EU Directive 2010/84/EU (amending 2001/83/EC) requires each application for Marketing Authorisation (MA) for the EU to have a Pharmacovigilance System Master File (PSMF) in place including the named Qualified Person responsible for Pharmacovigilance within the EEA.
The PSMF is a document containing all of the details of the pharmacovigilance system for the product. It must be made available to a Competent Authority on request, within 7 calendar days.
Why Companies Need Help To Compile or Revise Their PSMFs
A PSMF is required to be in place for all marketing authorization holders who hold Marketing Authorisations (MA) within the EEA. It is required to be in place at the time of submission of all new applications for Marketing Authorisations (MAs).
The structure of the PSMF is strictly controlled by the guidelines of the GVP, Module II. The PSMF must contain specified sections with details of the pharmacovigilance system. It is expected that:
The PSMF exists as a dynamic document with Annexes kept meticulously up to date at all times
The PSMF forms the basis of the pharmacovigilance system, as it describes the system as a whole
Therefore, the PSMF is to be considered as a key reference document for the company’s personnel, on all aspects of day-to-day drug safety operations. The PSMF contains all of the details of the pharmacovigilance system for the MAH and its products. It is therefore an important tool for providing oversight of the pharmacovigilance system and can be used by the EEA QPPV to assist with their oversight.
The PSMF, the standard operating procedures and training derived from and the operational guidelines implementing the standard operating procedures form the cornerstone of all pharmacovigilance activities
Consequently, the PSMF plays a pivotal role and requires expert knowledge to meet all of the regulator’s requirements.
The content of the file is defined in GVP Module II. There is no standard template, however, PrimeVigilance has an established template in place. The following sections of the PSMF main body are provided as a generalized guideline to indicate the broad nature of the required content:
Details of the qualified person responsible for pharmacovigilance (QPPV)
Details of the organization structure of the company that actually holds the Marketing Authorisation or applies for the Marketing Authorisation
Details of all of the sources of the relevant safety data
Details of all electronic (computerized) systems and databases
Details of all pharmacovigilance processes
Details of the performance of all drug safety systems
Details of all quality control systems
Additional annexes are required to provide detailed information to fully describe the system and in all cases the content must be meticulously documented for compliance. All companies are advised to seek advice from professional pharmacovigilance service providers to ensure the content of the Pharmacovigilance System Master File complies with the regulatory requirements. For more information talk to our team today on +44 (0)1483 307 920.