On 16 October 2023, the Data Tracking System (DTS) dossier will go live within the FAMHP. This application replaces four MeSeA applications. DTS provides additional functionalities that facilitate the effective management of dossiers in the context of marketing authorisation and vigilance.
On 16 October 2023, the Data Tracking System (DTS) file will go live within the FAMHP. This application replaces four MeSeA applications (for handling marketing authorisations and vigilance files for medicinal products for human use, for handling marketing authorisations for medicinal products for veterinary use, for handling marketing authorisations for plant-based medicinal products and for handling marketing authorisations for homeopathic medicinal products).
DTS provides additional functionalities that facilitate the effective management of files concerning marketing authorisations and vigilance. The system will later be connected with an eCTD viewer. The eCTD viewer will ensure future compatibility with eCTD 4.0.
In order to ensure a correct and smooth transition, it was opted to migrate the pending files from the MeSeA applications to DTS. For the applicant, this means that the previous MeSeA file ID will be replaced by a DTS ID. The FAMHP will include both file IDs (from MeSeA and from DTS) with each communication for these files. Automatic emails have also been updated and will include the new DTS file ID.
Along with the go-live of DTS, the allowance system for payment is being permanently abandoned; from now on, we will work through invoicing. When switching from MeSeA to DTS, 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.
The FAMHP reminds you that, in accordance with annex VII of the financing law, the holder of the registration or marketing authorisation (MA) is considered the fee payer for the files that will be processed within DTS. Therefore, when submitting your file, we request that you include the marketing authorisation holder's VAT number in the (electronic) Application Form. If the Application Form does not provide a field for this, you are requested to include this number in the cover letter in order to ensure a smooth invoicing process. If you use a PO number, you must mention it in the electronic application form or cover letter.
Invoicing procedure
Do not pay in advance but on an invoice basis. Please include the structured message that appears on the invoice with each payment, this is the only way we can link the payment to the correct invoice, even if a third party (e.g. the submitter) pays it.
Further clarifications
- You will receive one monthly invoice with all files from the previous month.
- Each invoice will have an attachment containing all the details.
- A PO number may be transmitted. This will be included in the attachment of the invoice.
- When submitting your file, please mention:
- the VAT number;
- the address of the marketing authorisation holder (= legal fee payer) who is to pay the invoice (if the marketing authorisation holder does not pay him-/herself, he or she is free to forward the invoice to the party who will make the payment. Using the PO number mentioned in the invoice attachment can help with this). - The FAMHP has switched to digital invoicing. Send your email address for invoicing to fin@famhp.be or sign up for invoicing through Peppol.
- Any bank costs for payments from abroad should not be charged to the FAMHP. These costs are borne by the payer.
We do not allow any exceptions to this practice.
Good to know
Invoicing for files newly uploaded into DTS: IDs start with 400.
Allowances remain valid for:
- pending MeSeA files migrated to DTS for further follow-up. DTS file IDs start with 100.
- MeSeA files: the file ID starts with a different number combination.