Pharmaceutical advertising regulation and medical device advertising in Belgium

1.1 Medicines 

The main rules applicable to advertising medicines are contained in the Law of 25 March 1964 on medicinal products, as well as in the Royal Decree of 7 April 1995 on information and advertising concerning medicinal products for human use. 

The main rules regarding advertising for medical devices are contained in the law of 25 March 1964 on medicinal products, in the law of 22 December 2020 on medical devices, and in the law of 15 June 2022 on in vitro diagnostic medical devices.

2.1 Medicines 

The pharma.be Code of Conduct is a code adopted by companies operating in the pharmaceutical sector, which defines the requirements with which the industry must comply. It covers all interactions between member companies and healthcare professionals, as well as healthcare organisations and patient organisations.

The Mdeon Guide regulates interactions between the pharmaceutical/medical device industry and healthcare professionals. This guide establishes strict ethical principles to preserve the independence of healthcare providers in the best interests of patients. 

2.2 Medical devices 

The BeMedTech Code of Ethics (Code established by the Belgian Federation of the Medical Technology Industry) applies and aims at ensuring that the information and advertising provided by companies regarding the medical devices they market adhere to high scientific standards, and that the industry’s contribution to continuing education and research on medical devices meets rigorous quality standards.

The MDeon Guide is also applicable to medical device. 

3.1 Medicines

For advertising aimed at the general public, Article 16 of the Royal Decree of 7 April 1995 stipulates that the Minister of Public Health must be notified of the advertisement at least 30 days before it is broadcast.

In the case of radio and television broadcasts of advertising or information campaigns relating to human health that refer directly or indirectly to a medicinal product, instead of notification, a visa must be requested from the Minister of Public Health, after assessment by the Medicines Advertising Control Commission.

Each visa/notification is valid for two years. The fees updated on 1 January 2026 are EUR 1,227.40 for a visa application (EUR 613.70 for a visa renewal application) and EUR 730.54 for a notification (EUR 365.91 for a notification renewal).

There is no visa or notification requirement for advertising aimed at healthcare professionals.

3.2 Medical devices 

There is no prior approval or license requirement for medical device advertisement. 

Yes. 

Under article 9 of the Law of 25 March 1964, advertising to the general public is not allowed to advertise medicines that are subject to a medical prescription. 

5.1 Medicines 

Advertising may only be carried out for medicines that are duly marketed in Belgium, and only for over-the-counter medicines (See Section 4). Any advertising directed at the general public for drugs that contain psychotropic substances or narcotics as defined by international conventions is also prohibited. 

Besides the fact that the advertisement must have been notified or that a visa must have been obtained (See Section 3), Article 13 of the Royal Decree of 7 April 1995 requires the marketing authorisation holder or registration holder, when the advertising originates from them, to involve a Minister‑licensed information representative (a healthcare professional registered on a list drawn up by the Minister) and maintain a permanent link with a scientific service responsible for ensuring the compliance of all medicinal‑product information.

In Belgium, it is prohibited to advertise medicines through certain channels of communication, which are exhaustively listed in Article 5 of the Royal Decree of 7 April 1995. Many of these prohibitions have fallen into disuse. Still (relatively) relevant is the prohibition on advertising in publications intended for children.

Furthermore, advertising of a medicinal product to the general public is prohibited if it contains any element that: 

• 1° would make medical consultation or surgical intervention appear unnecessary, in particular by offering a diagnosis or recommending treatment by correspondence;
• 2° would suggest that the effect of the medicinal product is guaranteed, without side effects, and superior or equal to that of another treatment or another medicinal product
• 3° would suggest that the normal good health of the subject can be improved by the use of the medicinal product
• 4° would suggest that the subject's normal good health could be affected if the medicine is not used
• 5° would be aimed exclusively or mainly at children
• 6° would refer to a recommendation from scientists, health professionals or persons who, although not scientists or health professionals, may, by virtue of their notoriety, encourage the consumption of medicines
• 7° would equate the medicine with a foodstuff, cosmetic product or other consumable product
• 8° would suggest that the safety or efficacy of the medicine is due to the fact that it is a natural substance
• 9° could lead to a false self-diagnosis through a detailed description or representation of the medical history 
• 10° would refer in an abusive, frightening or misleading manner to statements of healing
• 11° would use in an abusive, frightening or misleading manner visual representations of alterations to the human body due to disease or injury, or the action of a medicine in the human body or parts thereof
• 12° would use images, drawings, photographs or representations that could undermine the essentially informative and sober nature that advertising for medicines must have, or would play on the motivation of its recipients other than that of rationally persuading them to use a medicine to treat or prevent an ailment or disease, or to establish a medical diagnosis or restore, correct or modify organic functions

Advertisement aimed at the general public must be designed in such a way that the advertising nature of the message is obvious and the product is clearly identified as a medicine. 

It must also include certain mandatory information (See Section 8). 

5.2 Medical devices 

Only medical devices that have a CE marking may be advertised. 

It is permissible to advertise both non-reimbursable and reimbursable medical devices, but advertising that mentions that the medical devices are provided free of charge or refers to the contribution made by health insurance towards the cost of these services is prohibited.

It is also prohibited to advertise to the general public implantable medical devices and procedures involving the insertion or implantation of such medical devices.

6.1 Medicines

Advertising to HCPs for medicine is authorised (even for prescription-only medicines), provided that certain information appears in the advertisement (See Section 7). 

Free samples of medicines may be provided by the marketing authorisation holder to persons authorised to prescribe medicines, provided that : 

• The HCP must have specifically requested it in the first place; 
• These are samples of a medicinal product, at least one form of which is currently on the market; 
• A maximum of eight samples per product and per year is given to the HCP; 
• The sample is no larger than the smallest presentation available for sale in Belgium or smaller packaging described in the marketing authorisation; 
• These samples cannot be sold, and their package labels “free sample – cannot be sold” or any similar disclaimer in a visible and clear fashion; 
• The marketing authorisation holder has an appropriate system in place to monitor the distribution of those samples. 

6.2 Medical devices 

Advertising to HCPs of medical devices is allowed in Belgium. 

Medical devices can only be provided for free if it is aimed for the HCP to be acquainted with the product and as far as it cannot be considered as a illegitimate gift. 

7.1 Medicines 

Any advertising directed at a healthcare professional authorised to prescribe or dispense a medicinal product must clearly state (1) the name of the medicinal product, its qualitative and quantitative composition in terms of active ingredients and its pharmaceutical form, (2) all the information contained in the sections on indications, dosage, contraindications and adverse effects in the summary of product characteristics (or in the package leaflet or labelling if the advertisement concerns a homeopathic medicinal product), (3) the name or business name of the marketing authorisation or registration holder and the marketing authorisation or registration number of the medicinal product; (4) the classification of the medicinal product in terms of dispensing, and (5) for each package placed on the market, the retail price of the medicinal product concerned, as specified in the Royal Decree. 

The information referred to in points (1) to (3) must cover at least 50% of the surface area of the advertisement.

The documentation containing the above information must specify the date on which it was last drawn up or revised. The information contained therein must be accurate, up to date, verifiable and sufficiently comprehensive to enable the recipient to form their own opinion of the medicinal product’s therapeutic value. 

The summary of product characteristics, or the package leaflet and/or labelling in the case of a homeopathic medicinal product, must also be made available to the person authorised to prescribe or supply medicinal products.

7.2 Medical devices 

There are no specific advertising restrictions applicable to medical devices when advertising is directed at healthcare professionals.

8.1 Medicines

Advertising aimed at the general public must be designed in such a way that the promotional nature of the message is obvious and the product is clearly identified as a medicine.

All advertising aimed at the general public must also include certain mandatory information:

• 1° the name of the medicine, as well as the common name when the medicine contains only one active ingredient;
• 2° the information essential for the proper use of the medicinal product;
• 3° the statement ‘this is a medicinal product, do not use for prolonged periods without medical advice’;
• 4° the statement ‘traditional herbal medicinal product to be used for one or more specified indications based exclusively on long-standing use’, where the advertising concerns a traditional herbal medicinal product.
• 5° an express invitation to carefully read the instructions contained in the package leaflet or on the outer packaging, as applicable ; 
• 6° the name or business name of the marketing authorisation holder. 

8.2 Medical devices 

There are no legal specific advertising restrictions applicable to medical devices in advertising aimed at the general public, apart from the ban on advertising active implantable medical devices, and the fact that the contribution from the statutory health insurance scheme must not be mentioned.

The general prohibition on misleading advertising under the Belgian Economic Law Code requires advertisers to ensure that their promotional claims are accurate and scientifically sound, whether they concern medical devices or medicines.

In the context of advertising medicinal products to healthcare professionals, it is expressly stated that quotations, tables and other illustrations taken from medical journals or scientific publications and used in the product information must be reproduced accurately, and the exact source must be specified. The original text must be made available to any healthcare professional who requests it.

Advertisements directed at the general public must not contain any comparative reference to other medical devices, medicines or treatments that represent the advertised product as equivalent or superior. It is forbidden to make individual references, in particular by naming or graphic illustration. The reference to active substances is also prohibited in case the active substance is part of the trade name. 

Comparative advertising directed at HCPs is generally permitted. Statements must be up-to-date, verifiable and complete. Quotations, including references, must be reproduced exactly from specialist literature.

Furthermore, statements must neither be misleading nor discredit the medical device, the drug or the active substance of a competitor. 

There is no specific regulatory framework governing the advertising of medicines or medical devices on the internet. Such advertising is therefore subject to the same rules as those set out above. 

Advertising of medicines to the general public must be notified if it is published on the internet or on a social media platform.

For advertising of medicines to the general public, the fact that it is prohibited to include a recommendation from “any person who, by virtue of their notoriety, could influence the consumption of medicines” makes partnerships with well-known personalities or influencers a delicate matter.

The main body which supervises compliance with advertisement provisions is the Federal Agency for Medicines and Health Products (FAHMP). 

12.1 Medicines

Administrative sanctions 

The Minister may, on the advice of the Medicines Advertising Control Commission, suspend or withdraw the accreditation of the person responsible for the information, or withdraw the approval of the advertisement. 

He may also, if he considers it necessary in the public interest, proactively ban such advertising or order its cessation, where appropriate requiring the advertiser to publish his decision or issue a corrective statement, if necessary. 

Criminal sanctions 

Anyone who breaches a provision relating to the advertising of medicines is liable to imprisonment for a term of between one month and one year and a fine of between €2,000 and €150,000. 

If the person breaching this prohibition is a legal person, only a fine may be imposed, whose amounts range from 5.000 EUR to 300.000 EUR. 

12.2 Medical devices 

Any person who advertises implantable medical devices (or procedures intended to insert or implant such devices) to the general public shall be punished by imprisonment for one to three years and a fine of between €10,000 and €1,000,000, or by one of these penalties alone. If the entity in question is a legal entity rather than an individual, only a fine may be imposed, ranging from EUR 60,000 to EUR 2,000,000. 

Not as far as advertising is concerned, but the criminal Code will soon be reformed in Belgium (it is now supposed to enter into force for September 2026), which might incur a modification in the sanctions foreseen for violation of the aforementioned legal provisions (see Section 12).