Pharmaceutical advertising regulation and medical device advertising in Slovenia

1.1 Medicines 

• Medicinal Products Act (Zakon o zdravilih)
• Rules on Advertising of Medicines (Pravilnik o oglaševanju zdravil) 

1.2 Medical devices 

• Medical Devices Act (Zakon o medicinskih pripomočkih)

Yes.

2.1 Medicines 

The self-regulatory codes applicable to advertising of medicines in Slovenia are:

• Forum’s Code of Practice (Kodeks ravnanja) of the Slovenian Forum of International Research and Development Pharmaceutical Companies, which implements and supplements the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) at national level;
• Code of Medical Ethics (Kodeks zdravniške etike) of the Slovenian Medical Association.

2.2 Medical devices

No national self-regulatory code exists specifically for advertising of medical devices. The MedTech Europe Code of Ethical Business Practice applies, however it does not regulate advertising of medical devices in general and contains only limited provisions affecting promotional activities in the context of third‑party organised educational conferences.

In addition, the Slovenian Advertising Code (Slovenski oglaševalski kodeks) of the Slovenian Advertising Chamber is a self-regulatory code applicable to advertising of both medicines and medical devices.

3.1 Medicines

In the case of medicines, advertising can only be carried out by holders of marketing authorisations, which need to be obtained from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (“ JAZMP”).

Prior to commencing any advertising of medicines to healthcare professionals (i.e. the expert public which includes persons authorised to prescribe and dispense medicines), marketing authorisation holders must notify the JAZMP of the experts involved in the advertising of medicines. These experts must be entered in a register with the JAZMP. 

3.2. Medical devices

Advertising of medical devices is permitted provided that the medical device has been lawfully placed on the market in accordance with Regulation (EU) 2017/745 and the device is affixed with a valid CE marking prior to being advertised. 

Yes, different regimes apply to prescription-only and over-the-counter medicines. 

Any medicine that is covered by a marketing authorisation may be advertised to healthcare professionals (i.e. the expert public which includes persons authorised to prescribe and dispense medicines).

Advertising of prescription-only medicines is allowed only to healthcare professionals. However, there is an exception to the prohibition on advertising of prescription-only medicines to the general public, where the JAZMP may allow manufacturers of medicines to carry out vaccination campaigns with the necessary information on vaccines included in the vaccination and protection programme with medicinal products.

Only over-the-counter medicines (i.e. those that are available without a prescription and the advertising of which is allowed in the specific marketing authorisation) may be advertised to the general public. 

5.1 Medicines 

Only over-the-counter medicines for which a marketing authorisation has been obtained and the advertising of which is explicitly allowed by the JAZMP in the specific marketing authorisation may be advertised to the general public. 

Advertising must comply with the summary of product characteristics and must promote the rational use of the medicine. The medicine must be presented objectively, without exaggeration as to its characteristics and must not be misleading, in particular as regards the potential benefits or risks of using the medicine. 

The advertising of medicines must not contain any information that:

• gives the impression that a medical consultation with a physician or a surgical operation is unnecessary;
• indicates that the effects of taking the medicine are guaranteed, that the medicine has no adverse effects or that it is better than or equivalent to another medicine or treatment;#
• suggests that a person’s health can be improved solely by taking the advertised medicine;
• suggests that the health of a person could deteriorate without taking the advertised medicine (this prohibition does not apply to advertising of vaccines); 
• is directed exclusively or predominantly at children;
• refers to recommendations by scientists, healthcare professionals or other publicly well-known persons who, because of their media influence, could encourage consumption of the medicine;
• suggests that the safety and efficacy of the medicine are due to its natural origin;
• could lead to incorrect self-diagnosis due to the description or detailed presentation of medical history;
• uses inappropriate, alarming or misleading expressions regarding the possibilities of recovery;
• uses inappropriate, worrisome or misleading expressions or visual representations of changes in the human body caused by disease or injury or the action of the medicine on the human body or parts.

No samples of medicines may be distributed to end users for promotional purposes. 

5.2 Medical devices 

Advertising of medical devices is prohibited in accordance with Article 7 of Regulation (EU) 2017/745 and Article 7 of Regulation (EU) 2017/746, which stipulate that in the advertising of medical devices it is prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

• ascribing functions and properties to the device which the device does not have;
• creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
• failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
• suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out. 

An exemption from this prohibition applies to advertising of medical devices at fairs, exhibitions, demonstrations or similar events if a visible sign clearly indicates that such devices are intended only for presentation or demonstration purposes and cannot be made available until they comply with Regulation (EU) 2017/745 or Regulation (EU) 2017/746. 

In addition to the above, the Slovenian Advertising Code states that advertising of both medicines and medical devices for commonly known diseases must not include scientific terms that are not commonly known.

Note that advertising of medical devices means all forms of communication, including door-to-door communication, promotion and encouragement, intended to promote prescribing, dispensing, sale or use of medical devices. 

When advertising medicines and medical devices to healthcare professionals, it is prohibited to give, offer or promise gifts financial or material benefits, unless they are of a small value (as defined in the Integrity and Prevention of Corruption Act (Zakon o integriteti in preprečevanju korupcije) and the Rules on restrictions and duties of public employees regarding the acceptance of gifts (Pravilnik o omejitvah in dolžnostih uradnih oseb v zvezi s sprejemanjem daril)) and can be used in medical or pharmaceutical activity. 

Pursuant to the Code of Medical Ethics, medical doctors may not participate in advertising medicines or medical devices.

6.1 Medicines 

Medicines covered by a marketing authorisation may be advertised to healthcare professionals (i.e. the expert public which includes persons authorised to prescribe and dispense medicines):

• in professional publications, 
• by direct informing of persons authorised to prescribe and dispense medicines (other healthcare professionals may also be directly informed, where it is necessary for the safe and correct use of medicines), 
• exceptionally also by providing samples (otherwise, medicines may not be distributed to healthcare professionals for promotional purposes). 

If the healthcare professionals work within the public healthcare service, advertising by direct informing may only take place during time dedicated to preparation for work and not during time intended for direct work with patients. The marketing authorisation holder must keep records of such advertising. 

Note that informing healthcare professionals about characteristics and effects of medicines, sponsorship and organisation of promotional meetings for healthcare professionals, sponsorship of scientific conferences attended by healthcare professionals, distribution of samples of medicines and encouraging to prescribe or dispense medicines by way of promising or giving financial or material benefits is all deemed as advertising. Samples of prescription-only medicines may only be provided to persons authorised to prescribe medicines if the patient needs to be informed about how to use a new medicine that is not intended for oral use and if certain other requirements are also fulfilled.

6.2 Medical devices 

The same provisions as for advertising to the general public apply – see above under 5.2. In addition, medical devices intended for use only by healthcare professionals may only be advertised to healthcare professionals. If a healthcare professional receives a sample medical device, they must not sell it.

7.1 Medicines

• the name of the medicine;
• essential information from the summary of product characteristics (including the composition of the medicine, therapeutic indications, dosage and method of administration, information on adverse reactions, precautions, warnings, contraindications and interactions, name, logo and address of the marketing authorisation holder); 
• the manner and regime of prescribing and dispensing the medicine; 
• the date on which this information was prepared.

In addition, the promotional materials must include the classification of whether it is a prescription-only or over-the-counter medicine and when appropriate, the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies.

Advertising must be accurate, unambiguous, up-to-date and verifiable to enable the assessment of the medicine’s effect and for the healthcare professional to form his/her own opinion of the therapeutic value of the medicine . It must be based on an up-to-date evaluation and must not mislead by distortion, exaggeration, undue emphasis, omission or in any other way. Advertising claims about side effects must reflect available evidence or be capable of substantiation by clinical experience (substantiation does not need to be provided in relation to the validity of claims approved in the marketing authorization). Claims must also not imply that a medicine or an active ingredient have some special merit, quality or property unless this can be substantiated.

The marketing authorisation holder must ensure that any advertising for healthcare professionals only targets and reaches the persons authorised to prescribe or dispense medicines. Informational materials intended for healthcare professionals should be labelled “For expert public.”.

Pursuant to Forum’s Code of Practice and EFPIA Code, in exceptional cases when samples of prescription-only medicines are distributed, they must be labelled “free sample – not for sale” and accompanied by a copy of the summary of product characteristics.

7.2 Medical devices 

If samples of medical devices are distributed, they must be labelled as “sample”.

8.1 Medicines 

Advertising of medicines to the general public must be carried out in such a way that the promotional nature of the message is clearly recognizable and that the product in unambiguously presented as a medicine (and not foodstuff, cosmetic or other consumer product). 

Such advertising must include:

• the name of the medicine and, where the medicine contains only one active substance, its generic name;
• information necessary for the proper and rational use of the medicine;
• a visible and legible written, graphic or spoken warning: “Carefully read the instructions before use! Consult a doctor or pharmacist about risks and side effects.”

There are specific rules for advertising of vaccines in vaccination programmes.

8.2 Medical devices 

If samples of medical devices are distributed, they must be labelled as “sample”.

Pursuant to the Slovenian Advertising Code, advertising of medical devices must be carried out in such a way that the promotional nature of the message is clearly recognisable and that the product is unambiguously presented as a medical device. Advertising of medical devices must encourage their rational use and they must be presented objectively and without exaggeration as to their characteristics.

Advertising of medicines or medical devices for commonly known diseases must also not use scientific terms that are not widely known.

Advertising of medicines to healthcare professionals must rely on scientific data that are accurate, unambiguous, up-to-date and verifiable and must enable the assessment of the medicine’s effect and therapeutic value. When advertising medicines to healthcare professionals all statements, tables and other visual materials from medical journals or other scientific works must be accurately summarized with precise citation of the sources.

Furthermore, pursuant to Forum’s Code of Practice and EFPIA Code, when advertising refers to published studies, clear references must be given. All artwork (including graphs, illustrations, tables) taken from published studies and quotations from medical and scientific literature and personal communication must be faithfully reproduced, except where adaptation or modification is required under applicable codes, in which case it must be clearly stated that the artwork or quotation has been adapted or modified and in case of quotation, precise sources must be identified. Artwork included in advertisement must not mislead about the nature of a medicine (for example, whether it is appropriate for use in children) or mislead about a claim or comparison (for example, by using incomplete or statistically irrelevant information or unusual scales). Advertising claims must also be capable of substantiation which must be promptly provided in response to reasonable requests from healthcare professionals.

When advertising medicines to the general public, advertising that indicates that a medicine is better or  than equivalent to other medicines or treatments is prohibited. 

Comparative advertisement of medicines to healthcare professionals is generally permitted, however it must be based on relevant and comparable aspects of medicines and must not be misleading or disparaging. 

No, the general rules apply. 

The responsible authority for enforcement in this field is the JAZMP. It monitors compliance through regular inspections and its inspectors may also act on the basis of notifications, anonymous reports, referrals from other authorities, as well as information identified in the media and online. In the case of minor violations, where the circumstances of the case justify a preventive approach, the JAZMP may decide to issue a warning. In case of serious violations, the JAZMP is authorised to impose the following fines.

12.1 Regarding medicines:

A fine of between EUR 800 and EUR 4,000 may be imposed on a legal entity that fails to notify the JAZMP of the list of experts to be entered in the register of experts involved in the advertising of medicines prior to the commencement of medicinal product advertising or any changes thereto. A fine of between EUR 200 to EUR 1,000 may also be imposed on the responsible person of the legal entity.

A fine of between EUR 8,000 and EUR 120,000 may be imposed on a legal entity if:

• it advertises products presented as having properties for treating or preventing disease in humans without a relevant marketing authorisation; or
• it presents to patients or customers products without marketing authorisation as having properties for treating or preventing disease in humans; or
• it advertises non-routinely prepared medicines for advanced therapy, their preparation or treatment with them;
• it violates the abovementioned rules on advertising of medicines to general public or healthcare professionals.

A fine of between EUR 500 and EUR 5,000 may also be imposed on the responsible person of the legal entity.

Regarding medical devices:

A fine of between EUR 800 and EUR 4,000 may be imposed on a legal entity if it advertises a medical device contrary to the abovementioned rules. A fine from EUR 200 to EUR 1,000 may also be imposed on the responsible person of the legal entity.

No developments regarding advertising of medicines are anticipated in the near future.