Code: B.I.d.1.a.4 - QUALITY CHANGES - ACTIVE SUBSTANCE - Stability - Change in the re-test period/storage period or storage conditions of the active substance where no Ph. Eur. Certificate of Suitability covering the retest period is part of the approved dossier - Re-test period/storage period - [(B.I.d.1.a.4)] (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)
Type: Copy of approved specifications of the active substance. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
Input
Type: Confirmation that stability studies have been done to the currently approved protocol. The studies must show that the agreed relevant specifications are still met. [(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). This must contain results of appropriate real time stability studies, conducted in accordance with the relevant stability guidelines on at least two pilot or production scale batches of the active substance in the authorised packaging material and covering the duration of the requested retest period or requested storage conditions. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: Scope of the changeWith this application, the Company is seeking approval for the shelf-life extension of " for final confirmation on the acceptability of worksharing for this submission.
Input
Type: Other Applications [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
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)
Pharmaceutical dose form name part: Powder and suspension for suspension for injection
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 and suspension for suspension for injection [(100000074032)] (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)
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-nationalAuthInMRP fullUrl=(none)
Type: Variation Type IB [(100000155692)] (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 Authorisation id=ra-red-1-blue-1-1-euAuthorisation fullUrl=(none)
Type: Variation Type IB [(100000155692)] (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 Authorisation id=ra-red-1-blue-1-1-nationalAuthorisation fullUrl=(none)
Type: Variation Type IB [(100000155692)] (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)
Address: European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-2-1-1 fullUrl=(none)
Name: INFANRIX-IPV+HIB
Invented name part: INFANRIX-IPV+HIB
Pharmaceutical dose form name part: Powder and suspension for suspension for injection
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 and suspension for suspension for injection [(100000074032)] (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-2-blue-1-1-nationalAuthInMRP fullUrl=(none)
Type: Variation Type IB [(100000155692)] (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 Authorisation id=ra-red-2-blue-1-1-euAuthorisation fullUrl=(none)
Type: Variation Type IB [(100000155692)] (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 Authorisation id=ra-red-2-blue-1-1-nationalAuthorisation fullUrl=(none)
Type: Variation Type IB [(100000155692)] (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)
Address: European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/001(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/002(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/005(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/006(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/021(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/001(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/002(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/005(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/006(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/021(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/001(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/002(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/005(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/006(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization EU/1/00/152/021(id=ra-red-1-blue-1-1-nationalAuthInMRP)(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization 2-00370(id=ra-red-2-blue-1-1-nationalAuthInMRP)(id=ra-red-2-blue-1-1-euAuthorisation)(id=ra-red-2-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization 2-00370(id=ra-red-2-blue-1-1-nationalAuthInMRP)(id=ra-red-2-blue-1-1-euAuthorisation)(id=ra-red-2-blue-1-1-nationalAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization 2-00370(id=ra-red-2-blue-1-1-nationalAuthInMRP)(id=ra-red-2-blue-1-1-euAuthorisation)(id=ra-red-2-blue-1-1-nationalAuthorisation).