On 16 October, the Belgian federal agency for medicines and health products (FAMHP) has introduced a new application for the effective management of marketing authorisation and vigilance dossiers.
Data Tracking System (DTS) will replace 4 MeSeA applications:
- handling marketing authorisations and vigilance files for medicinal products for human use,
- handling marketing authorisations for medicinal products for veterinary use,
- handling marketing authorisations for plant-based medicinal products,
- handling marketing authorisations for homeopathic medicinal products
Along with the go-live of DTS, the allowance system for payment is being permanently abandoned; from now on, they will work through invoicing (on a monthly basis). If there is a remaining amount available on your allowance account, you will receive an invoice. Collection will take place through the remaining allowance, as long as it exists. All other invoices remain unchanged and must be paid.
When submitting a file, the following information should be included in the (electronic) Application Form or cover letter:
- the marketing authorisation holder’s VAT number
- PO number (if applicable)
Advance payments are therefore no longer required.