|
Pre-application meetings
|
Fee £ | ||
|---|---|---|---|
| Quality development only | 2,378 | ||
| Safety development only | 2,378 | ||
| Quality and safety development | 3,308 | ||
| Clinical development only | 2,986 | ||
| Quality and clinical development | 3,917 | ||
| Safety and clinical development | 3,917 | ||
| Quality, safety and clinical development | 4,849 | ||
| Discussion on development of paediatric forms and uses meeting criteria for waiver set down in schedule 5 paragraph 10 of SI 2008 No 552 | No fee | ||
| Pre-consultation application meetings on devices incorporating an ancillary medicinal substance* | |||
| Quality development only | 832 | ||
| Safety development only | 832 | ||
| Quality and safety development | 1,054 | ||
| Clinical development only | 1,054 | ||
| Quality and clinical development | 1,443 | ||
| Safety and clinical development | 1,443 | ||
| Quality, safety and clinical development | 1,831 | ||
| Company discussion meetings | 4,810 | ||
| Pharmacovigilance advice meetings | |||
| Standard meeting | 3,309 | ||
| Major meeting | 3,917 | ||
| Post-authorisation regulatory advice meetings | 2,986 | ||
| Advertising advice | 2,378 | ||
| Advice on labels and leaflets | 2,378 | ||
| Reclassification advice meetings | |||
| P to GSL switch | 2,986 | ||
| POM to P switch | 3,917 |
*Scientific advice on the medicinal substance aspects of the device product. For more information see our section on devices incorporating an ancillary medicinal substance.
