cander2
commented
1 year ago Do you need any particular number of ePIs or any particular languages?
Closed jkiddo closed 1 year ago
cander2
commented
1 year ago Do you need any particular number of ePIs or any particular languages?
jkiddo
commented
1 year ago Nope - 'just' two leaflets representing the same content but in different languages for now would do it. There may come more details to it but it is mostly for serving as an example and to align with the initial EMA thoughts.
jkiddo
commented
1 year ago @joofio can you make the list?
jkiddo
commented
1 year ago @adamzkover rumor says that you guys would be looking into making ePI's available eventually. Will you guys also embrace the use of the List as a mean of grouping things (initially proposed by EMA)? If so, you should probably be aware about this :)
adamzkover
commented
1 year ago Thanks @jkiddo I will be watching this. I would say that we are also trying to align with EMA's plans. It would be nice to get an update though, if using a List is still the plan...
cander2
commented
1 year ago @jkiddo, made the list here: https://build.fhir.org/ig/hl7-eu/gravitate-health/List-listKarvea.html
We don't have multiple karvea ePI documents so I used bundles from the others as a placeholder until we have different documents (SmPC, PL), different versions, or different languages.
See below for the Bundles in the list. We'll replace 2 to 4 with different variations of Karvea once available.
cander2
commented
1 year ago It's a shame List.Entry does not have a title element so we can add a descriptor to each one.
Do you think that is necessary? If so, we can ask for the List resource to be updated to include it. Or, do you think it is a non-issue to open each one to see what's in there?
cander2
commented
1 year ago Over the life of a product, especially an active one, there could be tens, maybe hundreds of rows in a list.
jkiddo
commented
1 year ago @cander2 any change we can have some actual translated ePI's?
jkiddo
commented
1 year ago This is an example how they where in the EMA example model:
{
"resourceType": "List",
"id": "d60656bd-a359-4c96-82bd-ca1398aacbb3",
"meta": {
"versionId": "106",
"lastUpdated": "2021-06-28T10:22:41.368+00:00"
},
"identifier": [
{
"system": "http://spor.ema.europa.eu/v2/medicine-name",
"value": "skilarence"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/001"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/002"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/003"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/004"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/005"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/006"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/007"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/008"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/009"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/010"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/011"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/012"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/013"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/014"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/01370"
},
{
"system": "http://spor.ema.europa.eu/v2/marketing-authorisation-numbers",
"value": "EU/1/17/1201/014210"
}
],
"status": "current",
"mode": "working",
"code": {
"coding": [
{
"system": "http://spor.ema.europa.eu/v1/example-pi-list-types",
"code": "00000021213",
"display": "ePI Master List"
}
]
},
"subject": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/medicine-name",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000000005",
"code": "Skilarence",
"display": "Skilarence"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/marketing-authorization-holder",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000000005",
"code": "mah-code",
"display": "None"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/active-substance",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000000005",
"code": "acive-substance-code",
"display": "None"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/domain",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000000004",
"code": "100000000012",
"display": "H"
}
}
]
},
"entry": [
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155532",
"display": "КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072142",
"display": "bg"
}
}
],
"reference": "Bundle/42cd1340-48f8-4273-a786-aeaf69dbfa03"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155533",
"display": "ПРИЛОЖЕНИЕ II"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072142",
"display": "bg"
}
}
],
"reference": "Bundle/35a22e58-58ae-40c5-b1e7-378841da8c7f"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155535",
"display": "A. ДАННИ ВЪРХУ ОПАКОВКАТА"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072142",
"display": "bg"
}
}
],
"reference": "Bundle/7068562d-b05f-4a21-82e0-e1cb39302259"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155538",
"display": "Б. ЛИСТОВКА"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072142",
"display": "bg"
}
}
],
"reference": "Bundle/ed336bc2-6f56-4166-884a-61cd71cf1fa6"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155532",
"display": "SOUHRN ÚDAJŮ O PŘÍPRAVKU"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072167",
"display": "cs"
}
}
],
"reference": "Bundle/81f7f994-75c5-4ffe-9a19-5343c9b1a443"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155533",
"display": "PŘÍLOHA II"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072167",
"display": "cs"
}
}
],
"reference": "Bundle/c49556b2-af6d-475e-991a-5ec83880e606"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155535",
"display": "A. OZNAČENÍ NA OBALU"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072167",
"display": "cs"
}
}
],
"reference": "Bundle/06a4897d-1244-4246-99cf-b0a847371907"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155538",
"display": "B. PŘÍBALOVÁ INFORMACE"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072167",
"display": "cs"
}
}
],
"reference": "Bundle/f28c009e-aa4a-400e-82f7-7eb90f9abe8c"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155532",
"display": "PRODUKTRESUMÉ"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072168",
"display": "da"
}
}
],
"reference": "Bundle/07912e62-3abd-4433-910d-0368fbe3d4d1"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155533",
"display": "BILAG II"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072168",
"display": "da"
}
}
],
"reference": "Bundle/8e26539b-5093-4f3f-bd5d-13c7f84c1e3e"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155535",
"display": "A. ETIKETTERING"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072168",
"display": "da"
}
}
],
"reference": "Bundle/9ccf8f9d-2d4a-4ba7-8696-a82da1fe1e87"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155538",
"display": "B. INDLÆGSSEDDEL"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072168",
"display": "da"
}
}
],
"reference": "Bundle/2ae91933-4281-43d5-800f-e0a1bd7b627f"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155532",
"display": "ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072178",
"display": "de"
}
}
],
"reference": "Bundle/78b824f4-fc1b-4b91-a4bc-2033fdceb34f"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155533",
"display": "ANHANG II"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072178",
"display": "de"
}
}
],
"reference": "Bundle/da32674b-b7a1-4913-88dc-7d45452c0b92"
}
},
{
"item": {
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{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155535",
"display": "A. ETIKETTIERUNG"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072178",
"display": "de"
}
}
],
"reference": "Bundle/e0e440c4-aa84-42b3-86e4-ee262017e705"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155538",
"display": "B. PACKUNGSBEILAGE"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072178",
"display": "de"
}
}
],
"reference": "Bundle/817e0d3f-3e3d-4d34-a4cf-a6ac2bff547e"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155532",
"display": "ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072181",
"display": "el"
}
}
],
"reference": "Bundle/36773c03-3040-45e2-82c2-bc3fc968b6a6"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155533",
"display": "ΠΑΡΑΡΤΗΜΑ ΙΙ"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072181",
"display": "el"
}
}
],
"reference": "Bundle/58add5bc-c568-4d46-8bfd-4303634a65ff"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155535",
"display": "Α. ΕΠΙΣΗΜΑΝΣΗ"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072181",
"display": "el"
}
}
],
"reference": "Bundle/15b01a3f-cb36-46ff-9faf-5a6077fec10a"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155538",
"display": "Β. ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072181",
"display": "el"
}
}
],
"reference": "Bundle/234d3626-fac0-4e69-86a6-556910eecfc9"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155532",
"display": "SUMMARY OF PRODUCT CHARACTERISTICS"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072147",
"display": "en"
}
}
],
"reference": "Bundle/910d1748-674b-430c-b4ab-3665b266a31f"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155533",
"display": "ANNEX II"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072147",
"display": "en"
}
}
],
"reference": "Bundle/464141ec-43e7-4779-baf6-09179a7abe7f"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155535",
"display": "A. LABELLING"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072147",
"display": "en"
}
}
],
"reference": "Bundle/13f82397-5897-4652-a140-199fd38d4e32"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155538",
"display": "B. PACKAGE LEAFLET"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072147",
"display": "en"
}
}
],
"reference": "Bundle/79147eac-56be-4aec-9e71-bee160e588b6"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155532",
"display": "FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072264",
"display": "es"
}
}
],
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"code": "100000155538",
"display": "B. NAVODILO ZA UPORABO"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072260",
"display": "sl"
}
}
],
"reference": "Bundle/2f2da456-8940-42d9-b88b-82da9118befb"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155532",
"display": "PRODUKTRESUMÉ"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072288",
"display": "sv"
}
}
],
"reference": "Bundle/3eb1db41-c97e-4fb2-89d1-5b38bdbb9ea9"
}
},
{
"item": {
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{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155533",
"display": "BILAGA II"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072288",
"display": "sv"
}
}
],
"reference": "Bundle/534113ab-609d-439d-aa29-112f2cd8f92f"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155535",
"display": "A. MÄRKNING"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072288",
"display": "sv"
}
}
],
"reference": "Bundle/2076d9ea-a846-4c76-b82b-88362a5e152e"
}
},
{
"item": {
"extension": [
{
"url": "http://ema.europa.eu/fhir/extension/documentType",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000155531",
"code": "100000155538",
"display": "B. BIPACKSEDEL"
}
},
{
"url": "http://ema.europa.eu/fhir/extension/language",
"valueCoding": {
"system": "http://spor.ema.europa.eu/v1/100000072057",
"code": "100000072288",
"display": "sv"
}
}
],
"reference": "Bundle/456f40ec-5cd6-4d61-b6f5-192c03e5c6b5"
}
}
]
}
Add a list as grouper for the same leaflet in different languages as suggested by EMA. See also https://github.com/Gravitate-Health/focusing-manager/issues/18