RECENT ACTIVITIES OF THE NATIONAL FOCAL POINT FOR VETERINARY PRODUCTS - SWAZILAND PRESENTATION TO

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RECENT ACTIVITIES OF THE NATIONAL FOCAL POINT FOR VETERINARY PRODUCTS - SWAZILAND PRESENTATION TO THE REGIONAL SEMINAR FOR THE OIE FOCAL POINTS FOR VETERINARY DRUGS EZULWINI, SWAZILAND 6 DECEMBER 2017 DR.ZIZWE M. CINDZI

PRESENTATION OUTLINE Overview of Swaziland Livestock Sector and the Department of Veterinary and Livestock Services Regulation of Veterinary Medicinal Products and Human Pharmaceutical Products in Swaziland Activities of the National Focal Point

SWAZILAND

LIVESTOCK SECTOR The Department of Veterinary and Livestock Services (DVLS) has principal function in preservation of the territorial and inter-territorial integrity with respect to animal disease invasion and spread The livestock production systems include, mainly; Ruminants Including mainly cattle (about 650 000) and goats (about 400 000) and to a lesser extent sheep Beef is the main export commodity in regional SADC markets and other international markets like the EU Poultry includes indigenous production and commercial broiler and egg production. The commercial broiler and egg production is very intensive Porcine mainly intensive but small to medium scale

REGULATION OF PHARMACEUTICALS Regulation of Human Medicines Ministry of Health Medicines and Related Substances Control Act 9/2016 repealing Opium and Habit Forming Drugs Act, 1922 Regulation of Veterinary Drugs and Medicinal Products Department of Veterinary and Livestock Services (DVLS), Ministry of Agriculture Animal Disease Act 7/1965, as Amended All Products are Imported, with no manufacturing in the country

REGULATION OF VMPS Animal Disease Act 7/1965, as Amended Regulation and Control of Veterinary Drugs and Medicinal Substances Regulations No. 1, 2012 The Regulations specify: The criteria and/or source of products that can be imported The categorization/classification and listing of VMPs for authorization of usage and regulation of distribution The criteria for authorization of retailers and the products allowed for sale/distribution The Regulations also empower the DVLS to conduct Retailer Inspections, and impose sanctions as necessary All VMP imports are regulated through a strict paper-based import permit control system regulated by the DVLS

NATIONAL FOCAL POINT ACTIVITIES Appointed in 2008 In 2010, assisted the CVO (Director) with the drafting of Regulations and Control of Veterinary Drugs and Medicinal Substances, which got Cabinet approval & gazetting in 2012 Serves as the National Contact Person for implementation of the Regulations - Ongoing Coordinates submission for requests of new product authorisation and listing thereof Coordinates approval of New Retailer Requests for authorisation by DVLS

NATIONAL FOCAL POINT ACTIVITIES Serves as the National Contact Person for implementation of the Regulations - Ongoing Coordinates the listing of authorised VMPs and production of updated versions of the Compendium of Registered Veterinary Drugs and Medicinal Substances in accordance with the Regulations Issuing of Import Permits for VMPs Representation of Swaziland in International Workshops and Conferences related to VMPs 2010 Johannesburg, South Africa: Regional Training Seminar for OIE NFPs for VMPs (1 st Cycle) 2011 Gaborone, Botswana: Sub-regional Training Seminar on Veterinary Legislation 2012 Mombasa, Kenya: Regional Training Seminar for OIE NFPs for VMPs (2 nd Cycle) 2013 Paris, France: OIE Global Conference on the Responsible and Prudent Use of Antimicrobial Agents in Animals

NATIONAL FOCAL POINT ACTIVITIES Swaziland Representations Cont. 2013 Maputo, Mozambique: OIE Regional Seminar for the OIE NFPs for VMPs (3 rd Cycle) 2015 Entebbe, Uganda: OIE Regional Training Seminar for the OIE NFPs for VMPs (4 th Cycle) 2017 Harare, Zimbabwe: WHO Workshop on Antimicrobial Resistance 2017 Johannesburg, South Africa: OIE GALVmed Stakeholder Workshop on the Harmonization of the Registration of Veterinary Medicinal Products in the SADC Region 2017 Nairobi, Kenya: Global Animal Health Workshop 2017; Good Regulatory Practice for the Marketing Authorization of Veterinary Products in an African Context

NATIONAL FOCAL POINT ACTIVITIES Coordination of Country Responses to OIE Other International VMP Related Questionnaires 2012 Monitoring of Quantities of Antimicrobials Questionnaire 2014 OIE Survey on Stability Testing Annual National Antimicrobial Usage Questionnaire: 2015/2016/2017 2016 Joint WHO/OIE/FAO National Self Assessment on Country Progress on AMR 2017 OIE Evaluation on Progress made on AMR Containment

NATIONAL FOCAL POINT ACTIVITIES Antimicrobial Resistance Related Activities Collection and compilation of National Antimicrobial Usage/Sales Data for submission to the OIE for the Global Database 2015 to date Co-chairperson for the National Antimicrobial Containment Committee Drafting of the National AMR Strategy & other activities Stakeholder Consultation and sensitization on AMR during drafting of AMR Strategy Lecturing Veterinary Assistant Students Pharmacology and AMR 2014 to 2015 Antimicrobial Resistance 2017

NATIONAL FOCAL POINT ACTIVITIES Antimicrobial Awareness Week Activities 2015 Presentation on the Prudent and Responsible Use of Antimicrobials / Antimicrobial Stewardship at the Swaziland Veterinary Association s Annual General Conference 2017 Hosted two National Radio Programs together with Ministry of Health on Public Awareness and Sensitization on AMR issues Live interactive listener phone-in program

NATIONAL FOCAL POINT ACTIVITIES Other Related National Committee Activities 2011 to 2013 Served as a member of a Project Management Unit for an FAO Technical Cooperation Project for Safeguarding and Disposal of Obsolete Pesticides

AMR CONTAINMENT COMMITTEE STAKEHOLDER CONSULTATION

NGIYABONGA KAKHULU THANK YOU VERY MUCH