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NEW QUESTION: 1
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product
does not meet one of the specific technical requirements of the regulation. However, competitors with
substantially similar products have claimed compliance with the requirement and received approval.
Which action should the regulatory affairs professional take FIRST?
A. Notify senior management that the product cannot be registered.
B. Inform the internal departments to redesign the product to comply with this requirement.
C. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
D. Inform the regulatory authority that such a requirement is not applicable to the product.
Answer: C

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