Brazil- Anvisa

Overview:

Material organized by Procomex brings description about the vaccine
importation process into Brazil.

PROCOMEX

The Alliance for the Logistical Modernization of Foreign Trade (Aliança Pró Modernização Logística de Comércio Exterior – Procomex) has made available for consultation the guideline on the Importation Process of Vaccines.

What is Procomex?

Procomex is “a civil entity, of informal, apolitical and non-partisan character, that gathers more than 100 institutions from the productive sector, bilateral entities, specialists and agents of Brazilian foreign trade, with the purpose of providing Brazil with a modern and competitive Customs Flow System, stimulating business activities.

GUIDEBOOK ON THE IMPORTATION PROCESS OF VACCINES

The material describes the import process, providing the necessary transparency of each step, in order to promote the necessary agility, and ensure an efficient flow for the vaccine import process, from the shipment of cargo abroad by air to the release of the cargo, in an uninterrupted manner.

The first module for the import process is briefly described below. There are 4 modules that describe from the process of issuing the Import License, to the Release of the State Department of Finance (SEFAZ) and the Delivery of the Cargo to the Importer.

Step 1: Check whether the intended import requires an Import License (LI) 

This step has the purpose of informing whether the intended import is subject to import licensing and, if so, which government agencies are responsible for analyzing and authorizing the import.

To find out this information, it is necessary to consult the website of the Integrated Foreign Trade System (Siscomex), using the product’s tax classification, NCM – Mercosur Common Nomenclature.

Step 2: Product Registration at Anvisa 

According to Anvisa’s RDC No. 55/2010, registration of vaccines is mandatory. Thus, only vaccines registered at Anvisa, manufactured or imported by duly authorized establishments, may be imported, marketed and distributed in the country.

After attaching the documents to the Petition, it will be necessary to pay the Sanitary Surveillance Fee.

Step 3: Anvisa’s Consent to Import 

After being submitted to the Product Registration process, the consent to import must be obtained through the registration and granting of the Import License.

The documents required for the application for authorization to import vaccines are described in Chapter XXXIX of RDC 81/2008 of Anvisa, and the Term of Responsibility provided in Article 4, of RDC 234/2005 of Anvisa, required for biological biological medicine and vaccines.

Step 4: The registration of the Import License – LI of the vaccines at Siscomex

(LI) is an electronic document registered by the importer or his legal representative in the Siscomex to present information about the goods to be imported and the import operation in general, such as: importer, exporter, country of origin, origin and purchase, tax regime, exchange coverage, among others.

Based on the documents listed above, the importer can register the Import License in Siscomex and submit the application for analysis and later approval by Anvisa.

Step 5: Registration of Import Licensing information in the Portal Único and in the Solicita System

To continue the Anvisa consent solicitation process, the importer or its authorized legal representative must provide the Importation Electronic Petitioning in the Visão Integrada System – Portal Único de Comércio Exterior, and in the Solicita System.

After attaching the documents to the Petition, it will be necessary to pay the Sanitary Surveillance Fee.

Step 6: Analysis for import licensing approval

Once all the requirements mentioned in the previous items are met, ANVISA will proceed with the analysis for later granting of the import license. The legal term for analysis is set at 60 (sixty) days.

 The licensing will be granted with the guardianship and responsibility agreement, with the following pending sanitary requirement: “To release the Term of Custody and Responsibility, attach to the LI dossier the continuous temperature records of the transport chain and the certificate of batch release issued by the importer’s Quality Assurance department, as established by Article 4 of RDC 234/2005, in addition to filing a petition for release of the custody and responsibility term and responsibility.”

The Term with the pendency cited above assigns to the importer the responsibility to submit to Anvisa at the end of the customs clearance the information and documents provided for in Article 4 of RDC 234/2005. The availability of this information terminates the health pendency assigned at the time of granting the Import License.

* Import license validity period

Licenses will be automatically cancelled after ninety (90) days from the date of granting, in the case of a license granted without restriction to the date of shipment.

The licensing may be extended only once for an equal period.

 

For more information, access the guide here (available only in Portuguese).

More Resources:

Fast track registration of COVID-19 vaccine in Brazil

Fast-Track Registration of COVID-19 Vaccines in Brazil

On 03/18/2020, Anvisa published a new regulation (RDC 348/2020), that defines the conditions of the priority review for the registration of covid-19 Vaccines .

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

 

Navigate the Global Regulatory Landscape 

Follow GRP on Social Media !

Subscribe to our Blogs & Newsletter

Share This Post:

Share on facebook
Share on twitter
Share on linkedin
Scroll to Top