To ensure a high level of consumer protection, advertising for medicinal products for human use is, beside the general rules about advertising, also subject to specific legislation whose objective is the rational use of medicines, objectively, on the basis of accurate and complete information.
The regulation of advertising for medicinal products for human use is based on:
Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 establishing a Community Code on medicinal products for human use, the law of 25 March 1964 (French version) on medicines and the Royal Decree of 7 April 1995 (French version) about information and advertising concerning medicinal products for human use.
Some general provisions regulate the content of advertising for medicinal products and limit its means of dissemination.
Some provisions are specific for advertising to the public or for advertising to health professionals.
The range of premiums or advantages to physicians, pharmacists, dentists and the institutions involved in prescribing, dispensing or administering of medicinal products is also strictly regulated. See in this regard circulars 465 (French version), 487 (French version), 489, 513, and communication 518 (French version).
If you know of any facts that are inconsistent with that law, you can communicate it to the contact point. For more information, see communication 572.
The contact point receives and centralizes information concerning events that may constitute violations of provisions relating to the fight against excessive promotion of medicinal products as referred to in the law of December 16, 2004 (French version).
Include under this law are the provisions of Article 10 of the law of 25 March 1964 (French version) on medicinal products that have also been made applicable to medical devices and accessories by the law of 27 April 2005 (French version) concerning the control of the health care budget and containing various provisions relating to health.
Any person in possession of such information may send it to:
Contact-point
Federal Agency for Medicines and Health Products
Directorate-general Inspection
Avenue Galilée 5/03
1210 Brussels
The information must be written and submitted by registered mail or hand delivered to a member of staff of the Directorate-general Inspection at FAMHP.
The information shall include, if possible, evidence of material elements.
The name and address of the author must be mentioned.
The anonymity of the person providing the information is preserved, unless if the person authorizes the disclosure of his/her identity.
If information is communicated anonymously, it will be considered only if accompanied by evidence of material elements.
You can find more information about this contact point in the Royal Decree of 10 June 2006 (French version).
The person responsible for pharmaceutical information checks the compliance of advertising
General dispositions
Only medicinal products that have a valid marketing authorization in our country may be the subject of advertising.
The advertising must be consistent with data that has been approved under the authorization of the medicinal product on the market.
The advertising must encourage the rational use of medicinal product by presenting it objectively and without exaggerating its properties. It cannot be misleading.
Advertising must contain a number of mandatory elements essential for proper use of the medicinal product. These mandatory elements must be legible.
See in this regard Circular 407 (French version) and Circular 441 (French version).
Some means of dissemination are not allowed for an advertisement for a medicinal product, for example:
- Signs on the motorway (except for nicotine-based medicines against dependence on smoking),
- Telephone, direct mail, electronic mail,
- Publications for children,
- Objects of any kind to be used, partially or totally, for any purpose other than to communicate information.
For more information, see sections 1-5 of the Royal Decree of 7 April 1995 (French version).
Practical information concerning the general dispositions: Regulations regarding advertising for medicinal products - General dispositions
Advertising for the general public
Only medicinal products that are not subject to prescription can be the subject of advertising to the public.
This advertising is subject to prior control before its release:
- Advertising broadcast on radio or television must obtain prior approval granted by the Minister of Public Health, upon notice from the Commission for the control of medicinal product advertising (meeting dates in 2021 - meeting 30/12/2021 - meeting dates in 2022) - circular 612 (French version).
- Advertising broadcast on other media must be notified to the Federal Agency for Medicines and Health Products (FAMHP) at least 30 days before publication
For more information see sections 6-8 and 16-19 of the Royal Decree of 7 April 1995 (French version) relating to information and advertising concerning medicinal products for human use.
Table of Fees (French version - update : 02/2022)
Practical information concerning advertising for the general public: Advertising to the general public (12/2014)
Questions and answers
The FAMHP will continue to accept the electronic submission of these files instead of submission by registered letter. Submission by registered letter cannot be refused. However, the FAMHP strongly recommends the electronic submission of a file.
The FAMHP requests that all documents required on the basis of Article 18, § 1 of the Royal Decree of 7 April 1995 relating to the information and advertising concerning medicinal products for human use should be submitted as separate documents, each with a univocal name. The submission of the various documents bundled into one large PDF file containing all documents will no longer be accepted. This will be checked when the file is submitted, and if the file does not meet this requirement, the file will be considered incomplete, in accordance with Article 17, §2 of the Royal Decree of 7 April 1995. The applicant will then have to complete the file.
Advertising to healthcare professionals
All advertising to doctors, pharmacists and dentists must conform to the summary of product characteristics and to elements of the case accepted with the marketing authorization.
If the advertising is written, it shall include, on at least half of its surface area, some scientific information extracted from the summary of product characteristics.
For more information, see articles 9-12 of the Royal Decree of 7 April 1995 (French version) relating to information and advertising concerning medicines for human use.
Practical information concerning advertising to healthcare professionals: Advertising intended for healthcare professionals
Premiums and advantages
It is forbidden when prescribing, providing, supplying or administering medicinal products, to promise, offer or grant, directly or indirectly, premiums or monetary advantages or benefits in kind to persons qualified to prescribe, dispense or administer medicinal products and to the institutions in which the prescribing, dispensing or administering of medicinal products take place.
However, this prohibition does not apply to certain premiums and advantages provided a number of cumulative conditions set forth in the law are strictly adhered to. This is the case, for example, for compensation for legitimate services of a scientific nature or the invitation and support costs related to participation in certain events for purely scientific purposes. In this regard, the regulations provide that prior to any scientific event comprising at least one night, it is mandatory to obtain a visa from ASBL Mdeon.
For more information see
- Article 10 of the law of March 25, 1964 (French version) about medicinal products
- Circulars 465 (French version), 487 (French version), 489, 513
- The website http://www.mdeon.be and Mdeon brochures
Fees for scientific services: guidelines (French version)
Medicinal samples
The delivery of free medicinal product samples by pharmaceutical companies which is also a form of advertising is regulated.
The person responsible for the marketing of a medicinal product can furnish samples, exceptionally, only to persons authorized to prescribe medicinal products and on their demand.
The maximum number of samples that can be awarded is limited to eight per medicinal product, per calendar year and per person authorized to prescribe medicinal products.
The person responsible for placing on the market must have an adequate system for controlling the distribution of samples, under the responsibility of the person responsible for pharmaceutical information.
For more information see the Royal Decree of 11 January 1993 (French version) establishing the conditions under which the delivery of medicinal products for human use as samples can be performed, and Circular 503 (French version) + Annex.
Practical information concerning medicinal samples: Samples legislation
The FAMHP has written a question-and-answer document (available in Dutch & French) to assist relevant MAH and registration holders in interpreting and enforcing medical sample legislation.