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S.L. 458.35 · Pharmacovigilance Regulations (S.L. 458.35)

S.L. 458.35 ст. 9Opportunity to file written observations.

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The Authority shall provide the marketing authorisation holder with an opportunity to present written observations in response to the imposition of the obligation within a time limit which it shall specify, if the marketing authorisation holder so requests within thirty days of receipt of the written notification of the obligation.