Common XML Mistakes Under Sanità Trasparente — and How to Avoid Them
Author
May Khan leads the Compliance Services team at Vector Health, a SaaS company specializing in life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams dedicated to data integrity, customer service, and regulatory alignment.
Vector Health Compliance
Il principale partner in Italia per la conformità al Sunshine Act
Cerchi supporto per la compliance al Sunshine Act?
Hai domande pratiche?
Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.
If you’re afraid of hitting “submit” on your Sanità Trasparente XML file and receiving a string of rejection errors, you’re not alone. Many compliance teams across the life sciences industry are discovering just how unforgiving the system can be when it comes to XML accuracy. One missing tag, one wrong province code, or a single extra space in your file name, and your entire submission is bounced back.
The Registro Pubblico Telematico della Trasparenza isn’t just another reporting platform. It’s an automated gatekeeper, applying over a dozen layers of technical and logical validation before it accepts a single record. Understanding what triggers rejections can save days of rework and keep your transparency reporting on track.
1. Getting the Basics Right: Timing and File Structure
Each submission under the Italian Sunshine Act follows a strict calendar and structure.
- Section A (payments, transfers of value, agreements, and conventions) must be filed within the semester following the reporting period.
- Section B (financial interests such as shares, bonds, or royalties) must be submitted by 31 January of the following year.
Miss those windows, and your XML will be automatically rejected with an error code even if every field is technically correct. For compliance teams juggling multiple affiliates or cross-border spend data, missing this deadline is one of the most costly mistakes.
Every XML file must also follow the official naming convention. A missing semester number or incorrect label will instantly invalidate your upload.
2. Precision Is Everything: Mandatory Fields and Validation Rules
The Ministry’s system checks every submission against the official XSD schema. That means each XML element must appear exactly where expected. Even small formatting errors can result in complete file rejection, since a single invalid record can cause the entire flow to fail.
Common validation pitfalls include:
- Missing required identifiers (either VAT number or Codice Fiscale, one is mandatory).
- Inconsistent address details where CAP doesn’t match Comune or Provincia.
- Country field not set to IT for legal or professional addresses.
- Monetary values not following the correct format (decimal point, two decimals, no thousands separator).
- Wrong pairing between relationship type and beneficiary, for example, using “Beneficiary” instead of “Counterparty” under “Convention.”
Each of these triggers its own rejection code — from one error (missing person element) to another (invalid role pairing).
3. Testing, Validating, and Correcting Before It’s Too Late
The Ministry allows test transmissions (TRA and TRB), and teams should use them. These dry runs don’t count as official filings but can highlight semantic or structural issues before final submission. They’re also visible in the Gestione Accoglienza Flussi web dashboard, where you can check for XML logic consistency before your official “VRA” or “VRB” submission.
Even with automation, human review remains critical. Many teams rely on system exports that don’t perfectly align with the Ministry’s schema. Running an internal pre-validation step against the official XSD, using the latest April 2025 version, is now best practice for all filers.
4. The Bigger Picture: Compliance Through Data Quality
Beyond avoiding technical rejections, clean and compliant XML submissions are becoming a reputational marker. Regulators, journalists, and the public will soon have access to your transparency data, meaning accuracy isn’t just an IT concern, it’s a governance one. Companies that treat XML quality as part of their compliance framework, not a back-office task, will be the ones that adapt fastest as the system matures.
Ready to Test Your XMLs?
If you want to test your systems against the Ministry’s latest specifications and help your compliance team avoid costly filing errors before the law is implemented, get expert opinion by visiting our frequently asked questions. In addition, if you need technology implementation and hands-on operational support, we recommend these partners as we consider them the best to support compliance with the Italian Sunshine Act.
If you’re afraid of hitting “submit” on your Sanità Trasparente XML file and receiving a string of rejection errors, you’re not alone. Many compliance teams across the life sciences industry are discovering just how unforgiving the system can be when it comes to XML accuracy. One missing tag, one wrong province code, or a single extra space in your file name, and your entire submission is bounced back.
The Registro Pubblico Telematico della Trasparenza isn’t just another reporting platform. It’s an automated gatekeeper, applying over a dozen layers of technical and logical validation before it accepts a single record. Understanding what triggers rejections can save days of rework and keep your transparency reporting on track.
1. Getting the Basics Right: Timing and File Structure
Each submission under the Italian Sunshine Act follows a strict calendar and structure.
- Section A (payments, transfers of value, agreements, and conventions) must be filed within the semester following the reporting period.
- Section B (financial interests such as shares, bonds, or royalties) must be submitted by 31 January of the following year.
Miss those windows, and your XML will be automatically rejected with an error code even if every field is technically correct. For compliance teams juggling multiple affiliates or cross-border spend data, missing this deadline is one of the most costly mistakes.
Every XML file must also follow the official naming convention. A missing semester number or incorrect label will instantly invalidate your upload.
2. Precision Is Everything: Mandatory Fields and Validation Rules
The Ministry’s system checks every submission against the official XSD schema. That means each XML element must appear exactly where expected. Even small formatting errors can result in complete file rejection, since a single invalid record can cause the entire flow to fail.
Common validation pitfalls include:
- Missing required identifiers (either VAT number or Codice Fiscale, one is mandatory).
- Inconsistent address details where CAP doesn’t match Comune or Provincia.
- Country field not set to IT for legal or professional addresses.
- Monetary values not following the correct format (decimal point, two decimals, no thousands separator).
- Wrong pairing between relationship type and beneficiary, for example, using “Beneficiary” instead of “Counterparty” under “Convention.”
Each of these triggers its own rejection code — from one error (missing person element) to another (invalid role pairing).
3. Testing, Validating, and Correcting Before It’s Too Late
The Ministry allows test transmissions (TRA and TRB), and teams should use them. These dry runs don’t count as official filings but can highlight semantic or structural issues before final submission. They’re also visible in the Gestione Accoglienza Flussi web dashboard, where you can check for XML logic consistency before your official “VRA” or “VRB” submission.
Even with automation, human review remains critical. Many teams rely on system exports that don’t perfectly align with the Ministry’s schema. Running an internal pre-validation step against the official XSD, using the latest April 2025 version, is now best practice for all filers.
4. The Bigger Picture: Compliance Through Data Quality
Beyond avoiding technical rejections, clean and compliant XML submissions are becoming a reputational marker. Regulators, journalists, and the public will soon have access to your transparency data, meaning accuracy isn’t just an IT concern, it’s a governance one. Companies that treat XML quality as part of their compliance framework, not a back-office task, will be the ones that adapt fastest as the system matures.
Ready to Test Your XMLs?
If you want to test your systems against the Ministry’s latest specifications and help your compliance team avoid costly filing errors before the law is implemented, get expert opinion by visiting our frequently asked questions. In addition, if you need technology implementation and hands-on operational support, we recommend these partners as we consider them the best to support compliance with the Italian Sunshine Act.
Author
May Khan leads the Compliance Services team at Vector Health, a SaaS company specializing in life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams dedicated to data integrity, customer service, and regulatory alignment.
Vector Health Compliance
Il principale partner in Italia per la conformità al Sunshine Act
Cerchi supporto per la compliance al Sunshine Act?
Hai domande pratiche?
Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.