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 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 Registration dossier structure for an immunological veterinary product(East African Community, 2015) East African CommunityRegistration dossier structure for an immunological veterinary productItem 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 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 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 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 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 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 Memorandum of understanding between the government of the united republic of Tanzania the government of the republic of Kenya on joint cross-border cooperation in the prevention and control of transboundary animal diseases and zoonoses(East African Community, 2021) East African CommunityTHIS MEMORANDUM OF UNDERSTANDING (herein after referred to as the MoU) is made between the Government of the Republic of Kenya (represented by the Ministry of Agriculture, Livestock, Fisheries and Cooperatives), and the Government of the United Republic of Tanzania (represented by the Ministry of Livestock and Fisheries) (hereinafter jointly referred to as the “Parties” and individually as the “Party”)Item 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 Guidelines on variations to a registered veterinary pharmaceutical product (VPP) approved through EAC mutual recognition procedure (MRP)(East African Community, 2021) East African CommunityA registered Veterinary Pharmaceutical Product (VPP) Marketing Authorization Holder (MAH) is responsible for the registered product throughout its life-cycle irrespective of the regular reviews by NRAs. The MAH is required to consider technical and scientific progress and therefore changes may be required to the registered VPP over time. The MAH may also wish to alter or to improve the VPP or to introduce an additional safeguard. Regulation of pharmaceutical products is, therefore considered dynamic, taking into account that changes to the original dossier that was used for registration of the VPP may become necessary during the lifetime of the product. Any changes to a registered VPP, i.e., variations, whether administrative or substantial, are subject to approval by NRAs.Item Application form for a variation to the marketing authorization of an immunological veterinary product registered through the EAC mutual recognition procedure(East African Community, 2021) East African CommunityApplication form for a variation to the marketing authorization of an immunological veterinary product registered through the EAC mutual recognition procedureItem Best practice guide for mutual recognition procedures for the registration of veterinary medicinal product(s) in the East African region(East African Community, 2021) 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 has been created. If an applicant wishes to have a Marketing Authorization (MA) granted in more than one Partner State, then the Applicant will have to use a Mutual Recognition Procedure (MRP). Two types of MRP are possible. One is where an Applicant already holds a Marketing authorization in one or more Partner States and wishes to have this recognized in other Partner States. The second type is where an Applicant applies for Marketing Authorizations for a new product in several Partner States simultaneouslyItem 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 Community