Update on the pharmacovigilance system for Luxembourg

Luxembourg

There has been an update on:

1. New instructions for the preparation and submission of additional risk minimisation material (aRMM) for evaluation and approval in Luxembourg:

• update contact detail adverse event reporting
• update address to send the printed materials to

2. New INSTRUCTIONS FOR MARKETING AUTHORISATION HOLDERS FOR DISTRIBUTION OF DIRECT HEALTHCARE PROFESSIONAL COMMUNICATION (DHPC) IN LUXEMBOURG
   1. Clear instructions on which information/documents must be submitted to the Directorate of Health, Division of Pharmacy and Medicinal Products before approval and after distribution of the DHPC.
   2. Important points to consider concerning DHPC content.

3. New form for the ‘Notification of the contact person for pharmacovigilance at national level’: a new form has been published and the postal address has been removed so as of now, the notification can only be submitted by means of this form.

Source: Information for MA holders – Health Portal – Luxembourg (public.lu)