Evidence & policy library
Every pathway is linked to the organizations responsible for the decision.
21 source records
Methodology
Pathway information draws on official regulator, HTA and payer materials. Consult the cited policy for its conditions and effective date, and see Content & use for guidance on applying Atlas to your research.
Matching documents: 40
Market / scopeOfficial evidence recordTypePolicy / reference dateLast checked
Europe
🇩🇪 GermanyOfficialcentralised scope, CHMP/EC roles, EU validityEU centralised legal frameworkLatest observed: current
🇩🇪 GermanyOfficialcentralised scope, CHMP/EC roles, EU validityEU centralised legal frameworkLatest observed: current
🇩🇪 GermanyOfficialBfArM/PEI boundary, DCP/MRP/nationalcurrent German proceduresLatest observed: checked live
🇩🇪 GermanyOfficialBfArM/PEI boundary, DCP/MRP/nationalcurrent German proceduresLatest observed: checked live
🇩🇪 GermanyOfficialday-1 dossier, 3+3 months, ACT, month-7 priceAMNOG effective 2011-01-01Latest observed: current 2026
🇩🇪 GermanyOfficialday-1 dossier, 3+3 months, ACT, month-7 priceAMNOG effective 2011-01-01Latest observed: current 2026
🇩🇪 GermanyOfficialextent/certainty, subgroups, resolution fieldscurrentLatest observed: checked live
🇩🇪 GermanyOfficialextent/certainty, subgroups, resolution fieldscurrentLatest observed: checked live
🇩🇪 GermanyOfficialEU JCA and national AMNOG linkage2025-07Latest observed: current implementation
🇩🇪 GermanyOfficialfirst 6 months, month 7, negotiation, price rules, mixed price, EU price removalcurrent rulesLatest observed: current through 2026
🇩🇪 GermanyOfficialR&D eligibility, 9%, confidential amount2024 law; option from 2025Latest observed: temporary to 2028-06-30
🇩🇪 GermanyOfficialR&D eligibility, 9%, confidential amount2024 law; option from 2025Latest observed: temporary to 2028-06-30
🇩🇪 GermanyOfficialorphan presumption/threshold/reassessmentthreshold change Nov 2022Latest observed: current 2026 cases
🇩🇪 GermanyOfficialorphan presumption/threshold/reassessmentthreshold change Nov 2022Latest observed: current 2026 cases
🇩🇪 GermanyOfficialeligible classes, group definition, cross-active tender, prescribing preference and medical exceptioneffective 2026-07-30Latest observed: current consolidated law
🇩🇪 GermanyOfficialoutpatient prescribing framework, restrictions, aut-idem, biosimilar authorisation relationships and Annex XII; Annex VIIa listing alone does not establish substitution eligibility for every indicationcurrent framework; Annex VIIa April and May updates effective 2026-09-24 and 2026-09-25Latest observed: current compilation effective 2026-09-25
🇩🇪 GermanyOfficialprescribing economy, abolition for new §130b agreements, legacy transition and regional reviewcurrentLatest observed: reform effective 2026-07-30
🇩🇪 GermanyOfficialprescribing economy, abolition for new §130b agreements, legacy transition and regional reviewcurrentLatest observed: reform effective 2026-07-30
🇩🇪 GermanyOfficialdual finance, DRG, ZE, bundled medicine costcurrentLatest observed: hospital page stand 2026-01-05
🇩🇪 GermanyOfficialdual finance, DRG, ZE, bundled medicine costcurrentLatest observed: hospital page stand 2026-01-05
🇩🇪 GermanyOfficiallocal NUB negotiation, ATMP supplement2026 cycleLatest observed: 2026-06-30
🇩🇪 GermanyOfficiallocal NUB negotiation, ATMP supplement2026 cycleLatest observed: 2026-06-30
🇩🇪 GermanyOfficialAbD, provider restriction, reassessment, ATMP qualitycurrentLatest observed: ATMP-QS effective 2026-04-22
🇩🇪 GermanyOfficialAbD, provider restriction, reassessment, ATMP qualitycurrentLatest observed: ATMP-QS effective 2026-04-22
🇩🇪 GermanyOfficialAbD, provider restriction, reassessment, ATMP qualitycurrentLatest observed: ATMP-QS effective 2026-04-22
🇩🇪 GermanyOfficialco-pay, fixed amount, substitution, mature phasecurrentLatest observed: checked 2026-08-01
🇩🇪 GermanyOfficialco-pay, fixed amount, substitution, mature phasecurrentLatest observed: checked 2026-08-01
🇩🇪 GermanyOfficialco-pay, fixed amount, substitution, mature phasecurrentLatest observed: checked 2026-08-01
🇩🇪 GermanyOfficialmandatory price-volume terms, statutory fallback adjustment, transition and effective datelaw passed 2026-07-10; relevant provisions effective 2026-07-30Latest observed: current consolidated law
🇩🇪 GermanyOfficialmandatory price-volume terms, statutory fallback adjustment, transition and effective datelaw passed 2026-07-10; relevant provisions effective 2026-07-30Latest observed: current consolidated law
🇩🇪 GermanyOfficialscope declaration, parallel notification, product-specific upload and submission-date changes2026-08-19Latest observed: 2026-09-02
🇩🇪 GermanyOfficialscope declaration, parallel notification, product-specific upload and submission-date changes2026-08-19Latest observed: 2026-09-02
🇩🇪 GermanyOfficialscope declaration, parallel notification, product-specific upload and submission-date changes2026-08-19Latest observed: 2026-09-02
🇩🇪 GermanyOfficialeligible legacy agreements and awards, termination deadline and continued effect until replacementrelevant reform effective 2026-07-30Latest observed: termination deadline 2026-10-01
🇩🇪 GermanyOfficialvoluntary participation, initial-application window, readiness dialogue and Letter of Intent milestones2026-08-28Latest observed: 2026-09-07
🇩🇪 GermanyOfficialvoluntary participation, initial-application window, readiness dialogue and Letter of Intent milestones2026-08-28Latest observed: 2026-09-07
🇩🇪 GermanyOfficialEU-level pre-JCA request window, product eligibility, platform deadline and national-reimbursement boundary2025-11-28 annual programme; 2026-09-22 announcementLatest observed: 2026-09-22
🇩🇪 GermanyOfficialEU-level pre-JCA request window, product eligibility, platform deadline and national-reimbursement boundary2025-11-28 annual programme; 2026-09-22 announcementLatest observed: 2026-09-22
🇩🇪 GermanyOfficialApBetrO §17 and §35c delivery/cold-chain requirements; AMPreisV §3a 2028 remuneration proposal; no automatic product reimbursement changeenacted 2026-09-16; promulgated 2026-09-21; main effect 2026-09-22; Article 1 No. 11 effective 2027-01-01Latest observed: official gazette 2026-09-21
🇩🇪 GermanyOfficialApBetrO §17 and §35c delivery/cold-chain requirements; AMPreisV §3a 2028 remuneration proposal; no automatic product reimbursement changeenacted 2026-09-16; promulgated 2026-09-21; main effect 2026-09-22; Article 1 No. 11 effective 2027-01-01Latest observed: official gazette 2026-09-21
For education only — not regulatory, pricing or legal advice.