Traditional Medicines and OTC Products
Get the lowdown on traditional medicines and OTC products in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional medicines are ruled through Decree 2266/04 which establishes regulatory requirements for phytotherapeutics. These are some of their main requirements:
Pharmaceutical forms: tisanes or any accepted pharmaceutical forms except sterile pharmaceutical forms (injectable and ophthalmic).
The medicinal plants used for the production should be included in the Colombian Vademecum of Medicinal Plants. In the event of not being in the Colombian vademecum of medicinal plants, it will be in the Specialized Room of Natural Products or whoever takes charge of approving and including them.
Its claim of use is not related to the identification of one or more active ingredients, but to the qualitative definition of ingredients and markers.
It will not contain in its formulation substances with narcotic or psychotropic activity.
It will not combine the material of the medicinal plant with active substances isolated and chemically defined.
The active ingredients coming from material of the medicinal plant that has been processed and obtained in pure form, will not be classified as a traditional phytotherapeutic product.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes. If these medicines can be sold without prescription, they can be advertised directly to the public prior to authorization from INVIMA.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Advertising of homeopathic and phytotherapeutic medicines that do not need prescription follows the same rules as advertising of OTC medicines.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Regulatory requirements for OTC medications are the same as for prescription drugs, i.e. Decree 677/95.
5. Are there any limitations on locations or channels through which OTC products may be sold?
The distribution and sale of OTC medicines and OTC homeopathic medicines may be carried out in drug stores, homeopathic pharmacies, legally authorized drugstores that meet the conditions established for storage, chain stores and department stores.
6. What health, advertising, and marketing claims may be made for OTC products?
7. Can OTC products be marketed or advertised directly to the public?
Yes, prior to authorization from INVIMA. Please refer to Marketing, Manufacturing, Packaging & Labelling, Advertising: Colombia
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
The mechanism is applying for a change of the MA with respect the sales condition of the product. This change implies an evaluation from “Sala Especializada de medicamentos” which will issue a technical opinion about the availability of the change as requested.
Once this commission approves the switch from prescription only to OTC, then interested party can apply for the change of the sales condition enclosing the approval issued by Sala Especializada de Medicamentos.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Requirements for importing traditional medicines or OTC are the same as for prescription drugs. Each product must have its own marketing authorization.