Summary of GVP II (Guideline on good pharmacovigilance practices ) modules- GVP II

(GVP) Module II – Pharmacovigilance system master file (PSMF)

Continuing the series on Guideline on good pharmacovigilance practices, in this blog i will jump right into module II having covered module I in previous blog.

This module describes the requirement, content, legal obligations and process for PSMF. 

1. Background 

• All MAHs are obligated to provide PSMF for all the medicinal product that are approved or under approval process in EU. 
• The document is summary of pharmacovigilance system, which is assessed by each countries regulatory agency or as it is called in EU "national competent authorities"  during marketing authorisation application(s) or post-authorisation. 
• PSMF may not be required for traditional homeopathic and herbal medicines but description of PV process is must and EMA/RA may request PSMF too.
• MAH can delegate the PSMF creation, maintenance and registration but it has to be explicitly stated and however the responsibility lies with MAH

2. Registration and maintenance of PSMF

• At the time of marketing authorisation application, the MAH to submit PSMF electronically 
• Once electronic submission is done, MAH gets the PSMF reference number, which is the unique code assigned by the EudraVigilance (EV) system to the master file when the EudraVigilance Medicinal Product Report Message (XEVPRM) is processed.
•  Once the product is approved, the PSMF number will be linked to the same product in  EVMPD product code(s). 
• All PSMFs must be registered in the Article 57 database
• PSMF physical location should be in EU or closest in EU where all PV activities are done. If the PV activities are sub contracted and/or conducted outside EU then PSMF location is QPPV location. The electronic PSMF should also be located at direct shared file for QPPV and relevant stakeholders.
• Any change  in PSMF should be immediately updated and informed to QPPV. 
• Changes that are must to be notified to QPPV are described in GVP, refer for details.

3. What is content of PSMF?

• The PSMF should describe the pharmacovigilance system. 
• The content of the PSMF should discuss and showcase how the MAH will utilize and ensure the global availability of safety information for medicinal products authorized in the EU to ensure patient safety. 
• PSMF should provide summary of PV process and systems and wherever possible the documents supporting this will undergo process change hence to be added as annexures
• PSMF should also provide QPPV details, Organizational position of QPPV, medicinal products covered
• PSMF should also provide details about computerized systems, infrastructure and tools
• PSMF should also provide details regarding how MAH will collect AE data from which sources, how this will be utilized to monitor risk-benefit analysis, details about PSUR, signal detection and risk management, how safety concerns will be communicated 
• PSMF should also provide details about delegation of any of this activities and details for same

4. When is PSMF due?

      1. As mentioned above, PSMF is required at the time of approval. 

     2. Any change in location of PSMF or QPPV or major changes should be done within 30 business' days so it reflects on EV portal.

5. How and who ?

• A PSMF is a very lengthy document and generally there is no single writer or owner when creating it. But there should be one compiler and a records is maintained by MAH on each section as to who will populate the section, who is owner and what are timelines. 
• This RACI (responsible, accountable, confirmed and informed) matrix is must especially when PSMF is owned by multiple stakeholders (MAH, QPPV, Vendors etc) . 
• This file along with PSMF should be accessible to all stakeholders involved. 
• There should be clear description and agreement for all stakeholders on their responsibilities and timelines.

 

Overall, the module does go in more and clear details on expectations and its best to read module thoroughly and completely when one has to compile, write or contribute to PSMF themselves. 

Here is the link: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file-rev-2_en.pdf

Written by:

Dr.shraddha Bhange.

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