This section has no associated Explanatory Memorandum
1. The application fee for a variation to a marketing authorisation of a type specified in the table below is that specified opposite it.
| Type of variation | Fee (£) | |
|---|---|---|
| 1 | Change following modification(s) to the manufacturing authorisation | 620 |
| 2 | Change in the name of the medicinal product (either invented name or common name) | 620 |
| 3 | Change in the name and/or address of the marketing authorisation holder | 240 |
| 4 | Replacement of an excipient with a comparable excipient (excluding adjuvants for vaccines and biologically derived excipients) | 620 |
| 5 | Change in the colouring system of the product (addition, deletion or replacement of colourant(s)) | 620 |
| 6 | Change in the flavouring system of the product (addition, deletion or replacement of flavour(s)) | 620 |
| 7 | Change in coating weight of tablets or change in weight of capsule shells | 620 |
| 8 | Change in the qualitative composition of immediate packaging material | 620 |
| 9 | Deletion of an indication | 620 |
| 10 | Deletion of a route of administration | 620 |
| 11 | Addition or replacement of measuring device for dosage forms | 620 |
| 12 | Change in the manufacturer(s) of active substance | 620 |
| 13 | Change in name of manufacturer of active substance | 240 |
| 14 | Change in supplier of intermediate compound used in the manufacture of the active substance | 620 |
| 15 | Minor change of manufacturing process of the active substance | 620 |
| 16 | Change in specification of starting material or intermediate used in the manufacture of the active substance | 620 |
| 17 | Change in batch size of active substance | 620 |
| 18 | Change in specification of active substance | 620 |
| 19 | Minor change in manufacture of the medicinal product | 620 |
| 20 | Change in in-process controls applied during the manufacture of the product | 620 |
| 21 | Change in the batch size of finished product | 620 |
| 22 | Change in specification of the medicinal product | 620 |
| 23 | Synthesis or recovery of non-pharmacopoeial excipients which had been described in the original dossier | 620 |
| 24 | Change in specification of excipients in the medicinal product (excluding adjuvants for vaccines) | 620 |
| 25 | Extension of shelf life as foreseen at time of authorisation | 620 |
| 26 | Extension of the shelf life or retest period of the active substance | 620 |
| 27 | Change in shelf life after first opening | 620 |
| 28 | Change in shelf life after reconstitution | 620 |
| 29 | Change in the storage conditions | 620 |
| 30 | Change in test procedure of active substance | 620 |
| 31 | Change in test procedure for a starting material or intermediate used in the manufacture of the active substance | 620 |
| 32 | Change in the test procedures of the medicinal product | 620 |
| 33 | Changes to comply with supplements to pharmacopoeias | 620 |
| 34 | Change in test procedures of non-pharmacopoeial excipients | 620 |
| 35 | Change in test procedure of immediate packaging | 620 |
| 36 | Change in test procedure of administrative device | 620 |
| 37 | Change in pack size for a medicinal product | 620 |
| 38 | Change in container shape | 620 |
| 39 | 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 | 620 |
| 40 | Change of dimensions of tablets, capsules, suppositories or pessaries without change of quantitive composition and mean mass | 620 |
| 41 | Change in the manufacturing process of a non proteinaceous component due to the subsequent introduction of a biotechnology step | 620 |