Check out our monthly Life Sciences Newsletter, which gathers information on recent legislation, news, public consultations and bills related to the Brazilian health and agriculture sectors.
For more information, please contact our lawyers.
Enjoy reading!
Demarest’s Life Sciences Team
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Anvisa prohibits the import of Cannabis in natura
On July 19, 2023, Anvisa published Technical Note No. 35/2023, which prohibited the import of Cannabis in natura, as well as flowers and parts of the plant.
The reason for the ban is the high risk of illicit use of such items, in addition to compliance with international treaties signed by Brazil regarding drug control policies.
As such, Anvisa has established:
- the suspension of new registration permits for Cannabis import as of July 20, 2023;
- 60 days to complete transactions within ongoing imports, calculated from the publication of the technical note; and
- that permits granted before the prohibition will remain effective until September 20, 2023.
Due to these changes, only cannabis-based products can be imported with Anvisa’s authorization.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Technical note clarifies inspection procedure in beauty and aesthetic establishments
On July 3, 2023, Anvisa published Technical Note No. 15/2023, which clarifies details regarding resolutions that apply to aesthetic services.
Considering new technologies and the increasing number of aesthetic medicine establishments, Anvisa seeks to assist health inspection agents (to ensure effective inspection criteria), as well as aesthetic clinics and beauty salons (regarding safety requirements of products and services available for consumers).
Note: On August 4, 2023, Anvisa has suspended Technical Note No. 15/2023 to ensure adequate legal certainty and caution in the assessment of such recommendations. The Technical Note has not been revoked and a new revised version must be published soon.
MS – BRAZILIAN MINISTRY OF HEALTH
Public call aims to stimulate the use of medicinal plants and phytotherapeutics as treatment options
On July 17, 2023, the Ministry of Health opened Public Call No. 4/2023, which initiates the screening process for “Living Pharmacy” projects.
Municipal and state health departments that meet the requirements of the notice can apply by August 21, 2023.
The program combines traditional medicine with pharmaceutical science by stimulating the use of medicinal plants and phytotherapeutic products, as a way of expanding people’s access to safe, efficient, and high-quality phytotherapeutics.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Resolution consolidates ban on pharmaceutical inputs in medicines for human use
On July 21, 2023, Anvisa published RDC No. 802/2023, which provides for pharmaceutical inputs of restricted or prohibited use in medicines for human use.
Despite not introducing any innovations, the new regulation consolidates other resolutions regarding this matter. As a result, RDC No. 802 maintains restrictions against the use of ethanol to produce appetite stimulants, mercury compounds, and boric acid, among others.
The resolution entered into force on August 01, 2023.
MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY
Pesticide bill approved by Commission on Agriculture
The Brazilian Senate’s Commission on Agriculture approved Bill No. 1459/2022, which seeks to modernize the registration system of agricultural pesticides.
The bill will be fast-tracked to the Senate for approval.
The proposal aims to improve pesticide evaluation procedures, in order to match other agricultural powerhouses in regard to scientific rigor and reduced red tape, given that the Brazilian legislation currently in place was published in 1989 and no longer meets the sector’s needs.
MS – BRAZILIAN MINISTRY OF HEALTH
Law establishes national strategy to advance Mais Médicos program
On July 14, 2023, Law No. 14/621/2023 was published, which implemented Brazil’s national strategy aimed at training health professionals to join the Mais Médicos program.
After Provisional Measure No. 1.165/2023 reinstated the program, the new law seeks to increase the number of health professionals in Brazil and expand access to specialized physicians for people who live in remote and vulnerable locations.
This measure offers qualification opportunities for physicians during the program. Additionally, professionals will receive benefits in proportion to the fellowship amount, according to the time as a member of the program and practicing in vulnerable locations.
PUBLIC CONSULTATIONS AND PUBLIC HEARINGS
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Public consultation receives proposals to standardize medicine registration criteria
A public consultation will remain open through September 25, 2023, to obtain contributions regarding a resolution proposed to regulate health requirements in regard to industrialized medicines for human use.
According to Anvisa, the current regulatory framework lacks a standard regulation for different types of medicines, which results in document disparities and complicates the development of registration dossiers.
MAPA – MINISTRY OF AGRICULTURE AND LIVESTOCK
Proposed regulation regarding similar plant-based products subject to public consultation
On July 03, 2023, the public consultation was opened to discuss a proposed ordinance regarding identification and quality standards of similar plant-based products, such as visual identity and labeling rules.
MAPA seeks to ensure that customers can easily identify similar plant-based products. The products must meet the minimum requirements regarding quality, registration procedure, sampling, trading and visual identity.
Contributions can be submitted by September 16 through MAPA’s webpage.
Public consultation seeks contributions to regulate poultry farms
On July 26, 2023, the MAPA opened a public consultation to discuss a proposed regulation for poultry farms and egg processing facilities, particularly in regard to infrastructure and operation requirements.
MAPA seeks to ensure that production facilities meet basic quality standards, and that the production process is aligned with good practices, such as:
- industrial areas must have proper infrastructure for cleaning;
- a specific area must be allocated to receive raw materials and inputs with appropriate protection against pests and disease vectors;
- dirty and cracked[1] eggs must be discarded immediately or, if that is not possible, must be disposed into a properly identified container.
Contributions can be submitted by September 09 through MAPA’s webpage.
[1] Dirty or cracked egg: Egg to which dirt or any foreign matter has adhered, in addition to crack or rupture of the shell (definition provided for in the proposal of the standard);
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