|
| Effective from | 01.06.2002 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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