On 7 April, 1995, a new Royal Decree on information and publicity regarding medicinal products for human use has been enacted. This Royal Decree replaces the Royal Decree of 9 July 1984 as amended, which only remains in effect with respect to medicinal products for veterinary use.

The new Royal Decree implements Council Directive 92/28EEC of 31 March 1992 on the advertising of medicinal products for human use.

The main changes, as compared to the Royal Decree of 9 July 1984, are summarised hereafter.

The definition of publicity for medicinal products is enlarged.

Advertising directed to the general public must be in line with the scientific instruction leaflet (whereas, until now, only the general instruction leaflet had to be complied with); advertising directed to the general public also must contain certain mandatory mentions and avoid any misleading representation as to its advertising purpose;

Advertising directed to persons qualified to prescribe or supply medicinal products can be carried out by mail or fax upon the request of these persons; such advertising does not need to include the normally required essential information or supply classification but may only refer to the name of the medicinal product concerned, if this advertising is intended solely as a reminder.

Medical sales representatives entrusted with the publicity and information regarding medicinal products must be adequately trained and have the necessary scientific background, these requirements being not specifically defined in the Royal Decree.

The organisation of symposia, lectures or other events intended for medical professionals and relating to the promotion of medicinal products must be reasonable and in proportion to the main purpose of the meeting which must remain scientific.

For advertising directed to the general public on radio or television, a prior authorisation must be obtained from the Ministry of Public Health, whereas all other advertising directed to the general public must only be notified to the Ministry of Public Health. For each authorisation or notification, a charge must be paid.

The content of this article is intended to provide general information on the subject matter. It is not a substitute for specialist advice.

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