Pharmaceuticals - New Royal Decree On Medicinal Products For Human Use

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;