Health product labeling: an essential requirement for import to Brazil

The label is an important communication tool between the manufacturer and the consumer. It is responsible for informing the consumer about the product and its risks, and for ensuring that the product is used safely and effectively.

Labeling is an essential element of any product, be it a consumer product, an industrial product, or a health product. The label is responsible for providing the consumer with important information about the product, such as:

  • Product name: The product name should be clear and concise, and should allow the
    consumer to easily identify it.-
  • Brand: The brand is an important identification element of the product, and should be
    presented in a clear and legible way.
  • Ingredients: The list of ingredients should be complete and accurate, and should include all of the ingredients used in the manufacture of the product.
  • Directions for use: The directions for use should be clear and concise, and should inform the consumer how to use the product safely and effectively.
  • Warnings: Warnings should inform the consumer about the potential risks associated with the use of the product.
  • Expiration date: The expiration date should be clearly and legibly displayed, so that the
    consumer knows how long the product can be used.
  • Storage: Storage information should inform the consumer how to store the product
    properly.

In addition to these mandatory information, the label may also include other information that may be useful to the consumer, such as:

  • Usage tips: Usage tips can help the consumer get the most benefit from the product.
  • Composition: The composition can inform the consumer about the active ingredients of the product and their benefits.
  • Reviews: The reviews of other consumers can help the consumer make a purchasing
    decision.

In Brazil, the labeling of cosmetics, hygiene, perfume, and health products has some
specificities and is regulated by the National Health Surveillance Agency (Anvisa). Anvisa
establishes norms and requirements for the labeling of these products, in order to guarantee safety and information to the consumer.

The labeling of health products is an essential requirement for import to Brazil. The National Health Surveillance Agency (Anvisa) establishes norms and requirements for the labeling of these products, in order to guarantee safety and information to the consumer.

In these cases, labeling is important for several reasons, including:

  • Consumer safety: Labeling provides consumers with important information about the product that can help them use it safely and effectively.
  • Consumer information: Labeling provides consumers with information about the product, such as its composition, directions for use, and warnings.
  • Product promotion: Labeling can help promote the product by providing information about its benefits and differences.

Products regulated by Anvisa

Anvisa establishes norms and requirements for the labeling of various types of products,
including:

  • Medications: Medications are pharmaceutical products that are used to prevent,
    diagnose, cure, or treat diseases or health conditions. The labeling of medications must contain important information about the product, such as its composition, directions for use, warnings, and contraindications.
  • Medical devices: Medical devices are products that are not medications and are used for medical purposes, such as diagnosis, treatment, or prevention of diseases. The labeling of medical devices must contain important information about the product, such as its purpose, instructions for use, and warnings.
  • Cosmetics: Cosmetics are personal care, perfumery, and toiletry products that are
    intended to be applied to the human body for the purpose of cleansing, protection,
    altering appearance, correcting body odors, or perfuming. The labeling of cosmetics mustcontain important information about the product, such as its composition, how to use, and warnings.
  • Food: Foods are products intended for human consumption. The labeling must contain
    the product name, brand, ingredients, nutritional information, expiration date, and
    storage.

Importation of products regulated by Anvisa

To import products regulated by Anvisa, the product labeling must be in compliance with
Anvisa’s norms and requirements. Anvisa may require that the product labeling be submitted for approval prior to importation.

To ensure that the product labeling is in compliance with Anvisa’s norms and requirements, it is important to consult a qualified professional, such as a regulatory consultant.

Here are some tips that help to prepare the labeling of products regulated by Anvisa:

  1. Start early: The labeling process can take some time, so it is important to start early.
  2. Consult a qualified professional: A regulatory consultant can help you understand
    Anvisa’s requirements and ensure that your labeling is in compliance.
  3. Use a professional translator: Make sure that the labeling is translated into Portuguese
    accurately and clearly.
  4. Submit the labeling to Anvisa: Anvisa may require that you submit the labeling of some
    products for approval prior to importation, such as cosmetics and health products.

By following these tips, you can ensure that your products are in compliance with Anvisa’s
requirements and can be successfully imported into Brazil.

For foreign manufacturers who wish to market their health products in Brazil, it is important to understand the Anvisa labeling requirements. These requirements may vary depending on the type of product and the intended use.

In general, the labeling of imported health products to Brazil must contain all the information already mentioned. In addition to these mandatory information, the label may also include other information that may be useful to the consumer, such as:

  • Usage tips: Usage tips can help the consumer get the most benefit from the product.
  • Composition: The composition can inform the consumer about the active ingredients of the product and their benefits.
  • Warnings: Some products may require more precise information about their use and that may harm the consumer in some way by improper use of the product.

Despite the points presented, it is of paramount importance that qualified people who
understand product labeling according to current legislation are involved in the labeling project.

With Novatrade, regulatory consulting services are offered to companies that wish to import products into Brazil. In addition to having a team of experienced and qualified consultants who are familiar with the Anvisa product labeling regulations.

Novatrade can help you ensure that the labeling of your products is in compliance with Anvisa norms and requirements. The company offers consulting services for all types of products regulated by Anvisa, including medical devices, cosmetics, and food.

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