Pharmaceutical advertising regulation and medical device advertising in Slovakia

• Act No. 147/2001 Coll. on Advertising, as amended (“Act on Advertising”);
• Act No. 264/2022 Coll. on Media Services (Media Services Act), as amended;
• Act No. 362/2011 Coll. on Medicines and Medical Devices, as amended (“Act on Medicines”);
• Act No. 187/2021 Coll. on Protection of Competition, as amended;
• Act No. 108/2024 Coll. on Consumer Protection, as amended;
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (“MDR”).

Yes, the main codes of conducts are the following (note: the list is not exhaustive): 

• EFPIA Code – industry self‑regulatory code (non‑statutory), which represents a collection of ethical rules agreed by EFPIA members for the Promotion of Medicinal Products to HCPs and the interactions with HCPs, HCOs and POs, with the intent of guaranteeing that these activities are conducted while respecting the most stringent ethical principles of professionalism and responsibility. This code applies to all types of communication and interaction (traditional and digital);
• Ethical code of the Pharmaceutical Industry of the Slovak Republic issued by Association of Drug and Health Device Suppliers;
• Ethical code of Association of Innovative Pharmaceutical Industry;
• Ethical code of Advertising issued by the Advertising Standards Council.

There are generally no specific requirements for prior approval or a license for advertising of medicines and medical devices to the general public or healthcare professionals, but such advertising must comply with the applicable statutory provisions.

Only non-prescription medicines that are not publicly reimbursed may be advertised to the general public, provided they are duly registered in the Slovak Republic.

Slovak law does not impose specific advertising fees or levies for the promotion of medicines or medical devices. The relevant entities specified in the Act on Medicines are subject to several notification obligations in relation to funds spent on marketing, advertisement, non-monetary considerations, scientific or other educational events, including annual reporting by 31 January and the publication of certain data by the authorities. 

Yes. The distinction plays an important role regarding advertisements that are addressed to the general public: while advertising of non-prescription medicines to the general public is permitted under certain conditions, advertising of prescription medicines to the general public is generally prohibited. 

5.1 Medicines 

The advertising of medicines not registered in the Slovak Republic, medicines containing narcotic, psychotropic drugs or supplements, prescription-only medicines and non-prescription medicines covered by health insurance is prohibited to the general public. The prohibition does not apply to vaccination campaigns organised by the marketing authorisation holder (or its representative) and permitted by the Ministry of Health of the Slovak Republic, and to advertising addressed to persons authorised to prescribe or dispense medicines..

In general, advertising of medicine must not be deceptive, must encourage rational usage of the medicine by providing objective information on characteristics of the medicine and must comply with data stipulated in the SmPC.

In addition to the above, several other restrictions apply to the content of advertising to the general public, such as:

• Advertised product must be unambiguously identified as medicine, and it must be obvious that the information is an advertisement;
• An advertisement must include the name of the medicine, the name of the active substance if it contains only one active substance, the necessary information for correct usage of medicine, and an explicit and comprehensible request to carefully read the written information for users;
• An advertisement must not include any information that would: (i) induce the impression that medical examination or medical treatment is unnecessary; (ii) offer determination of diagnosis or method of treatment via correspondence; (iii) give the impression that the effects of the medicine are guaranteed, without any side effects, or are better than or equivalent to the effects of another medicine or treatment; (iv) suggest that the good health of a person could be improved by taking the medicine; (v) suggest that the good health of a person could be affected by not taking the medicine; (vi) appeal exclusively or mainly to children; (vii) contain recommendations from scientists, healthcare professionals, or celebrities, whose popularity could encourage the consumption of medicines; (viii) liken a medicine to food, a cosmetic product, or other consumer goods; (ix) create the impression that the safety or efficacy of the medicine is due to its natural origin; (x) potentially, through a description or detailed depiction of a medical history, lead to incorrect self-diagnosis; (xi) refer in an excessive, alarming, or misleading manner to confirmation of the cure of a disease; (xii) use excessive, alarming, or misleading depictions of changes in the human body caused by disease or injury and illustrate the effect of the medicine on these changes in the human body;
• An advertisement must include following text: "Traditional herbal medicine intended for indications verified exclusively by long-term use", if the subject of the advertisement is a traditional herbal medicine.

It is prohibited to directly distribute medicines to the public for advertising purposes.

5.2 Medical devices 

Only general rules of advertising as stipulated in the Act on Advertising apply to the advertising of medical devices (e.g. advertising must not endanger mental and physical health of people, refer to statements made by other persons without their prior consent, etc.). In addition, Article 7 MDR applies directly: labelling, instructions and advertising for medical devices must not be misleading, including by attributing functions or performance the device does not have, creating unjustified expectations, or failing to disclose risks.

Further, also general rules of relevant codes of conduct must be observed (e.g. advertisement must include the name of the medical device, it must not include data which could lead to false self‑assessment of health condition, etc.).

6.1 Medicines 

Samples of medicines can be provided by the market authorisation holder, upon written request, only to a person authorized to prescribe medicines, and only up to two samples of the smallest packaging of the registered medicine per year, labelled "FREE MEDICAL SAMPLE - NOT FOR SALE," and accompanied by the summary of product characteristics. It is prohibited to provide samples of medicines that contain narcotic or psychotropic substances.

Offering or promising any kind of gifts, monetary or material benefits or advantages to the persons authorised to prescribe or dispense medication is prohibited. 

Hospitality at promotional events must be strictly limited to the purpose of the promotional event and may be provided only to healthcare professionals; this provision does not prevent hospitality from being provided, directly or indirectly, at events intended exclusively for professional and scientific purposes, provided that such hospitality is always strictly limited to the main scientific purpose of the event and is not offered to any persons other than healthcare professionals.

Persons authorized to prescribe medicines and persons authorized to dispense medicines are prohibited from requesting or accepting the aforesaid gifts, monetary or material benefits, or any other advantages, or from accepting hospitality in violation of the preceding paragraph.

It is also prohibited to conduct visits to persons authorized to prescribe medicines during their consultation hours for the purpose of promoting medicinal products. Likewise, persons authorized to prescribe human medicines are prohibited from receiving visits from medical representatives during their consultation hours for the purpose of advertising human medicinal products.

The medical representative must undergo training and must have sufficient scientific knowledge to be able to provide the most accurate and complete information about the drug they are promoting.

6.2 Medical devices 

Only general rules on advertising apply to the advertising of medical devices. Article 7 MDR prohibits misleading statements in device advertising, and Act on Medicines also prohibits influencing prescribers’ decision‑making regarding medical devices through inducements.

7.1 Medicines 

Advertisement of medicines directed at persons authorized to prescribe medicines and persons authorized do dispense medicines must contain all essential information about the medicine which must be in conformity with the SmPC and the classification of medicine according to its method of dispensing. Further, the advertisement must include the dates of its issuance and update.

The documentation relating to a medicine, which is provided as part of the promotion of that medicine to persons authorized to prescribe medicines and persons authorized to dispense medicines, must include accurate and up to date information, which is verifiable and sufficient enough for the recipient to form their own opinion on the therapeutic value of the promoted medicine. Price offerings, charts or any other materials used for illustration purposes taken from medical journals, or other scientific resources used in documentation must be truthfully reproduced and true and exact sources must be identified.

During each visit, medical representatives shall provide or make available to the persons authorized to prescribe medicines and the persons authorized to dispense medicines whom they have visited a summary of the product characteristics of the medicine they are promoting; they may also provide information on the price of the medicine and on the level and conditions of reimbursement of the medicine under public health insurance. 

Medical representatives shall provide the person responsible for the operation of the pharmacovigilance system with information on the use of the medicine they are promoting; this information shall include all adverse effects reported to them by the persons they have visited.

7.2 Medical devices 

Only general rules on advertising apply to the advertising of medical devices. There is no statutory list of mandatory particulars equivalent to those for medicines; instead, device advertising must comply with Article 7 MDR (no misleading claims) and with the general requirements of the Act on Advertising.

8.1 Medicines 

Any advertising of medicines intended for the public must:

1. be compiled in such a way as to make it clear that the information is an advertisement and to clearly identify the advertised product as a medicine,
2. contain the name of the medicine and the name of the active substance if it contains only one active substance,
3. include essential information for proper use,
4. include an explicit and understandable invitation to carefully read the instructions for proper use of the medicine contained in the written information for users, which is included with the medicine,
5. include the text: "Traditional herbal medicinal product for use in indications solely based on long- standing use," if the advertising is for a traditional herbal medicinal product.

In more detail, it is prohibited for advertising of medicines intended to the general public to:

1. give the impression that medical examination or treatment is unnecessary;
2. offer determination of diagnosis or method of treatment by correspondence;
3. give the impression that the effects of the medicine are guaranteed and are not accompanied by any side effects, or are better than or equivalent to the effects of another medicine or treatment;
4. suggest that the good health status of a person could be affected by not taking the medicine;
5. suggest that the good health of a person could be affected by not taking the medicine;
6. appeal exclusively or mainly to children;
7. contain recommendations from scientists, healthcare professionals, or celebrities, whose popularity could encourage the consumption of medicines;
8. liken a medicine to food, a cosmetic product, or other consumer goods;
9. create the impression that the safety or efficacy of the medicine is due to its natural origin;
10. contain an element which may, through a description or detailed depiction of a medical history, lead to incorrect self-diagnosis;
11. refer in an excessive, alarming, or misleading manner to confirmation of the cure of a disease;
12. use excessive, alarming, or misleading depictions of changes in the human body caused by disease or injury and illustrate the effect of the medicine on these changes in the human body.

8.2 Medical devices 

Only general rules on advertising apply to the advertising of medical devices. Device advertising must also comply with Article 7 MDR.

Scientific data used in the advertisement must be accurate, up‑to‑date, verifiable and sufficiently complete, and clearly sourced (including date of preparation or update). For materials provided to persons authorised to prescribe or dispense medicines, documentation must enable the recipient to form their own view of the product’s therapeutic value; quotations, tables or graphics taken from journals or other scientific works must be faithfully reproduced with precise sources identified. All claims must be consistent with the SmPC. While the law does not enumerate or prohibit particular study types (e.g., “data on file”, retrospective or subgroup analyses, meta‑analyses), any study relied upon must be robust enough to substantiate the claim and not mislead; if used in comparative advertising, the characteristic compared must be objective and verifiable.

In general, comparative advertising is admissible if it complies with the list of restrictions stipulated in the Act on Advertising (comparisons must be objective, of products meeting the same needs/purpose, based on specific, typical, essential and verifiable characteristics and not be misleading, disparaging or confusing; price may be compared). The advertiser bears the burden to substantiate factual claims on request within 15 days; failing this, the comparative ad is deemed impermissible.

The comparative advertising is allowed in advertisements for the general public as well as for healthcare professionals. The advertisement must objectively compare products used for the same purposes or needs and at the same time compare at least one of specific, typical, essential and verifiable characteristics of products (medicines). The price can be the subject of comparison as well. Ensure any medicine‑related comparison also remains consistent with the SmPC and general medicine‑advertising rules. We recommend reviewing the statutory list for compliance check of the comparative advertising rules before any commencement of such type of advertising.

There are no specific rules for advertisement of medicines and medical devices on the internet/in social media posting. The same restrictions must be applied as in the case of any other advertising method. The relevant codes of conduct must also be observed.

Electronic channels are subject to the general advertising rules, including opt‑in for advertising sent by e‑mail, fax or automated calling systems; audiovisual and on‑demand services must also comply with the Media Services Act as well as the Advertising Act.

A hyperlink in the advertising text is a reference to another information source. In practice, linked material that substantiates or elaborates an advertising claim is assessed as part of the overall advertising communication, so any linked source must itself satisfy the Advertising Act (e.g., not be misleading and, for HCP materials, accurately reproduce and cite scientific sources).

Monitoring of compliance in the advertisement of medicine and medical devices sector is carried out by several public bodies, which include: 

• The State Institute for Drug Control supervises the advertising of medicines.
• The Trade Inspection supervises the advertising of medical devices.
• Penalties include prohibition of dissemination and administrative fines under the Advertising Act: up to EUR 100,000 for disseminators of advertising depending on the breach, and up to EUR 200,000 for advertisers (including for impermissible comparative advertising and specified breaches of the provisions on advertising of medicines). 
• Further, the Ministry of Health also supervises compliance with respective provisions of the Act on Medicines (some of these touch upon the subject of promotion and marketing). Marketing‑ and promotion‑expenditure reporting must be submitted electronically to the national centre by 31 January and 31 July for the preceding half‑year; failure to file, failure to notify a nil return, or filing inaccurate/incomplete data may attract a fine of EUR 10,000 imposed by the Ministry of Health.
• Moreover, the Council for Media Services supervises advertising disseminated via audiovisual media and on‑demand services under the Media Services Act; sanctions include orders to cease or remove the communication and fines.

There are no planned legislative changes in Slovakia that would modify the rules for advertising medicines or medical devices as of early 2026. Recent or upcoming amendments to pharmaceutical laws focus on reimbursement, categorization and prescribing processes.