Journal of Pharmacology and Therapeutic Research

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Journal of Pharmacology and Therapeutic Research 44 7897 074717

Regulatory Affairs Journals Publications

A semi-structured questionnaire based descriptive study was conducted from May to June 2018 in four regions of Ethiopia, including Oromia, Tigray, SNNP and Afar with the target of assessing the regulatory alignment between federal and regional veterinary drugs regulatory bodies and identifying the main factors contributing to the fragmentation of regulatory functions between the agencies. Heads of the regulatory bodies, experts working within the
regulatory bodies and personal business actors were interviewed for the study purpose. A review of legislations was also done to assess the regulatory functions given to the regulatory bodies and their coincidence to every other.

Veterinary drug and animal feed administration and control proclamation 728/2011 is that the core national governing legislation for the regulation of veterinary drugs and animal feeds. Following directive, Veterinary Drug Retail Outlets Certification and Control Directive 02/2015 is additionally issued by VDFACA to administer and control the shops .
The regulatory functions of trans-regional and trans-boundary production, import, export and distribution of veterinary drugs are given to the federal veterinary drugs and animal feed administration and control authority (VDFACA); while the regional regulatory bodies are given the responsibility of regulating trade and distribution activities conducted within the regional territories. But functions that would be done concurrently by both agencies and therefore the system of harmonizing the regulatory activities aren't covered within the legislations. The border line between feed and medicine isn't covered on the legislations, resulting in conflict of interest between feed and medicine regulators on the regulation of medicated feeds. The inspection procedures of the way to inspect, what to examine , how frequent to examine , inspection approaches, and sampling techniques aren't described within the directives. albeit , the proclamation gives the responsibility to issue a list of veterinary drugs which will be prescribed by veterinary professionals aside from veterinarians and people which could be dispensed without prescription, it's not yet issued; which affects the great distribution and retail practice. Oromia regional state is that the only region established an independent veterinary drug and feed regulatory body. within the rest three study regions (Tigray, SNNP and Afar) regulatory body isn't established thanks to poor awareness of regional law making and better executive bodies and lack of budget; and therefore the regulation is being done by delegation.

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