Paragraph 2
The application fee for any other variation to a marketing authorisation (other than a mutually recognised marketing authorisation), or for any variation to a product licence, shall be £2,220 except in the following cases, where the fee shall be the amount specified:—
| Fee | ||
|---|---|---|
| Type of application | £ | |
| a. | Change which is made where there is identical supporting data relating to another product which is also being changed, all the products are from the same marketing authorisation holder and the change is identical to the first change and is made at the same time | 220 |
| b. | Change of distributor where no other aspects of the dossier are changed and the marketing authorisation holder remains the same | 220 |
| c. | Change of marketing authorisation holder where no other aspects of the dossier are changed | 220 |
| d. | Simple dosage instruction changes where the change is not the result of safety concerns, no new studies are required to support the change and the dose rate in mg/kg body weight remains the same | 560 |
| e. | Addition or change to user safety warnings where no other aspects of the dossier are changed, no user safety warnings are removed, no new studies are required to support the change and the proposed warnings serve to increase the protection of the user | 560 |
| f. | Corrections or simple text lay out changes to summary of product characteristics and/or product literature where the changes are not a result of safety concerns, no new studies are required to support the change and no other aspects of the dossier are changed | 560 |