Anvisa opens public consultation on rules for electronic prescription

​The Brazilian Health Regulatory Agency (Anvisa) is receiving contributions to the Public Consultation No. 1,018/2021 (CP 1,018/2021) regarding the regulation of requirements for issuing, prescribing, dispensing, and storing particular prescription forms and electronic prescriptions for antimicrobials, medicines subject to special control, and Cannabis-derived products.

Faced with the health crisis caused by the Covid-19 pandemic, in April 2020, the Ministry of Health published MS Ordinance 467/2020, which temporarily authorizes telemedicine services and also provides for the possibility of issuing prescriptions and medical certificates electronically — subject to compliance with health requirements to be established by Anvisa. Nevertheless, it is worth observing that the proposed Collegiate Board Resolution (RDC) under discussion is not linked to the Public Health Emergency status, meaning that it should be definitive, including the post-pandemic period.

Details of the proposal:

According to the proposal under discussion, electronic prescriptions contemplate:

• Particular controlled substances contained in “C1” Lists (other substances subject to exceptional control), “C5” (anabolic steroids), and the appendices of lists “A1”, “A2” (narcotics), and “B1” (psychotropics) of Annex I of Ordinance SVS/MS No. 344/1998;
• Antimicrobial drugs, under the terms of ANVISA’s ANVISA Normative Ruling No. 83/2021;
• Cannabis-derived products, under ANVISA’s RDC ANVISA No. 335/2020.

The draft regulation also establishes that the dispensation of drugs prescribed through electronic means can only occur after verifying the prescriber’s signature’s authenticity, integrity, and legal validity. The signature is verified by consulting a digital document validation portal, which must meet the National Institute of Information Technology (ITI) technical requirements and be recognized by Anvisa. Other points in the proposal include:

• The prescription must be required by a legally qualified professional and contain a qualified electronic signature that uses a digital certificate in the standard of the Infraestrutura de Chaves Públicas Brasileira (Brazilian Public Key Infrastructure). In order to fill out the prescriptions, the requirements established in the regulation of each class of drug must include: ANVISA RDC 471/2021 for antimicrobials, ANVISA RDC 335/2020 for Cannabis-derived products, and SVS Ordinance 344/1998 for particular controlled substances;
• Prohibition of subsequent dispensing, ensuring that the prescription is filled only once;
• The dispensing establishment is responsible for archiving electronic prescriptions, which must be available for inspection purposes;
• Prohibition to direct or limit the access of the prescription documents to certain establishments;
• Not applicable to drugs subject to the prescription drug monitoring program, under the terms of the SVS Administrative Rule No. 344/1998.

Interested parties may send their suggestions until May 24, 2021, through an electronic form available at Anvisa’s website.

For more information about applicable regulations to prescription medicines and cannabis products, visit Mattos Filho’s Life Sciences and Healthcare practice.

*With the cooperation of Camila Miranda Amaral.