{"id":121504,"date":"2025-12-09T12:40:27","date_gmt":"2025-12-09T12:40:27","guid":{"rendered":"https:\/\/my.legal500.com\/guides\/?post_type=comparative_guide&#038;p=121504"},"modified":"2025-12-09T12:58:26","modified_gmt":"2025-12-09T12:58:26","slug":"serbia-pharmaceutical-advertising","status":"publish","type":"comparative_guide","link":"https:\/\/my.legal500.com\/guides\/chapter\/serbia-pharmaceutical-advertising\/","title":{"rendered":"Serbia: Pharmaceutical Advertising"},"content":{"rendered":"","protected":false},"template":"","class_list":["post-121504","comparative_guide","type-comparative_guide","status-publish","hentry","guides-pharmaceutical-advertising","jurisdictions-serbia"],"acf":[],"appp":{"post_list":{"below_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Pe\u0161i\u0107 Law<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2025\/10\/logo-zlatna-linija.jpg\"\/><\/span><\/div>"},"post_detail":{"above_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Pe\u0161i\u0107 Law<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2025\/10\/logo-zlatna-linija.jpg\"\/><\/span><\/div>","below_title":"<span class=\"guide-intro\">This country specific Q&amp;A provides an overview of Pharmaceutical Advertising laws and regulations applicable in Serbia<\/span><div class=\"guide-content\"><div class=\"filter\">\r\n\r\n\t\t\t\t<input type=\"text\" placeholder=\"Search questions and answers...\" class=\"filter-container__search-field\">\r\n\t\t\t<\/div>\r\n\r\n\t\t\t\r\n\r\n\r\n\t\t\t<ol class=\"custom-counter\">\r\n\r\n\t\t\t\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What laws are used to regulate advertising on medicines in your jurisdiction?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Main regulations covering this topic are:<\/p>\n<p><strong>Primary:<\/strong> Law on Medicinal Products and Medical Devices (\u201cOfficial Gazette of the Republic of Serbia\u201d No. 30\/2010) (\u2018the Law\u201d)<\/p>\n<p><strong>Secondary:<\/strong> Rulebook on methods of Advertising of Medicinal Products and Medical Devices (\u201cOfficial Gazette of the Republic of Serbia\u201d No. 79\/2010 and 102\/2018) (\u201cthe Rulebook\u201d)<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Advertising of medicines is strictly governed by the official regulations.<\/p>\n<p><strong>a. If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?<\/strong><\/p>\n<p>Self-regulatory code has been adopted by the Association of manufacturers of innovative medicines. It applies only to member companies of the Association. It\u2019s worth noting that this Association has in its membership several highly reputable companies in the industry operating in Serbia. The code adopted by them regulates certain areas not specifically addressed by the applicable regulations (such as prohibition of gifts, donations and grants, contracted services, etc.)<\/p>\n<p><strong>b. What is the legal status of the self-regulatory codes?<\/strong><\/p>\n<p>Self-regulatory codes are not part of official regulations. They are applicable only to members of specific associations and cannot be enforced upon them except within such associations.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is there a statutory or generally accepted definition of \u201cadvertising\u201d? a) What does the definition cover? \u2013 does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes, both the Law and the Rulebook mentioned above contain definitions of advertising.<\/p>\n<p>The definition in the Law (Art. 164) states the following: \u201cAdvertising of medicinal products is every form of providing truthful information about a medicine to general and health-care audience with the aim of incentivising sales, consumption, supply and prescription for such medicines.\u201d<\/p>\n<p>The Rulebook in its Art. 2 defines advertising as: \u201cAdvertising of medicinal products is every form of providing truthful information about a medicine to general and health-care audience with the aim of incentivising sales, consumption, supply and prescription for such medicines by a person carrying a licence for such medicine, or a right of registration of a medical device in the Register of Medical Devices as well as by a physical or a legal person who is distributing medicinal products and medical devices.\u201d<\/p>\n<p>The Rulebook thus expands on the definition contained in the Law, clarifying who has the right to advertise medicinal products and medical devices. It also defines general and health-care public.<\/p>\n<p>General public is defined as citizens of Republic of Serbia.<\/p>\n<p>Health-care public contains health and veterinary professionals which issue prescriptions for medicinal products or medical devices as well as pharmacist or other health-cares in the production and distribution of medical products or medicinal devices and compulsory health insurance.<\/p>\n<p><strong>a. What does the definition cover?<\/strong> \u2013 does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?<\/p>\n<p>The definition covers any form of giving information (truthful) about the medicinal product or medical device to general or health-care public, for the purpose of stimulating prescription\/supply\/sale\/use.<\/p>\n<p>It is allowed to advertise medicinal products, having in mind restrictions on certain categories of medicinal products, in leaflets, in public spaces as well as online, depending on the category of medicinal products.<\/p>\n<p>What the definition does cover includes:<\/p>\n<ul>\n<li>Promotional information to both the general public and the health-care public;<\/li>\n<li>Advertising via various channels;<\/li>\n<li>Free samples and sponsoring of scientific or promotional meetings;<\/li>\n<\/ul>\n<p>What the definition does not cover:<\/p>\n<ul>\n<li>Advertising of medicinal products or medical devices without a licence or registration is strictly prohibited;<\/li>\n<li>Advertising medicinal products or medical devices as food, cosmetics or products of general nature;<\/li>\n<li>The Rulebook in Art. 6 states specific examples that fall outside of definition such as side-effects information, objective reporting in international scientific conferences, etc.<\/li>\n<\/ul>\n<p><strong>b. Does the definition apply equally to all target audiences?<\/strong><\/p>\n<p>No, the law differs between the general and health-care public as outlined above. The Rulebook provides specific rights and obligations for both target audiences.<\/p>\n<p>These include the requirements on content of advertising, marketing channels, compulsory messaging, prohibition of advertising of certain categories of medicinal products, promotional sample of medicinal product, etc.<\/p>\n<p>Most notably, advertising aimed at general public can only be aimed at over-the-counter medicines, while advertising aimed at health-care public can include prescription medicines.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes, although press releases are not explicitly mentioned in the regulations, they can be considered as acceptable method of advertising under the aforementioned definitions with certain conditions attached to such promotion.<\/p>\n<p>First of all, objective reporting on a medicinal product or medical devices, regardless of target audience in health magazines, or health columns and which has in its aim to answer specific questions with regards to such medicinal product or medical device, without advertising or promotional elements, will not be considered as advertising.<\/p>\n<p>Such press releases can be aimed at general or health-care audience with differing restrictions. Information must be true, substantiated by science, and not misleading and has to be consistent with the licence or registration of such medicinal product or medical device.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes, the Law sets out that the Medicines and Medical Devices Agency of Serbia (\u201cAgency\u201d) provides prior approval on promo materials and other documents used in advertising.<\/p>\n<p>Agency shall send its approval to the Ministry of Health within 15 days from publishing a decision.<\/p>\n<p>At the same time, per the Rulebook, a person advertising medicinal product or medical device must keep a record of all advertising, including original ads in writing, visual, audio or any other form and to deliver them upon notice to the inspectorate.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Do companies have to have material approved by regulatory bodies prior to release?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes, see under question 5.<\/p>\n<p>In addition, the approval of promotional materials is conducted in National centre for information on medicinal products and medical devices via phone.<\/p>\n<p>Given approval is valid indefinitely until the patient information leaflet or instructions of use are unchanged.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is comparative advertising for medicines allowed and if so, what restrictions apply?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Comparative advertising is not explicitly addressed, however, claims such as \u201cbetter than others\u201d are prohibited. Additionally, every claim has to be scientifically substantiated, therefore obliging any person using comparative advertising to prepare a robust case for their claims.<\/p>\n<p>Hence, we can conclude that such advertising is not prohibited per se, but highly restricted, marking it practically impossible to perform without major risks of potential legal dispute.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Advertising on unauthorised medicines is strictly prohibited for all target audiences. Regarding unauthorised indications, all information and advertising provided has to be in line with a licence or registration of medicinal product or medical device. Thus, unauthorised indications are prohibited.<\/p>\n<p>However, if there are no promotional elements attached to information provided on unauthorised medicines, this would fall outside of the definition of advertising. Information provided have to be with the intent of objective scientific reporting and only within the scientific community or an international conference.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, and include the information that must or must not be included.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>As outlined above in question 3 (b), advertising to the general public is allowed only for over-the-counter medicines. Prescription only medicines are prohibited from advertising to the general public.<\/p>\n<p>Advertising to the general public must:<\/p>\n<ul>\n<li>Be for authorised medicinal product or medical device;<\/li>\n<li>Contain clear information that the advertising product is a medicinal product or medical device;<\/li>\n<li>Not be misleading;<\/li>\n<li>Contain warning message outlined in Art. 8 of the Rulebook;<\/li>\n<li>Not create an impression that there are no side-effects;<\/li>\n<li>Not create an impression that use of such medicine would prevent from consulting a doctor or taking a medical;<\/li>\n<li>Not guarantee success in treating a condition;<\/li>\n<li>Not create an impression that such medicine is better than others;<\/li>\n<li>Not create an impression that health would deteriorate without taking such medicine (except in cases of information provided by Ministry of Health in epidemic or pandemic scenarios);<\/li>\n<li>Not direct taking a different medicine than the one recommended;<\/li>\n<li>Not create an impression that the medicine will obtain a licence or registration;<\/li>\n<li>Not market a medicine as food, cosmetic or products of general purpose.<\/li>\n<li>Not contain price or part of the price that will be covered by the compulsory health insurance;<\/li>\n<li>Not use recommendation by a popular person;<\/li>\n<li>Not use indications that the medicine will be on the list of medicines prescribed as part of compulsory health insurance covering its costs;<\/li>\n<li>Not use kids who are taking such medicines or direct advertising at kids;<\/li>\n<li>Not use names of establishments such as pharmacies in which medicine can be obtained;<\/li>\n<li>Not collect or use personal medical history;<\/li>\n<li>Not provide free samples;<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The legislation does not regulate industry-patients interaction in the advertising context.<\/p>\n<p>However, some general notes are worth mentioning here. The Rulebook prohibits offering or promising financial, material or other benefits in advertising with the intent of selling, prescribing or distributing of medicinal products or medical devices.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example, can companies provide information about clinical trials, or reprints of scientific journal articles?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Advertising aimed at health-care audience contains the following key requirements:<\/p>\n<ul>\n<li>Advertising is permitted only for prescription based medicines which are not prohibited by law;<\/li>\n<li>Advertising is aimed at characteristics of a medicine in order for health-care public to understand the effects of it;<\/li>\n<li>Advertising must contain data from the licence or registration and the information on prescribing a medicine;<\/li>\n<li>Price of medicine can be part of advertising as well as information on what part of the price will be covered by compulsory health insurance;<\/li>\n<li>Use of word \u201csafe use\u201d is restricted and it can be used only in accordance with the instructions given by the Agency;<\/li>\n<li>Promotion can be conducted by professional associates of advertising entity with a degree in medicine, pharmacy, dental medicine or veterinary. These associates have to be trained in foundations of clinical pharmacology. These trainings have to performed continuously with appropriate tests.<\/li>\n<\/ul>\n<p>Companies are prohibited from providing information on clinical trials except in cases of aftermarket clinical trials of a medicinal products or medical device.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes, but only products of symbolic value and which are in connection with their medical practice (medicine, dental medicine, pharmaceutical or veterinary).<\/p>\n<p>What is considered as symbolic value is not defined in the regulations and it would be assessed on a case-by-case basis.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies allowed to provide samples to healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes, free samples are allowed with conditions attached.<\/p>\n<p>Only one free sample of smallest package is allowed per calendar year for medicines aimed at continuous use, with note attached to the packaging: \u201cFree sample, not for sale\u201d. If medicines are only for one use, free samples are limited to 15 samples in a calendar year. .<\/p>\n<p>Additional conditions include:<\/p>\n<ul>\n<li>Medicine must be licensed or registered in the Republic of Serbia;<\/li>\n<li>Free sample must be aimed at familiarising with the characteristics of the medicine;<\/li>\n<li>Free sample can only be provided to health-care professionals who are issuing prescriptions for medicines;<\/li>\n<li>Free sample must come with a copy of the instructions of use;<\/li>\n<li>Free sample can be given based on a written request by a health-care professional and who are using or can use such medicine;<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies permitted to sponsor scientific meetings or congresses and\/or attendance by healthcare professionals to these events?  If so, which restrictions apply?  Do additional restrictions apply to events taking place abroad?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>In short, yes, this is allowed if requirements are fulfilled:<\/p>\n<ul>\n<li>Any such sponsorship must not be conditioned upon any material or non-material requests aimed at health-care professionals.<\/li>\n<li>Such events have to be of educational nature and in line with scientific results.<\/li>\n<li>They must not be organised solely for the purpose of advertising a medicinal product or medical device;<\/li>\n<li>All sponsors of such events must be publicly disclosed;<\/li>\n<li>Content of the events must not be influenced by the sponsors but they can have their own space at the event to provide information about a medicinal product or medical device in line with the applicable regulations;<\/li>\n<li>All speakers at the event must disclose at the beginning of their speech whether their appearance is sponsored; Such statement is also provided to that speaker\u2019s employer;<\/li>\n<li>These events can be sponsored only to the limit of necessary travel arrangements, accommodation, food and participation fee as well as event costs (location, publications, etc.) These costs can include only the duration of the event and maximum of two days on arrival and departure;<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Organisation of other events as well as sponsorship of such events in relation to scientific conferences is prohibited.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>This matter is not specifically regulated but it does fall under realm of advertising to the health-care public. Hence see more information under question 11.<\/p>\n<p>In addition, it has to be noted that if such activities are performed they must not be related or conditioned on health-care professionals proscribing such medicine or influencing their decision to do so.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Grants or donations are not regulated by the applicable regulations. However, this question raises significant debates in public and we could very well see a regulation in the upcoming years which would set out conditions under which such grants would be allowed.<\/p>\n<p>Grants or donations in any case must not be related or conditioned on health-care professionals proscribing such medicine or influencing their decision to do so. However, in practice, grants or donations are fairly frequent with the purpose of improving conditions in healthcare institutions.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and\/or companies that do not yet have products on the market?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Obligation to disclose details of transfers of value, akin to Sunshine Act, is not specifically regulated under the applicable regulations.<\/p>\n<p>However, promotional activities carry a requirement of record-keeping by advertisers and presenting it upon request to the Agency. It is debatable whether these transfers can fall under the definition of promotional activities or not.<\/p>\n<p>Only companies defined as advertisers with a licensed or registered medicinal product or medical device are allowed to advertise in the market to the exclusion of foreign companies and companies without a product on the market.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any restrictions (whether by law or Codes of Practice) on advertising for medicines on social media directed to healthcare professionals or directed to the general public?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Advertising on social media is not specifically regulated, however advertising online is allowed under almost the same conditions as in other media channels.<\/p>\n<p>The difference lies in Art. 9 of the Rulebook which proscribes that online ad must contain information on the medicinal product or medical device in the main or home page of the add and not contained on the linked content. By analogy, this can be extended to advertising on social media.<\/p>\n<p>Warning message online must be shown independently and in a separate frame to the ad itself.<\/p>\n<p>&nbsp;<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is advertising on the internet for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Please see under question 19.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any anti-bribery rules that apply to communications between pharmaceutical companies and healthcare professionals or healthcare organisations?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Communication between pharmaceutical companies and healthcare professionals must not be related or conditioned on health-care professionals proscribing such medicine or influencing their decision to do so.<\/p>\n<p>General provisions of Criminal Code are also applicable in this case.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Please refer to questions 14, 16 and 17 for answer on this question.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Primary body responsible for enforcement of the applicable regulation is the Agency as an administrative authority as well as Ministry of Health and its Inspectorate.<\/p>\n<p>For breach of advertising regulations, advertisers may be penalised by a monetary fine between 800.000,00 \u2013 2.000.000,00 RSD (approx. 7000 \u2013 17000 EUR). A prohibition on performing business activities can be imposed as an additional measure.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Companies may lodge a complaint to the Ministry of Health or the Agency against competitors for advertising infringements.<\/p>\n<p>However, this matter is not specifically regulated and such complaints are taken by the authorities as information obtained from the general public on matters under its competence.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The least restrictive measure that can be imposed is prohibition on the advertising or promotional activities. This measure is issued by the Inspectorate of the Ministry of Health.<\/p>\n<p>For breach of advertising regulations, advertisers may be penalised by a monetary fine between 800.000,00 \u2013 2.000.000,00 RSD (approx. 7000 \u2013 17000 EUR). A prohibition on performing business activities can be imposed as an additional measure.<\/p>\n<p>Courts are also authorised to hear claims under consumer protection regulations and award dagames or injunctions.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts\/government competent authorities?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Not applicable as only competent authorities may reach decisions under the governing regulations.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Most enforcement cases revolve around prohibiting sales or promotions of products advertised as medicines without proper licence or registration. Typically, such products are advertised online, mostly through social media. This serves to prove that authorities are monitoring advertising of products as medicines diligently and take action as necessary.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\r\n<div class=\"word-count-hidden\" style=\"display:none;\">Estimated word count: <span class=\"word-count\">3457<\/span><\/div>\r\n\r\n\t\t\t<\/ol>\r\n\r\n<script type=\"text\/javascript\" src=\"\/wp-content\/themes\/twentyseventeen\/src\/jquery\/components\/filter-guides.js\" async><\/script><\/div>"}},"_links":{"self":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide\/121504","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide"}],"about":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/types\/comparative_guide"}],"wp:attachment":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/media?parent=121504"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}