|
Licence variations applications
|
Fee £ | |
|---|---|---|
| Marketing authorisation Single applications 1 |
||
| Type IA | National/CMS | No fee |
| Type IA | RMS | No fee |
| Type IB | National/CMS | 300 |
| Type IB | RMS/or Reference Authority for work sharing | 594 |
| Type II | National/CMS | 794 |
| Type II | RMS/or Reference Authority for work sharing | 962 |
| Type II Complex | National/CMS | 8,981 |
| Type II Complex | RMS/or Reference Authority for work sharing | 15,571 |
| Extended Type II Complex | National/CMS | 27,716 |
| Extended Type II Complex | RMS/or Reference Authority for work sharing | 38,744 |
|
Licence variations applications groups 1
|
Fee £ |
|---|---|
| Minor variations (Type IB) group fee where UK is | |
| - Concerned Member State | 672 |
| - Reference Member State or Reference Authority for work sharing | 1,324 |
| Major variation (Type II) group fee where UK is | |
| - Concerned Member State | 1,786 |
| - Reference Member State or Reference Authority for work sharing | 2,158 |
| Major variations (Type II) complex group fee where UK is | |
| - Concerned Member State | 9,738 |
| - Reference Member State or Reference Authority for work sharing | 16,465 |
| Major variation (Type II) extended complex group fee where UK is | |
| - Concerned Member State | 28,401 |
| - Reference Member State or Reference Authority for work sharing | 39,693 |
| National variation applications groups | |
| Minor variations (Type IB) group fee | 672 |
| Major variations (Type II) group fee | 1,786 |
| Major variations (Type II) complex group fee | 9,738 |
| Major variation (Type II) extended complex group fee | 28,401 |
|
Other licence variations applications
|
Fee £ | |
|---|---|---|
| Parallel import (PI) | ||
| Standard | 386 | |
| Administrative | No fee | |
| Manufacturers' licences (includes traditional herbal medicines) | ||
| Standard |
|
500 |
| Administrative | 250 | |
| Non-orthodox practitioner (NOP) | 250 | |
| Wholesale dealers' licences (includes THMPD) | ||
| Standard | 473 | |
| Administrative | 250 | |
| Clinical trial authorisations | ||
| Amendments to: | One part of dossier | 265 |
| Two parts of dossier | 530 | |
| Three parts of dossier | 795 | |
| Traditional Herbal Registration Scheme | ||
| Technical: | ||
| Standard | 260 | |
| Complex | 687 | |
| New recipient | 7,767 | |
| Administrative | 164 | |
| Notes: 1. Reductions for 'bulks' of single or group variations (ie same changes different authorisations belonging to the same company) are available. The reduction is 50% for minor or major standard bulk cases and a reduction to the standard fee for bulk major complex or major extended complex cases. |
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