الفهرس 
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Abstract
Objectives:
This research project aimed to provide the necessary information to assist the
competent national veterinary authorities in Egypt to develop and operate a local
pharmacovigilance system for veterinary medicinal products such as medicines and
vaccines according to the pharmacovigilance systems established by international
organizations such as WHO, the European Committee and US-FDA.
Discussion:
Pharmacovigilance in veterinary medicine has developed considerably in recent
years. The increase in legislation in the area of veterinary medicinal products, as well
as the increased awareness of the veterinarian regarding the need to report the adverse
events observed during the use of the medicines in the animals in his care, has led to an
increase in the number of cases reported worldwide. For the preparation of this master’s
VII
dissertation, a review was made of the existing published references on the subject of
pharmacovigilance, namely the legal framework, the requirements for the marketing
authorization holder of the veterinary medicinal product as well as for the veterinarian
prescribing the medicines to the animals which are under her/his responsibility and
treatment. Signal management is currently considered the best way to carry out drug
surveillance and it follows a specific methodology. Signal management is the pillar of
the future legislation on veterinary medicinal products as well as human medicines
In this study, the pharmacovigilance systems established by international organizations such
as WHO, the European Committee and US-FDA were reviewed and analyzed to stand on
the best way for setting up a pharmacovigilance system for Veterinary medicinal products in
Egypt. The underreporting of adverse events by veterinarians is also discussed, as are
certain actions that can improve notification, including the adoption of new technology and
an improvement in the reporter’s feedback system, among others. the veterinary professional
is essential in the veterinary pharmacovigilance system, the continuous monitoring of
veterinary medicinal products, maintaining the positive benefit-risk balance and in the
protection of animal health and food safety, whether as a clinician, a veterinarian working in
the pharmaceutical industry as well as in the competent authorities, or both.
Conclusion:
Pharmacovigilance is one of the legal requirements for the MAH and in some
countries, there is even a legal obligation for the veterinarians to report adverse events.
There is a need to submit a dossier that includes a detailed description of the PhV system
(DDPS) in order to gain a marketing authorization and be able to place the VMP in the
market. The MAH has to continuously monitor the VMPs that are placed in the market and
perform a benefit-risk assessment throughout the product’s life. The MAH needs to have a
Qualified Person for Pharmacovigilance (QPPV) at his service to make sure that a
pharmacovigilance system is in place and all adverse events that are reported to all
personnel are handled and reported to the competent authorities.