# Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001, 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 ) 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

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Source: https://www.legislation.gov.uk/uksi/2001/3751/schedule/2/paragraph/1 (the official version)
Page: https://openlegislation.uk/medicines-products-for-animal-usefees-amendment-no-2-regulations-2001/schedule-2/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.