In cases where a marketing authorisation is transferred to a new MA holder, does the new MA holder report on the placement of the product on the market?

Yes, they do. As a result of the transfer to the new MA holder, the medicinal product is allocated a new SÚKL code for which distributor deliveries and pharmacy dispensing are subsequently reported. The new MA holder therefore has to report on the placement on the market for this new SÚKL code. The notification of placement of a medicinal product onto the market in case of transfer of the marketing authorisation to a new MA holder does not apply to centrally authorised medicinal products, as SÚKL codes of these products do not change upon a transfer of marketing authorisation to a new MA holder.