Traditional Medicines and OTC Products
Bolivian regulation regarding traditional medicines and OTC products. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Products must contain vegetal, mineral or animal components in order for them to be classified as “traditional, herbal, complementary or alternative medicines”.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, they can with previous authorization of the authority.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Regulations state that these affirmations must be exact, true, informative, updated, and be able to be proven. Words like “better”, “more potent”, “has no side effects”, “security” and “harmless” cannot be used.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
In order to be over the counter drugs, they must be included in the list provided by local authorities.
5. Are there any limitations on locations or channels through which OTC products may be sold?
There are no specific limitations, the law states that products must be sold by pharmacies, popular pharmacies and drugstores.
6. What health, advertising, and marketing claims may be made for OTC products?
If patients have adverse effects at any time, they can notify either the company or local health institutions.
7. Can OTC products be marketed or advertised directly to the public?
Medicines can be sold in pharmacies, drugstores, popular pharmacies, etc. In respect to advertising they can be promoted through TV, radio, press, public spaces etc but need previous analysis and authorization of authorities
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
One of the attributions of the Pharmacologic Commission is to counsel in the elaboration and revision of the list of medical products that are sold over the counter and products that need prescriptions. Therefore, this commission is the one authorized to make any eliminations or inclusion in the lists.
9. What are the requirements for the importation of either traditional medicines or OTC products?
In order to import any kind of medical products, the companies must be registered before the Health Agency (AGEMED), complying with all information and documents from the manufacturer. In these documents. information such as products, validity, and legal representation must be included.
Documents such as the ones listed below must also be presented:
- Health Authorization Certificate
- Quality Control Certificate issued by manufacture for each lot/batch to be imported.
- Copy of power of attorney.
- Origin invoice that includes lot and expiration dates
- Certificate issued by the health institution in the country of origin