To ensure a high level of protection of animals and consumers of food of animal origin, advertising for medicinal products for veterinary 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 veterinary use is based on:
Directive 2001/82/EC of the European Parliament and the Council of 6 November 2001 establishing a Community Code on medicinal products for veterinary use, the law of 25 March 1964 (Fench version) on medicines and the Royal Decree of 9 july 1984 (French version) about information and advertising concerning medicinal products.
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 veterinarians, pharmacists and managers of animals 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 (French version).
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 16 December 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 concerning the control of the health care budget and containing various provisions relating to health.
The law of 16 December 2004 (french version) also amended section 17 of the law of 28 August 1991 (French version) concerning the practice of veterinary medicine.
Any person in possession of such information may send it to:
Federal Agency for Medicines and Health Products
Place victor Horta, 40 bte 40
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.
Only medicinal products that have a valid marketing authorisation in our country may be the subject of advertising.
The advertising must be consistent with data that has been approved under the marketing authorisation of the medicinal product.
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.
Some means of dissemination are not allowed for an advertisement for a medicinal product, for example:
- Radio and television;
- Panels / posters in public places, illuminated signs;
- Publications for children;
- Objects of any kind to be used, partially or totally, for any purpose other than to communicate information. See in this regard the circular of 7 May 1996 (French version).
For more information, see sections 1-7 of the Royal Decree of 9 July 1984 (French version) relating information and advertising concerning medicinal products.
Advertising for the general public
Only medicinal products that are not subject to prescription can be the subject of advertising to the public.
For more information see sections 12-15 of the Royal Decree of 9 July 1984 (French version) relating to information and advertising concerning medicinal products.
Advertising to health professionals
All advertising to veterinarians or pharmacists must conform to the summary of product characteristics.
If the advertising is written, it shall include, clearly legible, some scientific information extracted from the summary of product characteristics.
For more information, see articles 8-11 of the Royal Decree of 9 July 1984 (French version) relating to information and advertising concerning medicinal products.
Premiums and advantages
It is forbidden when providing, prescribing, supplying or administering medicinal products for veterinary use, to promise, offer or grant, directly or indirectly, premiums or monetary advantages or benefits in kind to persons who provide medicinal products for veterinary use. Persons responsible for animals are also covered by this provision.
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 and 513.
- Communication 518 (French version)
- The website www.mdeon.be
Medicinal samples for veterinary use
The delivery of free samples of medicinal product for veterinary use 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 only to custodian veterinarians in exchange of a purchase order.
Medicinal products given as samples must be administrated by veterinarians themselves and must enable them to become familiar with the new medicinal products. The supply of samples is however limited to the following situations:
- The medicinal product contains a new composition in active ingredients;
- The medicinal product was approved for a new indication;
- The medicinal product was approved for a new administration mode;
- The medicinal product is intended for new target animals.
The maximum number of samples that can be given is limited to one per medicinal product and custodian veterinarian. The sample can only be given during the first year following the effective marketing of the medicinal product or after the approval of the new indication, the new administration mode or the new group of target animals.
The person responsible for the marketing must have an adequate system for controlling the distribution of samples, under the responsibility of the person responsible for pharmaceutical information.
Each year, the person responsible for information must communicate to FAMHP the number of samples that are given, clearly specifying each concerned medicinal product.
This communication should be addressed preferably by e-mail to email@example.com being sure to mention the name of the company concerned in the "Subject" field of the email. Communications by post should be addressed to:
The Federal Agency for Medicines and Health Products (FAMHP)
DG Inspection - Industry Division
Place victor Horta, 40 bte 40
For more information see the Royal Decree of 11 July 1993 (French version) establishing the conditions under which the delivery of medicinal products for veterinary use as samples can be performed.