Life Sciences Newsletter No.7 – October 2021

Our Public and Regulatory Law team presents the seventh edition of the Life Sciences Newsletter, with a compilation of the main news and information of the area occurred in October.

Demarest’s Public and Regulatory Law team continues to monitor developments in the Life Sciences area, and is available to provide any clarification or further information on these and other topics.

Happy reading!

Read the sixth issue here.

ANVISA – National Health Surveillance Agency

New regulation simplifies the importation of cannabis products

On October 6, 2021, Resolution of the Collegiate Board RDC 570/2021 was published in the Brazilian Official Gazette, which amends RDC 335/2020, in order to simplify patient access to Cannabis-based products for therapeutic purposes.

Among the updates brought by the new Resolution, it was determined that the registration of interested parties will occur in a simplified way, through verification of the regularity of the product in the import process only, that is, if it is produced and distributed by the duly authorized personnel in their countries of origin.

Another important change is related to medical prescriptions, which will now be valid for up to 6 months from the date of issue, and may also be issued electronically or physically, depending on the legally qualified professional responsible.For now, however, the prescription for the product will have an indefinite validity until a decree to be issued by the Ministry of Health is published recognizing that the state of Public Health Emergency is no longer in place.

The new Resolution aims to ensure greater speed in the approval process for importing these products and, consequently, accelerate access for those who need them.

ANVISA – National Health Surveillance Agency

Use of Remaining Drug Stocks for Covid-19 Prevention

Resolution of the Collegiate Board of Directors, RDC 568/2021, which has been in effect since September 29, temporarily authorizes the use of drugs and biological products from the remaining stock of clinical trials, already conducted or in progress, for the treatment and prevention of Covid-19. These drugs, however, must have sanitary registration or emergency use authorization in order to ensure patient safety at the time of their application.

The device in question simplifies access to drugs and vaccines already approved by ANVISA, due to the national public health emergency, as an attempt to reduce the number of patients in hospitals and those infected.

In addition, the new Resolution includes a series of mandatory regulations that condition the qualification for the use of these drugs. Among them, for example, is the monitoring of the patient, by the clinical trial sponsor or its legal representative, in order to verify possible adverse reactions. The complete list can be found at the link below:

http://antigo.anvisa.gov.br/documents/10181/6332786/RDC_568_2021_.pdf/76df2c2d-49de-42c8-9431-23e228dce561

ANVISA – National Health Surveillance Agency
MAPA – Ministry of Agriculture, Livestock and Food Supply

New standard for pesticide use and control

On October 8, 2021, Decree 10,833/2021 was published in the Official Gazette, which brought a series of changes and updates to Brazilian legislation on pesticides.

The device in question changes Decree 4,074/2002, which regulates research, experimentation, production, packaging and labeling, transport, storage, marketing, commercial advertising, use, import, export, the final disposal of waste and packaging, registration, classification, control, and inspection of pesticides, their components and the like.

The Decree was published due to the various advances in technical and scientific knowledge, as well as due to the need to harmonize with the regulation adopted by other countries, developed within the scope of international treaties.

Among its main changes, highlights include the rationalization of the analysis of pesticide registration work; the inclusion of the concept of risk assessment in the use of these products; the provision of technical and mandatory training for pesticide applicators; and the reduction in the deadline for analyzing registration requests.

MAPA believes that the new rules facilitate research activities with active ingredients already registered, since the Registro Especial Temporário (RET) will no longer be required for these activities. Therefore, this will encourage joint research with companies or educational entities in order to contribute even more to the scientific advancement of this sector.

It is important to emphasize that the Decree was also responsible for making the legal rule more strict regarding non-compliance with the sector’s specific legislation, ensuring the possibility of punishment and application of sanctions on offenders.

CFM – Federal Council of Medicine

New procedures for issuing medical documents

On October 26, 2021, the Federal Council of Medicine (“CFM”) updated the criteria for issuing electronic medical documents. Published in the Official Gazette, Resolution No. 2299/2021 establishes the rules and procedures for issuing, both in-person and remotely, the following medical documents: (i) Prescription; (ii) Certificate; (iii) Report; (iv) Request for examinations; (v) Record; and (vi) Technical Opinion.

The project will work through Digital Information and Communication Technologies (TCDIs) and will have its own electronic service, which will be in compliance with the procedures and recommendations provided for by the General Law of Data Protection (LGPD).

The public or private institutions responsible for managing this type of service, in partnership with the CFM, will be able to offer it free of charge to their users, ensuring the easiest possible manner to prepare the documents mentioned. Furthermore, these institutions will also be in charge of overseeing the status of the qualified professional through the CFM’s National Register of Physicians consultation service or through the certificates issued by the regulatory body itself.

ANVISA – National Health Regulatory Agency

ANVISA Approves New Cannabis-Based Product

On October 29, 2021, the authorization of another cannabis-based product by ANVISA was published, demonstrating the advances in this specific market in Brazil. With the latest approval, the Agency now has five products of its kind already registered in the country, the first authorization of which was issued in April 2020.

Once again, the importance of these advances is highlighted to improve the discussions of the“Marco Regulatório da Cannabis” (Cannabis Regulatory Framework) Bill of law in the National Congress. For more information about this Bill of law and other developments relevant to the subject, check out our Newsletters No. 1, No. 2, No. 3 and No. 5.