Home Who We Are
Medical Devices MDR IVDR Clinical Trials Pharmaceuticals For Manufacturers
Q&A Contact
|

Medicines — Market Access in Bulgaria

Full-journey support from launch strategy to real patient access — pricing, PDL inclusion, NHIF contracting, and post-launch obligations.

We support Marketing Authorisation Holders (MAHs), local affiliates/distributors and investors across the full journey from launch strategy to real patient access — including pricing, inclusion in the Positive Drug List (PDL), contracting with the NHIF, and post-launch obligations.

We work in alignment with the key Bulgarian institutions:

BDA (Bulgarian Drug Agency) NCPRMP (Pricing/PDL) Transparency Commission (Appeals) NHIF (Reimbursement/Contracting)

Services We Offer

Comprehensive support across the full medicines market access lifecycle in Bulgaria

1

Bulgaria Market Access Strategy & Roadmap

  • End-to-end launch roadmap (pre-launch → submission → reimbursement → uptake)
  • Indication and patient-segment positioning
  • Risk register and scenario planning (best/base/worst case)
2

Regulatory Strategy Support (EU → Bulgaria Launch)

  • Launch readiness and local gap assessment following EU approval
  • Bulgaria-specific requirements (labelling/SmPC/PIL alignment, distribution setup)
  • Coordination with partners (MAH, local affiliate, distributor)
3

Pricing & Reimbursement Preparation and Management

  • Pricing strategy and local scenario modelling
  • Preparation of the national pricing & reimbursement package
  • Support for lifecycle changes (price updates, packs, status changes)
4

Positive Drug List (PDL) Dossier, Submission & Defence

  • Full preparation of applications for inclusion/change/extension
  • Administrative process management and institutional communication
  • Value argumentation strategy and defence during assessment
5

HTA & Pharmacoeconomics / Value Story

  • Cost-effectiveness / cost-utility modelling (local adaptation)
  • Budget impact analyses for Bulgaria
  • Value dossier development (clinical benefit + system value narrative)
6

NHIF Contracting & Negotiation Support

  • Negotiation package and stakeholder alignment
  • Discount / managed entry agreement scenario design
  • Support through contracting steps and implementation readiness
7

New INN & First Reimbursement Pathway Support

  • Planning the sequence from PDL inclusion to first NHIF reimbursement
  • Submission coordination and timeline control
  • "Access readiness" support for clinical communities and patient pathway
8

Post-Launch Compliance & Pharmacovigilance Readiness

  • PV process setup/optimization and documentation
  • Training and inspection readiness support
  • Safety communication support (as required)
9

Patient Access Pathway & Protocol Requirements (NHIF)

  • Review of eligibility criteria and pathway bottlenecks
  • Practical pathway optimisation (patient → specialist → commission → dispensing)
  • Non-promotional educational materials aligned with compliance standards
10

Appeals & Process Strategy (Transparency Commission)

  • Evidence package preparation for appeals
  • Process mapping, timelines and documentation support
  • Alignment of regulatory, access and legal narratives
11

Parallel Import Access Support

  • Guidance and documentation for PDL-related steps
  • Process support for partners operating under parallel import authorisations
12

Policy Monitoring, Legislative Updates & Compliance

  • Monitoring of national policy changes impacting access
  • Impact assessment and implementation support
  • Internal SOPs and governance for pricing/discounting/distribution
13

Stakeholder Strategy (Non-promotional)

  • Stakeholder mapping and engagement planning
  • Scientific/expert meeting support (compliance-aligned)
  • Structured value messaging for different audiences
14

Launch Readiness & Lifecycle Management

  • Launch plan, KPI framework and risk mitigation
  • Support for indication extensions, new packs/forms, and status updates
  • Maintaining PDL status and ongoing administrative obligations

Ready to Access the Bulgarian Market?

Contact us to discuss your medicines market access strategy and build a clear path to patient access in Bulgaria.

Get in Touch