On July 12, 2024, the National Health Surveillance Agency (Anvisa) published RDC 885 (Anvisa’s RDC 885/24), which approved a pilot project with transitional guidelines for implementing the digital package leaflets. The measure allows for the optional waiver of the printed package leaflets in the packaging of certain medicines. The initiative requires that leaflets in printed format must be made available whenever requested by the health provider, the prescribing professional, or the patient.

The new resolution aims to regulate Law 14,338/22, which, among other aspects, establishes:

  • the possibility of Anvisa defining which medicines will have package leaflets in one single format;
  • the inclusion of a quick-read two-dimensional barcode that directs to an internet address where the medicine’s digital package leaflet will be available; and
  • the minimum characteristics of the digital package leaflet.

The pilot project launched by Anvisa will collect inputs for the ongoing regulatory impact analysis (AIR) conducted by the authority on this subject. AIR is a systemic approach to critically assessing the positive and negative effects of proposed and existing regulations and non-regulatory alternatives. This procedure begins with defining a regulatory problem and is used to support the authority's decision-making.

According to Anvisa, the new RDC was discussed through Public Consultation 1,224/23 and considered structured and standardized data on medicines, seeking regulatory reliance with foreign trends on the subject. Debates and discussions between Anvisa's technical areas and the regulated sector were also considered.

Waived printed package leaflets

To avoid any limitation on the public's access to the information that should appear on the package leaflet, Anvisa has decided to start a transition process by defining  a limited group of medicines will be able to have digital package leaflets. The agency considers that, for these medicines, wavering  the physical version of the package leaflet does not represent a major risk.

The medicines that can have their digital leaflets implemented and waived physical waived are:

  • Free samples: the delivery of free samples can only be carried out by health professionals to the patient during the consultation, with guidance on use for each treatment.
  • Medicines intended for health providers, except pharmacies and drugstores: medicines restricted to sale in hospitals, clinics, outpatient clinics, and home care services were selected because they are used under the supervision of health professionals.
  • Over-the-counter medicines (OTC), sold in multipacks: products considered low risk and offered on pharmacy shelves.
  • Medicines intended for the government, packaged containing the Ministry of Health's government brands: RDC Anvisa 769/22, which deals with the rules for preparing, harmonizing, updating, publishing, and making available package leaflets for medicines, has already considerably reduced the requirement for physical package leaflets for products sold to the public health system.

To implement the digital package leaflet, medicines must contain a QR code or equivalent digital mechanism, with specific identification based on an electronic data capture, storage, and transmission system on their secondary packaging. Specifically concerning medicines packaged in multipacks, the QR code or equivalent must also be inserted in the primary packaging.

Information available online

It will also be necessary to adopt a set of information on medicines available online - internationally known as electronic Product Information (ePI). This includes a summary of the characteristics of each product and labeling information.

The new resolution creates the Electronic Product Information Repository (Riep) to store, organize, and make available electronic product information. The aim is to guarantee direct access to the complete and identical content of the latest package leaflet approved by Anvisa.

The agency's intention is that Riep will be interoperable with other digital health platforms in the future, such as the National Health Data Network (RNDS) from the Ministry of Health.

Riep will allow the insertion of images, audios and videos that help patients and health professionals to store, preserve, check the batch number and expiry date, as well as prepare and use medicines correctly. Information on drug recalls and a direct access link to Anvisa's system for reporting adverse events related to medicines and vaccines should also be available.

Consumers' right to request printed package leaflets

Anvisa's RDC 885/24 stipulates that pharmacies and drugstores, as medicine dispensing establishments, must inform consumers, using visual communication, about the possibility of requesting the printed version of the package leaflet in cases where it is not included with the product.

RDC Anvisa 885/24 will come into force on September 12 this year and is expected to be valid until December 31, 2026.

The Life Sciences & Healthcare practice can provide more information on the subject.