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Every change to every register, with who made it and when. Entries are added, never altered or removed.

Changes
When (UTC)WhoRecordChange
4 Oct 2026, 15:14systemPSMF · IAnnex: (empty) → I
4 Oct 2026, 15:14systemPSMF · ICreated
4 Oct 2026, 15:14systemPSMF · HAnnex: (empty) → H
4 Oct 2026, 15:14systemPSMF · HCreated
4 Oct 2026, 15:14systemPSMF · GAnnex: (empty) → G
4 Oct 2026, 15:14systemPSMF · GCreated
4 Oct 2026, 15:14systemPSMF · FAnnex: (empty) → F
4 Oct 2026, 15:14systemPSMF · FCreated
4 Oct 2026, 15:14systemPSMF · EAnnex: (empty) → E
4 Oct 2026, 15:14systemPSMF · ECreated
4 Oct 2026, 15:14systemPSMF · DAnnex: (empty) → D
4 Oct 2026, 15:14systemPSMF · DCreated
4 Oct 2026, 15:14systemPSMF · CAnnex: (empty) → C
4 Oct 2026, 15:14systemPSMF · CCreated
4 Oct 2026, 15:14systemPSMF · BAnnex: (empty) → B
4 Oct 2026, 15:14systemPSMF · BCreated
4 Oct 2026, 15:14systemPSMF · AAnnex: (empty) → A
4 Oct 2026, 15:14systemPSMF · ACreated
4 Oct 2026, 15:14systemPSMF · 3.1Review cycle (months): (empty) → 12
4 Oct 2026, 15:14systemPSMF · 3.1Issue date: (empty) → 2025-11-04
4 Oct 2026, 15:14systemPSMF · 3.1Version: (empty) → 3.1
4 Oct 2026, 15:14systemPSMF · 3.1Created
4 Oct 2026, 15:14systemTraining · A. Lindqvist – Periodic reporting and the EURD listPerson: (empty) → A. Lindqvist
4 Oct 2026, 15:14systemTraining · A. Lindqvist – Periodic reporting and the EURD listCourse: (empty) → Periodic reporting and the EURD list
4 Oct 2026, 15:14systemTraining · A. Lindqvist – Periodic reporting and the EURD listRole: (empty) → Regulatory affairs
4 Oct 2026, 15:14systemTraining · A. Lindqvist – Periodic reporting and the EURD listDue: (empty) → 2027-02-01
4 Oct 2026, 15:14systemTraining · A. Lindqvist – Periodic reporting and the EURD listCreated
4 Oct 2026, 15:14systemTraining · M. Costa – Signal managementCompleted on: (empty) → 2026-08-20
4 Oct 2026, 15:14systemTraining · M. Costa – Signal managementPerson: (empty) → M. Costa
4 Oct 2026, 15:14systemTraining · M. Costa – Signal managementCourse: (empty) → Signal management
4 Oct 2026, 15:14systemTraining · M. Costa – Signal managementRole: (empty) → QPPV deputy
4 Oct 2026, 15:14systemTraining · M. Costa – Signal managementDue: (empty) → 2026-08-25
4 Oct 2026, 15:14systemTraining · M. Costa – Signal managementCreated
4 Oct 2026, 15:14systemTraining · L. Fischer – Adverse event recognitionPerson: (empty) → L. Fischer
4 Oct 2026, 15:14systemTraining · L. Fischer – Adverse event recognitionCourse: (empty) → Adverse event recognition
4 Oct 2026, 15:14systemTraining · L. Fischer – Adverse event recognitionRole: (empty) → Medical information
4 Oct 2026, 15:14systemTraining · L. Fischer – Adverse event recognitionDue: (empty) → 2026-12-18
4 Oct 2026, 15:14systemTraining · L. Fischer – Adverse event recognitionCreated
4 Oct 2026, 15:14systemTraining · E. Novak – GVP VI refresherPerson: (empty) → E. Novak
4 Oct 2026, 15:14systemTraining · E. Novak – GVP VI refresherCourse: (empty) → GVP VI refresher
4 Oct 2026, 15:14systemTraining · E. Novak – GVP VI refresherRole: (empty) → Local safety officer
4 Oct 2026, 15:14systemTraining · E. Novak – GVP VI refresherDue: (empty) → 2026-10-18
4 Oct 2026, 15:14systemTraining · E. Novak – GVP VI refresherCreated
4 Oct 2026, 15:14systempva_reconciliations · Iberica Wholesale S.L.period_start: (empty) → 2025-10-15
4 Oct 2026, 15:14systempva_reconciliations · Iberica Wholesale S.L.performed_on: (empty) → 2026-04-12
4 Oct 2026, 15:14systempva_reconciliations · Iberica Wholesale S.L.evidence_ref: (empty) → QMS-REC-0371
4 Oct 2026, 15:14systempva_reconciliations · Iberica Wholesale S.L.agreement_id: (empty) → d0000000-0000-4000-8000-000000000303
4 Oct 2026, 15:14systempva_reconciliations · Iberica Wholesale S.L.period_end: (empty) → 2026-04-12
4 Oct 2026, 15:14systempva_reconciliations · Iberica Wholesale S.L.outcome: (empty) → matched
4 Oct 2026, 15:14systempva_reconciliations · Iberica Wholesale S.L.Created
4 Oct 2026, 15:14systempva_reconciliations · Alpenmed Licensing GmbHdiscrepancy_count: (empty) → 2
4 Oct 2026, 15:14systempva_reconciliations · Alpenmed Licensing GmbHperiod_start: (empty) → 2025-12-29
4 Oct 2026, 15:14systempva_reconciliations · Alpenmed Licensing GmbHperformed_on: (empty) → 2026-06-26
4 Oct 2026, 15:14systempva_reconciliations · Alpenmed Licensing GmbHevidence_ref: (empty) → QMS-REC-0398
4 Oct 2026, 15:14systempva_reconciliations · Alpenmed Licensing GmbHagreement_id: (empty) → d0000000-0000-4000-8000-000000000302
4 Oct 2026, 15:14systempva_reconciliations · Alpenmed Licensing GmbHperiod_end: (empty) → 2026-06-26
4 Oct 2026, 15:14systempva_reconciliations · Alpenmed Licensing GmbHoutcome: (empty) → discrepancies
4 Oct 2026, 15:14systempva_reconciliations · Alpenmed Licensing GmbHCreated
4 Oct 2026, 15:14systempva_reconciliations · Nordfarm Distribution A/Speriod_start: (empty) → 2026-04-30
4 Oct 2026, 15:14systempva_reconciliations · Nordfarm Distribution A/Sperformed_on: (empty) → 2026-07-28
4 Oct 2026, 15:14systempva_reconciliations · Nordfarm Distribution A/Sevidence_ref: (empty) → QMS-REC-0412
4 Oct 2026, 15:14systempva_reconciliations · Nordfarm Distribution A/Sagreement_id: (empty) → d0000000-0000-4000-8000-000000000301
4 Oct 2026, 15:14systempva_reconciliations · Nordfarm Distribution A/Speriod_end: (empty) → 2026-07-28
4 Oct 2026, 15:14systempva_reconciliations · Nordfarm Distribution A/Soutcome: (empty) → matched
4 Oct 2026, 15:14systempva_reconciliations · Nordfarm Distribution A/SCreated
4 Oct 2026, 15:14systemPV agreements · Iberica Wholesale S.L.Reconcile every (days): (empty) → 180
4 Oct 2026, 15:14systemPV agreements · Iberica Wholesale S.L.Window (days): (empty) → 10
4 Oct 2026, 15:14systemPV agreements · Iberica Wholesale S.L.Type: (empty) → Distribution
4 Oct 2026, 15:14systemPV agreements · Iberica Wholesale S.L.Period: (empty) → quarterly
4 Oct 2026, 15:14systemPV agreements · Iberica Wholesale S.L.Review due: (empty) → 2027-08-20
4 Oct 2026, 15:14systemPV agreements · Iberica Wholesale S.L.How it is reconciled: (empty) → interval
4 Oct 2026, 15:14systemPV agreements · Iberica Wholesale S.L.Partner: (empty) → Iberica Wholesale S.L.
4 Oct 2026, 15:14systemPV agreements · Iberica Wholesale S.L.Scope: (empty) → ES, PT
4 Oct 2026, 15:14systemPV agreements · Iberica Wholesale S.L.Created
4 Oct 2026, 15:14systemPV agreements · Alpenmed Licensing GmbHReconcile every (days): (empty) → 180
4 Oct 2026, 15:14systemPV agreements · Alpenmed Licensing GmbHWindow (days): (empty) → 10
4 Oct 2026, 15:14systemPV agreements · Alpenmed Licensing GmbHType: (empty) → Licensing
4 Oct 2026, 15:14systemPV agreements · Alpenmed Licensing GmbHPeriod: (empty) → quarterly
4 Oct 2026, 15:14systemPV agreements · Alpenmed Licensing GmbHReview due: (empty) → 2026-12-03
4 Oct 2026, 15:14systemPV agreements · Alpenmed Licensing GmbHHow it is reconciled: (empty) → interval
4 Oct 2026, 15:14systemPV agreements · Alpenmed Licensing GmbHPartner: (empty) → Alpenmed Licensing GmbH
4 Oct 2026, 15:14systemPV agreements · Alpenmed Licensing GmbHScope: (empty) → DE, AT, CH
4 Oct 2026, 15:14systemPV agreements · Alpenmed Licensing GmbHCreated
4 Oct 2026, 15:14systemPV agreements · Nordfarm Distribution A/SReconcile every (days): (empty) → 90
4 Oct 2026, 15:14systemPV agreements · Nordfarm Distribution A/SWindow (days): (empty) → 10
4 Oct 2026, 15:14systemPV agreements · Nordfarm Distribution A/SType: (empty) → Distribution
4 Oct 2026, 15:14systemPV agreements · Nordfarm Distribution A/SPeriod: (empty) → quarterly
4 Oct 2026, 15:14systemPV agreements · Nordfarm Distribution A/SReview due: (empty) → 2027-04-22
4 Oct 2026, 15:14systemPV agreements · Nordfarm Distribution A/SHow it is reconciled: (empty) → interval
4 Oct 2026, 15:14systemPV agreements · Nordfarm Distribution A/SPartner: (empty) → Nordfarm Distribution A/S
4 Oct 2026, 15:14systemPV agreements · Nordfarm Distribution A/SScope: (empty) → DK, SE, NO
4 Oct 2026, 15:14systemPV agreements · Nordfarm Distribution A/SCreated
4 Oct 2026, 15:14systemCommitments · Update the product information after signal assessmentStatus: (empty) → open
4 Oct 2026, 15:14systemCommitments · Update the product information after signal assessmentOrigin: (empty) → Signal assessment outcome
4 Oct 2026, 15:14systemCommitments · Update the product information after signal assessmentCommitment: (empty) → Update the product information after signal assessment
4 Oct 2026, 15:14systemCommitments · Update the product information after signal assessmentOwner: (empty) → Regulatory affairs
4 Oct 2026, 15:14systemCommitments · Update the product information after signal assessmentDue: (empty) → 2027-02-01
4 Oct 2026, 15:14systemCommitments · Update the product information after signal assessmentCreated
4 Oct 2026, 15:14systemCommitments · Respond to the assessment report on the last periodic reportStatus: (empty) → open
4 Oct 2026, 15:14systemCommitments · Respond to the assessment report on the last periodic reportOrigin: (empty) → Assessment outcome
4 Oct 2026, 15:14systemCommitments · Respond to the assessment report on the last periodic reportCommitment: (empty) → Respond to the assessment report on the last periodic report
4 Oct 2026, 15:14systemCommitments · Respond to the assessment report on the last periodic reportOwner: (empty) → Safety physician
4 Oct 2026, 15:14systemCommitments · Respond to the assessment report on the last periodic reportDue: (empty) → 2026-11-18
4 Oct 2026, 15:14systemCommitments · Respond to the assessment report on the last periodic reportCreated
4 Oct 2026, 15:14systemCommitments · aRMM effectiveness survey reportStatus: (empty) → in_progress
4 Oct 2026, 15:14systemCommitments · aRMM effectiveness survey reportOrigin: (empty) → RMP, additional risk minimisation
4 Oct 2026, 15:14systemCommitments · aRMM effectiveness survey reportCommitment: (empty) → aRMM effectiveness survey report
4 Oct 2026, 15:14systemCommitments · aRMM effectiveness survey reportOwner: (empty) → QPPV
4 Oct 2026, 15:14systemCommitments · aRMM effectiveness survey reportDue: (empty) → 2026-09-26
4 Oct 2026, 15:14systemCommitments · aRMM effectiveness survey reportCreated
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsEURD list version: (empty) → Sample version
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsActive substance: (empty) → levothyroxine sodium
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsInterval (days): (empty) → 90
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsLegal basis: (empty) → art_10_1
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsPSUR basis: (empty) → eurd_list
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsDLP source: (empty) → Sample data
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsMA number: (empty) → PL/H/1128/002
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsMarkets: (empty) → PL, CZ
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsProduct: (empty) → Levothyroxine sodium 50 microgram tablets
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsData lock point: (empty) → 2026-07-01
4 Oct 2026, 15:14systemProducts · Levothyroxine sodium 50 microgram tabletsCreated
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletspsur_exemption_grounds: (empty) → no_entry_in_list
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsEURD list version: (empty) → Sample version
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsActive substance: (empty) → valerian root
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsInterval (days): (empty) → 70
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsLegal basis: (empty) → art_16a
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsPSUR basis: (empty) → not_required
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsDLP source: (empty) → Sample data
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsMA number: (empty) → PL/H/3391/001
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsMarkets: (empty) → PL
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsProduct: (empty) → Valerian root dry extract 500 mg tablets
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsData lock point: (empty) → 2026-03-18
4 Oct 2026, 15:14systemProducts · Valerian root dry extract 500 mg tabletsCreated
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsActive substance: (empty) → amlodipine / valsartan
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsInterval (days): (empty) → 90
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsLegal basis: (empty) → art_10b
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsPSUR basis: (empty) → ma_condition
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsDLP source: (empty) → Sample data
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsMA number: (empty) → ES/H/0463/001
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsMarkets: (empty) → ES, PT
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsProduct: (empty) → Amlodipine / valsartan 5 mg/80 mg film-coated tablets
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsData lock point: (empty) → 2026-11-03
4 Oct 2026, 15:14systemProducts · Amlodipine / valsartan 5 mg/80 mg film-coated tabletsCreated
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsEURD list version: (empty) → Sample version
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsActive substance: (empty) → rivaroxaban
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsInterval (days): (empty) → 70
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsLegal basis: (empty) → art_10_1
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsPSUR basis: (empty) → eurd_list
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsDLP source: (empty) → Sample data
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsMA number: (empty) → DE/H/5820/001
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsMarkets: (empty) → DE, AT
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsProduct: (empty) → Rivaroxaban 20 mg film-coated tablets
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsData lock point: (empty) → 2026-09-14
4 Oct 2026, 15:14systemProducts · Rivaroxaban 20 mg film-coated tabletsCreated
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsEURD list version: (empty) → Sample version
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsActive substance: (empty) → metformin
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsInterval (days): (empty) → 70
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsLegal basis: (empty) → art_10_1
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsPSUR basis: (empty) → eurd_list
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsDLP source: (empty) → Sample data
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsMA number: (empty) → NL/H/2417/001
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsMarkets: (empty) → NL, BE, LU
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsProduct: (empty) → Metformin hydrochloride 1000 mg film-coated tablets
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsData lock point: (empty) → 2026-08-02
4 Oct 2026, 15:14systemProducts · Metformin hydrochloride 1000 mg film-coated tabletsCreated
4 Oct 2026, 15:14systemWorkspaces · Meridian Pharma B.V.psmf_staleness_flag: (empty) → false
4 Oct 2026, 15:14systemWorkspaces · Meridian Pharma B.V.is_demo: (empty) → true
4 Oct 2026, 15:14systemWorkspaces · Meridian Pharma B.V.is_beta: (empty) → false
4 Oct 2026, 15:14systemWorkspaces · Meridian Pharma B.V.locale: (empty) → en-GB
4 Oct 2026, 15:14systemWorkspaces · Meridian Pharma B.V.plan: (empty) → standard
4 Oct 2026, 15:14systemWorkspaces · Meridian Pharma B.V.name: (empty) → Meridian Pharma B.V.
4 Oct 2026, 15:14systemWorkspaces · Meridian Pharma B.V.Created
4 Oct 2026, 13:50systemPSMF · DChanged outside the cycle: (empty) → 2026-09-14
4 Oct 2026, 13:50systemPSMF · DTrigger: (empty) → New distribution agreement
4 Oct 2026, 13:50systemPSMF · DLogbook note: (empty) → Annex D updated with the new partner and the exchange timelines agreed.
4 Oct 2026, 13:50systemPSMF · AChanged outside the cycle: (empty) → 2026-08-15
4 Oct 2026, 13:50systemPSMF · ATrigger: (empty) → Change of deputy QPPV
4 Oct 2026, 13:50systemPSMF · ALogbook note: (empty) → Annex A reissued with the new contact details.
4 Oct 2026, 13:50systemPSMF · IAnnex: (empty) → I
4 Oct 2026, 13:50systemPSMF · ICreated
4 Oct 2026, 13:50systemPSMF · HAnnex: (empty) → H
4 Oct 2026, 13:50systemPSMF · HCreated
4 Oct 2026, 13:50systemPSMF · GAnnex: (empty) → G
4 Oct 2026, 13:50systemPSMF · GCreated
4 Oct 2026, 13:50systemPSMF · FAnnex: (empty) → F
4 Oct 2026, 13:50systemPSMF · FCreated
4 Oct 2026, 13:50systemPSMF · EAnnex: (empty) → E
4 Oct 2026, 13:50systemPSMF · ECreated
4 Oct 2026, 13:50systemPSMF · DAnnex: (empty) → D
4 Oct 2026, 13:50systemPSMF · DCreated
4 Oct 2026, 13:50systemPSMF · CAnnex: (empty) → C
4 Oct 2026, 13:50systemPSMF · CCreated
4 Oct 2026, 13:50systemPSMF · BAnnex: (empty) → B
4 Oct 2026, 13:50systemPSMF · BCreated
4 Oct 2026, 13:50systemPSMF · AAnnex: (empty) → A
4 Oct 2026, 13:50systemPSMF · ACreated
4 Oct 2026, 13:50systemPSMF · 3.1Review cycle (months): (empty) → 12
4 Oct 2026, 13:50systemPSMF · 3.1Issue date: (empty) → 2025-11-04
4 Oct 2026, 13:50systemPSMF · 3.1Version: (empty) → 3.1
4 Oct 2026, 13:50systemPSMF · 3.1Created

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