Your distributor holds the INVIMA registration, so he holds the market

INVIMA is Colombia's food and medicines regulator. Food, beverages, cosmetics, medical devices, medicines and several other categories need a sanitary registration, notification or permit before they can be sold. Every consultancy that ranks for this explains how to file, because filing is the service they sell.

The commercially decisive question is different: whose name is on the registration. Get that wrong and you have handed the market to your distributor without noticing.

Why the registration ends up in the distributor's name

The holder of the registration, the titular, must be domiciled in Colombia or must act through a locally domiciled legal representative. A European manufacturer with no Colombian entity has no direct route to holding it in its own name, and the path of least resistance is to let the importer file.

The importer is usually your distributor, for the same structural reason set out in four ways to sell in Colombia: the importer of record must hold a Colombian NIT with the import activity registered.

So the default outcome, absent a decision, is that your distributor holds the import registration, the customer relationships and the regulatory authorisation for your product. That is three holds, and the third is the hardest to break.

What it costs you when the relationship ends

A sanitary registration is not a document that travels with the product. It is granted to a holder for defined products, and changing the holder is generally a new filing rather than an assignment. That means:

• your new distributor cannot legally sell until the registration is issued in their name,
• the old distributor can continue to sell whatever stock they hold,
• and the timetable is INVIMA's, not yours.

Registrations are granted for fixed terms that vary with the product's risk classification, with higher-risk categories renewed more often. Figures of five, seven and ten years circulate widely for the different classes; we have not been able to confirm them against the governing decree, so treat them as indicative and check your own category before you build a renewal schedule around them.

Colombia has also been modernising the process. INVIMA introduced the InvimAgil platform in May 2025 and has been moving submissions onto it. That changes the mechanics rather than the ownership question, which is the one that matters here.

The four things you can actually do

Register in your own name through a Colombian entity. The complete answer, and the reason a regulated-product entry into Colombia often justifies an SAS earlier than the revenue does. Your entity is the titular, your distributor is a customer, and terminating them is a commercial decision rather than a regulatory event.

Use a local legal representative who is not your distributor. A regulatory affairs firm can act as the domiciled representative for the registration while your distributor handles commerce. It costs a retainer and it separates the two holds. This is the pragmatic middle option and it is under-used.

Write a transfer and cooperation obligation into the contract. Better than nothing, and weaker than it sounds, for the same reason it is weak in Mexico: the regulator is not a party to your contract and will not enforce it. Where the outgoing distributor cooperates it works. Where they do not, you are litigating while your goods sit.

Accept it, and price it. Defensible for a first small market entry. Not defensible once Colombia is material, and the moment to fix it is before you need to.

What to ask before you sign

• In whose name will the registration be filed, and who pays for it?
• If we terminate, will you consent in writing to a transfer, and within what period?
• What is the current registration status of every product you already handle for other principals, and have any been cancelled or suspended?

For what termination itself costs in Colombia, which is a much bigger question than in Mexico, see what it costs to end a Colombian distribution agreement. For the wider country picture, our Colombia market page.

Common questions

Who can hold an INVIMA registration in Colombia?

A party domiciled in Colombia, or a foreign party acting through a locally domiciled legal representative. A European manufacturer without a Colombian entity or a local representative cannot hold one directly, which is why the registration usually ends up with the importer.

Can an INVIMA registration be transferred to a new distributor?

Changing the holder is generally treated as a new filing rather than a simple assignment, and the timetable belongs to INVIMA. Contractual transfer obligations help only where the outgoing party cooperates, because the regulator is not bound by your contract.

How long does an INVIMA registration take?

It depends on the category and the risk class, and submissions have been migrating to the InvimAgil platform introduced in May 2025. Treat it as a lead time item in the entry plan rather than a step to start after the distributor is appointed.

Should I register in my own name or let my distributor do it?

In your own name wherever you can, through a Colombian entity or an independent local representative. Letting the distributor hold it is the cheapest option at the start and the most expensive one at the end.