In case of a transfer of marketing authorisation to a new MA holder, which results in suspended or terminated marketing of the original medicinal product, is it necessary to report the suspension or termination and who should file such report? The new MA holder or the previous one?

Yes, suspended or terminated marketing in case of a transfer of marketing authorisation to a new MA holder has to be reported. If marketing is suspended or terminated before the decision on the transfer of marketing authorisation becomes final, the existing (previous) MA holder is obliged to inform SÚKL to this effect. After the finality of the decision on the transfer of marketing authorisation, the suspension or termination of marketing has to be reported by the new MA holder, as in compliance with Section 36, paragraph 4, sentence one and two of the Act on Pharmaceuticals, the new MA holder fully enters into the rights and obligations of the previous MA holder.
The notification on suspended/terminated marketing in case of a transfer of marketing authorisation to a new MA holder does not apply to centrally authorised medicinal products, as SÚKL codes of these medicinal products do not change upon the transfer of marketing authorisation to the new MA holder.