Paragraph 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:—
| 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 |
Annotations
Marginal citations
- M1
OJ 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.