Pharmaceutical advertising regulation and medical device advertising in Montenegro

1.1 Medicines

The Law on Medicines ("Official Gazette of Montenegro", No. 14/26, hereinafter: "Law on Medicines") and the Rulebook on the Manner and Conditions of Advertising of Medicines ("Official Gazette of Montenegro", No. 2/14, hereinafter: "Rulebook on Medicines") regulate advertising of medicines. 

1.2 Medical devices

The Law on Medical Devices ("Official Gazette of Montenegro", No. 24/19 and 84/24, hereinafter: "Law on Medical Devices") and the Rulebook on Detailed Conditions and Manner of Advertising of Medical Devices ("Official Gazette of Montenegro", No. 42/23, hereinafter: "Rulebook on Medical Devices") regulate advertising of medical devices. 

2.1 Medicines

Based on the available Montenegrin legal sources, there are no self-regulatory codes of conduct identified that specifically govern the advertising of medicines in Montenegro. The advertising of medicines is regulated solely through the applicable statutory and subordinate legislation referred to in Section 1.1 above. 

2.2 Medical devices

Based on the available Montenegrin legal sources, there are no self-regulatory codes of conduct identified that specifically govern the advertising of medical devices in Montenegro. The advertising of medical devices is regulated solely through the applicable statutory and subordinate legislation referred to in Section 1.2 above. 

It is unlawful to advertise a medicine for which a marketing authorisation (dozvola za lijek) has not been issued or which has not been registered in accordance with the Law on Medicines. All claims in advertising must be consistent with the data set out in the summary of product characteristics (SmPC). The marketing authorisation holder is obliged to make available or deliver to the Institute for Medicines and Medical Devices (hereinafter: the "Institute") copies of all advertisements, together with a statement indicating the target audience, the manner of publication, and the date of first publication. 

For medical devices, it is prohibited to advertise a medical device that has not been assessed for conformity with technical requirements or that has not been registered. It is also prohibited to advertise a medical device in a misleading manner or in a way that describes the disease and treatment successes so as to encourage self-treatment, as well as advertising in an inappropriate and sensationalist manner.

The Ministry of Health may also prescribe additional medical devices that cannot be advertised, in the interest of public health protection. 

Yes. It is prohibited to advertise to the general public medicines that are issued on a medical prescription. It is also prohibited to advertise to the general public medicines that contain psychotropic substances or drugs as defined by international conventions (such as the United Nations Single Convention of 1961 and the Convention of 1971), as well as medicines funded from compulsory health insurance. Over-the-counter medicines may be advertised to the general public, provided they are not prescribed and issued at the expense of the Health Insurance Fund. Promotion of prescription-only medicines to healthcare professionals is permitted, subject to the requirements of the Law on Medicines and the Rulebook on Medicines. 

5.1 Medicines

Advertising of a medicine to the general public must not:

• leave the impression that a medical examination or surgical intervention is unnecessary, particularly by offering diagnosis or suggesting treatment by post or without a visit to a doctor; 
• suggest that the effects of taking the medicine are guaranteed, that there are no or reduced adverse reactions, or that the medicine has the same or better effect than another medicine or treatment; 
• suggest that taking the medicine can improve the user's health; 
• suggest that not taking the medicine can worsen the user's health, except in the case of vaccination campaigns conducted by the manufacturer or its representative and approved by the Ministry; 
• be exclusively or primarily directed at children; 
• include recommendations by scientists, healthcare professionals, or persons who due to their popularity could encourage the consumption of the medicine; 
• suggest that the medicine is a food, cosmetic, or other consumer product; 
• suggest that the medicine is safe and effective because of its natural origin; 
• describe or provide a detailed depiction of a medical history that could lead to incorrect self-diagnosis; 
• in an inappropriate, disturbing, or misleading manner claim that recovery will occur; 
• use inappropriate, disturbing, or misleading terms and visual depictions of changes in the human body caused by illness, injury, or the action of a medicine on the human body or its parts. 

It is prohibited to distribute medicines to the general public for promotional purposes. 

In addition, under the Rulebook on Medicines, it is prohibited to collect or disclose personal data about a specific person's or group's illness, diagnoses, therapeutic procedures, or prescribed medicines when advertising to the general public. The advertising must not name specific pharmacies, veterinary establishments, or legal entities engaged in wholesale distribution of medicines. The advertising must also not include the price of the medicine or the price reimbursed from the Health Insurance Fund.

5.2 Medical devices

Advertising of medical devices to the general public must not create a false impression that:

• the medical device has no adverse effects; 
• it is not necessary to consult a doctor, pharmacist, or dentist before using the medical device; 
• the use of the medical device can avoid a medical or dental examination, advice, or surgical intervention; 
• the use of the medical device guarantees success in the treatment of disease; 
• a particular medical device is the best or better than other medical devices; 
• the medical device should be used even when there are no signs of illness, i.e., to improve health; 
• the health of a person not using the medical device will be impaired, except in the case of health promotion programs (prevention of epidemics, etc.), in accordance with the law; 
• the medical device is food, a dietary supplement, cosmetics, a toy, or another product on the market; 
• the medical device is registered or will be registered in the future; 
• the recommended or prescribed medical device can be replaced by the medical device being advertised; 
• the medical device is harmless due to its natural origin. 

In addition, the advertisement must not include the price of the medical device, recommendations of healthcare or scientific professionals encouraging the use of the device, or recommendations or likenesses of persons whose popularity could influence the use of the device. Advertising must not use medical histories or depictions of diagnostic procedures that could lead to self-treatment or self-diagnosis, inappropriate, disturbing, or misleading expressions and visual representations of changes in the human body, the name of healthcare institutions or specialized retail outlets, or personal data about a specific person's or group's illness. Advertising of medical devices to the general public must not be exclusively or primarily directed at children, and children must not be shown using a medical device without the presence of adults. Claims or conclusions about the effectiveness of medical devices that are the subject of clinical trials in Montenegro or abroad cannot be made in advertising to the general public. Medical devices funded from compulsory health insurance may not be advertised. 

6.1 Medicines

When advertising medicines to healthcare professionals, the following is prohibited:

• encouraging healthcare professionals to replace one medicine with another from the same therapeutic group without a clear medical indication; 
• making claims or conclusions about the efficacy of medicines that are the subject of clinical trials in Montenegro or abroad, except in the case of a post-marketing non-interventional study; 
• using the SmPC and the package leaflet with a font size smaller than 3 mm, or using another method of printing that hinders easy reading and understanding; 
• publishing through the media information that is intended for healthcare professionals; 
• diminishing the importance of warnings about precautionary measures or adverse reactions listed in the approved SmPC and the package leaflet; 
• diminishing the therapeutic value of another authorised medicine or in any other way encouraging doubt about the value of another medicine; 
• using material protected by any form of intellectual property protection without the prior consent of the owner; 
• using postcards or other forms of written correspondence whose content may be accessible or readable by persons other than the professional public; 
• using the telephone, fax, email, or other electronic systems of persons belonging to the professional public without their prior consent. 

Under the 2026 Law on Medicines, when advertising to persons authorised to prescribe or dispense medicines, it is prohibited to give, offer, or promise gifts, monetary rewards, or other material benefits, except items of minimal value related to the practice of medicine or pharmacy. At events organised exclusively for professional and scientific purposes, hospitality may be provided, directly or indirectly, provided that it is always strictly limited to the main scientific purpose of the event and does not include non-healthcare professionals.

The professional public cannot derive any benefit as an incentive for prescribing, dispensing, procuring, or consuming a medicine, other than items of symbolic value related to medical, dental, pharmaceutical, or veterinary practice. 

6.2 Medical devices

When advertising medical devices to healthcare professionals, the following is prohibited:

• encouraging the replacement of one medical device with another without a clear medical indication; 
• making claims or conclusions about the effectiveness of a medical device that is the subject of clinical trials in Montenegro or abroad, except in the case of post-marketing non-interventional clinical trials; 
• diminishing the importance of warnings about the intended use or adverse effects of the medical device; 
• diminishing the value of another registered medical device or in any other way encouraging doubt about its value; 
• using the name of the state administration body responsible for health, the Institute for Medicines and Medical Devices, or the name of a person participating in clinical trials, conformity assessment, or registration proceedings; 
• using postcards or other written correspondence whose content may be accessible or readable by other persons; 
• using the telephone, fax, email, or other electronic communication of a person belonging to the professional public without their prior consent; 
• using material protected by any form of intellectual property protection without the prior consent of the owner; 
• publishing information through the media that is used in the advertising of healthcare institutions or specialized retail outlets. 

Manufacturers, authorised representatives, and legal entities engaged in the trade of medical devices may not offer financial, material, or other benefits to persons who prescribe or dispense medical devices, or to members of their families, except that they may sponsor scientific and promotional gatherings by covering necessary travel, accommodation, food, and mandatory participation costs. 

7.1 Medicines

Advertising of a medicine to persons authorised to prescribe or dispense medicines must contain: (1) essential data about the medicine in accordance with the approved SmPC; and (2) information on whether the medicine is dispensed on a medical prescription or without a prescription. The advertising may also contain data on the sales price of the medicine and the conditions for reimbursement from the compulsory health insurance.

Additionally, all data in the promotional material must be accurate, up-to-date, complete, and verifiable, so as to enable the persons authorised to prescribe or dispense medicines to form their own opinion on the therapeutic value of the medicine. Citations, tables, or other illustrative data taken from medical journals or other scientific works that are part of the promotional material must be faithfully reproduced with precise references. The promotional material must also contain the date of preparation or the date of the last revision.

Access to materials used for advertising medicines to the professional public is restricted exclusively to the professional public. 

7.2 Medical devices

Promotional material for advertising medical devices to the professional public must contain:

• the indication: "For healthcare professionals only!";
• essential data about the medical device, which must be relevant, accurate, up-to-date, verifiable, and sufficiently complete for the professional public to form a professional opinion; 
• the date of registration of the medical device; 
• citations, tables, or other data taken from professional journals or scientific works, which must be current, relevant, and faithfully reproduced, with references to literature and the exact source of information; 
• the date of preparation and the last revision of the promotional material. 

The promotional material must not use the word "safe" unless it includes appropriate explanations in accordance with the essential requirements. 

For the purpose of informing healthcare professionals about the characteristics of a new medical device being promoted, it is permissible to give one medical device with the note on the packaging: "Free sample, not for sale." 

8.1 Medicines

Advertising of a medicine to the general public must: (1) be conducted so that it is clear that it is an advertisement and that the product being advertised is a medicine; and (2) contain at least the following information: the name of the medicine (as well as the common name if the medicine contains only one active substance); information necessary for the correct use of the medicine; and an explicit, legible invitation to the user to carefully read the information from the package leaflet or the outer packaging. 

Under the Rulebook on Medicines, the warning must read: "Before use, carefully read the instructions about the medicine. About indications, precautionary measures, and adverse reactions, consult your doctor or pharmacist, and for veterinary medicines – your veterinarian." The warning must be prominently displayed (in a conspicuous colour, framed, etc.) and must be at least one-tenth the size of the advertisement, written in appropriately sized letters so that it can be noticed and read without difficulty. In electronic media, the warning must be displayed independently in a separate frame, accompanied by a clear spoken message of identical content. For internet advertising, the warning must be an integral part of the initial or main internet message or advertisement, not a page given as a link.

8.2 Medical devices

Advertising of a medical device to the general public must contain:

• the name of the medical device; 
• the manner of use and data necessary for the correct use of the medical device; 
• a visible, legible, and understandably written, drawn, or spoken warning to the patient or user to carefully read the instructions for use and to consult a doctor of medicine, pharmacist, and/or dentist about the intended use and adverse effects of the medical device. 

The warning must read: "Before use, read the instructions! Consult a doctor of medicine or pharmacist about the intended use and adverse effects of the medical device," or for medical devices intended for use in dentistry: "Before use, read the instructions! Consult a dentist or pharmacist about the intended use and adverse effects of the medical device." 

The warning must comply with specific formatting requirements: in print media, it must be written in bold letters of appropriate size, easily visible, occupying at least one-tenth of the advertisement, and framed by a straight line; in electronic media, it must be displayed independently in a separate frame with an accompanying audio message of identical content; and on the internet, it must be an integral part of the initial or main advertising page, not a linked page.

Information about a medicine must be true and scientifically proven and must not mislead the professional or general public. The information is provided for the correct and rational use of the medicine, while respecting ethical standards. All claims in the advertising of a medicine must be consistent with the data set out in the approved SmPC. Advertising of a medicine must encourage rational use of the medicine by presenting it objectively and without exaggerating its characteristics. 

Citations, tables, or other illustrative data taken from medical journals or other scientific works that are part of the promotional material must be faithfully reproduced with precise references. The data must be accurate, up-to-date, complete, and verifiable.

For medical devices, the promotional material must not contain the word "safe" unless it includes appropriate explanations in accordance with the essential requirements. Citations, tables, or other data taken from professional journals or scientific works must be current, relevant, and faithfully reproduced, with references to literature and the exact source of information. It is prohibited to make claims or conclusions about the effectiveness of a medical device that is the subject of clinical trials in Montenegro or abroad, except in the case of post-marketing non-interventional clinical trials. 

When advertising a medicine to the general public, it is not allowed to suggest that the effects of taking the medicine are guaranteed, that there are no or reduced adverse reactions, or that the medicine has the same or better effect than another medicine or treatment. It is also prohibited to suggest that a prescribed medicine can be replaced with another medicine. 

When advertising medicines to healthcare professionals, it is prohibited to encourage the replacement of one medicine with another from the same therapeutic group without a clear medical indication, and it is prohibited to diminish the therapeutic value of another authorised medicine or in any other way encourage doubt about the value of another medicine. 

For medical devices, the general public must not be given the impression that a particular medical device is best or better than other medical devices, or that the recommended or prescribed medical device can be replaced by the device being advertised. When advertising to the professional public, it is prohibited to diminish the value of another registered medical device or in any other way encourage doubt about its value, or to encourage the replacement of one medical device with another without a clear medical indication. 

There are no specific stand-alone provisions for the advertising of medicines and medical devices on the internet or social media. However, the Law on Medical Devices explicitly includes advertising via the internet as a form of advertising of medical devices to the general public. 

The Rulebook on Medicines provides that, for internet advertising, the warning to the patient or user must be an integral part of the initial or main internet advertising message or advertisement, and not a page given as a link or reference to the main page. 

Similarly, the Rulebook on Medical Devices provides that, for internet advertising, the warning must be an integral part of the initial or main page of the internet message or advertisement, and not a page given as a link or reference to the main page. 

As regards the sale of medicines on the internet, the Law on Medicines provides that persons authorised to carry out pharmacy activities in Montenegro may offer for distance sale via the internet non-prescription medicines, subject to notifying the Institute with certain information, including the address of the internet page used for that purpose. The relevant internet page must contain the contact details of the Institute, the address of the Institute's internet page, and a common EU logo clearly displayed on each page connected with the distance sale of medicines.

Medicines: The Institute for Medicines and Medical Devices is the central regulatory body. The marketing authorisation holder is obliged to establish a scientific service responsible for providing information about the medicines it places on the market, make available or deliver to the Institute copies of all advertisements, ensure that advertising is in compliance with the law, ensure that its sales representatives are adequately trained, facilitate inspections, and fully implement inspection decisions without delay. 

Supervision over the implementation of the law is carried out through inspectors. The health inspector has the authority and obligation to prohibit the advertising of a product to which medical indications are attributed but which is not a medicine, to prohibit advertising that misleads the professional and general public (whether already published or in preparation), and to prohibit any advertising that is not in compliance with the law. These measures are taken without delay, with a temporary or permanent effect. In order to prevent further consequences of misleading advertising that has been prohibited by a final decision, the health inspector may publish that decision in whole or in part or publish a corrective statement. 

For non-compliance with the advertising provisions of the Law on Medicines, a legal entity may be fined between EUR 5,000 and EUR 20,000 per offence. The responsible person in the legal entity may be fined between EUR 1,000 and EUR 2,000. A natural person/entrepreneur may be fined between EUR 2,000 and EUR 6,000. In addition to the fine, a protective measure of prohibition of activity for a period of six months may be imposed.

Medical devices: The Ministry of Health oversees the implementation of the Law on Medical Devices and prescribes implementing regulations. The Health Inspection carries out inspection oversight over manufacturers and legal and natural persons engaged in the trade of medical devices. The Agency for Medicines and Medical Devices (under the Law on Medical Devices, which remains in force for medical devices) is responsible for the registration of medical devices and the vigilance system. 

For non-compliance with the provisions of the Law on Medical Devices, a legal entity may be fined between EUR 1,000 and EUR 20,000 per offence. The responsible person in the legal entity may be fined between EUR 250 and EUR 2,000. A natural person may be fined between EUR 250 and EUR 2,000 (or EUR 500 to EUR 2,000 depending on the type of offence). A protective measure of prohibition of activity for a period of up to six months may also be imposed. 

The advertiser of medical devices is obliged to maintain records of all advertising activities and to prepare an annual report on the advertising of medical devices, which must be published on its website and submitted to the state administration body responsible for health. The advertiser must also retain original advertising messages, promotional materials, and published professional papers for a period of five years. 

Montenegro adopted a new Law on Medicines on 2 February 2026, which entered into force on the eighth day following its publication in the Official Gazette. This new law transposes key EU directives, including Directive 2001/83/EC on the Community code relating to medicinal products for human use, Regulation (EU) 536/2014 on clinical trials, and Regulation (EU) 2019/6 on veterinary medicinal products. Implementing regulations are to be adopted within 12 months from the date of entry into force of the new law. Manufacturers, wholesale distributors, importers, and marketing authorisation holders are required to align their operations with the new law and its implementing regulations within 24 months from the date of entry into force. Certain provisions of the law will apply only from the date of Montenegro's accession to the European Union. The adoption of this new comprehensive law represents a significant development in the regulatory framework for advertising medicines in Montenegro, aligning the country further with EU standards.