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REPORT ON OIE ACTIVITIES, INCLUDING THE HARMONIZATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF VETERINARY MEDICINAL PRODUCTS (VICH)[28] (Agenda Item 4e)

50. The representative of the OIE reported on the progress achieved within VICH since its last report to the Committee in 1996. The VICH Steering Committee met twice at OIE Headquarters in Paris in August 1997 and February 1998.

51. Five draft guidelines relating to quality had been released for worldwide consultation. Having evaluated the work of and giving further guidance to its five working groups, it was expected that further draft guidelines would be available at the next Steering Committee meeting in October 1998. Two new working groups, on biologicals and pharmocovigilance, would take up their work as soon as one of the currently existing groups had advanced its draft guidelines to the broad consultation stage. Underlining the importance of efficiency of the VICH system, the Committee will consider a series of short and medium term measures at its next meeting.

52. While having always met in OIE Headquarters in Paris, the Committee decided that it would now meet on a rotating basis in the other two regions (United States, Japan). The next meeting will be held in Tokyo from 20-22 October 1998. In order to further foster communication, the Committee decided to establish a worldwide web site during the course of 1998 and to hold a public conference in the EU in 1999.

53. The OIE Representative further informed the Committee on the OIE programme on veterinary medicinal products, including as its main components international harmonisation (including VICH), conference organisation and participation, training and technology transfer and preparation of documentation on specific topics of importance to OIE.

54. Attention was also drawn to the 9th International Technical Consultation on Veterinary Drug Registration (ITCVDR), tentatively scheduled to be held in early 1999 in Asia, which would provide a forum to government registration authorities to be informed and to exchange information on international harmonisation (OIE, VICH, WTO, FAO and Codex Alimentarius), aquaculture and related good production practices, including veterinary medicinal product use, the use of antimicrobials in veterinary medicine and the possible impact on human health.


[28] Conference Room Document 3.

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