RDC 885/2024: What Changes, Who Is Affected, and How to Comply in Practice

In December 2024, ANVISA published Collegiate Board Resolution No. 885, which regulates the provision of electronic package inserts for medications in Brazil. This is not just a bureaucratic update: it redefines how the pharmaceutical industry communicates with patients and healthcare professionals, bringing significant operational, technological, and financial implications.

If you are responsible for regulatory affairs, IT, or operations at a pharmaceutical company, this guide covers everything you need to know.

Context: why ANVISA decided to regulate now

Brazil has over 14,000 registered medications with ANVISA. Each comes with a printed package insert that, in practice, few patients can read: the font is tiny, the paper is thin, and the technical language discourages even healthcare professionals. Research by Fiocruz estimates that only 30% of patients read the complete insert before starting treatment.

RDC 885 emerges in a global context where countries like the United States (FDA), European Union (EMA), and Japan already have digital insert initiatives. ANVISA follows this trend but goes further by including mandatory accessibility requirements from the outset, something no other regulator has required with this level of specificity.

What RDC 885 requires in practice

The resolution establishes that every medication registration holder must maintain an Institutional Electronic Publication Repository (RIEP). The RIEP is not simply a downloadable PDF. It is a web portal that must meet rigorous technical criteria:

WCAG 2.1 Level AA accessibility: This includes keyboard navigation, screen reader compatibility (NVDA, JAWS, VoiceOver), minimum contrast ratio of 4.5:1, text resizable up to 200% without content loss, and text alternatives for non-text content.
Multi-criteria search: Patients must be able to find inserts by commercial name, active ingredient, pharmaceutical form, and therapeutic category. The search must be tolerant of typos and accent marks.
QR Code on packaging: Every medication must contain a QR Code on the secondary packaging that links directly to the corresponding digital insert.
Versioning and traceability: The portal must maintain the version history of each insert, with approval dates and changes made. The current version must be clearly identified.
24/7 availability: The system must have a minimum uptime of 99.5%, with a documented contingency plan.

Who is affected

RDC 885 applies to all medication registration holders in Brazil, regardless of size. This includes large multinational laboratories, mid-size national companies, generics and similar drug manufacturers, and phytotherapeutic and biological product makers. The exception is compounded medications (compounding pharmacies), which follow specific regulations.

Compliance timeline

By June 2026: Laboratories with more than 50 active registrations must have the RIEP operational with at least 50% of the portfolio digitized.
By December 2026: 100% of registered medications must be available in the RIEP, regardless of company size.
From January 2027: New registrations will only be approved with the digital insert already available in the RIEP.

Penalties for non-compliance

Non-compliance may result in warnings, fines (from R$2,000 to R$1.5 million under Law 6,437/77), temporary registration suspension, or in extreme cases, cancellation of the medication registration. ANVISA has signaled that enforcement will be progressive, starting with guidance and escalating to sanctions from the second half of 2027.

Practical recommendations

Start with a portfolio audit: how many inserts, which versions, what formats exist today.
Decide whether to build internally or hire a platform. Consider the 5-year TCO (Total Cost of Ownership), not just initial costs.
Begin insert conversion with the highest-volume medications, prioritizing patient impact.
Plan packaging changes with at least 6 months lead time, considering existing inventory and production cycles.
Document the entire process for regulatory audit purposes.