
1 
These Regulations may be cited as the Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2002 and shall come into force on 1st November 2002.
2 

(1) In the Schedule, in respect of each provision of the Medicines (Products for Animal Use—Fees) Regulations 1998 specified in column (1), the fee in column (4) is substituted for the fee in column (3).
(2) In Schedule 3 to those Regulations—
(a) in Part II, paragraph 1 (calculation of annual fees) there shall be substituted the figure “£280” for the figure “£275”, the figure “£19,880” for the figure “£19,600”, and the figure “0.47%” for the figure “0.46%”;
(b) in Part II, paragraph 2 (calculation of annual fees) there shall be substituted the figure “0.71%” for the figure “0.7%”; and
(c) in Part III (calculation of annual fee—emergency vaccines) there shall be substituted the figure “0.71%” for the figure “0.7%”.
3 

(1) Subject to paragraphs (2), (3) and (4), these Regulations shall not apply in respect of any application made before these Regulations come into force or in respect of annual fees based on turnover in a past calendar year.
(2) The fee for any inspection made after these Regulations come into force in connection with any application made before they come into force is the fee specified in these Regulations.
(3) The fee for the renewal of a marketing authorisation, licence or certificate is the fee payable at the time the renewal is due.
(4) These regulations apply in respect of annual fees which are calculated on turnover in the calendar year 2001 and are still payable.
Elliot Morley
Parliamentary Under Secretary of State
Department for Environment, Food and Rural Affairs
4th October 2002Bairbre De Brun
Minister of Health, Social Services and Public Safety
9th October 2002Brid Rodgers
Minister of Agriculture and Rural Development
4th October 2002We consent
John Heppell
Jim Fitzpatrick
Two of the Lords Commissioners of Her Majesty’s Treasury
10th October 2002
SCHEDULE
Regulation 2


Column (1) Column (2) Column (3) Column (4)
Provision of the Medicines (Products for Animal Use—Fees) Regulations 1998 Subject matter Old fee £ New fee £
Regulation 12 Manufacturer’s licences: annual fees 210 215
Regulation 13 Wholesale dealer’s licences: annual fees  
Regulation 13(1) Turnover of £40,000 or more 420 430
Regulation 13(2) Turnover of less than £40,000 210 215
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 20,085 20,590
entry 2 Complex application 11,655 11,945
entry 3 Standard application 5,035 5,160
entry 4 Abridged standard application 3,930 4,030
entry 5 Simple application 1,400 1,435
Paragraph 1, Table A, column (3) Fee for an application for a type B marketing authorisation  
entry 1 Major application 11,085 11,360
entry 2 Complex application 6,655 6,820
entry 3 Standard application 3,325 3,410
entry 5 Simple application 885 905
Paragraph 1, Table A, column (4) Fee for an application for a product licence  
entry 1 Major application 20,085 20,590
entry 2 Complex application 11,655 11,945
entry 3 Standard application 5,035 5,160
entry 5 Simple application 1,400 1,435
Paragraph 2, Table B, column (2) Fee for an application for an Article 15.2 marketing authorisation  
entry 1 Major application 11,655 11,945
entry 2 Complex application 5,035 5,160
Paragraph 3 Application for a marketing authorisation by holder of Article 15.2 marketing authorisation  
Paragraph 3(a) Major application previously made 8,430 8,645
Paragraph 3(b) Complex application previously made 6,620 6,785
Paragraph 6 Manufacturer’s licences  
Paragraph 6(1)(b) Other cases 2,260 2,315
Paragraph 7 Wholesale dealer’s licences  
Paragraph 7(1) Application fee where anticipated turnover £40,000 or more 1,310 1,345
Paragraph 7(2) Application fee where anticipated turnover less than £40,000 535 550
Paragraph 8 Animal test certificate applications in relation to biological products or for administration to non-food producing animals 275 280
Paragraph 8 Other animal test certificate applications 665 680
Paragraph 9 Marketing authorisation (parallel import) 1,570 1,610
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 3,605 3,695
entry 2 Complex 2,410 2,470
entry 3 Standard 1,040 1,065
entry 4 Simple 350 360
Paragraph 4, Table C, column (3) Additional fee for the sixth and each additional member State  
entry 1 Major 780 800
entry 2 Complex 380 390
entry 3 Standard 195 200
Paragraph 5, Table D, column (2) Basic Fee  
entry 1 Category I application 8,840 9,060
entry 2 Category II application 5,900 6,050
entry 3 Category III application 4,715 4,835
Paragraph 5, Table D, column (3) Additional fee for the sixth and each additional member State  
entry 1 Category I application 1,105 1,135
entry 2 Category II application 740 760
entry 3 Category III application 590 605
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 1 Application for a minor variation  
entry 1 Changes in the content of the manufacturing authorisation 560 575
entry 2 Change in the name of the medicinal product (either invented name or common) 560 575
entry 3 Change in the name and/or address of the marketing authorisation holder 220 225
entry 4 Replacement of an excipient with a comparable excipient (excluding adjuvants for vaccines and biologically derived excipients) 560 575
entry 5 Addition, deletion or replacement of a colorant 560 575
entry 6 Addition, deletion or replacement of a flavour 560 575
entry 7 Change in coating weight of tablets or change in weight of capsule shells 560 575
entry 8 Change in the qualitative composition of immediate packaging material 560 575
entry 9 Deletion of an indication 560 575
entry 10 Deletion of a route of administration 560 575
entry 10a Addition or replacement of measuring device 560 575
entry 11 Change in the manufacturer(s) of active substance 560 575
entry 11a Change in name of manufacturer of active substance 220 225
entry 11b Change in supplier of intermediate compound used in the manufacture 560 575
entry 12 Minor change of manufacturing process of the active substance 560 575
entry 12a Change in specification of starting material or intermediate used in the manufacture of the active substance 560 575
entry 13 Batch size of active substance 560 575
entry 14 Change in specification of active substance 560 575
entry 15 Minor change in manufacture of the medicinal product 560 575
entry 15a Change in in-process controls applied during the manufacture of the product 560 575
entry 16 Change in the batch size of finished product 560 575
entry 17 Change in specification of the medicinal product 560 575
entry 18 Synthesis or recovery of non-pharmacopoeial excipients which had been described in the original dossier 560 575
entry 19 Change in specification of excipients in the medicinal product (excluding adjuvants for vaccines) 560 575
entry 20 Extension of shelf life as foreseen at time of authorisation 560 575
entry 20a Extension of the shelf life or retest period of the active substance 560 575
entry 21 Change in shelf life after first opening 560 575
entry 22 Change in shelf life after reconstitution 560 575
entry 23 Change in the storage conditions 560 575
entry 24 Change in test procedure of active substance 560 575
entry 24a Change in the test procedure for a starting material or intermediate used in the manufacture of the active substance 560 575
entry 25 Change in the test procedures of the medicinal product 560 575
entry 26 Changes to comply with supplements to pharmacopoeias 560 575
entry 27 Change in test procedures of non-pharmacopoeial excipients 560 575
entry 28 Change in test procedure of immediate packaging 560 575
entry 29 Change in test procedure of administration device 560 575
entry 30 Change in pack size for a medicinal product 560 575
entry 31 Change in container shape 560 575
entry 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 560 575
entry 33 Change of dimensions of tablets, capsules, suppositories or pessaries without change of quantitative composition and mean mass 560 575
entry 34 Change in the manufacturing process of a non protinaceous component due to the subsequent introduction of a biotechnology step 560 575
Paragraph 2 Application fee for any other variation other than the following specified cases 2,220 2,275
entry 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 220 225
entry b Change of distributor where no other aspects of the dossier are changed and the marketing authorisation holder remains the same 220 225
entry c Change of marketing authorisation holder where no other aspects of the dossier are changed 220 225
entry 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 560 575
entry 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 560 575
entry 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, no new studies are required to support the change and no other aspects of the dossier are changed 560 575
Paragraph 3, Table F, column (2) United Kingdom acting as the Reference Member State  
entry 1 Type I variation—Administrative 590 605
entry 2 Type I variation, Scientific 2,360 2,420
entry 3 Type I variation, Scientific—Type II procedure 3,880 3,975
entry 4 Type II variation 8,250 8,455
entry 5 Variation with extras 9,435 9,670
Paragraph 3, Table F, column (3) United Kingdom not acting as the Reference Member State  
entry 1 Type I variation—Administration 115 120
entry 2 Type I variation—Scientific 560 575
entry 3 Type I variation, Scientific—Type II procedure 1,105 1,135
entry 4 Type II variation 2,220 2,275
entry 5 Variation with extras 3,945 4,045
Paragraph 5 Manufacturer’s licences  
Paragraph 5(b) Variation in any other case  
Paragraph 5(b)(i) Requiring assessment 400 410
Paragraph 5(b)(ii) Not requiring assessment 135 140
Paragraph 6 Wholesale dealer’s licences  
Paragraph 6(a) Variation requiring assessment 400 410
Paragraph 6(b) Variation not requiring assessment 135 140
Paragraph 7 Variation of animal test certificate 220 225
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 335 345
Paragraph 1(c) Other cases 1,000 1,025
Paragraph 2 Manufacturer’s licences 100 105
Paragraph 3 Animal test certificates 100 105
SCHEDULE 2 Fees relating to site inspections  
Paragraph 2(1), Table A, column (2)   
entry 1 Supersite inspection 9,295 9,525
entry 2 Major inspection 4,890 5,010
entry 3 Standard inspection 3,500 3,590
entry 4 Minor inspection 1,890 1,935
Paragraph 2(2), Table B, column (2)   
entry 1 Supersite inspection 15,410 15,795
entry 2 Major inspection 8,515 8,730
entry 3 Standard inspection covering immunological Veterinary Medicinal Products 5,555 5,695
entry 4 Other standard inspection 4,185 4,290
entry 5 Minor inspection covering immunological Veterinary Medicinal Products 2,800 2,870
entry 6 Other minor inspection 2,800 2,870
Paragraph 2(3), Table C, column (2)   
entry 1 Supersite inspection 6,750 6,920
entry 2 Major inspection 4,560 4,675
entry 3 Standard inspection 2,235 2,290
entry 4 Minor inspection 1,155 1,185
Paragraph 2(4)(b) Site limited solely to manufacture and assembly of emergency vaccines 105 110
Paragraph 3(1) Either or both of premises and procedures for quality control of a biological product which is not a dormant product 1,335 1,370
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 115 120
entry 2 Product which is either prepared solely from repeat stock or is of a repeat formulation 335 345
entry 3 Any other application 560 575
Paragraph 1, Table, column (3) Fees for applications in respect of products prepared from more than 5 homoeopathic stocks  
entry 1 Product both prepared soley from repeat stock and being of repeat formulation 275 280
entry 2 Product which is either prepared solely from repeat stock or is of a repeat formulation 495 505
entry 3 Any other application 720 740
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 115 120
Paragraph 2(ii) Product prepared from more than 5 homoeopathic stocks 275 280
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 1,580 1,620
entry 2 Complex application 905 930
entry 3 Standard application 420 430
entry 4 Simple application 160 165
Paragraph 2 Animal test certificate 550 565