Traditional Medicines and OTC Products
Hoet Pelaez Castillo & Duque / Venezuela
Traditional medicines and OTC products in Venezuelan Pharma – a comprehensive legal overview. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
The Constitution of Venezuela recognizes the practice of traditional medicine in indigenous peoples and communities. Alternative medicine is not regulated.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
The promotion and publicity of the traditional and alternative medicine must be carried out in accordance with the standards established by the Pharmaceutical Products Review Board.
The promotion must be compatible with the National Health Policy and adjusted to the ethical criteria for the promotion of medicines, which include: offering truthful information, avoiding any type of deception or exaggeration; be carried out within the ethical-sanitary criteria; and induce the rational use of the product.
4. What are the regulatory requirements for over-the- counter (non-prescription) medications?
The Ministry of Popular Power for Health (MPPS) is the governing body of the health sector in Venezuela, is responsible for the regulation, formulation, design, evaluation, control and monitoring of health, social development and health policies, programs and plans; Applicable to OTC products.
5. Are there any limitations on locations or channels through which OTC products may be sold?
The Autonomous Health Comptroller Service, attached to the Ministry of Popular Power for Health, establishes the requirements for obtaining health perisology; as well as the minimum sanitary conditions necessary for the distribution or commercialization of OTC products with therapeutic activity; These requirements are established in Administrative Providence No. 236- 2016 of the aforementioned Autonomous Service.
6. What health, advertising, and marketing claims may be made for OTC products?
The promotion and publicity of OTC Drugs should be carried out in accordance with the standards established by the Pharmaceutical Products Review Board. The promotion must be compatible with the National Health Policy and adjusted to the following ethical criteria for the promotion of medicines: Offer truthful information, avoiding any type of deception or exaggeration; Be carried out within the ethical-sanitary criteria; and induce the rational use of the product.
7. Can OTC products be marketed or advertised directly to the public?
Yes, as long as they comply with the standards established by the Pharmaceutical Products Review Board.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
The prescription of OTC products must be carried out in a mandatory manner, indicating their concentration, pharmaceutical form, route of administration and dose per dosage unit, using prescriptions or medical recipes, as established in the Official Gazette of the Bolivarian Republic of Venezuela N °. 40,131 dated 03/19/2013.
9. What are the requirements for the importation of either traditional medicines or OTC products?
N/A.
