show codes show debug x
Task id=task-application fullUrl=(none)
Code: id=(none) fullUrl=(none)Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Identifier: EMEA/H/C/004254/II/xxxx/G (http://ema.europa.eu/fhir/procedureIdentifierNumber)
Status: requested
Intent: order
Date: Next Production Run/Next Printing - false
Task id=variation-1 fullUrl=(none)
Code: B.I.b.1.e - QUALITY CHANGES - ACTIVE SUBSTANCE - Control of active substance - Change in the specification parameters and/or limits of an active substance, starting material / intermediate / reagent used in the manufacturing process of the active substance - Deletion of a specification parameter which may have a significant effect on the overall quality of the active substance and/or the finished product [(B.I.b.1.e)] (https://spor.ema.europa.eu/v1/lists/100000152091-todo-scope-type)
Status: requested
Intent: order
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: II [(typeII)] (https://spor.ema.europa.eu/v1/lists/100000155688-temp)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: II [(typeIIapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Article 5 [(exampleArticle5Code)] (https://spor.ema.europa.eu/v1/lists/900000003554-dummy)
Value: true
Task id=variation-2 fullUrl=(none)
Code: B.I.a.1.z - QUALITY CHANGES - ACTIVE SUBSTANCE - Manufacture - Change in the manufacturer of a starting material/reagent/intermediate used in the manufacturing process of the active substance or change in the manufacturer (including where relevant quality control testing sites) of the active substance, where no Ph. Eur. Certificate of Suitability is part of the approved dossier - Other variation [(B.I.a.1.z)] (https://spor.ema.europa.eu/v1/lists/100000152091-todo-scope-type)
Status: requested
Intent: order
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IBunforeseen [(typeIBun)] (https://spor.ema.europa.eu/v1/lists/100000155688-temp)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IB [(typeIBapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IBunforeseen [(typeIBunapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: II [(typeIIapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Article 5 [(exampleArticle5Code)] (https://spor.ema.europa.eu/v1/lists/900000003554-dummy)
Value: true
Focus: Wonderpill (MedicinalProductDefinition[id=variationProduct-1-1-1])
Focus: Wonderpill (MedicinalProductDefinition[id=variationProduct-1-1-2])
Focus: Wonderpill (MedicinalProductDefinition[id=variationProduct-1-1-3])
Focus: Wonderpill (MedicinalProductDefinition[id=variationProduct-1-1-4])
Input
Type: Grouping details [(grouping-code-tbc)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: id=(none) fullUrl=(none)Grouped Regulatory Activity [(100000155555)] (https://spor.ema.europa.eu/v1/lists/100000155553)
Input
Type: Change concern [(change-concern)] (https://spor.ema.europa.eu/v1/lists/example/variation-parameter-tbc)
Value: id=(none) fullUrl=(none)Quality [(Quality)] (https://spor.ema.europa.eu/v1/lists/example/change-concern-type-tbc)
Input
Type: Domain [(100000000777)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: id=(none) fullUrl=(none)Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: id=(none) fullUrl=(none)Variation Type IB unforseen (invented) [((unknown))] (https://spor.ema.europa.eu/v1/lists/100000155688)
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: id=(none) fullUrl=(none)Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Input
Type: Scope [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: With this application the MAH is submitting the following grouping of one Type II and one Type IB: · Type II B.I.b.1. Change in the specification parameters. · Type IB B.1.a. Change in manufacture of the substance z) other variation:GMP detail related. GMP detail concerning specifications .
Input
Type: noOtherChanges [(100000002345-temp-noOtherChanges)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: conditionsSet [(100000002345-temp-conditionsSet)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: submitted [(100000002345-temp-submitted)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
For
Company Name
Requested by
Organization id=applicant-org-id fullUrl=(none)
Name: Company Ltd
email: poni.heppa@company.com
Phone: +353140312233
Address:
1 Riverroad
Citywest Business Campus
D24VK12
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
↸arrow indicates that this points back to the parent Task rather then being linked forwards from it
Provenance (Signature) id=signature-id fullUrl=(none)
Type: Author's Signature [(1.2.840.10065.1.12.1.1)] (urn:iso-astm:E1762-95:2013)
When: 2020-08-03
By
Role id=signature-person-id fullUrl=(none) - id=(none) fullUrl=(none)EU Regulatory Manager, Global Regulatory Affairs - EU Region [(tbc)] (https://spor.ema.europa.eu/v1/lists/100000154441)
Practitioner id=signature-practitioner-id fullUrl=(none)
Name: Mr Poni Heppa
Organization id=applicant-org-id fullUrl=(none)
Name: Company Ltd
email: poni.heppa@company.com
Phone: +353140312233
Address:
1 Riverroad
Citywest Business Campus
D24VK12
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Recorded date: 2020-08-03
Target
Resource: Task[id=task-application]
Activity: attest (http://terminology.hl7.org/CodeSystem/iso-21089-lifecycle)
Product id=variationProduct-1-1-1 fullUrl=(none)
Name: Wonderpill
Invented name part: Wonderpill
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-1-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/17/1196/001 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EU/1/17/1196/002 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EU/1/17/1196/009 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
company Ltd
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2020-08-03
Based on: B.I.a.1.z
Based on: B.I.b.1.e
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Company Ltd
email: poni.heppa@company.com
Phone: +353140312233
Address:
1 Riverroad
Citywest Business Campus
D24VK12
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-2 fullUrl=(none)
Name: Wonderpill
Invented name part: Wonderpill
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-2-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/17/1196/003 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EU/1/17/1196/004 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EU/1/17/1196/010 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
company Ltd
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2020-08-03
Based on: B.I.a.1.z
Based on: B.I.b.1.e
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Company Ltd
email: poni.heppa@company.com
Phone: +353140312233
Address:
1 Riverroad
Citywest Business Campus
D24VK12
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-3 fullUrl=(none)
Name: Wonderpill
Invented name part: Wonderpill
Pharmaceutical dose form name part: Solution for injection in pre-filled pen
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled pen [(100000074039)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-3-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/17/1196/005 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EU/1/17/1196/006 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EU/1/17/1196/011 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
company Ltd
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2020-08-03
Based on: B.I.a.1.z
Based on: B.I.b.1.e
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Company Ltd
email: poni.heppa@company.com
Phone: +353140312233
Address:
1 Riverroad
Citywest Business Campus
D24VK12
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-4 fullUrl=(none)
Name: Wonderpill
Invented name part: Wonderpill
Pharmaceutical dose form name part: Solution for injection in pre-filled pen
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled pen [(100000074039)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-4-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/17/1196/007 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EU/1/17/1196/008 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EU/1/17/1196/012 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
company Ltd
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2020-08-03
Based on: B.I.a.1.z
Based on: B.I.b.1.e
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
New data: "For the ease of review, variation overview and redlined sections have been provided in appendix to this application form (Module 1)"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Company Ltd
email: poni.heppa@company.com
Phone: +353140312233
Address:
1 Riverroad
Citywest Business Campus
D24VK12
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Warning - Found 4 copies of Ingredient SARILUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1).
Warning - Found 4 copies of Ingredient SARILUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1).
Warning - Found 4 copies of Ingredient SARILUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1).
Warning - Found 4 copies of Ingredient SARILUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1).