Contents
2.The qualified person responsible for pharmacovigilance shall have completed veterinary surgeon training in accordance with Article 38 of Directive 2005/36/EC of the European Parliament and of the Councilnote. Where such training has not been completed, marketing authorisation holders shall make arrangements to ensure that the qualified person responsible for pharmacovigilance is assisted by a veterinary surgeon on a continuous basis. That assistance shall be duly documented.
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