The export and import of medicines is a complex and rigorous process that requires compliance with various norms and regulations. In Brazil, this procedure is essential to ensure the availability of quality and effective medicines for both the national and international markets. Fast Shipping, specialized in freight forwarding, offers a comprehensive view on how to navigate the challenges and requirements of this crucial sector.

Applicable Rules, Regulations, and Laws

1. Norms and Regulations: The import and export of medicines are governed by a series of strict norms established by the National Health Surveillance Agency (ANVISA). Among the main regulations are:

• RDC 81/2008: Defines the procedures for importing and exporting products subject to health surveillance.
  
  

• RDC 204/2006: Regulates the international transit of medicines.
  
  

• Law No. 6,360/1976: Establishes health surveillance norms to which medicines, pharmaceutical inputs, drugs, and correlates are subject.
  
  

2. Technical Requirements and Handling: Medicines require special handling to ensure the maintenance of their efficacy and safety. This includes strict control of temperature, humidity, and protection against contamination. Moreover, medicines must be transported in appropriate and secure packaging that meets international standards for the transport of dangerous goods.

3. Necessary Documentation: For the import and export of medicines, it is necessary to present a series of documents, such as:

• Import License (LI): Prior authorization granted by ANVISA.
  
  

• Good Manufacturing Practices Certificate (BPF): Document that proves that the manufacturer complies with quality standards.
  
  

• Operating License Certificate (AFE): Required for companies that manufacture, distribute, or import medicines.
  
  

• Commercial Invoice and Packing List: Documents detailing the transaction and the items transported.
  
  

Main Trading Countries and Types of Medicines

1. Import and Export Countries: Brazil primarily imports medicines from the United States, Germany, Switzerland, and China. These countries are leaders in the production of high-tech and biotechnological medicines. In terms of export, the main destinations for Brazilian medicines include Argentina, Mexico, Colombia, and Chile, as well as other countries in Latin America.

2. Taxation and Taxes: The import of medicines is subject to taxes such as the Import Tax (II), Tax on Manufactured Products (IPI), PIS/COFINS, and ICMS, depending on the state. However, some medicines may be exempt from taxes, especially those without a domestic equivalent and considered essential for public health.

ANVISA's Analysis Process

ANVISA plays a crucial role in quality control of imported and exported medicines. The analysis process involves:

• Request for Import License: The importer must request an Import License from ANVISA before starting the import process.
  
  

• Inspection and Supervision: ANVISA conducts thorough inspections to ensure that imported medicines comply with safety and quality standards.
  
  

• Release of Goods: After inspection and approval, ANVISA releases the goods for distribution in the market.
  
  

Health Surveillance Inspection Fee (TFVS)

The Health Surveillance Inspection Fee (TFVS) is a fee charged by ANVISA for carrying out control and inspection activities. This fee varies according to the type of product and the complexity of the evaluation process.

1. What is TFVS: TFVS is a fee established by Law No. 9,782/1999 and regulated by ANVISA's Ordinance No. 422/2010. It is charged to fund the inspection and sanitary control services performed by the agency.

2. Calculation of TFVS: The TFVS amount is calculated based on a series of factors, including the type of product, the associated risk category, and the nature of the activity (import, manufacturing, etc.). The fee schedule is updated periodically by ANVISA and can be consulted on the agency's website.

3. TFVS Amount for Medicines: The TFVS amount for the import of medicines can vary significantly. For 2023, the amounts can range from R$500.00 to R$5,000.00, depending on the complexity of the process and the category of the medicine.

Costs Associated with the Import Process

The process of importing medicines involves a series of costs, in addition to the TFVS. Among the main costs are:

1. Licensing and Registration Costs: The registration of a medicine at ANVISA can cost between R$10,000.00 and R$50,000.00, depending on the type of medicine and the complexity of the registration process.

2. Transportation and Logistics Costs: The transportation of medicines, especially those requiring special storage conditions, can be expensive. Air transportation costs and logistics to ensure that medicines are maintained in ideal conditions can add thousands of reais to the total cost.

3. Taxes and Customs Duties: Taxes and customs duties can represent a significant part of the import costs. This includes the Import Tax, IPI, PIS/COFINS, and ICMS.

4. Consulting and Agency Costs: We at Fast Shipping offer services that can help mitigate risks and reduce costs associated with the import of medicines. These services include regulatory compliance consulting, logistics management, and of course, follow-up so that you are updated 24/7 about your process.

How Fast Shipping Facilitates the Air Import and Export Process of Medicines

Fast Shipping offers integrated solutions to simplify and expedite the import and export process of medicines. Our services include:

• Specialized Consulting: We guide our clients through all stages of the process, from obtaining the necessary licenses to complying with health regulations.
  
  

• Safe and Efficient Transport: We ensure the proper transport of medicines, with strict control of storage conditions.
  
  

• Complete Monitoring: We monitor the import and export process in real time, ensuring that all procedures are followed according to legal requirements.
  
  

With Fast Shipping, you are guaranteed an agile, safe, and compliant agency service with all applicable regulations. Contact us and find out how we can help your company navigate the challenges of import and export of medicines.