牛灌注产品临床有效性指导原则-EMEA.pdfVIP

The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/CVMP/344/99-FINAL-Rev.1 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS GUIDELINE FOR THE CONDUCT OF EFFICACY STUDIES FOR INTRAMAMMARY PRODUCTS FOR USE IN CATTLE APPROVAL BY CVMP FOR RELEASE FOR CONSULTATION 15 - 17 JUNE 1999 TRANSMISSION TO INTERESTED PARTIES 18 JUNE 1999 DEADLINE FOR COMMENTS 17 DECEMBER 1999 DISCUSSION IN EFFICACY WORKING PARTY 7 FEBRUARY 2000 ADOPTION BY CVMP 8 MARCH 2000 DATE OF COMING INTO EFFECT 8 SEPTEMBER 2000 REVISION 1 (includes further clarifications to paragraph 5.4) 12 FEBRUARY 2003 Public 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel: (+44-171) 418 8400 Fax: (+44-171) 418 8447 E-Mail: mail@ /emea.html EMEA 2003 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged GUIDELINES FOR THE CONDUCT OF EFFICACY STUDIES FOR INTRAMAMMARY PRODUCTS FOR USE IN CATTLE This note for guidance replaces the three previous guidance notes (III/9041/90, III/3576/91, III/3173/92) in Volume 7A (1998). 1. OBJECTIVE The objective of the trial is to assess the efficacy of a medicinal product administered via the teat duct for the treatment of clinical and/or subclinical mastitis during lactation, or for the elimination of udder in