Biobank Product Sales and Use Policy
- Purpose and Scope
This Product Sales Policy (“the Policy”) regulates the conditions under which ACB makes available, in the Biobank section of its website, information regarding biological and biochemical products (including, but not limited to, peptides, mesenchymal stem cells -MSCs-, and human-derived exosomes) intended exclusively for duly qualified health professionals. Accessing, consulting, or requesting information through this site implies full acceptance of this Policy by the user.
- Nature and Classification of Products
2.1. The products referenced in the Biobank section (peptides, MSCs, and exosomes) correspond to biological and biochemical material for technical, professional, and research use.
2.2. To date, these products do not have a health registration issued by INVIMA, nor an approved therapeutic indication by the Colombian health authority. Consequently:
- They are not medications.
- They are not registered medical devices.
- They are not approved for the diagnosis, prevention, treatment, mitigation, or cure of any disease.
The information published on the site does not constitute a medical recommendation, prescription, therapeutic indication, or an invitation for direct clinical use by ACB.
2.3. ACB warns that the regulatory framework applicable to biological and biochemical products in Colombia is currently under development and may vary. ACB monitors regulatory changes and will adjust this Policy and its operations when required.
- Authorized Recipients: Exclusive Sale to Health Professionals
3.1. ACB does not sell directly to patients, consumers, or end users. The commercialization of the products referenced in the Biobank section is directed exclusively and strictly to:
Physicians and health professionals legally qualified to practice in their jurisdiction.
Health Service Provider Institutions (IPS), clinics, laboratories, and research centers.
Legal entities that demonstrate a technical, professional, or research purpose.
3.2. By the mere act of requesting information or placing an order, every buyer declares that:
(i) they hold the professional or institutional status required in section 3.1;
(ii) they acquire the product under their full professional responsibility; and
(iii) the declared purpose corresponds to professional use, clinical use under their own medical judgment, or research, and not to a resale to an end consumer under the protection of ACB.
3.3. ACB may require supporting documentation (professional license, RUT, institutional registration) prior to the dispatch of any product, and may refrain from processing any operation when, at its discretion, there is a risk of unauthorized use or non-compliance with the conditions declared herein.
- Medical Professional Responsibility — ACB Disclaimer
4.1. The definition of the procedure, clinical indication, dosage, route of administration, and, in general, any protocol in which the health professional decides to use the products supplied by ACB, is the exclusive responsibility of said professional, who acts under their own judgment, lex artis, and legal, ethical, and civil responsibility.
4.2. ACB acts solely as a supplier of biological/biochemical material to a professional buyer. ACB does not intervene in, supervise, authorize, or take responsibility for the procedures, applications, or treatments that the health professional develops with the acquired product, nor for the results, adverse effects, or consequences derived from its clinical use in the final patient.
4.3. Consequently, ACB shall not be liable, under any circumstances, for:
- Clinical decisions, protocols, or indications adopted by the purchasing professional.
- Use of the product outside the conditions declared in section 3.2.
- Resale, distribution, or supply of the product by the purchasing professional to third parties or patients without the proper doctor-patient relationship and informed consent provided by said professional.
- Non-compliance by the buyer with the health, sectoral, or ethical regulations applicable in their jurisdiction.
4.4. The purchasing professional is solely responsible for obtaining informed consent from the patient, informing them of the product’s non-registered status with INVIMA where applicable, and complying with any applicable reporting, pharmacovigilance, or technovigilance obligations.
- Traceability and Quality
ACB provides, along with each product, the corresponding quality documentation (control certificates, characterization, and/or sterility certificates, depending on the type of product), without this constituting regulatory approval or therapeutic indication.
- Reservation of Rights
ACB reserves the right to modify, update, or discontinue the availability of the referenced products at any time, as well as to reject requests that do not meet the conditions of this Policy, without this generating any liability on its part.
- Validity and Modifications
This Policy may be updated by ACB at any time to reflect regulatory or operational changes. The current version is the one published on this site at the time of consultation.
