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SOP: Summary of the Pharmacovigilance System (SPS)

SOP: Summary of the Pharmacovigilance System (SPS)

€189.00Price
Excluding VAT
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.

  • Product Details & Purchase Terms

    You will receive:

    • Downloadable Word files (.docx)
    • ~98% pre-filled templates
    • Immediate access after purchase

    Important:

    • No refunds (digital product)
    • Requires customization

    Read full Terms and Conditions here.

  • Consulting Support

    If you prefer expert guidance, OZQA provide PV Services, such as:

    • Establishment of full PV system, including PSMF and PV SOPs
    • Gap analysis of existing PV system
    • PV audits
    • QPPV support, including management of PV Agreements, PV intelligence, PV SOPs, PV training and PV compliance

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OZQA provides many regulated documents for pharmaceutical, medical device and other industries that need a compliant QMS. If you can't find the SOP, log form or other quality document on our website - don't hesitate to contact us.

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Ready-to-use quality documents designed for regulated companies. OZQA's editable Word documents are ready for company specific customisation and expandable for later development stages.

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QMS PACKAGES

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A functioning QMS requires more than SOPs. The package therefore includes relevant supporting documentation to help put the procedures into practice. The documents are designed to work together as one QMS rather than as isolated templates.

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Quality requirements evolve as products, organisations and regulatory responsibilities develop. What is appropriate before a first clinical trial may no longer be enough at Phase III, just as a MedTech company preparing its first Quality system will have very different needs from one approaching certification or market launch.​​

​OZQA helps you identify what your organisation needs now, while building with the next milestone in mind. Explore the journey for pharmaceuticals to see how Quality systems, documentation, oversight and compliance typically evolve as you move forward.

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