Anvisa permits remote delivery of controlled medications to continue

On September 4, 2023, the Brazilian Health Regulatory Agency (Anvisa) published Board Resolution (RDC) No. 812/2023, permanently authorizing pharmacies and drugstores to home-deliver controlled medications.

In 2020, Anvisa permitted home delivery via Board Resolution (RDC) No. 357 as a temporary measure to tackle the Covid-19 pandemic. However, the validity of this measure was set to run out on September 21, 2023.

Now, Anvisa has determined to permanently include the home delivery of medications in SVS/MS Ordinance No. 344/1998, which generally regulates activities involving controlled medications in Brazil.

In order to lawfully carry out home deliveries, dispensing establishments must:

• Provide pharmaceutical care to the patient;
• Control and monitor how remotely delivered medications are dispensed from the establishment;
• Verify the prescription or special control prescription at the patient’s provided address or receive a digital version of the prescription provided for in specific legislation. Establishments may only proceed with the delivery of the medication (collecting the necessary information and signatures) after a pharmacist has verified the regularity of the prescription.

Furthermore, dispensing establishments must keep records to allow for patient follow-ups and inspections by the health authorities. The draft of the resolution can be viewed on Anvisa’s website (available in Portuguese).

This latest decision from Anvisa follows the recent trend of making health sector regulations more flexible. This shift has been largely driven by changing demands and behavior in the wake of the Covid-19 pandemic, and has included the regulation of telehealth and electronic prescriptions.

It is worth noting that Anvisa has determined that the concepts of ‘remote delivery’ and ‘electronic dispensation’ are technically different, and the latter is still prohibited. In other words, while the remote delivery of controlled medications is now possible in Brazil, they cannot be legally bought or sold on the internet.

However, in light of the similarity between these two practices, the restriction on electronic dispensation is expected to be reviewed. Indeed, the matter has been included in Anvisa’s 2021-2023 Regulatory Agenda (Project No. 1.7), suggesting the two practices will be further aligned and coordinated in the future.

For further information on this subject, please contact Mattos Filho’s Life Sciences & Healthcare practice area.

*With the collaboration of Andressa Deis and Leandro Rodrigues.