PART IIU.K. REPLACEMENT OF PARAGRAPHS 1 AND 2 OF PART IV OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
1. The application fee for a minor variation (Type 1) to a marketing authorisation (other than a mutually recognised marketing authorisation) as referred to in Annex 1 to Commission Regulation (EC) No. 541/95 (concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a member State M1) shall be as follows:—U.K.
| Fee | ||
|---|---|---|
| Type of application | £ | |
| 1. | Change following modification(s) to the manufacturing authorisation | 560 |
| 2. | Change in the name of the medicinal product (either invented name or common name) | 560 |
| 3. | Change in the name and/or address of the marketing authorisation holder | 220 |
| 4. | Replacement of an excipient with a comparable excipient (excluding adjuvants for vaccines and biologically derived excipients) | 560 |
| 5. | Change in the colouring system of the product (addition, deletion or replacement of colourant(s)) | 560 |
| 6. | Change in the flavouring system of the product (addition, deletion or replacement of flavour(s)) | 560 |
| 7. | Change in coating weight of tablets or change in weight of capsule shells | 560 |
| 8. | Change in the qualitative composition of immediate packaging material | 560 |
| 9. | Deletion of an indication | 560 |
| 10. | Deletion of a route of administration | 560 |
| 10a. | Addition or replacement of measuring device for dosage forms | 560 |
| 11. | Change in the manufacturer(s) of active substance | 560 |
| 11a. | Change in name of manufacturer of active substance | 220 |
| 11b. | Change in supplier of intermediate compound used in the manufacture of the active substance | 560 |
| 12 | Minor change of manufacturing process of the active substance | 560 |
| 12a. | Change in specification of starting material or intermediate used in the manufacture of the active substance | 560 |
| 13. | Batch size of active substance | 560 |
| 14. | Change in specification of active substance | 560 |
| 15. | Minor change in manufacture of the medicinal product | 560 |
| 15a. | Change in in-process controls applied during the manufacture of the product | 560 |
| 16. | Change in the batch size of finished product | 560 |
| 17. | Change in specification of the medicinal product | 560 |
| 18. | Synthesis or recovery of non-pharmacopoeial excipients which had been described in the original dossier | 560 |
| 19. | Change in specification of excipients in the medicinal product (excluding adjuvants for vaccines) | 560 |
| 20. | Extension of shelf life as foreseen at time of authorisation | 560 |
| 20a. | Extension of the shelf life or retest period of the active substance | 560 |
| 21. | Change in shelf life after first opening | 560 |
| 22. | Change in shelf life after reconstitution | 560 |
| 23. | Change in the storage conditions | 560 |
| 24. | Change in test procedure of active substance | 560 |
| 24a. | Change in test procedure for a starting material or intermediate used in the manufacture of the active substance | 560 |
| 25. | Change in the test procedures of the medicinal product | 560 |
| 26. | Changes to comply with supplements to pharmacopoeias | 560 |
| 27. | Change in test procedures of non-pharmacopoeial excipients | 560 |
| 28. | Change in test procedure of immediate packaging | 560 |
| 29. | Change in test procedure of administrative device | 560 |
| 30. | Change in pack size for a medicinal product | 560 |
| 31. | Change in container shape | 560 |
| 32. | Change of imprints, bossing or other markings (except scoring) on tablets or printing on capsules, including addition or changes of inks used for product marking | 560 |
| 33. | Change of dimensions of tablets, capsules, suppositories or pessaries without change of quantitive composition and mean mass | 560 |
| 34. | Change in the manufacturing process of a non proteinaceous component due to the subsequent introduction of a biotechnology step | 560 |
Marginal Citations
M1OJ No. L55, 11.3.95, p. 7 as last amended by Commission Regulation (EC) No. 1146/98, OJ No. L159, 3.6.98, p.31.
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:—U.K.
| 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 |
2A. Notwithstanding the above, the fee for a variation where the licence relates solely to an emergency vaccine shall be £40 for each variation.U.K.