Companies registered with their products in the Belgian reimbursement system with the AFMPS (Agence fédérale des médicaments et des produits de santé) must submit the annual turnover declaration on the sale or provision of medical devices by 31 March 2021 at the latest.
Please note that all economic operators, acting as manufacturers, distributors or importers (regardless of whether they are liable to pay contributions or not) must submit the turnover declaration to the AFMPS.
Liable to pay contributions or not?
- You are liable to pay contributionsif you supply Medical Devices to retailers and healthcare institutions. You must therefore provide all information from the turnover declaration, i.e. the total turnover, the total turnover for medical devices and the turnover for medical devices supplied in Belgium. The contribution is calculated based on this last turnover declaration.
- You are not liable to pay the contribution::
- if you do not provide medical devices to retailers and healthcare institutions
- if you are a retailer - a retailer who is a distributor and does not provide medical devices
In the latter case, you must still complete the declaration of turnover and tick the box ‘Je ne distribue pas de dispositifs médicaux ou leurs accessoires à un détaillant ni à un utilisateur final, je ne suis donc pas sujet à la contribution’ (I do not distribute medical devices or their accessories to retailers or end users, therefore I am not liable for the contribution).
It is important to note that the authorities no longer accept declarations in paper form or by e-mail.
- The application can be accessed via the following Link ,
- The declaration of turnover can be found under this Link
Please also note that this document must be certified by an auditor or accountant. The certificate must be scanned and uploaded to the turnover declaration in the AFMPS application.
If you have completed the registration via BEO BERLIN, you will be informed and prepared by us so that your registration and thus the reimbursement of your products remains valid.
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