INVIMA health registration and notification for food and beverages

The first decision is not a form

Before filling in any form, the product has to be defined for health purposes: a food, a beverage, an alcoholic drink, a dietary supplement or a raw material. That characterisation determines the type of authorisation, the technical information to be gathered, who should appear as the holder and how much time must be set aside before the launch date. A hasty classification is the most frequent cause of rejected files and of campaigns pushed into the next quarter.

Resolution 2674 of 2013 sorts foods by their public health risk and assigns each level a different route before INVIMA: notification, permit or health registration. We review the composition, the manufacturing process, the presentation and the intended use of the product, and settle the applicable route before the technical team starts collecting documents it may not need.

How we build the file

1. Product map. Work with the technical and commercial teams to understand the formula, the process, the packaging, the shelf life and the market it is aimed at.
2. Document review. Technical sheet, quantitative composition, process description, shelf-life support, plant documents and certifications from the manufacturer or co-packer. This is where the gaps almost always appear.
3. Coordination with the manufacturer. Where the product is co-packed or imported, much of the file sits with a third party. We request each document in the format the authority expects.
4. Filing. We submit the application and follow it through to the response.
5. Information requests. We prepare the answer within the deadline, with the right technical support and without opening fronts nobody asked about.

We offer no guarantee of approval, and it is worth being wary of anyone who does. What we do offer is a complete file from the first submission, a timetable the commercial team can plan around, and an honest reading of the product's weak points before it is presented.

Imported products

With imported product the work runs on two fronts. On one side, the file before INVIMA, which requires documents from the foreign manufacturer with the translations and legalisations the authority demands. On the other, coordination with the importer, the customs agent and the procurement team, because a container held up over a missing document costs more than the whole procedure. We settle early who will hold the authorisation in Colombia, what that decision means vis-à-vis the manufacturer, and what happens to the file if the distributor changes later.

When the product changes

A health authorisation is not a one-off. The formula changes, an ingredient supplier is swapped, the packaging is redesigned, a new presentation is added, production moves to another plant, or the brand passes to another company in the group. Each of those moves may require the file to be amended, and the real risk is selling for months a product whose formula or label no longer matches what was authorised.

• Amendments for changes in formula, presentation, packaging or label.
• Change of holder, manufacturer, co-packer or importer.
• Extension to new references and presentations in the same line.
• Timely renewal of authorisations in force, with date control.

What the client receives

• A written opinion on how the product is classified and which route applies, with the list of documents and who has to obtain each one.
• The file submitted to INVIMA and sustained through to the decision, including responses to any information requests.
• A realistic timetable for planning the launch, flagging the points where the project can stall.
• A record of the authorisations in force, their renewal dates and the amendments still pending.

Typical situations we handle

• An emerging brand is about to launch its first product and does not know which authorisation it needs or in whose name it should sit.
• An importer wants to bring in a line already sold abroad and needs to know what the Colombian market requires.
• A company changed the formula on the plant floor and finds the health file out of date.
• A restaurant or chain wants to pack and sell its own branded product, not just serve it on site.
• An investor is assessing the purchase of a company in the sector and needs to know whether its products are properly covered.