Livestock
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Item Livestock policy:(EAC Secretariat, 2014-05) East African CommunityThe EAC secretariat has developed this livestock policy to foster focused and coherent set of strategic policy decisions and actions relevant to propelling and transforming EAC Partner States Livestock industry beyond the outcomes attained with the past and current livestock subsector policy instruments. The goal of EAC livestock policy is to attain an annual growth rate of at least 5.0% with significant livestock contribution to the agricultural GDP surpassing 50% and to contribute to the reduction of poverty, hunger, unemployment and degradation of natural resources.Item Registration dossier structure for an immunological veterinary product(East African Community, 2015) East African CommunityRegistration dossier structure for an immunological veterinary productItem Templates for the summary of product characteristics and packaging for immunological veterinary products(East African Community, 2015) East African CommunityTemplates for the summary of product characteristics and packaging for immunological veterinary productsItem Application form for a pre-submission meeting for the registration of veterinary medicinal product(s) in the East African region(East African Community, 2016) East African CommunityApplication form for a pre-submission meeting for the registration of veterinary medicinal product(s) in the East African regionItem Guidance for pre-submission meetings for a mutual recognition application for the registration of veterinary medicines and immunologicals in the East African region(East African Community, 2016) East African CommunityApplicants are encouraged to contact their selected Reference Country (RC) to arrange a pre-submission meeting when intending to seek MAs through MRPs.Item Check list for the pre-submission meeting for the registration of veterinary medicinal product(s) in the East African region(East African Community, 2016) East African CommunityCheck list for the pre-submission meeting for the registration of veterinary medicinal product(s) in the East African regionItem EAC livestock policy(EAC Secretariat, 2016-09) East African CommunityThe EAC secretariat has developed this livestock policy to foster focused and coherent set of strategic policy decisions and actions relevant to propelling and transforming EAC Partner States Livestock industry beyond the outcomes attained with the past and current livestock subsector policy instruments. The goal of EAC livestock policy is to attain an annual growth rate of at least 5.0% with significant livestock contribution to the agricultural GDP surpassing 50% and to contribute to the reduction of poverty, hunger, unemployment and degradation of natural resources.Item Repeat-use mutual recognition procedures in the East African region(East African Community, 2017) East African CommunityFollowing the adoption of the Mutual Recognition Procedure (MRP) by the East African Community (EAC) and subsequent constitution of the EAC-Technical Working Group and the Coordination Group for Mutual Recognition (CGMR), a new Mutual Recognition Procedure was created. When an applicant wishes to have a Marketing Authorisation (MA) granted in more than one Partner State, then the Applicant uses a Mutual Recognition Procedure (MRP).Item Guidance for the appeal process during a mutual recognition application for the registration of immunological veterinary product(s) in the East African region(East African Community, 2017) East African CommunityDuring a Mutual Recognition Procedure (MRP) in the EAC, if the Reference Country and/ or any of the Concerned Countries cannot agree to issue Marketing Authorisations for an immunological veterinary product (IVP) by Day 200, the Applicant has the right to request an APPEAL. The appeal must be heard and the result notified to the Applicant by Day 240.Item Templates for the draft summary of product characteristics and packaging for veterinary pharmaceutical medicinal products(East African Community, 2018) East African CommunityTemplates for the draft summary of product characteristics and packaging for veterinary pharmaceutical medicinal productsItem Guideline for variations to marketing authorisations for registered veterinary immunological products approved through a mutual recognition procedure(East African Community, 2018) East African CommunityThe holder of a Marketing Authorisation for a registered Veterinary Immunological Product (IVP), is responsible for the registered IVP throughout its life and is required to take into account technical and scientific progress that may affect the product since the Marketing Authorisation (MA) was first granted. He or she is required to make any amendment that may be required to enable the registered IVP to be manufactured and controlled by means of generally accepted scientific methods. Marketing Authorisation Holders (MAHs) may also wish to alter or to improve the IVP or to introduce additional claims or safeguards.Item Application form for a mutual recognition application for the registration of veterinary pharmaceutical product(s) in the East African Community(East African Community, 2019) East African CommunityApplication form for a mutual recognition application for the registration of veterinary pharmaceutical product(s) in the East African CommunityItem The East Africa Community standard operating procedures on animal health 2019(EAC Secretariat, 2019-06) East African CommunityEAC partner states have been collaborating with the Food and Agriculture Organization of the United Nations (FAO) and the World Organization for Animal Health (OIE) to improve and harmonize aquatic animal management in EAC since 1999. The EAC has suffered cases of transboundary animal diseases. Better control and harmonized regulation of movement of live animals across borders was identified as an important area to improve biosecurity at the regional and national levels in EAC. This Standard Operating Procedure is intended to provide control of trade sensitive diseases while trading in live animals within the East African Community (EAC) territory.Item Guideline for processing variations to marketing authorisations for veterinary medicinal products approved through EAC mutual recognition procedures(East African Community, 2020) East African CommunityThe Mutual Recognition Procedure (MRP) for registering veterinary medicinal products through a harmonised process in East African Community (EAC) Partner States (PSs) was developed in 2015 and introduced in 2016 in accordance with the direction from the EAC Council of Ministers on 26 September 2016 for National Regulatory Authorities (NRAs) of the EAC Partner States to implement MRP (EAC/CM34/Decision 35). Following the issue of a Marketing Authorisation (MA), the Applicant may wish to make changes or improvements to the way that a veterinary medicine is manufactured or sold. Such changes are known as Variations. Any Variations to a Marketing Authorisation must be notified to the relevant National Regulatory Authority (NRA) and in some cases they must be reviewed and approved before the change can be introduced.Item Mutual recognition procedure for the registration of veterinary medicines in the East Africa(East African Community, 2021) East African CommunityThis version was issued in October 2021 to incorporate changes adopted as a result of a survey conducted in June-July 2021 whose objectives was to obtain feedback from industry, National Regulatory Agencies (NRA) and the EAC secretariat on regulatory obstacles around the implementation of MRP in areas such as adherences to MRP timelines, communication during the MRP process, GMP inspections, MRP sustainability, Stakeholders involvement and national regulatory fee policy. The results were subsequently discussed by the EAC MRP Technical Working Group (TWG) who recommended extension of MRP timelines to reflect internal NRA approval processes. The revised timelines are more realistic as they include the internal time taken by NRA Boards and Councils to ratify the recommendations of the technical staff/committee regarding issuing MAs, which had not been factored in during the setting of previous timelines. TWG also noted the importance of continuous stakeholders’ involvement during the implementation of MRP. A consultative workshop was held with the global animal health industry in February 2021 during which questions were raised and clarifications provided. This version seeks to be comprehensive and incorporates the questions raised by industry and the answers provided by the EAC -MRP Technical Working Group (TWG).Item Application form for a repeat use mutual recognition procedure for a veterinary immunological product registered through a mutual recognition procedure in the East African Community(East African Community, 2021) East African CommunityApplication form for a repeat use mutual recognition procedure for a veterinary immunological product registered through a mutual recognition procedure in the East African CommunityItem Working together to uniformly license veterinary medicines in East Africa:(East African Community, 2021) East African CommunityMost countries in the world have a system of assessment and approval of medicines to ensure that they meet high standards of safety, quality and efficacy before they are authorised for sale. This process is often called registration. It results in the issue of a license or Marketing Authorisation (MA) granted by the national regulatory authority to the applicant/manufacturer of the product. Similar systems exist for both human and veterinary medicines.Item Application form for a mutual recognition procedure for the registration of immunological veterinary product(s) in the East Africa region(East African Community, 2021) East African CommunityApplication form for a mutual recognition procedure for the registration of immunological veterinary product(s) in the East Africa regionItem Templates for the summary of product characteristics and labelling for immunological veterinary products (IVPs)(East African Community, 2021) East African CommunityTemplates for the summary of product characteristics and labelling for immunological veterinary products (IVPs)Item Guideline on the technical documentation required to be included in a registration dossier for an immunological veterinary product(East African Community, 2021) East African CommunityThis document is intended for use by applicants developing immunological veterinary products for registration within the East African Community (EAC). This Guideline GL2 has annex I for the annotated GL2 version 3 for applicants intending to submit application for (Foot and Mouth disease) FMD vaccine. The information provided in this document is intended to provide guidance to the applicant in generating the appropriate data for inclusion in a registration application dossier. It is intended to facilitate the interpretation and application of the EAC legislation concerning the sale and supply of immunological veterinary products within the East African Community.