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February 1, 2026
Approximately 5 minutes
Regulations on Advertising, Premiums, Advantages, and Samples for Medicines in Belgium
Regulations on Advertising, Premiums, Advantages, and Samples for Medicines in Belgium
1. Overview
The Federal Agency for Medicines and Health Products (FAMHP) in Belgium oversees regulations on advertising, premiums, advantages, and samples for medicinal products for human use, ensuring rational use based on accurate information. These rules stem from EU Directive 2001/83/EC, the Belgian law of 25 March 1964 on medicines, and the Royal Decree of 7 April 1995. Source: https://www.famhp.be/en/human_use/medicines/medicines/proper_use/Advertising-premiums-advantages-samples
2. General Provisions for Advertising
Advertising is permitted only for medicines with valid marketing authorization in Belgium. It must align with approved data, promote rational use objectively without exaggeration, and avoid misleading claims. Mandatory elements for proper use must be included and legible. Prohibited dissemination methods include motorway signs (except nicotine-based anti-smoking medicines), telephone, direct mail, electronic mail, publications for children, and non-communicative objects. Source: https://www.famhp.be/en/human_use/medicines/medicines/proper_use/Advertising-premiums-advantages-samples
3. Advertising to the General Public
Only non-prescription medicines can be advertised to the public. Radio and television ads require prior approval from the Minister of Public Health based on the Commission for the control of medicinal product advertising's notice. Other media ads must be notified to FAMHP at least 30 days before publication. Source: https://www.famhp.be/en/human_use/medicines/medicines/proper_use/Advertising-premiums-advantages-samples
4. Advertising to Healthcare Professionals
Ads must conform to the summary of product characteristics and accepted marketing authorization elements. Written ads must dedicate at least half their surface to scientific information from the summary. Source: https://www.famhp.be/en/human_use/medicines/medicines/proper_use/Advertising-premiums-advantages-samples
5. Premiums and Advantages
It is forbidden to promise, offer, or grant premiums, monetary advantages, or in-kind benefits to prescribers, dispensers, administrators of medicines, or related institutions. Exceptions exist if conditions are met, such as compensation for legitimate scientific services or costs for scientific events. For events with overnight stays, prior visa from ASBL Mdeon is mandatory. Source: https://www.famhp.be/en/human_use/medicines/medicines/proper_use/Advertising-premiums-advantages-samples
6. Medicinal Samples
Free samples can be provided exceptionally only to authorized prescribers upon request, with a maximum of eight per medicine per year per prescriber. The marketing authorization holder must maintain a control system under the person responsible for pharmaceutical information. Source: https://www.famhp.be/en/human_use/medicines/medicines/proper_use/Advertising-premiums-advantages-samples
7. Reporting Violations
Violations can be reported to FAMHP's Directorate-general Inspection via written submission with evidence. Anonymity is preserved unless otherwise authorized. Source: https://www.famhp.be/en/human_use/medicines/medicines/proper_use/Advertising-premiums-advantages-samples
8. Additional Resources
Practical information, circulars, and Q&A documents are available for detailed guidance on approvals, fees, and electronic submissions. Last updated: 24/07/2024. Source: https://www.famhp.be/en/human_use/medicines/medicines/proper_use/Advertising-premiums-advantages-samples
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