ANVISA permanently authorizes home delivery of controlled medicines

Today, the Brazilian Health Regulatory Agency (“ANVISA”) published Collegiate Board Resolution – RDC No. 812/2023, permanently authorizing the home delivery of medicines that are subject to special control (controlled medicines), which had been previously allowed on a temporary basis, due to the COVID-19 pandemic and the consequent Public Health Emergency of International Concern (PHEIC).

Such delivery services will be allowed for both private and public medicine dispensing establishments, as well as government programs.

The new resolution amends the following regulations:

• Ordinance No. 344/1998 of the Ministry of Health, which approved the technical regulation regarding medicines that are subject to special control, in order to include two provisions authorizing the home delivery of such products, as well as establishing an appropriate procedure for such dispensing services.
• Paragraph 2 of article 52 of ANVISA RDC No. 44/2009, which provides for good practices in the dispensing and sale of products in pharmacies and drugstores. This provision expressly prohibited the dispensing of controlled medicines through home delivery but has now been updated as follows: “The sale of controlled medicines requested remotely is prohibited, with the exception of permissions provided for in specific legislation”.

The delivery of these products is subject to the same rules as in-person sale, that is, the dispensing establishment must retain the original controlled medicine prescriptions, as well as comply with the following requirements and procedures:

1. The dispensing establishment must provide pharmaceutical care to the patient.
2. The establishment is responsible for overseeing the home delivery of the medicines.
3. Before dispensing the medicines, the establishment must collect the prescription at the patient’s address or through electronic channels, as provided for in the specific legislation. The delivery of the medicine, as well as the collection of any required information and signatures, must only occur after the prescription has been validated by the competent pharmaceutical professional.
4. The establishment must keep records of each sale for the purpose of monitoring patients and providing data to the competent health authority.

Despite such changes, the purchase and sale of controlled medicines online remains prohibited.

The new RDC entered into force today, September 04, 2023.

Demarest’s Life Sciences team will monitor the updates of the industry and is available to provide any further clarifications that may be necessary.