2. What procedure does the FSMA use to assess a distributor's compliance with the moratorium?

The assessment is carried out in the context of the classic procedure for the approval of marketing materials or of the registration of a product, where applicable (usual contact persons).

Compliance with the moratorium may also be discussed informally beforehand (

Where no approval of marketing materials or of a product is involved, the assessment is made on an ad hoc basis (

The FSMA will respond to a request for approval within a period of five working days starting from the day when the requisite information to be submitted to the FSMA is complete.