Traditional Medicines and OTC Products
Need info on traditional medicine and OTC products in Ecuador? Read on! Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional, complementary or alternative medicines are governed by the General Health Law (HL) and its regulations.
These medicines are known as natural, whose active ingredients are formed by any part of natural medicinal resources or combinations thereof, such as a crude drug, extracts or a recognized pharmaceutical form, used for therapeutic purposes.
These will not be considered a processed natural product for medicinal use if the natural resource for medicinal use is combined with chemical active substances, including constituents of natural resources, isolated and chemically defined.
These medications will not be injectable; their use will only be oral or topical.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Advertising is possible with prior authorization from the General Health Directorate. Advertising can be through any means.
It is not possible to advertise medicines that require a prescription.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
The advertising of traditional, herbal, complementary, or alternative products directed at the general public should include the therapeutic indications or uses of the medicine and must be in accordance with the marketing authorization certificate. The information contained in the advertising material cannot
induce a false, erroneous and/or confusing interpretation of the product. It must be clear and in an understandable language.
The product should include the following phrases: “medicinal product, keep out of the reach of children” and “in case of adverse effects, immediately contact ARCSA and the Holder of the Marketing Authorization”.
4. What are the regulatory requirements for over-thecounter (non-prescription) medications?
OTC medications must demonstrate efficacy and safety in relation to the prevention and relief of symptoms or signs of mild diseases of easy identification; that they have a wide range of safety, in such a way that the voluntary or involuntary administration of doses higher than those recommended does not
represent a serious danger to the patient’s health; that they have a wide range of dosage, which can be adapted to the age and weight of the patient; that their use does not generate tolerance or dependence and that they are not susceptible to abuse; that when used according to the instructions, they do not mask serious diseases or delay the diagnosis and treatment of a condition that requires medical attention; that their use is safe in all groups of the population; that the dosage forms are generally oral or topical and not injectable; that the active ingredient has been marketed under medical prescription for at least ten (10) years, demonstrating a favorable safety and efficacy index documented with drug monitoring data; that reports of adverse reactions have not increased during the period in which the medication has been in use.
5. Are there any limitations on locations or channels through which OTC products may be sold?
OTC is defined as an oral or topical medication that, due to its composition and the pharmacological action of its active ingredients is authorized to be sold or dispensed without prescription.
6. What health, advertising, and marketing claims may be made for OTC products?
The HL states that all medicines including OTC products must be commercialized in legally authorized establishments, which hold the mandatory permits.
7. Can OTC products be marketed or advertised directly to the public?
The advertising of OTC products directed at the general public should include the therapeutic indications or uses of the medicine and must be in accordance with the marketing authorization certificate. The information contained in the advertising must be in a clear and understandable language.
The phrase “If the symptoms persist, consult your doctor” should be included on the product.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
The Directorate General of Health will authorize the advertising of OTC products classified in the marketing authorization. Once such authorization is issued the product can be freely advertised in accordance with the terms of the issued authorization.
9. What are the requirements for the importation of either traditional medicines or OTC products?
There is no process expressly established to convert a product sold only by prescription into an OTC product. However, the holder of the marketing authorization may submit a written request to ARCSA to request the reclassification. ARCSA will determine the reclassification process, in accordance with the criteria mentioned at point number 4.
The HL establishes that marketing authorizations for medicines in general must be obtained from ARCSA prior to importation.