Notice to pharmaceutical companies concerning the reporting of the commercialisation of medicinal products to the FAMHP
How to report the commercialisation of a medicinal product?
The pharmaceutical company involved is to report the commercialisation of a medicinal product by completing the online form for the designated reporting point.
When to report the commercialisation of a medicinal product?
The pharmaceutical company involved is to report the commercialisation of a medicinal product as soon as the effective date of commercialisation is known.
In order to keep all commercialisation status information up-to-date, it is imperative that commercialisation be reported at least 15 working days before the effective date of commercialisation.
Why is it important to report commercialisation promptly?
Prompt notification of commercialisation is essential in order to keep the medicinal product databases up-to-date on the websites of the FAMHP, the asbl CBIP - BCFI vzw, SANITEL-MED and the Authentic Source on Medicines (SAM).
The Authentic Source on Medicines is used for:
- electronic application procedures for Chapter IV of the RIZIV/INAMI,
- electronic medical prescriptions,
- updating pharmacotherapeutic information (e.g. International Non-Proprietary Name (INN) prescription groups).
Circular 605 from 23 December 2013