S.L. 458.35 · Pharmacovigilance Regulations (S.L. 458.35)
S.L. 458.35 ст. 9Opportunity to file written observations.
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.