Second edition · Rev. 2.0 · regulatory verification 30/09/2026
Who owns the system, which text governs each obligation, with what legal force, in which jurisdiction, and which record proves the QPPV's oversight.
An operational guide for the QPPV, the deputy and the pharmacovigilance team: EU legal basis with IR 520/2012 as amended by IR 2025/1466, QPPV requirements, PSMF, quality system, delegation and outsourcing, ICSRs, signals and ESIs, PSURs, RMPs and PASS, audits and GVP inspections, with Italy, the United Kingdom and a comparison with the United States. 16 chapters in five parts, 4 appendices and 14 editable tools in Word and Excel.
165 pages (ITA) · 167 (ENG) · PDF A416 chapters in five parts + 4 appendices14 tools: 4 Word + 10 Excel127 source IDs in the register8 legal-force labelsDigital product: download after payment
One language per purchase: the variant decides. The ITA - Italiano variant gives you the PDF guide and the 14 tools in Italian; the ENG - English variant gives you them in English. The two editions have the same structure, the same tools and the same codes PV-TK-01…14. There are no French, German or Spanish files.
What has changed since the December 2025 edition
Rev. 2.0 is a rewritten second edition, checked against the sources in force at 30/09/2026. The title changes too: the first edition, Guide to the Role of the Qualified Person Responsible for Pharmacovigilance (QPPV) and Their Team, equated the QPPV with a repealed Italian national role. If you have the first edition, this is what you will find different.
| Topic | December 2025 edition | Rev. 2.0 (verification 30/09/2026) |
|---|
| Structure and toolkit | about 85 pages, 10 chapters; one checklist in an appendix | 16 chapters in five parts, Appendices A–D; 14 tools PV-TK-01…14, one file per tool |
| Legal force of statements | numbered notes 1 to 137, some citing Wikipedia | eight labels and source IDs with article or paragraph; 127 IDs resolved in the Appendix C register |
| IR 520/2012 | IR 2025/1466 absent | IR 520/2012 as amended by IR 2025/1466: in force since 12/08/2025, applicable in full since 12/02/2026 |
| GVP | modules without revision or date | inventory with revision and effective date; Module III Rev 2 in effect since 10/09/2026 |
| Italy | Articles 130–131 of Legislative Decree 219/2006 presented as in force | Ministerial Decree of 30/04/2015; Title IX of Legislative Decree 219/2006 repealed |
| Roles around the QPPV | deputy "not formally notified"; local contacts confused with the QPPV | back-up, national contact person, trusted deputy and RLFV kept distinct |
| United Kingdom and USA | local "UK QPPV", pre-Windsor Framework rules; USA only in scattered remarks | QPPV in the United Kingdom or the EU, national contact person, UK PSMF, UK-wide MAs since 01/01/2025; US chapter and synoptic comparison |
| Day 0 and ICSR timelines | "15 working days"; EU non-serious cases mandatory "since 2022" | 15 calendar days from Day 0; non-serious cases occurring in the Union within 90 days (Article 107(3)); 30/06/2022 is the E2B(R3) format date |
| Signals | notified "in PSURs" | no standalone notification of validated signals since 12/08/2025; ESIs within 3 working days |
| PSMF and audits | generic content; fixed audit frequencies | logbook, major or critical deviations, copy within 7 days; risk-based audits, including subcontractors |
| Inspections and examples | unstructured questions; undocumented real cases | GVP Module III Rev 2 and a question bank; a single fictitious dataset (Quelvara Pharma) for book and toolkit |
The December 2025 edition should no longer be used as an operational reference. The front matter of the guide gives the full comparison, with the chapter that covers each change.
The problems it tackles
The misconceptions the guide takes apart, each traced to a text with its source ID, its status and its legal force in the jurisdiction where it applies.
"The QPPV must be a physician." EU law asks for something else: where the QPPV has not completed basic medical training, the MAH ensures that the QPPV is assisted by a medically trained person, and documents who, under which assignment and within which scope (Chapter 3).
"Every Member State wants a national QPPV." One QPPV per system, a natural person who resides and operates in the Union. A national authority may request a national contact person, who reports to the QPPV and is not a second QPPV (Chapters 1, 3 and 13).
"Day 0 is when PV opens the case." The 15-calendar-day timeline for serious ICSRs runs from the moment any personnel of the MAH receives information meeting the four minimum criteria; the date of receipt in PV is information only (Chapter 8).
"Signals are notified in PSURs." Since 12/08/2025 the MAH no longer notifies validated signals; ESIs are notified within 3 working days, and the resulting actions go through variations and PSURs (Chapter 9).
"In Italy, Legislative Decree 219/2006 applies." Title IX has been repealed from the entry into force of the Ministerial Decree of 30/04/2015. The QPPV resides and carries out their activity in the Union: there is no obligation to reside in Italy (Chapter 13).
"The UK and the USA want a local QPPV." Under regulation 182 of the Human Medicines Regulations 2012 the QPPV resides and operates in the EU or the United Kingdom, with a national contact person where the QPPV is outside the United Kingdom. In the USA the provisions read require no named person comparable to the QPPV: the obligations belong to the company (Chapters 14 and 15).
Values "required by law" that no source sets. Indicator thresholds, audit frequency, PSMF review, back-up availability, headcount, training, frequency of signal detection: the guide leaves them <to be defined> in the PV quality system and explains who decides, on what evidence and in which record.
The guide
16 chapters in five parts, each built on one question, and 4 appendices. Every regulatory statement carries one of the eight legal-force labels and a source ID with article or paragraph; Appendix C resolves the 127 IDs. Chapters 1–15 have a guided case; every chapter ends with inspector questions, the operational checklist (codes CL-NN.k) and the tools with the sources.
The toolkit
14 tools: 4 Word templates and 10 Excel workbooks, one file per tool, with the same PV-TK code as the book. The Excel workbooks have README, PARAMETERS, LISTS, TEMPLATE, EXAMPLE, TEST and SOURCES sheets; parameters that no source sets stay empty and block the outputs that depend on them. The tools calculate deadlines, consistency and completeness: none of them returns a verdict on the compliance of the system or an inspection outcome.
One case, from start to finish
The fictitious company Quelvara Pharma has three MAHs (Italy, United Kingdom, USA), three products and five third parties: a case processing provider, a literature provider, a co-marketing partner, a patient support programme and an audit firm. Its cases, signals, audits and deviations run through the chapters and the EXAMPLE sheets of the toolkit; they are declared fictitious and are neither criteria nor data of a real company.
Regulatory status verified as of 30/09/2026
Every verb in the present tense in the guide describes the status of the sources at 30/09/2026. The points that most often change how a source is read:
- IR 520/2012: applies as amended by Commission Implementing Regulation (EU) 2025/1466, in force since 12/08/2025 and applicable in full since 12/02/2026.
- GVP Module III Rev 2 (EMA/119871/2012 Rev 2): in effect since 10/09/2026, replacing Rev 1. EMA has announced updates of Module VI (for ICH E2D(R1)) and Module IX; as of 30/09/2026 no text has been published.
- ICH E2D(R1): in effect in the EU since 18/03/2026; the transition period ended on 18/09/2026.
- EU pharmaceutical package: Council first-reading position of 28/09/2026 (ST 7106/2/26 REV 2 and ST 7105/2/26 REV 2). The acts still need to be approved by the European Parliament; they are not adopted and not in force. Title IX of Directive 2001/83/EC, Regulation (EC) No 726/2004 and IR 520/2012 remain applicable.
- Italy: the Ministerial Decree of 30 April 2015 (Official Gazette No 143 of 23/06/2015) is in force; Title IX of Legislative Decree 219/2006 has been repealed.
- United Kingdom: a QPPV who resides and operates in the EU or the United Kingdom (regulation 182 of the Human Medicines Regulations 2012); since 01/01/2025 marketing authorisations have been UK-wide, with Category 1 and Category 2 products under the Windsor Framework.
- USA: from 01/10/2026 postmarketing ICSRs submitted to AEMS (formerly FAERS) through the ESG NextGen must use the ICH E2B(R3) standard; E2B(R2) ICSRs are accepted until 30/09/2026.
Updates included. The guide lists the events that require a new verification of the status: updated GVP Module VI or IX, revision of other modules for IR 2025/1466, publication of the pharmaceutical package in the Official Journal, a change of the QPPV and PSMF notification route away from the Article 57 database (XEVMPD), updates of the MHRA and AIFA pages, a new version of the EURD list. When the texts change you receive the revised guide and toolkit at no extra cost.
The 14 tools, in four groups
Exact titles of the English edition, grouped by the part of the book in which each is a main tool (Appendix D). No operational value that a source does not set is preloaded: where one is needed, the field stays <to be defined> and the choice belongs to the MAH, based on a documented risk assessment.
Part I — The QPPV in law · Chapters 1–3
EXCELPV-TK-01 · Applicability and Source Status Register
Dated register of sources with label, version, status at 30/09/2026 and triggers for a new verification; rows for Italy, the United Kingdom and the USA and the status of the pharmaceutical package.
WORDPV-TK-02 · QPPV Role Description and Back-up Plan
Job description, residence, 24-hour contact point, medical support and a back-up plan with tests; sections on the national contact person and the trusted deputy.
EXCELPV-TK-03 · QPPV Qualification and Onboarding File
Documentary completeness of residence, operation, medical support, training and handover, with no judgement on the suitability of the person.
Part II — Governing the system · Chapters 4–7
WORDPV-TK-04 · PSMF Template with Logbook
PSMF structure aligned with Articles 2–3 of IR 520/2012, with model tables for the logbook, deviations and audit notes.
EXCELPV-TK-05 · PSMF Change Register and QPPV/PSMF Notifications
Logbook with the five-year window, 7-day deadline for the copy, deviations to be reported in the PSMF; EudraVigilance, Article 57 database and G0109 deadlines calculated from the date of the change.
EXCELPV-TK-06 · PV System Delegation and RACI Matrix
RACI matrix with a one-A-per-process check; register of the QPPV's delegations with qualification, supervision and cross-reference to the PSMF Annex.
WORDPV-TK-07 · PV Agreement / SDEA and Subcontract Clause Checklist
Clause-by-clause review of subcontracts and SDEAs, with the Article 6(3) clauses and <to be defined> fields for exchange timelines and reconciliations.
EXCELPV-TK-08 · PV Oversight Indicator Dashboard
Indicators with numerator, denominator and anti-gaming rule, reconciliation with the monthly EVDAS compliance reports; no threshold preloaded.
Part III — Processes under QPPV oversight · Chapters 8–10
EXCELPV-TK-09 · Day 0 and ICSR Deadline Calculator
Day 0, EV, MHRA and US deadlines and an outcome per channel, with no roll-over and no internal forwarding times; report type for PSPs.
EXCELPV-TK-10 · Signal and Emerging Safety Issue Tracker
Signal register with calculated status, ESI sheet with the deadline in working days on the approved calendar, EV data monitoring against the defined frequency.
EXCELPV-TK-11 · Literature Monitoring Register
Strategy, searches with a check of the 7-day interval, articles with MLM exemption or a calculated deadline, local Italian journals.
WORDPV-TK-14 · SOP "QPPV Oversight and Escalation"
Oversight cycle, safety meeting, decisions reserved to the QPPV, escalation, regulatory calendar and management review.
Part IV — Assurance · Chapters 11–12
EXCELPV-TK-12 · Risk-Based PV Audit Programme and CAPA
Strategy, audit universe with coverage calculated over the period, programme with auditor independence, findings with the note in the PSMF and CAPA status.
EXCELPV-TK-13 · Inspection Readiness Kit, Request Tracker and Question Bank
Documents with measured retrieval times, requests with the PSMF copy deadline, question bank BD-01…BD-42 and the CL rows of Chapters 1–16.
In the ITA - Italiano variant the same 14 tools carry the titles of the Italian edition and the same codes PV-TK-01…14. Chapters 13–16 (Italy, United Kingdom, USA, regulatory horizon) work mainly with PV-TK-01, PV-TK-02 and PV-TK-05. Each Excel workbook contains an EXAMPLE sheet completed with the Quelvara Pharma case; each Word file has an EXAMPLE annex, with the notice "FICTITIOUS EXAMPLE — DO NOT USE OPERATIONALLY".
Use it tomorrow morning
| The situation | What you use |
|---|
| The QPPV resigns and a new one is appointed | Chapter 3 + PV-TK-02, PV-TK-03 and PV-TK-05: requirements, back-up arrangements, notifications to EudraVigilance (10 calendar days), to the Article 57 database (no later than 30 calendar days) and, for UK marketing authorisations, G0109 (14 days). |
| The inspector asks for the PSMF | Chapters 4 and 12 + PV-TK-04, PV-TK-05 and PV-TK-13: immediate availability at the site, copy within 7 days, logbook, major or critical deviations. |
| A report reaches Medical Information on a Friday evening | Chapter 8 + PV-TK-09: Day 0 from first receipt by any personnel of the MAH, 15 calendar days for serious ICSRs, 90 for non-serious cases occurring in the Union. |
| The EVDAS report and the internal KPI do not match | Chapters 5 and 7 + PV-TK-08: reconciliation of the monthly report with internal data, indicator definitions with an explicit start date. |
| An emerging safety issue on a product | Chapter 9 + PV-TK-10 and PV-TK-14: 3-working-day deadline, EU and MHRA recipients, decisions reserved to the QPPV, escalation. |
| A co-marketing partner discards "not related" reports | Chapter 6 + PV-TK-06 and PV-TK-07: mandatory subcontract clauses since 12/02/2026, SDEA, reconciliation, delegation that does not transfer responsibility. |
| Planning pharmacovigilance audits | Chapter 11 + PV-TK-12: risk-based universe including subcontractors, auditor independence, note in the PSMF, CAPA. |
| Products with UK marketing authorisations | Chapter 14 + PV-TK-01, PV-TK-02 and PV-TK-05: QPPV in the EU or the United Kingdom, national contact person, UK PSMF, Categories 1 and 2. |
| A global SOP that provides for a "US QPPV" | Chapter 15 + PV-TK-01 and PV-TK-09: company obligations, PADER/PAER, US timelines in calendar days and business days, E2B(R3) from 01/10/2026. |
| Preparing the system for the EU reform | Chapter 16 + PV-TK-01: status of the pharmaceutical package, announced GVP revisions and verification triggers, without treating the Council text as an obligation. |
What the guide does not do
It does not invent numbers. No universal value for indicator thresholds, audit frequency, PSMF review, back-up availability, headcount or training. Values that a source sets (15 and 90 days for ICSRs, 7 days for the PSMF copy) appear with their ID; the others stay <to be defined> in the PV quality system, based on a documented risk assessment.
It does not treat drafts as law. The Council text on the pharmaceutical package and the announced GVP revisions carry the [DRAFT] label: they serve readiness planning, not a current decision.
It does not decide for the QPPV. Decisions on the pharmacovigilance system remain with the MAH and the QPPV. No tool returns a verdict on the compliance of the system or an inspection outcome.
It is not legal advice. It describes texts, status and legal force of sources; quotations are short and verbatim, everything else is paraphrase.
Contents: five parts, 16 chapters
Chapter titles of the English edition. Every chapter ends with inspector questions, the operational checklist and the toolkit tools with the chapter sources.
Part I — The QPPV in law
- 1. The pharmacovigilance system and who is responsible for it
- 2. EU legal basis and map of sources
- 3. The QPPV: requirements, availability, residence, deputy, registration and replacement
Part II — Governing the system
- 4. The PSMF: content, location, logbook and availability
- 5. The pharmacovigilance quality system
- 6. Organisation, team, delegation and outsourcing
- 7. Safety database, EudraVigilance and computerised systems
Part III — Processes under QPPV oversight
- 8. ICSRs under QPPV oversight
- 9. Signals and emerging safety issues
- 10. PSURs, RMPs, risk minimisation, PASS and safety communication
Part IV — Assurance
- 11. Pharmacovigilance audits and CAPA
- 12. GVP inspections and inspection readiness
Part V — National overlays and comparison
- 13. Italy: Ministerial Decree of 30/04/2015, AIFA and the national network
- 14. United Kingdom: QPPV, national contact person and UK PSMF
- 15. United States and synoptic comparison EU – UK – Italy – US
- 16. Regulatory horizon
Appendices A–D. A Deadlines and timelines · B ITA–ENG glossary · C Source register (127 IDs) · D Toolkit index.
What the package contains
After payment you download the guide and the toolkit in the language of the variant you chose.
- The complete PDF guide. 165 A4 pages in the Italian edition, 167 in the English edition; clickable table of contents and bookmarks.
- 10 Excel workbooks (.xlsx). README, PARAMETERS, LISTS, TEMPLATE, EXAMPLE, TEST and SOURCES sheets; input cells unlocked and calculation cells protected without a password, against errors; no macros, no external links.
- 4 Word templates (.docx). Document control, instructions, numbered sections, references with source ID and label, approvals to be completed, change log and EXAMPLE annex.
- One file per tool and the toolkit index. File names and PV-TK codes match Appendix D; the PDF index lists each tool with format and linked chapters, the rules of use and the anti-dogma statement.
Read the preview before you buy
The free excerpt is made of real pages of the guide: 15 pages in the Italian edition, 15 in the English edition, with the Regulatory Status Box, the table of contents, pages from Chapters 4, 8 and 15 and four tools.
Specifications
| Format | A4 PDF with clickable table of contents and bookmarks; tools in .docx and .xlsx |
| Pages and chapters | 165 pages (ITA edition) · 167 pages (ENG edition) · 16 chapters in five parts + 4 appendices (A–D) |
| Toolkit | 14 editable tools: 4 Word + 10 Excel, codes PV-TK-01…14, one file per tool, plus the toolkit index in PDF |
| File languages | One language per purchase: ITA - Italiano or ENG - English. There are no French, German or Spanish files. |
| Edition and revision | Second edition · October 2026 · Rev. 2.0 · tools rev. 1.0; supersedes the December 2025 edition |
| Regulatory verification | 30/09/2026 (status of every source at that date) |
| Jurisdictions | EU/EEA · Italy · United Kingdom · US comparison · medicinal products for human use |
| Sources and labels | 127 source IDs in the Appendix C register · 8 legal-force labels |
| Free excerpt | 15 pages (ITA edition) · 15 pages (ENG edition) |
| Updates | When the texts change you receive the revised guide and toolkit at no extra cost. |
| Delivery | Digital product: download after payment. Nothing is shipped: the 3D image of the volume is a graphic rendering, there is no printed book. |
| Software requirements | A PDF reader; Microsoft Word and Excel (formulas compatible with Excel 2016 and later) or compatible programs: the Excel workbooks were recalculated in LibreOffice during testing. No macros, no external links. |
| Licence | Individual use and internal use within the purchasing company: a personal, non-exclusive and non-transferable licence under the site's Legal Notice; printing for internal use only; sharing the files with third parties is not permitted. |
Limits of use
- The Excel workbooks are calculation templates with test sheets, not validated software: before GxP use the company verifies them in its own system, repeating the cases on the TEST sheet.
- Quelvara Pharma is a fictitious company: entities, people (shown as role codes), products, cases, signals, audits, dates and figures are invented and are neither criteria nor data of a real company.
- The tools calculate deadlines, consistency and completeness; none of them returns a verdict on the compliance of the system or an inspection outcome: that judgement remains with the QPPV and the MAH.
- The guide does not replace the official texts cited and is not personalised legal, regulatory or quality advice.
- The inspector questions are built for teaching purposes and anchored to the texts cited; they do not reproduce questions from any authority. No guarantee of any audit or inspection outcome.
Who it is for. QPPVs in post or in training, deputy and back-up QPPVs, Heads of PV and process owners (case management, literature, signals, aggregate reports, risk management), PV QA and pharmacovigilance auditors, affiliate PV contacts and national contact persons, consultants and outsourced PV service providers, Regulatory Affairs handling QPPV and PSMF notifications, QPs and quality managers who interface with pharmacovigilance. It assumes the reader knows basic pharmacovigilance.
Who it is not for. It does not cover veterinary medicinal products, national positions of Member States other than Italy, or requirements of countries other than the EU/EEA, the United Kingdom and the USA; the sponsor's safety reporting in clinical trials appears only as an interface. It is not a complete operations manual for each process: it looks at them from the QPPV's oversight perspective. Validation of the safety database, data integrity governance, the general deviation and CAPA system and batch certification stay in the sister guides.
Frequently asked questions
In which language do I receive the files?
In the language of the variant you choose: ITA - Italiano or ENG - English. Each purchase includes the guide and the toolkit in one language. There are no French, German or Spanish files.
I have the December 2025 edition: what has changed?
Rev. 2.0 is a rewritten second edition with a new title: 16 chapters instead of 10, 14 tools in separate files instead of one checklist in an appendix, eight labels and source IDs instead of numbered notes, IR 520/2012 as amended by IR 2025/1466, the Ministerial Decree of 30/04/2015 for Italy, dedicated chapters on the United Kingdom and the United States. The table on this page summarises the differences; the December 2025 edition should no longer be used as an operational reference.
Do the tools tell me whether the pharmacovigilance system is compliant?
No. They calculate deadlines, consistency and completeness: the outputs flag open or missed deadlines, missing data, inconsistencies or undefined parameters. No tool returns a verdict on the compliance of the system or an inspection outcome; that judgement remains with the QPPV and the MAH.
Is the pharmaceutical package treated as if it were already in force?
No. At 30/09/2026 there is the Council first-reading position of 28/09/2026; the acts are neither adopted nor published, and the text of the pharmacovigilance articles has not been verified for this edition. Chapter 16 and PV-TK-01 treat it only in conditional form, for readiness.
Does it cover the United Kingdom and the United States?
Yes, with dedicated chapters. For the United Kingdom: regulation 182 and Schedule 12A of the Human Medicines Regulations 2012, national contact person, UK PSMF, G0109 notifications, Category 1 and Category 2 under the Windsor Framework. For the United States: 21 CFR 314.80 and 600.80, PADER/PAER, E2B(R3) through the ESG NextGen from 01/10/2026, plus a synoptic comparison EU – UK – Italy – US.
Does it apply to veterinary medicinal products?
No. The guide covers medicinal products for human use.
Are the Excel workbooks validated?
They are not validated software. Each has a TEST sheet with the test cases and expected results, and a SOURCES sheet with the IDs used: the company verifies them in its own system before GxP use.
What happens when the reference texts change?
The Regulatory Status Box of the guide lists the events that require a new verification, starting with updated GVP Modules VI and IX and the publication of the pharmaceutical package in the Official Journal. When the texts change you receive the revised guide and toolkit at no extra cost. The revision on sale is shown on this page, with the date of the regulatory verification.
Is it a printed book?
No. It is a digital product: after payment you download the PDF and the tools. Nothing is shipped; the 3D image is only a representation of the volume.
Can I share the files with colleagues at other companies or with consultants?
The licence is for individual use and internal use within the purchasing company, personal, non-exclusive and non-transferable: sharing the files with third parties, including external suppliers and consultants, is not permitted. Printing is allowed for internal use only.
Do you have a system, a delegation or an inspection to sort out?
Describe the pharmacovigilance system, the jurisdictions involved and where you are stuck. GuideGxP will review the request and, where appropriate, may put you in touch with a specialist suited to your technical needs and your geographical area.
Describe your situation →No purchase required. Each request is reviewed before any referral to a specialist.
GuideGxP guides do not replace official legislation or the guidance and standards cited (European Commission, EMA, ICH, AIFA, MHRA, FDA): they are operational support tools, they do not constitute legal advice, and users remain responsible for the correct application of the rules in force in their own company context. Decisions on the pharmacovigilance system remain with the MAH and the QPPV. The Council text on the pharmaceutical package and the announced GVP revisions are not adopted and are shown as such. Regulatory status verified at 30/09/2026. Quelvara Pharma is a fictitious company. Digital product: no physical shipment.
