Pharmaceutical advertising regulation and medical device advertising in Serbia

1.1 Medicines 

The Law on Medicines and Medical Devices (“Official Gazette of RS”, No. 30/2010, 107/2012, 113/2017 and 105/2017) (hereinafter: “Law on Medicine”) and the Rulebook on Advertising Medicines and Medical Devices (“Official Gazette of RS”, No. 79/2010 and 102/2018) (hereinafter: “Rulebook on Medicine”) regulate advertising of medicines. 

1.2 Medical devices 

The Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the Rulebook on Advertising Medical Devices (“Official Gazette of RS”, No. 102/2018) regulate advertising of medical devices. 

Serbian Association of Innovative Medicine Manufacturers has the Code of conduct regarding advertising of prescription-only medicines and communications with healthcare professionals. 

Subject to very limited exceptions, it is unlawful to advertise a medicinal product and medical devices unless the medicine or medicine device is authorised (generally) via a marketing authorisation (“MA”).

For both medicine and medical devices, the Agency for Medicines and Medical Devices (hereinafter: the Agency) has to approve every advertisement and advertising material beforehand. Agency is obliged to provide the Ministry of Health with the approval within the 15 days from approving advertisement of medicine or medical device. If requested by the Ministry of Health, the Agency is obliged to provide materials used in the advertisement of the medicine. 

The Ministry of Health can also further determine which medicine or medical device are not allowed to be advertised, apart from the medicine or medical devices depicted as such by the relevant laws and bylaws. 

Yes. It is unlawful to promote prescription only medicines to the general public. Promotion to healthcare professionals is permitted (subject to the requirements of the Law on Medicines and the Rulebook on Advertising of Medicines).

5.1 Medicines 

It is generally prohibited to advertise a medicine which:

• are misleading or lead to the conclusion that the safety and efficacy of the drug is insured by its natural origin;
• are describing the illness and the successes of treatment in such a way as to self-healing; and
• advertising in an inappropriate and sensationalist way about healing achievements of medicine, by displaying images. 

It is prohibited to advertise a medicine that states that the medicine is food, cosmetics or other items of general use. 

It is prohibited from advertising a medicine to encourage prescribing and issuing medicines by giving or promising financial or other benefits. 

It is prohibited from advertising the following medicines to the general public:

• prescription only medicine;
• medicine which are issued at the expense of health insurance funds;
• medicine which contain intoxicating drugs or psychoactive substances;
• tuberculosis medicine, medicines for sexually transmitted diseases,  infectious diseases, chronic insomnia, diabetes and other metabolic diseases. 

It is prohibited from advertising drugs directly to children, which are intended for their treatment. 

In addition to the above mentioned, the Minister in charge of health affairs may by decision determine other medicines that cannot be advertised, which are published in the Official Gazette of Serbia. 

It is prohibited to give free samples to the public.  

5.2 Medical devices 

The Law on Medical Devices states that when advertising medical devices, clear information must be provided that the product advertised is a medical device and advertisement must not be misleading or contrary to the provisions of this law and other bylaws. 

When advertising medicinal devices, the general public cannot be given the impression that:

• the medical device has no adverse reactions;
• prior to the application of medical device, it is not necessary to consult a physician;
• the application of medical device may avoid medical examination, advice or surgical intervention;
• the application of medical device guarantees success in the treatment of disease;
• a particular medical device is best, i.e., better than other medical devices;
• the medical device is good to take or apply when there are no signs of illness, i.e., to improve health;
• the health of the person not using the medical device will be violated, except in the case of a campaign conducted by the Ministry of Health (prevention of epidemics), in accordance with the law;
• the medical device is food, cosmetics or other product of general use;
• the medical device is registered in the Register of Medical Devices, i.e., it will be registered in the succeeding time period;
• the recommended medical device may be replaced with another medical device;
• the medical device is harmless and effective because of its natural origin 

When advertising medical devices to the general public, the following cannot be used:

• Medical history or depiction of diagnostic procedures that could lead to incorrect self-treatment or self-diagnosis;
• Inappropriate, distressing, or misleading expressions and visual representations of changes in the human body caused by illness, injury, or the action of a medical device on the human body or body parts. 

The advertising of medical devices to the general public cannot show children using medical device, i.e., who have a medical device available without the presence of adults. 

Advertising medical device to the general public must not be solely or mainly aimed at children.  

Advertising medical device to the general public cannot include naming pharmacies, private practices, specialized shops and wholesale names in which a medical device can be purchased. 

Allegations or conclusions about the effectiveness of medical devices that are subject to clinical trials in the Republic of Serbia or abroad cannot be made in the advertising of medical devices to the general public. 

Advertising of medical devices issued at the expense of mandatory health insurance funds cannot be advertised. 

Among the above, for the sake of public health protection, the Ministry of Health can prescribe other medical devices that cannot be advertised. 

6.1 Medicines 

When advertising medicines to the healthcare professionals, it is not allowed: 

1. encouragement to prescribe, dispense, obtain, recommend the use or purchase of a medicine, by offering and giving a reward in money, by giving gifts or by giving and providing any other material and non-material benefits, or by promising or giving some privilege or reward;
2. encouraging the healthcare professionals that one medicine can be replaced by another medicine from the same treatment group without a clear medical indication;
3. make claims or conclusions on the efficiency of the medicine subject to clinical trials in the country or abroad, except in the case of post-marketing non-interventional clinical trial of a medicine or medical device;
4. to promote a medicine that is in the process of amending the SmPC and the package leaflet;
5. use of the SmPC and the instructions for a medicine whose letter size is less than 3 mm, or the use of another ways of printing that make it easy to read and understand;
6. publication of information through the media, which is used in the advertising process of health institutions, that is private practices, that is, veterinary organizations and specialized stores;
7. diminishing the importance of warnings about precautionary measures or adverse reactions to the medicine listed in the SmPC and the drug package;
8. diminishing the therapeutic value of another medicines authorized by the medicines or in any other way raising suspicion of the value of another medicine;
9. use of the name of the ministry competent for health affairs, the ministry competent for veterinary affairs, the Agency, that is, persons participating in the process of examination and authorization of a medicinal product;
10. use of material protected by any form of intellectual property protection without the prior consent of the owner;
11. use of postcards or other forms of written items whose content may be accessible or readable by persons other than healthcare professionals;
12. use of telephone, fax, e-mail or other electronic systems of persons belonging to the group of healthcare professionals without their explicit prior written consent, in such a way that they advertise or inform about their work. 

6.2 Medical devices 

Advertisement of medical devices to the healthcare professionals, cannot be conducted

1. By promoting the prescription, issuance, procurement, recommending the use or purchase of a medical device, offering and giving monetary rewards, giving gifts, or providing any other tangible and intangible benefits, or by promising or giving any privileges or rewards;
2. By encouraging the healthcare professionals to replace one medical device with another without clear medical indication;
3. By making claims or conclusions about the effectiveness of a medical device that is the subject of clinical trials in the Republic of Serbia or abroad, except in the case of post-marketing non-interventional clinical trials;
4. By publishing information through the media, which are used in the process of advertising healthcare institutions or private practices, or specialized stores;
5. By devaluing the importance of warnings about precautions or adverse reactions to a medical device;
6. By devaluing the value of another medical device that is registered or in any other way inciting doubt about the value of another medical device;
7. By using the names of the Ministry of Health, Agency, or persons participating in the process of clinical trials, conformity assessment, as well as registration in the registers prescribed by this law;
8. By using material protected by any form of intellectual property protection without the prior consent of the owner;
9. By using postcards or other forms of written correspondence whose content may be accessible or readable by other persons besides the healthcare professionals;
10. By using phones, fax machines, electronic mail, or other electronic systems of persons belonging to the health care professionals without their clear expressed prior written consent, and who advertise or inform about their work in this way. 

7.1 Medicines 

The advertising of medicines to the healthcare professionals must include basic information on the medicine from MA, i.e. data that are harmonized with the SmPC, as well as data related to the medicine issuance regime.

The above-mentioned information must be accurate, up-to-date, verifiable and sufficiently complete for the recipient to form his or her opinion on the therapeutic value of a particular medicine, and there needs to the date when the medicine was made or last revised.

Advertising materials intended for the healthcare professional must be labelled “for healthcare professional only". For the purpose of informing the healthcare professionals about the characteristics of a new medicine being promoted, it is permissible to give one small package of a new medicine with the note on the packaging: “Free sample, not for sale". 

7.2 Medical devices 

The advertisement of medical devices must contain the essential information on medical device. Such information must be accurate, up-to-date, verifiable and sufficiently complete for the recipient to form his or her opinion on the therapeutic value of a particular medical device. 

Materials used for advertisement of medical device must be labeled “for healthcare professionals only”. 

Materials used for advertisement of medical device must contain data on the date of registration of medical device, information, tables or other information taken from the medical journals or other publications which must be up to date, relevant and truthfully presented with listing of the literature and precise source of information.  

Materials used for advertisement of medical devices, for description of medical device words “safe” cannot be used without the proper explanation in compliance with the basic requests. 

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

Generally, advertisements of both medicine and medical devices to the general public must contain a clear information indicating that the product being advertised is medicine or a medical device and must not be misleading. 

8.1 Medicines 

The advertising must contain information relating to: 

1. the name of the medicine, in accordance with the law;
2. means of use and data necessary for the proper use of the medicine.
3. a visible, legible and comprehensibly written, drawn or spoken warning to the patient or user to read carefully the medication instructions and to consult a doctor or a pharmacist about the possible risk, as well as about adverse reactions to the medicine, and for veterinary medicines - with a vet. 

Warning must read as follows: “Prior to use study the instructions in detail! About indications, precautions and adverse reactions to the medicine, consult with a physician, or pharmacist, and for veterinary medicine – with the vet.” 

Warning in advertising messages in electronic media is required to be displayed independently and in a separate frame with an accompanying voice message of identical content. 

8.2 Medical devices 

The advertisement of medical device to the general public must, at least contain information relating to: 

• The name of the medical device;
• Information essential for the correct use of the medicine; and
• Visible, readable and understandably written, drawn or spoken warning to the patient or user to
• carefully read the instructions for the use of medical device and to discuss the possible risk, as well as adverse reactions to the medical device, consult with a doctor, or pharmacist, and for veterinary medicines – with a veterinarian.
• Advertising medical device to the general public cannot include naming pharmacies, private practices, specialized shops and wholesale names in which a medical device can be purchased.
• Allegations or conclusions about the effectiveness of medical devices that are subject to clinical trials in the Republic of Serbia or abroad cannot be made in the advertising of medical devices to the general public.

The information on the medicine or medical device must be true and scientifically proven and must not mislead the professional and general public. The information is given for the proper and rational use of the medicine or medical device, while respecting ethical standards. 

Materials used for advertisement of medical devices, for description of medical device words “safe” cannot be used without the proper explanation in compliance with the basic requests. 

When advertising medicine, medical device to the general public, it is not allowed to: 

• Give the impression that a particular medicine or medical device is better than other medicines and medical devices;
• Indicate that the recommended medicine or may be replaced by another medicine.

When advertising medicine and medical devices to the healthcare professional, it is not allowed to:

• Encouraging them that one medicine can be replaced by another medicine from the same treatment group without a clear medical indication;
• Diminish the therapeutic value of other authorized medicines or in any other way raisie suspicion of the value of another medicine; 

There are no specific provisions for advertisement of medical devices and medicine on the internet, but only a broad formulation that advertisement through internet is considered as advertising of medicine, medical devices. 

Only the Rulebook on Advertising Medicines provides the following:

If an advertising message is provided over the Internet, information about medicine must be an integral part of the initial or main advertising internet messages or advertisements, not the page provided as a link, i.e., a reference to the main page. 

The Agency is the main regulatory for medicines and medical devices with the broad competence in the area of medicine and medical devices.

The Ministry of Health supervises the implementation of the provisions of the relevant legal acts (as named in the Q1), as well as the work of the Agency. The Ministry of Health exercises supervision through the Inspector for Medicines and Inspector for Medical Devices. 

For non-compliance with the provisions of the laws the legal entity may be fined:

• Medicine- between RSD 800,000 and RSD 2,000,000 (approx. EUR 6,800 and EUR 17,000) per commercial offence and the reposnsible person in the legal entity between RSD 80,000 and 150,000 (approx. EUR 700 and EUR 1,300);
• Medical devices- between RSD 1,500,000 and RSD 3,000,000 (approx. EUR 13,000 and EUR 25,500) per commercial offence and the responsible person in the legal entity between RSD 100,000 and RSD 200,000 (approx. EUR 850 and EUR 1,700).

No, for the time being, no developments have been announced.