3. INTRODUCTION
The cannabis industry currently represents an
opportunity for Colombia's economic growth, since
it is fully aligned with one of Colombia’s main
Although it is a relatively new industry, it is already
a global trend. The last year has witnessed
accelerated growth in the manufacture of new
products associated with the cannabis
industry—such as cosmetics, dietary supplements,
and food.
commitment, governments are regulating this market
to take advantage of the opportunity to be part of
this great global trend, and Colombia is no
exception.
It is important to highlight that Colombia has been a
pioneer in the region in terms of implementing a
regulatory framework to produce and sell medical,
in Colombia having one of the region’s most
complete regulatory frameworks, which covers the
entire value chain.
At Procolombia, we are convinced that this
commitment is of great importance, especially in
these times of economic recovery, given that this
industry has great potential to create jobs, further
local development, and increase economic growth
through local sales and the exportation of
value-added products.
This is why we support both domestic and foreign
investors in understanding this sector in Colombia
and all the opportunities it represents. This booklet is
designed to provide reference information as a
complement to the services and support you will
receive from our agency.
The information in this document is current as of the date it was prepared. The information contained in this document is merely
informative and for reference purposes. We recommend consulting with the competent authorities beforehand in order to determine
the necessary permits, licenses, and other requirements for the various processes. It is highly advisable to consult specialized law
person for any decisions or actions you may take in relation to the commercial information provided; therefore, it should be taken
for reference purposes only.
LEGALGUIDE2023 3
5. REGULATION
REGULATORY DEVELOPMENT - MAIN STANDARDS
framework can be found below:
5
LEGALGUIDE2023
Seeds for planting plant material, grain production, and non-psychoactive cannabis derivatives for
9. TYPES OF LICENSES
2
License
License for manufacture
of cannabis derivatives
License for manufacture
of non-psychoactive
cannabis derivatives
License for seeds for
planting and grain
production
License for psychoactive
cannabis plant
cultivation
License for
non-psychoactive
cannabis plant
cultivation
Special license for
cannabis plant
cultivation
Special license for the
manufacture of
derivatives
Granted in a single category
Category
Granting
Authority Licensed Activity
INVIMA (Colombia
National Food
and Drug
Surveillance
Institute)
INVIMA (Colombia
National Food
and Drug
Surveillance
Institute)
Ministry of Justice
and Law
INVIMA (Colombia
National Food
and Drug
Surveillance
Institute)
Manufacturing of psychoactive
and non-psychoactive derivatives
Manufacturing of non-psychoactive
derivatives
Handling of seeds for planting
and grain production (does not
include cannabis plant cultivation)
Production of seeds for planting,
grains, plant material, and
psychoactive cannabis
Production of seeds for planting,
grains, plant material, and
non-psychoactive cannabis
Depletion of current stock or
cultivation of cannabis plants for
research purposes.
Depletion of stocks of cannabis
or cannabis derivatives or the
manufacture of cannabis
derivatives for research.
Ministry of Justice
and Law
Ministry of Justice
and Law
9
LEGALGUIDE2023
- Production of seeds for
planting
- Grain production
- Manufacture of derivatives
- Industrial purposes
- Research
- Export
- Domestic use
- Research
- Export
11. FREQUENTLY ASKED QUESTIONS
GENERAL QUESTIONS
In this section, we share the most frequently asked questions we received from
stakeholders:
11
WHAT ARE THE SPECIFIC REQUIREMENTS TO
OBTAIN MY LICENSE?
License for the manufacture of cannabis
derivatives:
Derivatives manufacturing plan (organization chart,
manufacturing facilities, among others)
Safety protocol
Letter of intent to hire a technical director for the
manufacturing process (must be a pharmaceutical
chemist, chemist, industrial chemist, or chemical
engineer)
the chemist listed in the letter of intent
Statement signed by the legal representative expressing
their commitment to comply with the protection and
strengthening of small and medium growers,
producers, and domestic cannabis traders
Research category: Corporate purpose must expressly
include the research activity
Export category: Must submit a plan for activities to be
carried out, a projection of the volume to be exported
for 1 year, and potential importing countries
For the manufacture of non-psychoactive derivatives: In
production process must be submitted, indicating in which
stage the derivative will be obtained.
WHAT ARE THE GENERAL REQUIREMENTS TO
APPLY FOR LICENSES?
Natural persons
Citizenship card/visa
Proof of payment of the application fee
more than 3 months prior to the application date)
Anti-corruption commitment document
Legal entities
(Cannot be more than three (3) months prior to the
license application date)
Legible photocopy of the main and alternate legal
for natural persons).
LEGALGUIDE2023
more than 3 months prior to the application date)
Anti-corruption commitment document
structure (Cannot be more than three (3) months
prior to the license application date)
Legible photocopy of the main and alternate legal
-
ments for natural persons).
Legal entities
For the manufacture of non-psychoactive derivatives: In addition
process must be submitted, indicating in which stage the
derivative will be obtained.
Safety protocol
12. 12
License for seeds for planting and grain
production
Description of equipment to be used
Description of areas where activities will be carried out
Photographic records of the property to be used
Safety protocol
(Colombian Agriculture and Livestock Institute) registers
the importer, trader, and/or exporter of seeds for
planting (Does not apply to applicants in the grain
production-only category)
The research category must present the documentation
that accredits the research project and the corporate
purpose must expressly contain research and/or plant
breeding.
License for psychoactive and non-psychoactive
cannabis plant cultivation:
Cultivation plan (work schedule, farming procedures,
responsibilities of each position)
Description of equipment to be used
Description of areas where activities will be carried out
When applicable, indicate areas where activities
involving psychoactive and non-psychoactive cannabis
plants will be carried out
Photographic record of the site where the activities will
be carried out
Safety protocol (for cultivation of psychoactive cannabis
plants)
Approval in prior control visit
Letter of intent to hire a technical director for cultivation
Origin and access to seeds
Research category: The corporate purpose must
expressly include research and/or plant breeding
LEGALGUIDE2023
License for seeds for planting and grain production
License for psychoactive and non-psychoactive
cannabis plant cultivation:
When applicable, indicate areas where activities
involving psychoactive and non-psychoactive cannabis
plants will be carried out
Photographic record of the site where the activities will
be carried out
Safety protocol (for cultivation of psychoactive cannabis
plants)
Approval in prior control visit
Letter of intent to hire a technical director for cultivation
Origin and access to seeds
Research category: The corporate purpose must
expressly include research and/or plant breeding.
13. 13
WHAT DO I NEED TO KNOW IF I WANT TO
MANUFACTURE MAGISTRAL PREPARATIONS?
These types of products for human consumption may only
be manufactured by authorized pharmaceutical
Compliance with Good Manufacturing Practices granted
by INVIMA, which covers plant material derivatives or
cannabis derivatives. A pharmaceutical chemist must
oversee technical management.
The product’s packaging, container, or label must include
the medical prescription and also, at the very least,
indicate the THC and CBD concentrations.
The derivatives needed for its preparation must be
supplied by natural persons or legal entities that have a
license for the manufacture of cannabis derivatives for
domestic use or a license for non-psychoactive derivatives.
The use of imported derivatives is not permitted, except for
magistral homeopathic medicines.
WHAT DO I NEED TO KNOW IF I WANT TO
MANUFACTURE ANOTHER FINISHED PRODUCT?
chemically synthesized, phytotherapeutic, or homeopathic
medications, as well as magistral preparations.
For the manufacture of controlled products, prior
registration with the National Narcotics Fund is required.
In the case of non-controlled products, registration with the
Fund is not required, provided that the products are
derived from non-psychoactive derivatives.
The products deemed controlled must be limited to
pharmaceutical products only and must be sold under
medical prescription and special contro
HOW DO I APPLY?
and other procedures associated with seeds for
planting, grain production, plant materials, cannabis
must be carried out through the MICC (Cannabis
Control Information Mechanism)..
HOW LONG WILL MY LICENSE BE VALID?
It shall be valid for 10 years from the date it is granted.
It is possible to renew it for an equal period, as many
times as the licensee requests. Renewal of licenses must
be requested at least three (3) months prior to their
expiration date.
The license shall remain in force until a resolutory
condition is set or it is cancelled at a party’s request.
HOW LONG DOES IT TAKE FOR THE
AUTHORITY TO MAKE A DECISION ABOUT MY
LICENSE?
The study and decision of the license applications shall
be resolved within 30 days, provided that the
requirements corresponding to the license type and
category are met.
WHAT RAW MATERIALS CAN I USE IN FOOD?
For the manufacture of food and beverages, plant
material, grains, and non-psychoactive cannabis
derivatives can be used as raw material.
CAN I MARKET FOOD WITH CBD WITHIN
COLOMBIA?
Food and alcoholic beverages containing CBD intended
for human consumption may not be marketed within
Colombian territory until the Ministry of Health issues the
corresponding regulations.
LEGALGUIDE2023
14. 14
WHAT DOCUMENTS DO I NEED TO HAVE TO
IMPORT AND EXPORT NON-PSYCHOACTIVE
DERIVATIVES OR NON-CONTROLLED
PRODUCTS?
In order to import, enter the free trade zone, or export
that it is a non-controlled product (when applicable)
issued by the National Narcotics Fund must be
obtained.
WHAT DO I NEED TO KNOW ABOUT THE
IMPORT PROCESS?
The importation of seeds for planting, grains, plant
material, cannabis plants, cannabis derivatives, and
regime with previously approved licenses.
The import license must be processed through the
VUCE (Single Window for Foreign Trade). The
following are the respective competent authorities
who will approve the import license and permit the
entry into the free trade zone:
Ministry of Justice, ICA, INVIMA: seeds for planting,
grains, plant material, and live cannabis plants.
National Narcotics Fund, ICA, and INVIMA:
psychoactive and non-psychoactive cannabis,
psychoactive and non-psychoactive derivatives,
consumption.
LEGALGUIDE2023
IMPORTING/ EXPORTING
to the rest of the world is permitted—from the national
customs territory or from free trade zones, only for
Ministry of Justice, ICA, INVIMA: seeds for planting,
grains, plant material, and live cannabis plants.
National Narcotics Fund, ICA, and INVIMA:
psychoactive and non-psychoactive cannabis,
psychoactive and non-psychoactive derivatives,
consumption.
IS IT POSSIBLE TO EXPORT DRIED CANNABIS
FLOWERS FOR COMMERCIAL PURPOSES AND
REQUIREMENTS ARE THERE?
The importation of seeds for planting, grains, plant
material, cannabis plants, cannabis derivatives, and
nished products shall be subject to the import
regime with previously approved licenses.
The import license must be processed through the
VUCE (Single Window for Foreign Trade). The
following are the respective competent authorities
who will approve the import license and permit the
entry into the free trade zone:
WHAT DO I NEED TO KNOW ABOUT THE
IMPORT PROCESS?
15. 15
is listed.
national regulations.
This process takes 15 business days from the submission date.
WHAT DO I NEED TO CONSIDER WHEN EXPORTING?
Identify the product with the corresponding tariff item. The tariff subheadings covering cannabis plants, cannabis
seeds, and chemical substances controlled by the Ministry of Justice and Law can be found here.
If you are not sure which subheading corresponds to your product, you can request the product’s technical data
sheet from the DIAN. The cost corresponds to half of the current minimum monthly wage and takes approximately
3 months.
Have the license required for the product’s category and the activity to be carried out.
Comply with the product’s export requirements established in Resolution 539 of 2023.
National Narcotics Fund.
product to be exported.
LEGALGUIDE2023
16. 15
16
FREE TRADE ZONES
to the national customs territory shall comply with the
requirements established in Decree 1165 of 2019 and
shall not require the prior approvals contained in Article
corresponding import declaration.
FOR THE DEPARTURE FROM THE FREE TRADE
ZONE TO THE REST OF THE WORLD, CAN
CANNABIS PRODUCTS BE HANDLED THROUGH
CUSTOMS TRANSIT OR A SHIPPING FORM?
From the customs perspective and under the assumption
that the merchandise intends to leave the free trade
zone, there is no restriction on authorizing the customs
transit category through a different jurisdiction.
When the departure of goods from the free trade zone
to the rest of the world takes place in the same
jurisdiction, the only form required is the Movement of
Goods - Exit form or the Shipping Authorization request
form.
ARE THERE ANY QUANTITY OR WEIGHT LIMITS
FOR EXPORTS FROM THE FREE TRADE ZONE TO
THE REST OF THE WORLD?
The regulations governing this matter do not establish
quantity and weight limits for exports to the rest of the
world.
and requirements for the merchandise to enter the free
activity must prove compliance with them; therefore, the
operator will not require additional documents other
than those mentioned in Resolution 539 of 2023 or in
the current regulations.
DO OPERATORS NEED TO VERIFY AND KEEP
TRACK OF THE TYPE OF QUOTA OR QUANTITY?
The operator’s role does not include verifying the quota;
those responsible for controlling and verifying the
quotas are the control authorities. At the respective
control points, they will verify the type and amount of
products entering the country, and whether or not they
responsibility and obligation is related to the importation
and processing of the authorized goods.
ARE THERE ANY CUSTOMS RESTRICTIONS FOR
A QUALIFIED USER IN A FREE TRADE ZONE TO
TEMPORARILY REMOVE THE MATERIAL FOR
LABORATORY ANALYSIS?
From a customs perspective, there is no restriction on a
temporary exit for technical testing, by virtue of Article
489 of Decree 1165 of 2019, added by Article 100 of
Decree 360 of 2021, in accordance with the provisions
of Articles 542 and 543 of Resolution 46 of 2019.
AS AN OPERATOR, WHICH DOCUMENTS DO I
NEED TO REQUEST FROM THE QUALIFIED USER
IN ORDER TO EXIT THE FREE TRADE ZONE AND
ENTER INTO THE NATIONAL CUSTOMS
TERRITORY OF FINISHED PRODUCTS?
products, the merchandise covered in the import
declaration must be released, or the import conditions
established for Special Import Declaration, indicated in
Article 526-1 et seq. of Resolution 046 of 2019, must
be met.
In accordance with Resolution 539 of 2023, the
importation of seeds for planting, grains, plant material,
cannabis plants, cannabis, and cannabis derivatives
and related products from free trade zones
LEGALGUIDE2023
