Summary of the Pharmacovigilance System (SPS)

This template for the Summary of the Pharmacovigilance System (SPS) supports pharmaceutical and biotechnology companies in preparing the required pharmacovigilance declaration for EU Marketing Authorisation Applications (MAA).
 
The SPS is a mandatory document included in Module 1.8.1 of the Common Technical Document (CTD) and confirms that the Marketing Authorisation Holder has an established pharmacovigilance system and an appointed EU Qualified Person for Pharmacovigilance (EU-QPPV).
 
 
The template provides a structured format to document:
Confirmation of the company’s pharmacovigilance system
Details of the EU-QPPV and contact information
Location of the Pharmacovigilance System Master File (PSMF)
Declaration of compliance with EU pharmacovigilance legislation
 
The document can be easily customized to reflect the company’s pharmacovigilance system and regulatory submission requirements.
 
Typical use cases
Preparing EU Marketing Authorisation Applications (MAA)
Establishing core pharmacovigilance system documentation
Supporting regulatory submissions to EMA and EU authorities
Ensuring EU GVP-compliant PV system documentation
 
Document format
Editable template provided in Word format, allowing easy customization to fit the company’s pharmacovigilance system and regulatory submission documentation.