National Competent Authorities Requests

National Competent Authorities /Regulatory Authorities (RA)/Health Authorities (HA) requests refer to a written request or direction from an Authority, signed by an Authorized Office related to the obligations of Marketing authorization holders (MAH) in the territory.

National Competent Authorities Responsibility

NCA is responsible for the implementation of pharmacovigilance tasks assigned to it in accordance with the relevant national legislation. To this end, the NCA ensures the functioning of the pharmacovigilance system, creates and implements a Good, effective quality system of pharmacovigilance activities.

The NCA cooperates with the competent authorities of other countries to continuously improve pharmacovigilance systems to achieve high standards of public health, including the use of combined international resources to optimize the use of existing resource base.

NCA must apply and ensure the effective operation of the pharmacovigilance system during the implementation of its tasks and participation in pharmacovigilance activities in the country. In this context, they are responsible for monitoring the safety of each medicinal product registered in the territory.

The tasks and responsibilities of the authorized body for pharmacovigilance include cooperation in the identification of signals and the application of risk minimization measures in the adoption of relevant decisions.

MAH Obligations

MAHs in the territory are obligated on timely identification and provision of complete and accurate data to the requests within the specified deadline. 

PharmExpert LLC supports MAHs on handling of National Competent Authorities requests, queries fully and in a timely manner.

National Competent Authorities requests may be following types including, but not limited to:

– safety communication;

– submission of a Pharmacovigilance System Master File (PSMF);

– information on PSMF’s storage address and maintenance;

– information on QPPV (Qualified Person responsible for PV), LCPPV (Local Contact Person responsible for PV);

– unplanned submission of Periodic Safety Update Report (PSUR);

– submission/revision of Risk Management Plan (RMP);