| FEE STRUCTURE (updated July 2015) |
| |
|
Per Application: |
Per Site: |
Per Amendment: |
Fee set by Legislation: |
| MEDICINES for Human Use |
Sponsor-Led Clinical Trials |
€1,000 |
€150 |
€200 |
Yes |
| Investigator-Led Clinical Trials |
€150 (waived) |
Nil |
€50 (Waived) |
Yes |
| MEDICAL DEVICES for human use |
Sponsor-Led Clinical Trials |
€1,000 |
Nil |
Nil |
No |
| Investigator-Led Clinical Trials |
Nil |
Nil |
Nil |
No |
| COSMETIC PRODUCTS for human use |
Sponsor-Led Clinical Trials |
€1,000 |
Nil |
Nil |
No |
| Investigator-Led Clinical Trials |
Nil |
Nil |
Nil |
No |
| FOOD AND FOOD SUPPLEMENTS for human use |
Sponsor-Led Clinical Trials |
€1,000 |
Nil |
Nil |
No |
| Investigator-Led Clinical Trials |
Nil |
Nil |
Nil |
No |
| Other Applications: |
Submitted by a pharmaceutical company / medical device company |
€600 |
Nil |
Nil |
No |
| OTHER |
NIL |
NIL |
NIL |
No |