How to apply for INVIMA sanitary registration

How to Apply for Your INVIMA Registration: A Step-by-Step Guide

In a previous post, we discussed what INVIMA is and why it's important to have this registration if you plan to sell products for human consumption. If you'd like to read our previous entry, click here.

Now, we want to explain the process of applying for your registration with the National Institute for Drug and Food Surveillance (INVIMA).

Step 1: Mercantile Registry

You must have a mercantile registry, either as a natural person or a legal entity. Make sure it's no older than 30 days. For more information on the importance of this registry, consult The Importance of Legally Establishing a Company or, if you're looking to expedite the process, consider Fast Company Creation (SAS) in Colombia.

Step 2: Factory Registration with INVIMA

You must register your factory on the INVIMA website. To do this, you can click here. If your company is already registered, you can skip this step.

Step 3: Product Classification According to Risk

You must classify your product according to its risk category, as established in Annex 1 of Resolution 719 of 2015. This is important because it will tell you which permit you must request and the duration of the permit. There are three risk categories:

1. High: For this category, you must process a Sanitary Registration valid for 5 years.
2. Medium: For this category, you must process a Sanitary Permit valid for 7 years.
3. Low: For this category, you must process a Sanitary Notification valid for 10 years.

If your product is a medical device, cosmetic, or pharmaceutical, you can consult more details at: Sanitary Registration of Medical Devices in Colombia, Sanitary Registration of Cosmetics in Colombia, Sanitary Registration of Medicines and Biological Products in Colombia.

Step 4: Covering Foods Under a Single Permit

Keep in mind, and as mentioned in Article 42 of Resolution 2674 of 2013, that you can cover foods under a single Sanitary Registration, Permit, or Notification. These cases include:

• Foods produced by several manufacturers but under the same commercial brand.
• The same food with different brands, only if the manufacturer and the holder are the same natural or legal person.
• Foods with the same basic composition that differ only in secondary elements.
• The same product in different commercial presentations.
• Plant-based foods with the same specific name in different varieties.

Step 5: Verification of Requirements

You must verify that you meet the requirements to request one of these permits. The requirements for a Sanitary Registration or Permit are enshrined in Article 38 of Resolution 2674 of 2013; the requirements for a Sanitary Notification are in Article 40 of the same decree.

Step 6: Completing Forms

Complete the basic information form and the application form for Sanitary Registration, Permit, or Notification, as applicable. These forms can be downloaded here.

Step 8: Payment of Fees

Verify the fee to be paid according to the required procedure and make the corresponding payment at the designated offices. The fees can be consulted on the INVIMA website.

Step 9: Submission of Documentation

Finally, submit all documentation in a white folder, foliated and with a plastic file clip, to the INVIMA Citizen Service Office:

1. Unique food format according to the case you are requesting.
2. Mercantile registry no older than 30 days.
3. Original deposit slip.
4. Copy of the legal representative's national identity card.
5. Letter of request.

If you find the INVIMA registration process complex, Servicio Legal is here to help. We will support you throughout the process, advising you on each step and obtaining the necessary documents. To learn more about our services, click here. We offer Corporate Lawyers in Colombia and Legal Advisory Plans for Companies in Colombia to provide the support you need.