European Medicines Agency (EMA) or other EU Health Authorities (HAs) might need clarification or additional information to complete the technical review of the content that has been submitted to them through various procedures, which would be requested to MAH as day 120/150/180/210 queries. These queries should be addressed timely with scientific inputs/justifications as the review cycle will be on hold until the response. Also, inadequate response to the queries will lead to a further round of queries and delayed approval of the Marketing Authorization Application (MAA).
So, to get an MAA submission done in time, an applicant should notify EMA at least 7 months before the submission to provide an estimated date of submission to the agency. Freyr has extensive experience in handling MAA submissions approval to EU countries for all types of formulations.
Thorough review of the deficiencies received from EMA/other EU HAs against registered content.
Preparation of action plan with responsibilities to meet the response submission timelines.
Preparation of response strategy and guidance to the applicant on activities to be performed.
Assessment of additional data and/or inputs and identifying the gaps.
Preparation of response package with scientific justifications and supporting documents.
Correspondence with the EMA/other EU countries for extension request and negotiation on the strategy