TEAB members. Annex I - Requirements High-level requirements "Motivation Business [legislation, Requirement Requirement Name Description organisation, process ID integration ref, Stakholder comments" BRQ-0002 Automated two-way Automated two-way exchange of B.09b_FINAL PSUR exchange (Repository documents held in the PSUR Repository auditable API) Repository between NCA functionalities - section 4 systems and the PSUR COM10, COM40, COM41 Repository to reduce See sheet "Traceability for administrative burden for NCAs post-audit req" Detailed requirements Detailed Detailed Description MoSCoW requirements requirements (see note ID name for defintion) DR_001 Search query The PSUR repository will provide parameterised Must queries executed with the following parameters: EU single assessment Non-EU single assessment Procedure number Country code Document type Submission date range Data lock point DR_0020 Search query: A user must be able to search for one or more Must Document type of the following document types: PSUR submission (the original package that was submitted by the MAH) Supplemental Info (the original package that was submitted by the MAH) Documents uploaded in relation to single assessment Preliminary AR (applicable to EU single assessment only) Updated AR (applicable to EU single assessment only) Comments on PAR (applicable to EU single assessment only) PRAC recommendation (applicable to EU single assessment only) CHMP Opinion (applicable to EU single
TEAB members. Annex I - Requirements High-level requirements Business Requirement ID Requirement Name Description "Motivation [legislation, organisation, process integration ref, Stakholder comments" BRQ-0002 Automated two-way exchange (Repository API) Automated two-way exchange of documents held in the PSUR Repository between NCA systems and the PSUR Repository to reduce administrative burden for NCAs B.09b_FINAL PSUR Repository auditable functionalities - section 4 COM10, COM40, COM41 See sheet "Traceability for post-audit req" Detailed requirements Detailed requirements ID Detailed requirements name Description MoSCoW (see note for defintion) DR_001 Search query The PSUR repository will provide parameterised queries executed with the following parameters: EU single assessment Non-EU single assessment Procedure number Country code Document type Submission date range Data lock point Must DR_0020 Search query: Document type A user must be able to search for one or more of the following document types: PSUR submission (the original package that was submitted by the MAH) Supplemental Info (the original package that was submitted by the MAH) Documents uploaded in relation to single assessment Preliminary AR (applicable to EU single assessment only) Updated AR (applicable to EU single assessment only) Comments on PAR (applicable to EU single assessment only) PRAC recommendation (applicable to EU single assessment only) CHMP Opinion (applicable to EU single Must
PSUR-Repository-API-Specification.docx