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How to Get the Invima Health Registration in Colombia If I Am a Food Manufacturer

January 29, 2018

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Woman Shopping Personal Products
Most food manufacturers and importers know it is mandatory to obtain a registration certificate from INVIMA (National Medicine and Food Surveillance Institute) if they want to produce and distribute their products in Colombia. However, only a few people know the necessary steps and procedures to obtain such registration. That is why it is imperative to get legal advice from qualified health registration attorneys in Colombia.

The best health registration lawyers in Colombia can release the stress of dealing with legal procedures, as they are familiarized with the legal system and all related procedures.

Every natural person or legal entity that sells any product for human application in Colombia must have the INVIMA health registration.

The exception to this rule is explained in Article 41 of Decree 3075 of 1997, which stipulates that it is not mandatory to obtain the registration for the following merchandise:

  • Fruits, fresh vegetables, grains, bee honey, and other non-processed, natural foods.
  • Raw, frozen, and refrigerated food of animal origin that has not been altered in any way.
  • Food and raw materials that have been produced inside or outside Colombia that will be exclusively used by the culinary sector to manufacture and prepare food.
Colombia Health Registration Attorney Checking a Rquirements ListWhat Are the Requirements for the INVIMA Health Registration?
According to the Article 38 of Resolution 2674 of 2013, it is necessary to provide certain documents to start the health registration process. The list of requirements may vary depending on the origin of the product—if it is produced inside the country or comes from abroad.
  • Requirements for domestic products:
    1. Payment receipt—the amount paid must match what is specified in INVIMA's list of fees.
    2. Application form.
    3. Certificate of existence and legal representation of the title holder and manufacturer. In the absence of these documents, commercial registrations are accepted.
  • Requirements for Imported Products:
    1. All the documents required for domestic products.
    2. Certificate of free sale issued by the country where the product was originally produced. An official translation of the document is needed if it was not originally written in Spanish.
    3. Fact sheet of the product in accordance with the template specified by INVIMA.
    4. Producer's signed authorization for the importer to initiate distribution and commercialize the product in the country. The producer can also use this to authorize the importer to be the health registration holder in Colombia.
    5. If you are doing this procedure through an intermediary, it is imperative to submit the corresponding power of attorney.
Steps to Get the INVIMA Health Registration
To obtain the INVIMA health registration, you need to do the following:
  • Register with INVIMA. Click here to start your application.
  • Determine your product's category according to the classification of food for human consumption. You can find this classification in the Resolution 719 of 2015. According to this resolution, the risk of food and medical products can be classified as low, medium, or high. If the product is high risk, it is mandatory to obtain the (RSA) health registration. If not, you must request another kind of registration. Check with your health registration attorneys in Colombia before you submit your application. Also, you can process one INVIMA health registration for more than one product. According to the Article 42 of Resolution 2674 of 2013, this can be done only in the following cases:

    Woman Buying Medical Products at a Pharmacy
    • If it is a product produced by more than one manufacturer and has only one commercial brand.
    • If you plan to apply for one product distributed by more than one trademark and the title holder and manufacturer are the same individual or legal entity.
    • When the same product is distributed in different presentations but is the same product.
    • If the products have the same basic composition and varied secondary elements.
    • When food of vegetal origin has the same exact name and comes in different varieties.

  • Pay the corresponding fee at the bank. It is possible to make this payment online or at one of its branches.
Apply for the health registration by submitting the required documents at INVIMA's office. Given that the process takes time and that most business owners have busy schedules, it is advisable to get help from experienced health registration attorneys in Colombia. Hiring the service of an expert will definitely ease the stress of legal procedures and minimize errors throughout the process. At AGT Attorneys, we take pride in offering you the most qualified attorneys with experience in INVIMA health registrations. Call us at +57 1 702-3671 or fill out the form in the "Contact" section of our website to learn more about our services. Remember to subscribe to our newsletter to stay up to date with the latest information in the legal field. Find us on Facebook at AGT Attorneys and follow us on Twitter @AttorneysAGT.

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