Before commercialisation, a health supplement must be sanitary registered by INVIMA, classified by INVIMA, labelled, and meet import requirements. Minor gaps in compliance can result in delays for approval and market entry.
This guide covers the regulatory framework, registration process, documentation and compliance requirements for the successful registration of health supplements in Colombia.
Regulatory Authority for Health Supplements in Colombia
INVIMA is the regulatory authority for health supplements in Colombia and carries out sanitary registration, compliance, market authorisation and post-market surveillance.
Regulations Governing Health Supplements in Colombia
Health supplements are mainly governed by Decree 3249 of 2006, amended by Decree 3863 of 2008.
What Are Health Supplements Under Colombian Regulations?
According to Colombian legislation, health supplements are processed food products designed to be used with the regular diet. They include:
- Vitamins
- Minerals
- Amino acids
- Or other nutrients
- and/or botanicals with nutritional or physiological properties.
These should be sold as capsules, tablets, powders, sachets, softgels, ampoules, drops, or liquids. They also cannot claim to diagnose, treat, cure, or prevent disease. These supplements need to comply with Decree 3249 of 2006 before commercialisation.
Compliance Checklist for Health Supplement Approval in Colombia
When applying to INVIMA, make sure you:
- Correctly classify the product as a health supplement.
- Check all ingredients for acceptability.
- Get a valid GMP certificate for the manufacturing facility.
- Create an extensive technical report.
- Make sure the label meets INVIMA specifications and is in Spanish.
- Only use approved health claims.
- Designate a Colombian registration holder or legal representative as necessary.
- Get Sanitary Registration when importing or marketing the product.
Health Supplements Registration Process in Colombia
In Colombia, the registration process follows the step-by-step process outlined below.
Step 1: Determine the Registration Modality
Register the product as Manufacture and Sell or Import and Sell.
Step 2: Check the Classification and Formulation of the Product
Verify that the product is a health supplement and that the ingredients, dosage form, additives and claims are in accordance with the Colombian requirements.
Step 3: Prepare the Registration Dossier
Prepare administrative and technical files such as the application form, formulation, manufacturing information, GMP evidence, labels, and supporting certificates.
Step 4: Apply and Pay the Appropriate Fee
Send the application to INVIMA with the corresponding documentation and payment of the fee.
Step 5: Technical Review by INVIMA
INVIMA validates formulation, labelling, claims, and supporting documents. When deficiencies are detected, more information will be required.
Step 6: Get the Sanitary Registration
INVIMA grants the Registro Sanitario after approval, allowing the product to be manufactured, imported, and commercialised within the approved registration modality.
Documents Required for Health Supplements Registration in Colombia
For locally manufactured or imported products, the requirements differ. Generally, applicants must submit:
- Completed sanitary registration application form.
- Formulation (qualitative and quantitative composition of the product).
- Specifications and manufacturing processes of the product.
- Valid GMP certificate.
- Free Sale Certificate or equivalent (for imported products).
- Create a Spanish label that meets INVIMA standards.
- Legal representation and certificate of incorporation.
- Power of attorney, if applicable.
- Proof of payment of the registration fee.
INVIMA Labelling Requirements for Health Supplements in Colombia
Labels should be compliant with Decree 3249 of 2006 and should be included in the registration dossier and should be in the Spanish language. They must include:
- Product name.
- Ingredient list.
- Net contents.
- Recommended daily serving and directions for use.
- Nutritional information (where applicable).
- Details of manufacturer and/or importer.
- Country of origin (when the product is imported).
- Batch/lot number.
- Manufacturing and expiry dates.
- Storage conditions.
- Where applicable, a mandatory warning such as “Not a medicine, will not cure a balanced diet”.
Labels cannot contain a statement that suggests the product is a diagnosis, treatment, cure or prevention of disease.
Also Read: Nutraceutical Regulations and Registration in Colombia (INVIMA)
INVIMA Licensing Requirements for Health Supplements in Colombia
Businesses must:
- Get a Sanitary Registration prior to commercialisation.
- Appoint a Colombian registration holder or importer for imported products.
- Manufacture locally from an INVIMA-approved facility.
- Notify or obtain approval for changes in formulation, manufacturer, labelling or a change in registration holder, where applicable.
GMP Requirements for Health Supplements in Colombia
To guarantee that the product is of good quality and safe to use, the manufacturers are required to follow the Good Manufacturing Practices (GMP). INVIMA requires GMP evidence during registration.
For imported products, the usual requirements are:
- A valid GMP certificate from the competent authority of the country of manufacture.
- Supporting GMP documentation.
- Apostilled/legalised GMP certificate in Spanish (if applicable).
Health Claims and Advertising Regulations in Colombia
The advertising and health claims fall under the scope of Decree 3249 of 2006, Decree 3863 of 2008 and Decree 272 of 2009. Advertising must be registered with INVIMA.
Requirements include:
- Claims in keeping with the approved composition and purpose.
- No false, misleading or exaggerated statements.
- No claims for disease prevention, treatment or rehabilitation.
- No reference to the product as a medicine.
- Promotional claims in line with the approved Sanitary Registration.
Also Read: Pharmaceutical Regulations and Registration in Colombia (INVIMA)
Import Regulations for Health Supplements in Colombia
Health supplements must be imported and sold with a valid INVIMA Sanitary Registration. Applicants must also:
- Submit a Free Sale Certificate from the country of origin.
- Include manufacturer authorisation for the importer or registered person in Colombia.
- Regulate the import of products that are identical to the approved formulation, manufacturer, packaging and labelling.
- Fill in VUCE import procedures as appropriate.
- Provide documents in Spanish or with official translations as appropriate.
Health Supplement Registration Timelines in Colombia
INVIMA does not have a statutory review period, but applications that have been well-prepared are usually processed within 15 business days. Clarifications required for applications may take up to 1–3 months or more.
Timelines depend on:
- Dossier completeness.
- Classification and formulation of products.
- Label compliance.
- Time taken for INVIMA observations.
- Translation and legalisation of supporting documents.
Health Supplement Registration Costs in Colombia
Official fees imposed by INVIMA for registration, renewal and variation of a product depend on the dosage form, as described in its Manual Tarifario.
Applicants are required to have some additional funds available for the following:
- Translation and legalisation of foreign documents.
- Registration holder/representative fees.
- Label adaptation.
- Fees for renewal and variation post-approval.
Conclusion
To market a health supplement in Colombia, compliance with INVIMA is required for its classification, sanitary registration, labelling, GMP, and importation. A full and compliant submission streamlines the regulatory process and provides a faster pathway to market.
Artixio offers end-to-end regulatory support, from classification and dossier preparation to INVIMA registration in Colombia, labelling review and lifecycle compliance. To know more, get in touch with us today at info@artixio.com.
FAQs
1. How long is a health supplement registration valid?
There’s a 10-year sanitary registration, which is usually renewable.
2. Is it possible for a foreign manufacturer to apply to INVIMA?
Yes. Foreign manufacturers normally use a Colombian registration holder or a local representative to take care of their regulatory obligations.
3. Is a Free Sale Certificate required?
Yes. Imported health supplements normally need a Free Sale Certificate from the competent authority of the country of origin, along with apostille and/or legalisation, and a Spanish translation, if necessary.
