Advertising

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).

Concerning notified homeopathic medicines, specific and transitional provisions were adopted by agreement between the FAMHP and RASH (Regulatory Affairs Society for Homeopathics) on the dossier contents to be submitted prior to the advice of the Homeopathic Medicine Commission (submission of a dossier made at least of module 1, part of Module 3 and Module 5 in full).
This advice will form the baseline upon which the procedures laid down by the aforementioned Royal Decree will be initiated.
The fees for obtaining this advice are those for the introduction of an application for registration or an application for marketing authorisation, to be paid upon submission of the dossier.
Further information can be obtained from

Wim Huygh
homeo@fagg-afmps.be

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 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
Place victor Horta, 40  bte 40
1060 Bruxelles

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 authorisation in our country may be the subject of advertising.
The advertising must be consistent with data that has been approved under the authorisation 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 - note 05.01.2017) - 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.

Advertising fee form

Table of Fees (2016 - French version)

Practical information concerning advertising for the general public: Advertising to the general public (12/2014)

 

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 authorisation.
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

- Communication 518

- The website http://www.mdeon.be and Mdeon brochures

   image de la brochure: visa pour le sponsoring de la formation continue     image de la brochure MDeon code de déontologie

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 authorised 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 authorised 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

 

 

 

 

 

 

 

 

 

 

 

 

Last updated on 18/07/2017