| 7.01 |
Fee for issuing a certificate |
144,71 |
| 7.02 |
Fee for scientific advice for medicines, including multidisciplinary questions on (a) quality, safety and clinical development, or (b) quality and clinical development or (c) safety and clinical development, or (d) presubmission advice |
4.309,3 |
| 7.03 |
Fee for scientific advice for medicines, including questions about (a) clinical development, or (b) quality and safety or (c) quality and bioequivalence studies in the case of generic medicines |
3.122,97 |
| 7.04 |
Fee for scientific advice for medicines, including questions about (a) quality or (b) safety or (c) bioequivalence studies in the case of generic medicines |
2.063,4 |
| 7.05 |
Fee for follow-up advice in those cases included in subsection 7.2 |
2.063,4 |
| 7.06 |
Fee for follow-up advice in those cases included in subsection 7.3 |
1.561,5 |
| 7.07 |
Fee for follow-up advice in those cases included in subsection 7.4 |
1.003,82 |
| 7.08 |
Fee for advice on classifying variations that have not been classified, in accordance with article 5, and for the grouping of variations, in accordance with article 7 of European Commission (EC) Regulation 1234/2008 |
501,9 |
| 7.09 |
Fee for scientific advice on medicines for paediatric use in any of the cases included in the above subsections |
209,13 |
| 7.10 |
Scientific/technical advice on the design of facilities and manufacturing processes in accordance with good manufacturing practices |
501,9 |
