The Collegiate Board of the National Health Surveillance Agency (Anvisa) decided, on August 30, to maintain, on a definitive basis, the permission for remote delivery of drugs subject to special control, including within the public health programs scope.
The new rule approved by Anvisa permanently modifies Ordinance SVS 344/98, which approves the technical regulation on substances and drugs subject to special control, and Anvisa RDC 4/2009, which establishes good practices for dispensing and marketing products in pharmacies and drugstores.
For context, it should be remember that due to the quarantine and social distancing measures adopted during the covid-19 pandemic, Anvisa published in March 2020 the Anvisa RDC 357/20. The goal was to temporarily increase the maximum quantities of drugs subject to special control and allow remote delivery during the Public Health Emergency of International Importance (PHEIC) period.
The pandemic period has brought significant changes in the behavior and the way products are consumed in the digital environment (via e-commerce platforms or marketplaces), including an increase in transactions involving drugs, medical devices, supplements and food.
The same happened with assistance services, which led to the approval of Law 14,510/22. This standard establishes guidelines for the practice of remote services by health professionals (so-called telehealth), including physicians, nurses, psychologists, physiotherapists, occupational therapists and speech therapists.
Definitive changes in the controlled medicinal products rules
The standard approved by Anvisa permanently modifies Ordinance SVS 344/98, which approves the technical regulation on substances and drugs subject to special control and Anvisa RDC 44/09, which establishes good practices for dispensing and marketing products in pharmacies and drugstores.
From now on, in order for pharmacies or drugstores to deliver drugs subject to special control remotely, including via government programs, the original copy of the corresponding prescription notification or special control prescription must be retained.
In addition, the dispensing establishment must provide pharmaceutical care to the patient and monitor the drugs remote dispensing.
Regarding the procedures that must be adopted, the regulation establishes that the prescription notification or special control prescription must be withdrawn at the address informed by the patient or received via electronic prescription – that is, a prescription that necessarily has a digital signature certified by the Brazilian Public Key Infrastructure system (ICP-Brasil) and can be forwarded to the patient or his legal representative via SMS, email or QR Code.
Online dispensing remains prohibited
Drugs subject to special control purchase and sale over the internet remains expressly prohibited, but is expected to be relaxed soon.
In 2021, Anvisa held an event to discuss the issue, recognizing the need to update the existing rules due to the evolution of consumer behavior and the adoption of technologies in recent years.
In the first half of 2022, the agency also created a working group, through Anvisa Ordinance 76/22, to review the technical requirements for remote request for drug dispensing, under the coordination of the Inspection and Supervision of Drugs and Pharmaceutical Supplies Management (Gimed).
The agency is currently preparing a Regulatory Impact Analysis, to be completed by the end of the current regulatory agenda. it is expected that a draft modernizing the current sanitary rule will be put out for public consultation in the coming months.
