VETERINARY MEDICINES GUIDANCE NOTE No 3

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VMGN No 3 two diagrams shown at Annex A, except that in Wales it may be in Welsh as well as in English; two pairs of gloves, which must be non-lined, PVC or nitrile, heavy duty gauntlet style – 0.5mm thick and at least 300mm long, or providing demonstrably superior protection to the proposed user against exposure to the dip than would be provided by gloves described. Adverse Events (AE) - Pharmacovigilance 85. Reports of any AE to a veterinary or human medicine may be made to the VMD by the animal owner, the prescribing veterinary surgeon, pharmacist or SQP, or the person who dispensed the prescription. If an animal owner wishes to seek veterinary advice about an AE in their animal they should consult the prescribing person. For further information please refer to VMGN 11 Pharmacovigilance Guidance on Adverse Events, which is published on the VMD‟s website: http://www.vmd.defra.gov.uk/pdf/vmr11/VMGN11.pdf 86. A new electronic AE report form, which is an alternative to the existing paper version is now available online and can be found on the home page of the VMD website www.vmd.defra.gov.uk under “Report an Adverse Event (yellow form)”. 87. The VMD would like to encourage reporters to make use of this interactive form to facilitate notification of any AE in animals or humans involving VMP, or in animals following treatment with a human medicine. AE can be reported for all authorised veterinary medicines, including those classified as AVM-GSL. Further Information 88. Further information is available from the Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey, KT15 3LS. Tel: +44 (0)1932 336911; Fax: +44 (0)1932 336618 or E-mail: VMGNotes@vmd.defra.gsi.gov.uk. Veterinary Medicines Guidance Notes and other information, including details of VMD contacts, are available on the VMD website www.vmd.defra.gov.uk 20
VMGN No 3 ANNEX A SHEEP DIPPING NOTICE 21
Page 1 and 2: VETERINARY MEDICINES GUIDANCE NOTE
Page 3 and 4: VMGN No 3 Inspections of Non-PSS pr
Page 5 and 6: VMGN No 3 TABLE OF CONTENTS Content
Page 7 and 8: VMGN No 3 supplying veterinary surg
Page 9 and 10: VMGN No 3 19. Products marketed und
Page 11 and 12: VMGN No 3 registered VPP or premise
Page 13 and 14: VMGN No 3 44. Pharmacy premises are
Page 15 and 16: VMGN No 3 the dosage and administra
Page 17 and 18: VMGN No 3 Out of date products 64.
Page 19: VMGN No 3 To access the SPC, you wi
Page 23 and 24: VMGN No 3 23
Page 25 and 26: VMGN No 3 Inspection Criteria for V
Page 27 and 28: VMGN No 3 The CD Register/informal
Page 29 and 30: VMGN No 3 - A veterinary surgeon mu
Page 31 and 32: VMGN No 3 (b) Records of products a
Page 33 and 34: VMGN No 3 If the manufacturer is th
Page 35 and 36: VMGN No 3 The controls set out in t
Page 37 and 38: VMGN No 3 Inspection Criteria for S
Page 39 and 40: VMGN No 3 An SQP who prescribes a P
Page 41 and 42: VMGN No 3 Where an annual or more f
Page 43 and 44: VMGN No 3 SQP SPC VMP WDA Suitably

VETERINARY MEDICINES GUIDANCE NOTE No 3

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