How to obtain a Sanitary Registration in Colombia

How to obtain a Sanitary Registration in Colombia – Sanitary Registration

Are you a food manufacturer or importer in Colombia? If the answer is positive, you must obtain the Sanitary Registration before the “Invima” for your products. It is possible that you have heard this before, but you may not know the necessary steps to get this mandatory permit. Don’t worry, you have come to the right place. At Pinzón Pinzón & Asociados (PPA), we have prepared a special publication clarifying everything related to this process. Join us!

First things first: What is a Sanitary Registration?

It is mandatory and prior permission granted by the Health Authority (Invima), which authorizes a natural or legal person to manufacture, pack, import, and market food for human consumption. Without this permit, you will not be able to sell food in Colombia.

What does Invima mean?

Invima is for “Instituto Nacional de Vigilancia de Medicamentos y Alimentos”. The objectives of this Colombian entity are the protection and surveillance of individual and collective health, as well as the control of technical and scientific character through the application of sanitary norms associated with the consumption and use of food, medicines, medical devices, and other products subjected to sanitary surveillance.

Now that you know the meaning and importance of this document, we reiterate that all natural and legal persons who sell food to consumers are required to obtain sanitary registration for their products. However, Article 41 of Decree 3075 of 1997 refers that the following merchandise doesn’t need to have sanitary registration:

Natural foods that were not processed before being sale, such as fruits, vegetables, grains, fresh vegetables, and honey, among others.
Raw, frozen, or refrigerated foods of animal origin that have not been modified.
Raw materials and foods created in Colombian territory or abroad are used exclusively by the manufacturing and culinary sector to produce food and prepare meals.

What documents do I need to obtain the Invima Sanitary Registration?

As any other procedure, a series of documents are necessary, depending on whether the food is made in the country or comes from abroad. Below, we present the requirements to begin the process of processing a sanitary registration in the area of food, according to Article 38 of Resolution 2674 of 2013:

For national food products:

Form corresponding to the procedure.
Certificate of existence and legal representation of the holder and the manufacturer; or, in its absence, its commercial registration.
Receipt of payment, the amount of which must coincide with that indicated in the Invima fee schedule.

For imported food products:

Documents detailed in the previous point.
Certificate of free sale issued in the country where the food product comes from. It is essential to highlight that the official translation must be attached if this document is not written in Spanish.
Document signed by the producer authorizing the importer to introduce the food into the country, distribute it, commercialize it, or be the holder of the sanitary registration of the product in Colombian territory.
Technical data sheet of the food product according to the format defined by Invima.

Important note: If you are doing the procedure through an advisor, you must provide the corresponding power of attorney.

Learn step by step how to obtain the Invima Sanitary Registry

Once you have all the requirements at hand, follow these steps, and you will be able to carry out this necessary procedure effectively:

Step 1: To start, you must register your company before Invima.

Step 2: You must specify the category of your product according to the food classification for human consumption according to the public health risk. This can be found in the technical annex of Resolution 719 of 2015. This regulation indicates and divides foods that can be high medium or low risk. If your product is a high risk, the permit will be a sanitary registration (RSA) with five years of validity. For medium risk, the permit will be a sanitary permit (PSA) with seven years of validity. If it is a low risk, the permit will be a sanitary notification (NSA) with ten years of validity. Do you already have your product defined?

It is important to note that you can process a single sanitary registration. Following the guidelines of Article 42 of Resolution 2674 of 2013, this can be done in the following cases:

In the case of a food product produced by several manufacturers under a single trademark.
If the procedure is to be carried out for the same food product marketed under various trademarks, the holder and the manufacturer are the same natural or legal entity.
When there are several presentations, but the food remains the same.
If goods with the same elemental composition and different secondary elements are handled.
When foods of vegetable origin have the same specific name and different varieties, interesting, don’t you think?

Step 3: Afterwards, you will have to pay the corresponding fees at one of the offices designated for this purpose. Something that can save you time is to make the payment online.

Step 4: You are getting closer to success. In this opportunity, you must take to Invima the documents mentioned above to request sanitary registration, and that’s it.

Congratulations, you have successfully processed the sanitary registration of your product! It is no secret that when we must carry out a procedure, we are concerned that everything goes well and that this is achieved positively. For this and many other reasons, in PPA, we have at your disposal experts in technical and legal matters to provide you with the advice you deserve.