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Guidelines for Submission of Documents for Registration of Veterinary Medicines in Zimbabwe

País/Territorio
Zimbabwe
Tipo de documento
Miscelanea
Fecha
2015
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Medicamentos Registro Cuestiones de procedimiento Recopilación de datos/informes Comercio interior Sanidad animal Envasado/etiquetado Normas Comercio internacional Educación Salud pública Protección del medio ambiente Límite máximo de residuos
Área geográphica
Africa, Africa Oriental, Naciones en desarrollo sin litoral
Resumen

These guidelines have been adopted mainly from the guidelines for Registration of Veterinary medicines in the SADC, VICH guidelines region and the Health Canada Preparation of Veterinary Abbreviated New Drug Submission – Guidance for Industry Generic Drugs. Applicants interested in having their FPPs evaluated for registration in Zimbabwe should submit a product dossier reflecting the data and information requested below. The current version of any guideline or pharmacopoeia referred to in this guideline shall be applicable in all instances. Any deviations must be highlighted, justified and require approval by the MCAZ. The present guidelines have been prepared taking into consideration the need for worldwide harmonization, which will assist the medicine manufacturers in the preparation of a well-structured dossier to be submitted for the registration of veterinary medicines in order to facilitate their screening and subsequent review. Veterinary medicine use and residues are some of the most important issues with regard to health, food safety and trade. Misuse of medicines in animal production, prohibited medicines residue levels on food of animal origin, agricultural commodities and feedstuffs can endanger human life and lead to constraints in trade within the region and internationally. To exercise the necessary management and control over veterinary medicines it is necessary to have the relevant legislation in place to enable management and control all aspects related to the registration, availability, use, labelling, marketing, manufacture, import, export, transport and disposal of these products. Therefore structures must also be put in place to ensure compliance to legislation and to monitor the use of veterinary medicines. This document is intended to provide guidance on the format of the information required for active pharmaceutical ingredients (APIs) and their corresponding FPPs. The text under the section titles is intended to be explanatory and illustrative only. The content of these sections may include relevant information as described in existing guidelines of the SADC, the OIE and VICH guidelines. In assembling the product dossier, applicants should also take into account other MCAZ or MCAZ – adopted guidelines relating to the safety, efficacy and quality of FPPs. The veterinary medicines guidelines are necessary to ensure appropriate health care to animals, in Member States of the SADC Region and to authorise only the use of veterinary medicines of proven safety, efficacy and quality. One important method of ensuring the safety, efficacy and quality of these products is thorough evaluation and registration of veterinary medicines, which are to be imported or locally manufactured in Zimbabwe before they are offered for sale. The Veterinary Medicines Registration Guidelines provide a general scientific framework including basic methodology, technical requirements, ethical principles as well as regulatory aspects for registration of veterinary medicines in Zimbabwe with the following objectives: provide appropriate health care to animals; provide the Zimbabwean and regional market with medicines that have proven safety, efficacy and quality; provide transparency in trade of agricultural products including animal and animal products within and outside the region; raise public awareness in the use of veterinary medicines; protect public health against zoonotic diseases; protect the environment; provide the regulatory basis for management and control of veterinary medicines; and provide a relevant approach for the observance and compliance with Maximum Residues Limits.

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