Sheet 4 - Veterinary Medicines Directorate - Defra

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VETERINARY MEDICINES REGULATIONS 2013FEES PAYABLESHEET 4 - MANUFACTURERS AND WHOLESALE DEALERSDESCRIPTIONFEE FROM01/10/13FEE FROM01/10/11PREVIOUSFEEVMR 2013SCH 7£ £SO34 Standard site - Schedule 6 products only 5,055 4,595 4,335 35SO32 Minor site - Schedule 6 products only 2,728 2,480 2,340 352.4 PHARMACEUTICAL SITE INSPECTIONS - NON-UK SITESSS91A Super site - Sterile 22,157 24,680 24,680 34SS61A Major site - Sterile 12,359 13,770 13,635 34SS71A Standard site - Sterile 7,832 8,725 8,725 34SS81A Minor site - Sterile 4,770 4,350 4,305 34SO91A Super site - non-sterile 13,471 15,015 14,865 35SO61A Major site - non-sterile 7,909 8,810 8,725 35SO71A Standard site - non-sterile 6,511 7,250 7,250 35SO81A Minor site - non-sterile 3,600 4,010 3,970 35SA91A Super site - Assembly of products only 10,474 11,665 11,665 36SA61A Major site - Assembly of products only 5,652 6,295 6,295 36SA71A Standard site - Assembly of products only 4,671 4,255 4,255 36SA81A Minor site - Assembly of products only 1,933 1,760 1,745 36SO31A Standard site - Schedule 6 products only 4,802 4,380 4,335 35SO32A Minor site - Schedule 6 products only 2,592 2,365 2,340 35(Note: travel & subsistence costs are payable in addition to the abovefees).2.5 TEST SITES, BLOOD BANKS, STEM CELLSSS47 Test site inspection - UK site 3,344 3,040 2,870 37SS47A Test site inspection - non-UK site 3,177 2,900 2,870 37BBA1 Blood bank - authorisation to operate - first inspection 3,113 2,830 2,800 38(1)aBBA5 Blood bank - subsequent inspection - UK site 3,113 2,970 2,800 38(1)b(i)BBA5A Blood bank - subsequent inspection - non-UK site 2,966 2,830 2,800 38(1)b(ii)BBV1 Variation of a blood bank authorisation 320 305 300 38(3)BSC1 Stem Cell product - authorisation 3,427 3,270 3,240 38(2)BSC2 Stem Cell product - subsequent inspection - UK site 3,092 3,435 3,240 38(2)BSV1 Stem Cell product - variation 320 305 300 38(3)3. WHOLESALE DEALER'S AUTHORISATIONS:WA30 Application - turnover more than or equal to £35,000 1,745 1,760 1,745 39(1)(a)WA40 Application - turnover less than £35,000 or AVM-GSL, homeopathic orSchedule 6 products only 785 785 775 39(1)(b)/(c)WV30 Variation requiring scientific or pharmaceutical assessment 515 515 510 40(a)WV31 Variation only involving change of ownership 430 430 425 40(b)WV32 Variation not requiring scientific or pharmaceutical assessment 300 300 295 40(c)WF30 Annual Fee - turnover more than or equal to £35,000 483 330 325 41(1)aWF31 Annual Fee - turnover less than £35,000 or AVM-GSL, or homeopathicremedies 315 215 215 41(1)bWF32 Annual Fee -Schedule 6 products only 215 215 215 41(1)cWIL10 Inspection - AVM-GSL, homeopathic remedies 1,442 830 820 42(b)(i)WIL10 Inspection - turnover in previous calendar year less than £35,0001,442 830 820 42(b)(ii)WIJ10 Inspection - Schedule 6 products only 830 830 820 42(c)WI01 Inspection - otherwise 3,058 1,760 1,745 42(a)WDIC1 Wholesale Dealers Import Certificate* 1,320 760 750 50(1)* only payable if, in the twelve month period immediately before theapplication, the applicant has supplied the veterinary medicinalproduct to which the certificate relates in accordance with at least 100certificates. 50(2)4. REFERRAL TO AN APPOINTED PERSONthe appellant is liable for the full economic cost of a referral, subjectto a maximum of £5,000. - - 56Veterinery Medicines DirectorateWoodham Lane, New, Haw, Addlestone, Surrey, KT15 3LS, United Kingdom+44(0)1932 336911 www.vmd.defra.gov.uk2 of 3
VETERINARY MEDICINES REGULATIONS 2013FEES PAYABLESHEET 4 - MANUFACTURERS AND WHOLESALE DEALERSDESCRIPTIONFEE FROM01/10/13FEE FROM01/10/11PREVIOUSFEEVMR 2013SCH 7£ £5. IMPROVEMENT NOTICESThe full economic cost of any inspection necessary as a result of theissue of an improvement notice is payable by the person on whom thenotice was served. - - 59Veterinery Medicines DirectorateWoodham Lane, New, Haw, Addlestone, Surrey, KT15 3LS, United Kingdom+44(0)1932 336911 www.vmd.defra.gov.uk3 of 3
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Sheet 4 - Veterinary Medicines Directorate - Defra

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