On May 27, 2024, the Brazilian National Health Surveillance Agency (Anvisa) approved  Board of Directors' Resolution 873/2024, which establishes criteria and procedures for the creation of the National Prescription Control System (SNCR), through a computerized platform to manage the numbering distribution of notifications and receipts from prescriptions in the national territory.

Controlled use medications

In general, substances containing psychoactive, analgesic properties with high potency, anesthetic, teratogenic, or that may cause dependence are considered to be under stricter control in Brazill. The regulation is established by  Ordinance SVS/MS 344/98, which sets forth control measures, risk classification, and requirements for dispensing medicines containing these substances.

In the case of medicines based on substances listed in Lists A1, A2, A3, B1, B2, C2, and C3 of Annex I of the regulation, dispensing is subject to the presentation of a prescription (prescribed by the physician to the patient) and a prescription notification (a standardized document that enables the sale and sanitary control of the medicines).

Control and traceability

One of the responsibilities of the local health authority (state or municipal) is to issue the numbering of receipts and prescription books for controlled-use medicines. Currently, this process involves diversified procedures, as there is no alignment between the federative units.

The new Board of Directors' Resolution aims to implement a centralized tool for the numbering of notifications of receipts and prescriptions books through the National System for the Control of Prescriptions (SNCR). This regulation is the result of contributions presented in the  Public Hearing 588/18.

Among the positive points of the measure, we highlight the following:

  • allow traceability of information and speed up the process;
  • greater control in the distribution of prescriptions and better detection of fraud;
  • safety and traceability about the use of medicines subject to special control; and
  • possibility for local health authorities to consult and extract reports.

National Prescription Control System (SNCR)

Since the platform is already developed and ready for implementation, health authorities who wish to do so will be able to start using it to issue new numbers in 2024, as soon as Anvisa authorizes it.

Moreover, the use of the platform by all health authorities will be mandatory from January 1, 2025.

Prescription books printed before January 1, 2025 (which do not contain the numbering issued by the SNCR) may be distributed by the competent health authority for up to 24 months.

The Life Sciences & Health practice can provide more information on the topic.