Article 4 Medicinal products for human use covered by the procedures laid down in Directive 2001/83/ECF1F2

Referral fee

A referral fee of F3EUR 73 800 shall apply where the procedures laid down in Article 30(1) and Article 31 of Directive 2001/83/EC are initiated by the applicant of a marketing authorisation or the holder of an existing marketing authorisation.

Where more than one applicant of marketing authorisations or holder of existing marketing authorisations are concerned by the procedures referred to in the first subparagraph, the applicants or holders may be grouped for the purpose of the payment of one single referral fee. If however, the same procedure concerns more than ten different applicants or holders, the fee shall be charged by the application of the abovementioned referral fee.