Responsible for information

Each firm responsible for the marketing of a medicinal product needs the cooperation of a person responsible for pharmaceutical information, who checks, before publication, that all advertising made by the company conforms with the laws and regulations concerning medicinal products advertising.

The person responsible for information is a doctor or a pharmacist approved by the Ministry of Public Health.

To be approved the person must prove experience of at least one year in the field of pharmaceutical information.

For more information see Articles 13-15 of the Royal Decree of 7 April 1995 (French version) about information and advertising concerning medicinal products for human use.

Practical information concerning the person responsible for information: Responsible for information and publicity

The FAMHP letter of October 2017 sent to all  Marketing Authorization Holders (MA) and registration of medicinal products for human use, located in Belgium and abroad, describes the legal obligation to appoint a certified responsible for information and to communicate his designation to the FAMHP.

It is recommended that the standard form be used to communicate this designation to the FAMHP.

The FAMHP has compiled a document containing questions and answers to help professionals interpret and apply the legislation concerning the responsible for information correctly (only availabe in Dutch & French).

More information regarding fees: Dutch: Meer informatie i.v.m. de bijdragen & French: Plus d’information sur les rétributions


Last updated on 22/03/2024