Question 1

Art. 3 - Provision of electronic package inserts in an institutional repository

Accepted Answer

Dedicated RIEP Portal with a public URL, indexable by search engines and accessible 24/7.

Question 2

Art. 5 - Accessibility for people with disabilities

Accepted Answer

e-MAG 3.1 and WCAG 2.1 AA compliance, text-to-speech (TTS) reading, high contrast and keyboard navigation.

Question 3

Art. 7 - Search by commercial name, active ingredient and pharmaceutical form

Accepted Answer

Search engine with autocomplete, advanced filters and phonetic search.

Question 4

Art. 9 - Provision in accessible digital format

Accepted Answer

Semantic HTML, responsive, with screen reader support and adjustable font size.

Question 5

Art. 11 - QR Code on medication packaging

Accepted Answer

Automatic generation of QR Codes in SVG/PNG with a direct link to the digital package insert.

Question 6

Art. 13 - Versioning and change history

Accepted Answer

Versioning system with approval workflow and complete audit trail.

ANVISA RDC 885/2024 Compliance