The Medicines (Products for Animal Use—Fees) Regulations 2004 (revoked)

PART 4 U.K. Fees Relating to Applications for the variation of Marketing Authorisations, Product Licences, Manufacturer’s Licences, Wholesale Dealer’s Licences and Animal Test Certificates

1.  The application fee for a variation to a marketing authorisation of a type specified in the table below is that specified opposite it. U.K.

	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

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 £2,460 save as provided in the table below. U.K.

	Type of variation	Fee (£)
1	Change made simultaneously as a change made to another product by the same marketing authorisation holder where the changes are identical and there is identical supporting data	240
2	Change of distributor where no other aspects of the dossier are changed and the marketing authorisation holder remains the same	240
3	Change of marketing authorisation holder where no other aspects of the dossier are changed	240
4	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 in mg/kg body weight remains the same	620
5	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	620
6	Corrections or simple text layout 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	620
7	Any change to a licence relating solely to an emergency vaccine	40

Mutually recognised marketing authorisations U.K.

3.—(1) The fee for an application for the variation of a mutually recognised marketing authorisation shall, in respect of each individual variation to which the application relates, be that specified in the table below. U.K.

(2) In the table, “connected variation” means a variation to which sub-paragraph (1) applies made simultaneously or after a variation application for another such authorisation for which a fee is paid in pursuance of sub-paragraph (1), and where, for both applications the data relied upon and the applicant is the same.

Mutually recognised marketing authorisation variation type	Fee—United Kingdom acting as the Reference Member State (£)	Fee—United Kingdom not acting as the Reference Member State (£)
Type IA notification	1,590	240
Type IB	2,615	240
Type II	9,145	2,460
Variation with extras	10,460	4,375
Connected variation	1,590	240

Manufacturer’s licences U.K.

4.  The fee for an application for the variation of a manufacturer’s licence is £150 for each individual variation save that the fee is— U.K.

(a) £110 in respect of a licence to which paragraph 4(2) of Part 2 of this Schedule applies;

(b) £445 where scientific or pharmaceutical assessment is required.

Wholesale dealer’s licences U.K.

5.  The fee for an application for a variation of a wholesale dealer’s licence is £150 for each individual variation save that the fee is £445 where scientific or pharmaceutical assessment is required. U.K.

Animal test certificates U.K.

6.  The fee for an application for the variation of an animal test certificate is £240 in respect of each individual variation. U.K.