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
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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
InputType: 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
InputType: The site is appropriately authorised. [(exampleConditionCode)] (https://spor.ema.europa.eu/v1/lists/200000003554)
Value: (no text)
Condition Applies: true
InputType: 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
InputType: 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
InputType: 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
InputType: 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
InputType: 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
InputType: Article 5 [(exampleArticle5Code)] (https://spor.ema.europa.eu/v1/lists/900000003554-dummy)
Value: true
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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
InputType: Other Applications [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: some other applications text
InputType: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-summary, summary
InputType: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-package, package
↸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
ByRole 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
Activity: attest (http://terminology.hl7.org/CodeSystem/iso-21089-lifecycle)