
1 

(1) These Regulations may be cited as the Medicines (Products of Animal Use—Fees) (Amendment No. 2) Regulations 2001 and shall come into force on 15th December 2001.
(2) In these Regulations “the Principal Regulations” means the Medicines (Products for Animal Use—Fees) Regulations 1998 .
2 

(1) In respect of each provision of the principal Regulations specified in the entries in column (1) (the subject matter of which is described in column (2)) of Part I of the Schedule to these Regulations, where a fee is specified opposite that provision in column (3) there shall be substituted the fee specified opposite that provision in column (4).
(2) Paragraphs 1 and 2 of Part IV of the principal Regulations shall be replaced with the provisions of Part II of the Schedule to these Regulations.
(3) In Schedule 3 to the principal Regulations—
(a) in Part II, paragraph 1 (calculation of annual fees) there shall be substituted the figure “£275” for the figure “
                    £269
                  ”, the figure “£19,600” for the figure “
                    £18,956
                  ”, and the figure “0.46%” for the figure “
                    0.451%.
                  ”;
(b) in Part II, paragraph 2 (calculation of annual fees) there shall be substituted the figure “0.7%” for the figure “
                    0.677%
                  ”; and
(c) in Part III (calculation of annual fee—emergency vaccines) there shall be substituted the figure “0.7%” for the figure “
                    0.677%
                  ”.
3 

(1) Subject to paragraphs (2) and (3) below, these Regulations shall not apply in respect of any application made before the date these Regulations come into force.
(2) These Regulations shall apply in relation to any fee payable in respect of any inspection made after these Regulations come into force in connection with any application made before they come into force.
(3) Where, in connection with an application to renew a marketing authorisation, licence or certificate made before these Regulations come into force, the authorisation, licence or certificate is due to expire on or after the date these Regulations come into force, regulation 17(4) and (5) of the principal Regulations shall apply to that application on the basis that the fee payable for the application following the coming into force of these Regulations is the appropriate fee payable.
(4) Nothing in these Regulations shall have effect in relation to an annual fee relating to a calendar year earlier than 2000.
 Whitty
Parliamentary Under Secretary of State Ministry of Agriculture, Fisheries and Food
22 November 2002 Signed by authority of the Secretary of State for Health
 Hunt
Parliamentary Under Secretary of State
Department of Health
16 November 2001 Bairbre De Brún
Minister of Health, Social Services and Public Safety
21 November 2001 Brid Rodgers
Minister of Agriculture and Rural Development
19 November 2001 We consent
 Nick Ainger
 Tony McNulty
Two of the Lords Commissioners of Her Majesty’s Treasury
19 November 2001
SCHEDULE
Regulation 2
PART I
Column (1) Column (2) Column (3) Column (4)
Provision in the principal Regulations Subject matter Old fee New fee
  £ £
Regulation 12 Manufacturer’s licences: annual fees 205 210
Regulation 13 Wholesale dealer’s licences: annual fees
Regulation 13(1) Turnover of £40,000 or more 410 420
Regulation 13(2) Turnover of less than £40,000 205 210
Regulation 14 Registration of Homoeopathic Veterinary Medicinal Products  
Regulation 14(3) Alteration of dossier 90 95
SCHEDULE 1, PART II FEES RELATING TO APPLICATIONS FOR THE GRANT OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES  
Paragraph 1, Table A, Column (2) Fee for an application for a type A marketing authorisation  
Entry 1 Major application 19,595 20,085
Entry 2 Complex application 11,370 11,655
Entry 3 Standard application 4,910 5,035
Entry 4 Abridged standard application 3,835 3,930
Entry 5 Simple application 1,385 1,400
Paragraph 1, Table A, Column (3) Fee for an application for a type B marketing authorisation  
Entry 1 Major application 10,815 11,085
Entry 2 Complex application 6,490 6,655
Entry 3 Standard application 3,245 3,325
Entry 5 Simple application 865 885
Paragraph 1, Table A, Column (4) Fee for an application for a product licence  
Entry 1 Major application 19,595 20,085
Entry 2 Complex application 11,370 11,655
Entry 3 Standard application 4,910 5,035
Entry 5 Simple application 1,365 1,400
Paragraph 2, Table B, Column (2) Fee for an application for an Article 15.2 marketing authorisation  
Entry 1 Major application 11,370 11,655
Entry 2 Complex application 4,910 5,035
Paragraph 3 Application for a marketing authorisation by holder of Article 15.2 marketing authorisation  
Paragraph 3(a) Major application previously made 8,225 8,430
Paragraph 3(b) Complex application previously made 6,460 6,620
Paragraph 6 Manufacturer’s licences  
Paragraph 6(1)(b) Other cases 2,205 2,260
Paragraph 7 Wholesale dealer’s licences  
Paragraph 7(1) Application fee where anticipated turnover £40,000 or more 1,280 1,310
Paragraph 7(2) Application fee where anticipated turnover less than £40,000 520 535
Paragraph 8 Animal test certificate applications in relation to biological products or for administration to non food-producing animals 270 275
Paragraph 8 Other animal test certificate applications 650 665
Paragraph 9 Marketing authorisation (parallel import) 1,530 1,570
SCHEDULE 1, PART III FEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS  
Paragraph 4, Table C, Column (2) Basic fee  
Entry 1 Major 3,515 3,605
Entry 2 Complex 2,350 2,410
Entry 3 Standard 1,015 1,040
Entry 4 Simple 340 350
Paragraph 4, Table C, Column (3) Additional fee for the sixth and each additional member State  
Entry 1 Major 760 780
Entry 2 Complex 370 380
Entry 3 Standard 190 195
Paragraph 5, Table D, Column (2) Basic Fee  
Entry 1 Category I application 8,625 8,840
Entry 2 Category II application 5,755 5,900
Entry 3 Category III application 4,600 4,715
Paragraph 5, Table D, Column (3) Additional fee for the sixth and each additional member State  
Entry 1 Category I application 1,080 1,105
Entry 2 Category II application 720 740
Entry 3 Category III application 575 590
SCHEDULE 1, PART IV FEES RELATING TO APPLICATIONS FOR THE VARIATION OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES  
Paragraph 3, Table F, Column (2) United Kingdom acting as the Reference Member State  
Entry 1 Type I variation—Administrative  575  590
Entry 2 Type I variation—Scientific  2,300  2,360
Entry 3 Type 1 variation, Scientific—Type II procedure  3,785  3,880
Entry 4 Type II variation  8,050  8,250
Entry 5 Variation with extras  9,205  9,435
Paragraph 3, Table F, Column (3) United Kingdom not acting as the Reference Member State  
Entry 1 Type I variation—Administrative  110  115
Entry 2 Type I variation—Scientific  545  560
Entry 3 Type I variation, Scientific—Type II procedure  1,080  1,105
Entry 4 Type II variation  2,165  2,220
Entry 5 Variation with extras  3,850  3,945
Paragraph 5 Manufacturer’s licences  
Paragraph 5(b) Variation in any other case  
Paragraph 5(b)(i) Requiring assessment  390  400
Paragraph 5(b)(ii) Not requiring assessment  130  135
Paragraph 6 Wholesale dealer’s licences  
Paragraph 6(a) Variation requiring assessment  390  400
Paragraph 6(b) Variation not requiring assessment  130  135
Paragraph 7 Variation of animal test certificate  215  220
SCHEDULE 1, PART V FEES RELATING TO APPLICATIONS FOR THE RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES AND ANIMAL TEST CERTIFICATES  
Paragraph 1 Marketing authorisations and product licences
Paragraph 1(b) Herbal products  325  335
Paragraph 1(c) Other cases  975  1,000
Paragraph 2 Manufacturer’s licences  95  100
Paragraph 3 Animal test certificates  95  100
SCHEDULE 2 FEES RELATING TO SITE INSPECTIONS  
Paragraph 2(1), Table A, Column (2)  
Entry 1 Supersite inspection  9,070  9,295
Entry 2 Major inspection  4,770  4,890
Entry 3 Standard inspection  3,415  3,500
Entry 4 Minor inspection  1,845  1,890
Paragraph 2(2), Table B, Column (2)  
Entry 1 Supersite inspection 15,035 15,410
Entry 2 Major inspection  8,305  8,515
Entry 3 Standard inspection covering immunological Veterinary Medicinal Products  5,420  5,555
Entry 4 Other standard inspection  4,085  4,185
Entry 5 Minor inspection covering immunological Veterinary Medicinal Products  2,730  2,800
Entry 6 Other minor inspection  2,730  2,800
Paragraph 2(3), Table C, Column (2)  
Entry 1 Supersite inspection  6,585  6,750
Entry 2 Major inspection  4,450  4,560
Entry 3 Standard inspection  2,180  2,235
Entry 4 Minor inspection  1,125  1,155
Paragraph 3(1) Either or both of premises and procedures for quality control of a biological product which is not a dormant product  1,305  1,335
SCHEDULE 5, PART II FEES RELATING TO APPLICATIONS FOR REGISTRATION OF HOMOEOPATHIC VETERINARY MEDICINAL PRODUCTS  
Paragraph 1, Table, Column (2) Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks  
Entry 1 Product both prepared solely from repeat stock and being of repeat formulation  110  115
Entry 2 Product which is either prepared solely from repeat stock or is of a repeat formulation  325  335
Entry 3 Any other application  545  560
Paragraph 1, Table, Column (3) Fees for applications in respect of products prepared from more than 5 homoeopathic stocks  
Entry 1 Product both prepared solely from repeat stock and being of repeat formulation  270  275
Entry 2 Product which is either prepared solely from repeat stock or is of a repeat formulation  485  495
Entry 3 Any other application  700  720
Paragraph 2 Equivalent product registered under Part II of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 or in an EEA State  
Paragraph 2 (i) Product prepared from not more than 5 homoeopathic stocks  110  115
Paragraph 2(ii) Product prepared from more than 5 homoeopathic stocks  270  275
SCHEDULE 6 MARKETING AUTHORISATIONS, PRODUCT LICENCES AND ANIMAL TEST CERTIFICATES: FEES FOR REFERENCES TO THE VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION  
Paragraph 1, Table, Column (2)  
Entry 1 Major application  1,540  1,580
Entry 2 Complex application  885  905
Entry 3 Standard application  410  420
Entry 4 Simple application  155  160
Paragraph 2 Animal test certificate  535  550
PART II
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
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 £2,220 except in the following cases, where the fee shall be the amount specified:—
  Fee
 Type of application £
a. Change which is made where there is identical supporting data relating to another product which is also being changed, all the products are from the same marketing authorisation holder and the change is identical to the first change and is made at the same time 220
b. Change of distributor where no other aspects of the dossier are changed and the marketing authorisation holder remains the same 220
c. Change of marketing authorisation holder where no other aspects of the dossier are changed 220
d. 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 rate in mg/kg body weight remains the same 560
e. 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 560
f. Corrections or simple text lay out 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 560
2A 
Notwithstanding the above, the fee for a variation where the licence relates solely to an emergency vaccine shall be £40 for each variation.