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

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

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.