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RDC 885/2024 Compliance

ANVISA Compliance for electronic package inserts. No technical complexity.

Complete platform to digitize, manage, and publish electronic package inserts in compliance with RDC 885/2024. Implementation in weeks, not years.

ANVISA deadline approaching

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100% RDC 885 Compliant
19 Mapped Sections
Implementation in 15 days
LGPD Compliance

The challenge of digital package inserts in Brazil

ANVISA published RDC 885/2024 requiring all pharmaceutical companies to make accessible electronic package inserts available by December 2026.

Art. 1 This Resolution sets out the rules for making electronic package inserts of medications available.

RDC 885/2024 — ANVISA

The complete solution for electronic package inserts

Three integrated modules to meet 100% of ANVISA requirements

RIEP Portal

Institutional Electronic Publication Repository accessible to the public.

  • Search by medication, active ingredient or barcode
  • Text-to-speech (TTS) reading with karaoke highlighting
  • WCAG 2.1 AA accessibility
  • SEO optimized with Schema.org
  • Responsive for all devices

Admin Panel

Manage medications, package inserts and publications with full control.

  • CRUD for medications and package inserts
  • Review and approval workflow
  • Package insert versioning
  • QR Code generation
  • Dashboard with metrics

Mobile Web

Optimized experience for smartphone access.

  • PWA with offline support
  • QR Code reading on packaging
  • Touch-friendly interface
  • Ultra-fast loading
  • Multi-language support

Why choose Bula360?

Bulletproof security

Encryption, LGPD compliance, RBAC with 7 roles and full audit logging. Your data, protected.

Guaranteed compliance

ANVISA RDC 47/2009, e-MAG 3.1 and WCAG 2.1 AA. Reduce regulatory risk with full traceability.

Your brand, your domain

Full whitelabel: colors, logo and custom domain. Patients see your brand, not ours.

Everything in one platform

Leaflets, QR Codes, TTS, analytics and workflows — no need for 5 vendors.

Pricing that makes sense

Up to 90% cheaper than building in-house. Positive ROI in the first quarter.

Live in days, not months

AI-powered PDF extraction + ready-made templates. From contract to publication in under 1 week.

Investment tailored to your operation

Plans by number of leaflets. Estimated values — request a personalized quote.

Essential

Up to 30 electronic leaflets

Starting atR$ 2,990/month
Most chosen

Professional

Up to 150 electronic leaflets

Starting atR$ 5,990/month

Enterprise

Over 150 electronic leaflets

Contact us

* Estimated values. Final pricing depends on leaflet volume, features, and support level.

Ready to digitize your package inserts?

Ensure ANVISA compliance before the deadline.

Bula360 — Electronic Package Insert Platform | ANVISA RDC 885