Anvisa changes the Importation of Controlled Drugs


The import declaration, also known as ID, is a document that records the data of the goods import process. It is where details such as manufacturer and importer data, tax classification of the goods, and tax amounts are informed.


The import declaration is a fundamental step in importing goods into Brazil. Without it, customs clearance does not take place, and the goods transported do not reach the hands of the importer.

This document presents financial and commercial information about the foreign trade operation and the purchased goods. Therefore, it needs to be registered in the correct way so as not to cause problems in the following stages of importation.

What is Import Declaration:

  • This is a prerequisite for the customs clearance to be carried out. It is through the import declaration that the customs officer checks that all information is in accordance with the documents presented and with the imported product.
  • The import declaration is the first step in the clearance process.
  • It is registered right after the payment of taxes and duties is made by the importer.
  • The document cannot have errors, because this can generate problems in taxation and even prevent the shipment of the items.
  • This document, in most cases, is formulated through the Integrated Foreign Trade System, Siscomex.
  • In cases where the goods require an import license, it is sufficient to register the number of this document in Siscomex, and the data to be included in the Import Declaration (ID) are filled in automatically.
  • If there is no import license, then you must carefully fill in the data manually.

Types of Import Declaration:

The choice of model occurs in accordance with the import conditions, the nature of the goods transported, and the tax treatment of the operation. The declaration can be made both in Siscomex and outside it.

Declaration with Registration at Siscomex: There are two types of import declaration that can be made with Registration at Siscomex. Check them out:

  • Import Declaration: Is the document that ID: As we have already mentioned, is the document that records information about the import operation and the commercial, fiscal and exchange details about the goods.
  • Simplified Import Declaration: SID Electronic: used for the clearance of goods under specific conditions.

Declaration without Registration in Siscomex

Not all ID must, necessarily, be made in Siscomex.  Forms of presentation of the document without registration:

  • Simplified Declaration of Import Form: This is a form accompanied by specific documents for the conditions of the operation. Import samples without commercial value, goods imported by individuals up to 500 dollars.
  • Declaration of Imports of Express Delivery: The express shipment is a document, or an international package imported by air. Used for clearance of items such as documents and imported by individuals.
  • Simplified taxation bill: Used to dispatch international postal consignments up to 500 dollars in customs value and that are subject to the Simplified Taxation Regime.

The import declaration is a very detailed process. If you want to import regulated health products into Brazil. GRP Brazil can support you.

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GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).

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, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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