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introduction to safety data exchange agreements it may not be possible for pharmaceutical companies to have subsidiaries Affiliates vendors or even employees in every country they operate or hold licenses one that it may not be cost effective or the local requirements that is regulations or business policies may make it difficult to operate at times it may be necessary to have business Arrangements even in the countries where the company has established operations all these situations May necessitate the need for legal contract or agreements between the entities specifying the pharmacovigilance obligations at the end of the day the marketing authorization holder is accountable responsible for fulfilling all the pharmacovigilance obligations safety data exchange Agreements are legal contracts meant for ensuring prompt exchange of safety data with the business partner that will ensure fulfillment of legal obligations by the marketing authorization holder safety data exchange Agreements a
