There has been an update on:
- 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
- New INSTRUCTIONS FOR MARKETING AUTHORISATION HOLDERS FOR DISTRIBUTION OF DIRECT HEALTHCARE PROFESSIONAL COMMUNICATION (DHPC) IN LUXEMBOURG
- 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.
- Important points to consider concerning DHPC content.
- 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.