The Belgian Regulatory Authority (FAMHP) published background information on the structure and content of the Risk Management Plan that may be required for some medicinal products.
Prior to their distribution, educational materials developed as part of the organisation of risk limiting activities, require FAMHP approval.
Circular letter 532 bis explains the in detail the procedure to be followed. Also a document listing 10 key attention points is published. Applicants can contact our Qualified Persons for Pharmacovigilance for hands-on support and assistance.