Pharmaceutical Advertising Guide in Bosnia and Herzegovina

Pharmaceutical Advertising Guide in Bosnia and Herzegovina

Bosnia and Herzegovina
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The Law on Medication and Medical Devices (Official Gazette no. 58/08) and the Rulebook on Manner of Marketing of Medicines and Medical Devices (Official Gazette no. 40/10) regulate the advertising of medicines and medical devices in Bosnia & Herzegovina.

Bosnian & Herzegovinian law defines advertising of medicines/medical devices as providing information about medicines/medical devices to the general and professional public in order to encourage their prescription, supply, sale, and/or consumption in written, pictorial, audio, oral, electronic, or any other form.

Advertising medicines/medical devices without a marketing authorization or asserting claims or conclusions about the effectiveness of medicines/medical devices that are subject of ongoing clinical trials is strictly prohibited.

The advertising must provide true and scientifically-proven information about the medicines/medical device, respecting ethical criteria, and with the aim of ensuring their proper and rational use, without misleading consumers. Directly addressing children in the advertising of medicines/medical devices is prohibited.

Advertising to the general public is only permitted for over-the-counter medicine/medical devices, and under the condition that the medicine/medical device has a marketing authorization issued by the state regulatory agency. Advertising a medicinal product to the general public by attributing properties to it that do not exist, exaggerating its positive effect, sensationally and inappropriately describing it, or misleading the user in any other way, is prohibited.

Advertising of medicines/medical devices to health care professionals may be done verbally or in written, pictorial, sound, electronic, or any other form. All information contained in promotional materials that are part of the advertising of the medicine/medical device must be accurate, current, verifiable, and sufficient to enable the healthcare professional to form his or her own opinion about the therapeutic value.

When marketing medicines/medical devices, marketing authorization holders are not allowed to encourage healthcare professionals to prescribe, issue, procure, recommend, or purchase medicines or medical devices by offering or providing cash remuneration, gifts, material benefits, or other benefits or rewards. Health care professionals are also prohibited from receiving such encouragements. The only gifts which may be given to health care professionals are gifts of symbolical value that are strictly related to the medical/pharmaceutical practice – e.g., pens, notepads, calendars, and other similar items of small value.

Promotional gatherings must be scientifically-based and educational, always be limited to the basic purpose of the meeting, and involve only the professional public. The contents of the mentioned meetings must not be for promotional purposes only.

It is worth mentioning that comparative advertising is not allowed – on the contrary, it is strictly forbidden, when advertising medicines/medical devices to the general public, to suggest that a particular medicine/medical device is undoubtedly better than other medicines/medical devices. Advertisers are also not allowed to indicate that the recommended medicine/medical device may be replaced by a different medicine/medical device.

Advertisements to healthcare professionals may not encourage the healthcare professionals that one medicine/medical device can be replaced with another from the same therapeutic group in the absence of clear medical indications. Furthermore, diminishing the therapeutic value of another medicine/ medical device that is authorized to be placed on the market or in any other way encouraging doubt in the value of another medicine/medical device is strictly prohibited.

When advertising a medicine/medical device that is dispensed without a prescription, the following message must be included: “Read the package leaflet carefully before use. For information on indications, precautions and adverse reactions to the medicine/medical device, consult a doctor or pharmacist.” In printed media, this warning has to be highlighted and take up at least 1/10th of the ad, and must be written in the appropriate font size so that it can be read without difficulty. In the case of television advertisements, this warning has to be visible on the screen for at least one quarter of the advertisement and be clearly readable. In the case of online advertising (on the Internet or social media), the warning has to be an integral part the main page of the ad, not its link.

Fines for non-compliance of between EUR 10,000 and EUR 25,000 for a legal entity, and EUR 1,500 to EUR 5,000 for its authorized representative, may be imposed.

By Anisa Tomic and Bojana Bosnjak-London, Partners, Maric & Co

This Article was originally published in Issue 8.5 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.