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    Solutions in Regulatory Affairs

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    Specialized Technical Team

Latini Group

The Latini Group began in 2017 Latini consolidation of a group of companies that offer a range of services to identify and meet the needs of the world market strategically. Today is world reference in the development of regulatory processes, manufactures, nationalizes, import and export products according to the best use and needs of each client with efficiency and agility.
Our expertise allows minimizing market risks to the commercial ticket through quality and regulatory standards for highly trained professionals and in tune with the technological innovations supported by research, publications, works with institutions and important national and international partnerships. This initiative was created to Copacabana Holding: multi-service company with a proposal to offer the world market solutions to promote the commercial ticket between Nations and add value to products and services sold.

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Our Services

Health Licensing

Health Licensing

We are a company specialized in the rendering of services of the Regulatory Area, with thousands of processes approved
Registration

Registration

Latini Group has extensive experience in the area of ​​product registration, with a multidisciplinary team
Consulting

Consulting

Consult our team and see how we can help your company to better understand the technical concepts
Due Diligence

Due Diligence

Due Diligence processes are of fundamental importance to guide decision making
INMETRO/ Ministry of Labor

INMETRO/ Ministry of Labor

The Latini Groupteam has the technical knowledge and experience necessary for the rapid development of the label
Controlled Substances

Controlled Substances

The technical support offered by the Latini Group ranges from the physical-functional adequacy to Licensing
Real Estate Regulation

Real Estate Regulation

We work in the main public agencies as: city hall, fire department, environmental secretaries, Contru and registry offices
Foreign Trade

Foreign Trade

The Latini Group has all the licenses, certificates and AFE’S, to ensure the quality in foreign trade processes

Blog

RDC 327/2019 - Medicinal use of Cannabis-based products in Brazil

RDC 327/2019 - Medicinal use of Cannabis-based products in Brazil

The Brazilian Regulatory Authority (ANVISA) published the regulation RDC 327/2019, determining the technical requirements that technical dossiers for Cannabis-based Products should contain for future analysis by the Agency. This new legislation should be in force in 90 days from the date of publication in the Brazilian Official Gazette. This approval by ANVISA creates a class of products, i.e. those based on Cannabis spp. Read more...

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ANVISA approves the use of Cannabis sp.-based products in Brazil

ANVISA approves the use of Cannabis sp.-based products in Brazil

After the Meeting of the Collegiate Board (DICOL) of the National Health Surveillance Agency (ANVISA), on Dec/03/19, the medicinal use of Cannabis sp. products was approved. The next step is the publication by ANVISA of the Collegiate Board Resolution (RDC), which will standardize the rite of registration of these products, determining the technical requirements that technical dossiers should contain for future analysis by the Agency. Once published, the Collegiate Board Resolution (a.k.a. RDC) should be in force in 90 days from the date of publication in the Brazilian Official Gazette. This approval by ANVISA creates a class of products, i.e. those based on Cannabis sp.

Regulatory Requirements for Companies to Hold the Market Approval

Companies that will submit the registration processes to market Cannabis sp. products in the future, must meet the following regulatory requirements:

  1. Only companies established in Brazil can submit registration with ANVISA for products based on Cannabis sp.;
  1. The company must have Working Permit granted by ANVISA (a.k.a. AFE) to Manufacture and/or Import Pharmaceutical Medicines and Ingredients (as applicable to each case), in addition to the Distribution activity, for those who wish to import only finished products. For manufacturers, it is not necessary to have this activity highlighted in AFE, since manufacturing activity already encompasses the distribution of their own products;
  1. Have Special Working Permit (a.k.a. EA) for Controlled Products, since both Canabidiol (CBD) and Tetrahydrocannabinol (THC) are described in Ordinance SVS/MS No. 344 / 98, updated by RDC no. 325/19 (03/12/19);
  1. Have a Certificate of Good Manufacturing Practices (both for domestic manufacturers and foreign laboratories). Companies exclusively Importers and Distributors (of finished products) must have a Certificate of Good Distribution and Storage Practices;
  1. Operating conditions to perform Quality Control in Brazilian territory. Therefore, analytical processes should be implemented and validated;
  1. Have a Pharmacovigilance system that allows the processing of notifications of adverse effects, relying on a database for systematic recording of these adverse effects. Emergency situations should be reported to ANVISA within 72 hours of the date of occurrence. It should be noted that the company should count on a responsible for the Pharmacovigilance system and a substitute, both duly registered in the ANVISA system (this is a general requirement for the class of medicines and not specific to Cannabis sp.-based products);

Regulatory Requirements for Cannabis sp. based Products:

  1. Labelling and packaging may not contain:
    1. Designations, names, symbols, drawings or figures that induce the consumer to error or confusion;
    2. The terms like Medicine, Herbal Medicine, Supplement, Natural or any other that bears similarity to them.
  1. Packaging should have a horizontal strip of black color, covering all its sides, with the dimensions defined in specific legislation;
  1. Cannabis products containing up to 0.2% THC should bring engraved on the black stripe the following phrases in Portuguese (in capital letters): "SALE UNDER PRESCRIPTION" and "CAN ONLY BE SOLD WITH PRESCRIPTION RETENTION";
  1. Cannabis products containing above 0.2% THC should bring engraved, on the black strip, the following phrases in Portuguese (in capital letters):  "SALE UNDER PRESCRIPTION" and "THE USE OF THIS PRODUCT CAN CAUSE PHYSICAL OR PSICOLOGICAL DEPENDENCE".

Regulatory Requirements for the Prescription of Cannabis sp. Products:

  1. The indication and use of Cannabis sp. products are on behalf the responsibility of the Doctor;
  2. The patient must sign a Free and Informed Consent Form (a.k.a. TCLE), which should detail the specific product data based on Cannabis sp.;
  3. The Prescribing Physician should use Brazil’s Type B Prescription for products with THC concentration up to 0.2% and Brazil’s Type A Prescription (similar to that used for morphine) for products with concentrations greater than 0.2% THC.

 

Handling of Cannabis sp. Products:

  1. Handling of Cannabis products is prohibited by handling pharmacies;
  2. The regulation is specific for medicinal products intended for use in humans and there is no provision for the veterinary use of such products;
  3. The product sale may only occur through pharmaceutical assistance in drugstores and pharmacies, under a Doctor’s prescription, without handling by a handling pharmacy.

 

Planting Cannabis Sativa L. :

It is forbidden to plant Cannabis sativa L. throughout the Brazilian territory, according to Ordinance SVS/MS no. 344/98, List E, adhering, Item 1.

 

Ordinance SVS/MS no. 344/98 (Prescription Products Controlled by ANVISA)

Ordinance SVS/MS no. 344/98 was updated on Dec/03/19, through RDC no. 325/19. Cannabidiol is listed in List C1 (item 23) and Tetrahydrocannabinol is listed in List F2 (item 139).

Technical annotations on these pharmaceutical active ingredients are described as follows:

    1. List A3, adhering, item 2;
    2. List C1, adhering, item 1.3;
    3. List E, adhering, items5, 7 and 8;
  • List F2, adhering, items 1.2; 3 and 6.

Want to register Cannabis sp.-based products in Brazil? Contact us:

Phone: +55-11-5090-5080 | e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

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Who issues yellow fever warning for countries bordering Brazil

Who issues yellow fever warning for countries bordering Brazil

The World Health Organization (WHO) has warned countries neighbouring Brazil of the risk of yellow fever. The occurrence of the disease in animals in the states of Roraima (which borders Venezuela), Mato Grosso do Sul (which has a border with Argentina) and Paraná (close to Argentina and Paraguay) "represents a virus circulation risk to these countries, especially in the areas with the same ecosystem," says the bulletin released last Friday (3 February).

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