Publicidad
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Publicidad
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Publicidad
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Publicidad
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Cartilla_Cannabis_2023_ENG_FINAL.pdf
Próximo SlideShare
CANNABIS INDUSTRY IN COLOMBIA 2018CANNABIS INDUSTRY IN COLOMBIA 2018
Cargando en ... 3
1 de 17
Publicidad

Más contenido relacionado

Publicidad

Cartilla_Cannabis_2023_ENG_FINAL.pdf

  1. AN OVERVIEW OF THE CANNABIS INDUSTRY IN COLOMBIA IMPORTANT INFORMATION AND CURRENT ISSUES OF A GROWING INDUSTRY 2023 W E L L N E S S F R O M I T S
  2. INDEX 01 Introduction Page 3 02 Regulatory Development - Main standards Page 4 03 Page 6 04 Types of licenses in Colombia Page 8 05 Frequently Asked Questions Page 10
  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
  4. REGULATION
  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
  6. IMPORTANT DEFINITIONS
  7. IMPORTANT DEFINITIONS 7 LEGALGUIDE2023
  8. TYPES OF LICENSES
  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
  10. FREQUENTLY ASKED QUESTIONS
  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
Publicidad