http://ema.europa.eu/fhir/Bundle/e4760773-4635-4f49-8f3f-4d085f049199
type: Bundle
node role: treeRoot
meta:
  profile:
    v: http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/1.2.0
    link: http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/1.2.0
  profile:
    v: http://ema.europa.eu/fhir/definition/fhir-adapter/1.2.0.0
    link: http://ema.europa.eu/fhir/definition/fhir-adapter/1.2.0.0
type:
  v: transaction-response
entry:
  full url:
    v: http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068
  resource: http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068
  response:
    status:
      v: 200
    location:
      v: MedicinalProductDefinition/600000709068
entry:
  full url:
    v: http://ema.europa.eu/example/api/PackagedProductDefinition/7868766
  resource: http://ema.europa.eu/example/api/PackagedProductDefinition/7868766
  response:
    status:
      v: 200
    location:
      v: PackagedProductDefinition/7868766
entry:
  full url:
    v: http://ema.europa.eu/example/api/ActivityDefinition/123456
  resource: http://ema.europa.eu/example/api/ActivityDefinition/123456
  response:
    status:
      v: 200
    location:
      v: ActivityDefinition/123456
entry:
  full url:
    v: http://ema.europa.eu/example/api/RegulatedAuthorization/345678
  resource: http://ema.europa.eu/example/api/RegulatedAuthorization/345678
  response:
    status:
      v: 200
    location:
      v: RegulatedAuthorization/345678
entry:
  full url:
    v: http://ema.europa.eu/example/api/ActivityDefinition/7371703
  resource: http://ema.europa.eu/example/api/ActivityDefinition/7371703
  response:
    status:
      v: 200
    location:
      v: ActivityDefinition/7371703
entry:
  full url:
    v: http://ema.europa.eu/example/api/RegulatedAuthorization/6756012
  resource: http://ema.europa.eu/example/api/RegulatedAuthorization/6756012
  response:
    status:
      v: 200
    location:
      v: RegulatedAuthorization/6756012
entry:
  full url:
    v: http://ema.europa.eu/example/api/RegulatedAuthorization/6362767
  resource: http://ema.europa.eu/example/api/RegulatedAuthorization/6362767
  response:
    status:
      v: 200
    location:
      v: RegulatedAuthorization/6362767
entry:
  full url:
    v: http://ema.europa.eu/example/api/RegulatedAuthorization/6094279
  resource: http://ema.europa.eu/example/api/RegulatedAuthorization/6094279
  response:
    status:
      v: 200
    location:
      v: RegulatedAuthorization/6094279

http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068
type: MedicinalProductDefinition
id:
  v: 600000709068
meta:
  version id:
    v: 4
text:
  status:
    v: extensions
  div: Generated Narrative: MedicinalProductDefinition 600000709068 version: 4 Authorised Dose Form: Pharmaceutical Dose Form 100000073683: Prolonged-release tablet identifier: http://spor.azure-api.net/pms/api/v2/6055417 domain: Human use status: Nullified combinedPharmaceuticalDoseForm: 100000073683 indication: legalStatusOfSupply: Medicinal product not subject to medical prescription additionalMonitoringIndicator: False pediatricUseIndicator: True classification: 100000098024, Full application (Article 8(3) of Directive No 2001/83/EC), Other attachedDocument: DocumentReference: status = current masterFile: DocumentReference: status = current contact type: Pharmacovigilance Enquiry Information contact: Organization Dummmy Organization contact type: Qualified Person in the EEA for Pharmacovigilance contact: PractitionerRole name productName: StopCold 5 mg/120 mg comprimidos de liberación prolongada. part part: StopCold type: Invented name part part part: 5 MG/120 MG type: Strength part part part: COMPRIMIDOS DE LIBERACIÓN PROLONGADA type: Pharmaceutical dose form part Usages - Country Language * Spain Spanish operation id 6519944 Types - Reference * This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently confidentialityIndicator: Confidential operation Types - Reference * Bundle: type = transaction-response confidentialityIndicator: Public Characteristics - Type * true
extension:
  url:
    v: http://ema.europa.eu/fhir/extension/authorisedDoseForm
  value: Coding
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 38
    system:
      v: http://spor.ema.europa.eu/v1/lists/200000000004
    code:
      v: 100000073683
identifier:
  system:
    v: http://spor.azure-api.net/pms/api/v2
  value:
    v: 6055417
domain:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 7
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000000004
    code:
      v: 100000000012
status:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 3
    system:
      v: http://spor.ema.europa.eu/v1/lists/200000005003
    code:
      v: 200000005007
combined pharmaceutical dose form:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 38
    system:
      v: http://spor.ema.europa.eu/v1/lists/200000000006
    code:
      v: 100000073683
indication:
  extension:
    url:
      v: http://ema.europa.eu/fhir/extension/language
    value: Coding
      extension:
        value: string
      system:
        v: http://spor.ema.europa.eu/v1/lists/100000072057
      code:
        v: 100000072147
legal status of supply:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/codeSystemName
      value: string
        v: Legal Status From the Supply
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000072051
    code:
      v: 100000072076
additional monitoring indicator:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/codeSystemName
      value: string
        v: Additional Monitoring Indicator
    system:
      v: http://ema.europa.eu/fhir/additionalMonitoringIndicator
    code:
      v: False
pediatric use indicator:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/codeSystemName
      value: string
        v: Paediatric Use Indicator
    system:
      v: http://ema.europa.eu/fhir/paediatricUseIndicator
    code:
      v: True
classification:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 3
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000093533
    code:
      v: 100000098024
classification:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 8
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000116045
    code:
      v: 100000116046
classification:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 2
    system:
      v: http://spor.ema.europa.eu/v1/lists/200000000324
    code:
      v: 200000003517
attached document:
  link: http://ema.europa.eu/fhir/DocumentReference/13709
  reference:
    v: DocumentReference/13709
master file:
  link: http://ema.europa.eu/fhir/DocumentReference/mf1
  reference:
    v: DocumentReference/mf1
contact:
  type:
    coding:
      extension:
        value: integer
      system:
        v: http://spor.ema.europa.eu/v1/lists/100000154441
      code:
        v: 200000017719
  contact:
    link: http://ema.europa.eu/fhir/Organization/phv5633366
    reference:
      v: Organization/phv5633366
contact:
  type:
    coding:
      extension:
        value: integer
      system:
        v: http://spor.ema.europa.eu/v1/lists/100000154441
      code:
        v: 100000155057
  contact:
    link: http://ema.europa.eu/fhir/PractitionerRole/qppv5633367
    reference:
      v: PractitionerRole/qppv5633367
name:
  product name:
    v: StopCold 5 mg/120 mg comprimidos de liberación prolongada.
  part:
    part:
      v: StopCold
  part:
    part:
      v: 5 MG/120 MG
  part:
    part:
      v: COMPRIMIDOS DE LIBERACIÓN PROLONGADA
operation:
  id:
    v: 6519944
  type:
    reference:
      link: http://ema.europa.eu/fhir/ActivityDefinition/7371703
      reference:
        v: ActivityDefinition/7371703
  confidentiality indicator:
    coding:
      system:
        v: http://spor.ema.europa.eu/v1/lists/200000004983
      code:
        v: 200000004984
operation:
  type:
    reference:
      link: http://ema.europa.eu/fhir/ActivityDefinition/123456
      reference:
        v: ActivityDefinition/123456

http://ema.europa.eu/example/api/PackagedProductDefinition/7868766
type: PackagedProductDefinition
id:
  v: 7868766
text:
  status:
    v: generated
  div: Generated Narrative: PackagedProductDefinition 7868766 identifier: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575/1141415566651 packageFor: Bundle: type = searchset status: Nullified containedItemQuantity: 20(unit 200000002152 from http://spor.ema.europa.eu/v1/lists/200000000014) (Details: Units Of Presentation code200000002152 = 'Tablet') description: 5MG/120MG PROLONGED RELEASE TABLET MarketingStatuses - Country Status * United Kingdom Marketed
identifier:
  system:
    v: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575
  value:
    v: 1141415566651
package for:
  link: http://ema.europa.eu/fhir/MedicinalProductDefinition/600000709068
  reference:
    v: MedicinalProductDefinition/600000709068
status:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 3
    system:
      v: http://spor.ema.europa.eu/v1/lists/200000005003
    code:
      v: 200000005007
contained item quantity:
  value:
    v: 20
  system:
    v: http://spor.ema.europa.eu/v1/lists/200000000014
  code:
    v: 200000002152
description:
  v: 5MG/120MG PROLONGED RELEASE TABLET
  extension:
    url:
      v: http://ema.europa.eu/fhir/extension/language
    value: Coding
      extension:
        value: integer
      system:
        v: http://spor.ema.europa.eu/v1/lists/100000072057
      code:
        v: 100000072264
marketing status:
  country:
    coding:
      extension:
        value: string
      system:
        v: http://spor.ema.europa.eu/v1/lists/100000000002
      code:
        v: 100000000556
      display:
        v: United Kingdom
  status:
    coding:
      extension:
        value: string
      system:
        v: http://spor.ema.europa.eu/v1/lists/100000072052
      code:
        v: 100000072083
      display:
        v: Marketed

http://ema.europa.eu/example/api/ActivityDefinition/123456
type: ActivityDefinition
id:
  v: 123456
text:
  status:
    v: extensions
  div: Id: 123456 Effective Period: 2025-03-31.. Code: system: http://spor.ema.europa.eu/v1/lists/100000160406 code: 100000160480
status:
  v: active
effective period:
  start:
    v: 2025-03-31
code:
  coding:
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000160406
    code:
      v: 100000160480
participant:
  type:
    v: organization
  type reference:
    identifier:
      system:
        v: http://spor.ema.europa.eu/v1/locations
      value:
        v: LOC-100068460
    display:
      v: Pharma X

http://ema.europa.eu/example/api/RegulatedAuthorization/345678
type: RegulatedAuthorization
id:
  v: 345678
text:
  status:
    v: generated
  div: Generated Narrative: RegulatedAuthorization 345678 identifier: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber/12345 subject: Bundle: type = transaction-response type: Manufacturing Authorisation validityPeriod: 2025-03-31 --> (ongoing) regulator: Finnish Medicines Agency (Identifier: http://spor.ema.europa.eu/v1/locations/LOC-100000015)
identifier:
  system:
    v: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber
  value:
    v: 12345
subject:
  link: http://ema.europa.eu/fhir/ActivityDefinition/123456
  reference:
    v: ActivityDefinition/123456
type:
  coding:
    system:
      v: http://spor.ema.europa.eu/v1/lists/220000000060
    code:
      v: 200000051585
validity period:
  start:
    v: 2025-03-31
regulator:
  identifier:
    system:
      v: http://spor.ema.europa.eu/v1/locations
    value:
      v: LOC-100000015
  display:
    v: Finnish Medicines Agency

http://ema.europa.eu/example/api/ActivityDefinition/7371703
type: ActivityDefinition
id:
  v: 7371703
text:
  status:
    v: extensions
  div: Id: 7371703 Effective Period: 2024-12-01.. Code: system: http://spor.ema.europa.eu/v1/lists/100000160406 code: 100000160478
status:
  v: active
effective period:
  start:
    v: 2024-12-01
code:
  coding:
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000160406
    code:
      v: 100000160478
participant:
  type:
    v: organization
  type reference:
    identifier:
      system:
        v: http://spor.ema.europa.eu/v1/locations
      value:
        v: LOC-100068457
    display:
      v: 1 4 U Pharma GmbH

http://ema.europa.eu/example/api/RegulatedAuthorization/6756012
type: RegulatedAuthorization
id:
  v: 6756012
text:
  status:
    v: extensions
  div: Generated Narrative: RegulatedAuthorization 6756012 Regulated Authorization - Date of First Authorisation: 1987-04-15 Regulated Authorization - International Birth Date: 2000-04-15 identifier: http://ema.europa.eu/fhir/MarketingAuthorizationNumber/62.102 subject: Bundle: type = searchset type: Marketing Authorisation region: Spain status: Not valid - Superseded by marketing authorisation transfer statusDate: 2025-02-18 00:00:00+0000 validityPeriod: 2019-06-03 --> (ongoing) holder: Kern Pharma S.L. (Identifier: http://spor.ema.europa.eu/v1/locations/LOC-100002956) regulator: ES (Identifier: http://spor.ema.europa.eu/v1/locations/ES) Cases - Type * National Procedure
extension:
  url:
    v: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
  value: date
    v: 1987-04-15
extension:
  url:
    v: http://ema.europa.eu/fhir/extension/internationalBirthDate
  value: date
    v: 2000-04-15
identifier:
  system:
    v: http://ema.europa.eu/fhir/MarketingAuthorizationNumber
  value:
    v: 62.102
subject:
  link: http://ema.europa.eu/fhir/MedicinalProductDefinition/600000709068
  reference:
    v: MedicinalProductDefinition/600000709068
type:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 1
    system:
      v: http://spor.ema.europa.eu/v1/lists/220000000060
    code:
      v: 220000000061
region:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 22
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000000002
    code:
      v: 100000000529
status:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 3
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000072049
    code:
      v: 200000032263
status date:
  v: 2025-02-18T00:00:00Z
validity period:
  start:
    v: 2019-06-03
holder:
  identifier:
    system:
      v: http://spor.ema.europa.eu/v1/locations
    value:
      v: LOC-100002956
  display:
    v: Kern Pharma S.L.
regulator:
  identifier:
    system:
      v: http://spor.ema.europa.eu/v1/locations
    value:
      v: ES
  display:
    v: ES
case:
  type:
    coding:
      extension:
        value: integer
      system:
        v: http://spor.ema.europa.eu/v1/lists/100000154442
      code:
        v: 100000155062

http://ema.europa.eu/example/api/RegulatedAuthorization/6362767
type: RegulatedAuthorization
id:
  v: 6362767
text:
  status:
    v: generated
  div: Generated Narrative: RegulatedAuthorization 6362767 identifier: http://ema.europa.eu/fhir/MarketingAuthorizationNumber/62.102 subject: Bundle: type = searchset type: Marketing Authorisation region: Spain status: Not valid - Superseded by marketing authorisation transfer statusDate: 2025-02-18 00:00:00+0000
identifier:
  system:
    v: http://ema.europa.eu/fhir/MarketingAuthorizationNumber
  value:
    v: 62.102
subject:
  link: http://ema.europa.eu/fhir/PackagedProductDefinition/7868766
  reference:
    v: PackagedProductDefinition/7868766
type:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 1
    system:
      v: http://spor.ema.europa.eu/v1/lists/220000000060
    code:
      v: 220000000061
region:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 22
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000000002
    code:
      v: 100000000529
status:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 3
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000072049
    code:
      v: 200000032263
status date:
  v: 2025-02-18T00:00:00Z

http://ema.europa.eu/example/api/RegulatedAuthorization/6094279
type: RegulatedAuthorization
id:
  v: 6094279
text:
  status:
    v: generated
  div: Generated Narrative: RegulatedAuthorization 6094279 subject: This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently type: Manufacturing Authorisation status: Valid validityPeriod: 2024-12-01 --> (ongoing) regulator: Finnish Medicines Agency (Identifier: http://spor.ema.europa.eu/v1/locations/LOC-100000015)
subject:
  link: http://ema.europa.eu/fhir/ActivityDefinition/7371703
  reference:
    v: ActivityDefinition/7371703
type:
  coding:
    system:
      v: http://spor.ema.europa.eu/v1/lists/220000000060
    code:
      v: 200000051585
status:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/termVersion
      value: integer
        v: 17
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000072049
    code:
      v: 100000072099
validity period:
  start:
    v: 2024-12-01
regulator:
  identifier:
    system:
      v: http://spor.ema.europa.eu/v1/locations
    value:
      v: LOC-100000015
  display:
    v: Finnish Medicines Agency

string
v: Domain

integer
v: 3

integer
v: 1

url:
  v: http://ema.europa.eu/fhir/extension/termVersion
value: integer
  v: 9

v: 220000000002

url:
  v: http://ema.europa.eu/fhir/extension/termVersion
value: integer
  v: 9

v: 220000000004

url:
  v: http://ema.europa.eu/fhir/extension/termVersion
value: integer
  v: 8

v: 220000000005

url:
  v: http://ema.europa.eu/fhir/extension/termVersion
value: integer
  v: 19

v: 100000000529

v: urn:ietf:bcp:47

v: es

url:
  v: http://ema.europa.eu/fhir/extension/termVersion
value: integer
  v: 2

v: 100000072264

coding:
  system:
    v: http://spor.ema.europa.eu/v1/lists/200000004983
  code:
    v: 200000004985

type:
  coding:
    extension:
      url:
        v: http://ema.europa.eu/fhir/extension/compliesWithDirective
      value: boolean
        v: true
    system:
      v: http://ema.europa.eu/fhir/gmo
    code:
      v: true

integer
v: 2

string
v: Country

string
v: Marketing Status

integer
v: 14