show codes show debug x
Task id=task-application fullUrl=(none)
Code: id=(none) fullUrl=(none)Variation Type IAIN [(100000155691)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Identifier: EMEA/H/C/001234/xxxx/II (http://ema.europa.eu/fhir/procedureIdentifierNumber)
Status: requested
Intent: order
Task id=variation-1 fullUrl=(none)
Code: B.II.b.2.c.1 - QUALITY CHANGES - FINISHED PRODUCT - Manufacture - Change to importer, batch release arrangements and quality control testing of the finished product - Replacement or addition of a manufacturer responsible for importation and/or batch release - Not including batch control/testing [(B.II.b.2.c.1)] (https://spor.ema.europa.eu/v1/lists/100000152091-todo-scope-type)
Status: requested
Intent: order
Description: Variation implementation note
Date: from 2021-01-12
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IAIN [(typeIAIN)] (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: IAIN [(typeIAINapplicable)] (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: 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: conditions [(conditionsapplicable)] (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: documentations [(documentationsapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: At least one batch control/testing site remains within the EU/EEA or in a country where an operational and suitably scoped GMP mutual recognition agreement (MRA) exists between the country concerned and the EU, that is able to carry out product testing for the purpose of batch release within the EU/EEA. [(exampleConditionCode)] (https://spor.ema.europa.eu/v1/lists/200000003554)
Value: There is some condition text here
Condition Applies: true
Input
Type: The manufacturer responsible for batch release must be located within the EU/EEA. At least one batch release site remains within the EU/EEA that is able to certify the product testing for the purpose of batch release within the EU/EEA. [(exampleConditionCode)] (https://spor.ema.europa.eu/v1/lists/200000003554)
Value: This is an unselected condition text
Condition Applies: false
Input
Type: The site is appropriately authorised. [(exampleConditionCode)] (https://spor.ema.europa.eu/v1/lists/200000003554)
Value: (no text)
Condition Applies: true
Input
Type: The variation application form should clearly outline the ‘present’ and ‘proposed’ finished product manufacturers, importer, batch control/testing and batch release sites as listed in section 2.5 of the application form for marketing authorisation. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
Input
Type: For a site within the EU/EEA: Attach copy of manufacturing authorisation(s) or where no manufacturing authorisation exists a certificate of GMP compliance issued within the last 3 years by the relevant competent authority. For a manufacturing site outside the EEA where an operational GMP mutual recognition agreement (MRA) exists between the country concerned and the EU: a GMP certificate, issued within the last 3 years by the relevant competent authority. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
Input
Type: For centralised procedure only: contact details of new contact person in the EU/EEA for product defects and recalls, if applicable. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
Input
Type: A declaration by the Qualified Person (QP) responsible for batch certification stating that the active substance manufacturer(s) referred to in the marketing authorisation operate in compliance with the detailed guidelines on good manufacturing practice for starting materials. A single declaration may be acceptable under certain circumstances — see the note under variation No B.II.b.1. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
Input
Type: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate) including revised product information as appropriate. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
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])
Input
Type: Grouping details [(grouping-code-tbc)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: id=(none) fullUrl=(none)Single Regulatory Activity [(100000155554)] (https://spor.ema.europa.eu/v1/lists/100000155553)
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 IAIN [(100000155691)] (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: I just type free text here, as much as I want
Input
Type: Other Applications [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: some other applications text
Input
Type: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-summary, summary
Input
Type: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-package, package
Input
Type: noOtherChanges [(100000002345-temp-noOtherChanges)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: requiredDocuments [(100000002345-temp-requiredDocuments)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
For
GlaxoSmithKline Sante Grand Public LOC-100044105 (https://spor.ema.europa.eu/v1/locations)
Requested by
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100003329 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: GlaxoSmithKline Sante Grand Public
email: test1@test.com
Phone: +3312345
Address:
23 Rue Francois Jacob
Rueil Malmaison
92500
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100044105 (https://spor.ema.europa.eu/v1/locations)
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: 2021-01-26
By
Role id=signature-person-id fullUrl=(none) - id=(none) fullUrl=(none)head of RA [(tbc)] (https://spor.ema.europa.eu/v1/lists/100000154441)
Practitioner id=signature-practitioner-id fullUrl=(none)
Name: Mrs Test Person
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100003329 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: GlaxoSmithKline Sante Grand Public
email: test1@test.com
Phone: +3312345
Address:
23 Rue Francois Jacob
Rueil Malmaison
92500
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100044105 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Recorded date: 2021-01-26
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: Prolonged-release wound solution
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
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Prolonged-release wound solution [(200000010456)] (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
(unknown resource type)
which is linked to this by contained resource.id
Authorisation id=(none) fullUrl=(none)
Type: Extended Data Exclusivity/Marked Protection [(220000000077TODO-)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Status: Applied [(applied)] (https://spor.ema.europa.eu/v1/lists/todoAuthorisationStatus)
Holder
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100003329 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: GlaxoSmithKline Sante Grand Public
email: test1@test.com
Phone: +3312345
Address:
23 Rue Francois Jacob
Rueil Malmaison
92500
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100044105 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
↸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: EMEA/00101010 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EMEA/23939506- (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
GlaxoSmithKline Sante Grand Public LOC-100044105 (https://spor.ema.europa.eu/v1/locations)
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 IAIN [(100000155691)] (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: 2021-01-26
Based on: B.II.b.2.c.1
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "teslk"
New data: "jlkdjs;a"
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: "teslk"
New data: "jlkdjs;a"
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)
Identifier: ORG-100003329 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: GlaxoSmithKline Sante Grand Public
email: test1@test.com
Phone: +3312345
Address:
23 Rue Francois Jacob
Rueil Malmaison
92500
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100044105 (https://spor.ema.europa.eu/v1/locations)
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: Powder for oral suspension
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
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Powder for oral suspension [(100000073649)] (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: EMEA/00101011 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Identifier: EMEA/23939507- (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
GlaxoSmithKline Sante Grand Public LOC-100044105 (https://spor.ema.europa.eu/v1/locations)
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 IAIN [(100000155691)] (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: 2021-01-26
Based on: B.II.b.2.c.1
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "teslk"
New data: "jlkdjs;a"
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: "teslk"
New data: "jlkdjs;a"
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)
Identifier: ORG-100003329 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: GlaxoSmithKline Sante Grand Public
email: test1@test.com
Phone: +3312345
Address:
23 Rue Francois Jacob
Rueil Malmaison
92500
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100044105 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Warning - Found 2 copies of Ingredient PARACETAMOL(id=Ingredient-p1-1)(id=Ingredient-p2-1).
Warning - Found 2 copies of Ingredient PARACETAMOL(id=Ingredient-p1-1)(id=Ingredient-p2-1).