Part III FEE FOR ASSESSMENT IN THE CONTEXT OF REFERRALS INITIATED AS A RESULT OF THE EVALUATION OF PHARMACOVIGILANCE DATA REFERRED TO IN ARTICLE 6F1

United Kingdom Repealed

1. 1The fee for the assessment of the procedure referred to in Article 6(1) shall be EUR 190 740 where one or two active substances and/or combinations of active substances are included in the assessment. That fee shall be increased by EUR 41 350 per each additional active substance or combination of active substances as of the third active substance or combination of substances. That fee shall not exceed EUR 314 790 irrespective of the number of active substances and/or combinations of active substances.
2. 2For the purpose of calculating the amount to be levied on each marketing authorisation holder in application of Article 6(4), the Agency shall calculate the proportion of chargeable units held by each marketing authorisation holder concerned of the total number of chargeable units held by all marketing authorisation holders involved in the procedure.
3. 3In application of Article 6(5), the amount payable by the marketing authorisation holder shall be two thirds of the applicable fee laid down in point 1 of this Part. Small and medium-sized enterprises shall pay 60 % of that amount.
4. 4Division 4