Traditional Medicines and OTC Products
The environment surrounding traditional and OTC products in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Herbal and vegetable medicines are regulated by ANMAT. They are defined as medicine that contains as an active ingredient one or more plant medicines, or one or more preparations of plant medicines, or one or more plant medicines in combination with one or more preparations of plant medicines.
All activities related to the preparation and commercialization of these medicines may only be carried out with the prior authorization of the ANMAT, in facilities duly authorized, under the technical direction of a pharmaceutical professional.
Herbal medicines and herbal medicines of traditional use may not contain synthetic or natural isolated active substances in their composition. Products containing synthetic or natural isolated active substances will be considered as medicinal specialties.
The labeling of herbal medicines and herbal medicines of traditional use may not indicate uses or applications other than those authorized.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Herbal and vegetable medicines advertisement and marketing is regulated under ANMAT Regulation No. 4,980/05. Please see answer to Question 20 of Marketing, Manufacturing, Packaging & Labeling, Advertising.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
The advertising of herbal and vegetable medicines addressed to the general public may present the product’s objectively demonstrated properties without deception or misleading, providing accurate, precise and clear information according to its use and dosage in accordance with the scientific information approved by ANMAT. The promotion must be based on the characteristics of the product and its proven characteristics for the conditions recognized in the indications authorized by ANMAT. In the event that the advertising makes reference to the dosage and posology of the product, it needs to comply with the provisions of the prospect. It is a condition for this promotion and advertisement to be carried out in Spanish, in accessible and understandable language.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Minimum regulatory requirements for over-the-counter (non-prescription) medicines:
- That the medicinal specialty has demonstrated efficacy and safety over time, to be used in the relief of symptoms or signs easily recognizable by the user.
- That has a wide therapeutic margin in such a way that the voluntary or involuntary administration of a dose higher than recommended or for an unapproved use, or the use for a longer time, does not represent a serious damage to the health of the population; nor that its use in accordance with approved uses masks serious diseases, nor delay the diagnosis and treatment of an underlying condition.
- That does not generate tolerance or dependency and that is not susceptible to abuse.
- That the administration way be exclusively oral or topical.
- That the duration of treatment is limited to the proposed indication (posology).
- That the units of sale or presentations that are requested for said medicinal specialties adjust to the time of treatment approved in their respective leaflet.
- That the medicinal specialty has been commercialized under the condition of sale under prescription in the country, at least during the last 5 years, without having presented reports of serious adverse events, through the pharmacovigilance system, that affect the benefit risk balance.
- That the medicinal specialty has a low risk of causing serious type A adverse reactions and a very low risk of causing serious type B adverse reactions in the general population.
- That does not possess genotoxic, carcinogenic or relevant reproductive toxicity properties.
- That it does not present interactions with commonly used medicinal specialties that could modify the therapeutic effect of them or generate serious adverse reactions.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Yes, the delivery and sale of drugs, medicines and pharmaceutical products to the public can only be carried out in duly licensed pharmacies.
6. What health, advertising, and marketing claims may be made for OTC products?
See answer to Question 46 above.
7. Can OTC products be marketed or advertised directly to the public?
Yes. See answer to Question 20 of Marketing, Manufacturing, Packaging & Labeling, Advertising.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
That the medicinal specialty has been commercialized under the condition of sale under prescription in the country, at least during the last 5 years, without having presented reports of serious adverse events, through the pharmacovigilance system, that affect the benefit risk balance. This mechanism is regulated under ANMAT Regulation No. 3,686/2011.
9. What are the requirements for the importation of either traditional medicines or OTC products?
To import a pharmaceutical product (traditional medicine or OTC products) it is necessary to obtain the marketing authorization with ANMAT. Once a company is licensed as a pharmaceutical company with ANMAT, it will be allowed to apply for the marketing authorization certificates for manufacturing or importing products for sale in the Argentine market.
However, there are some main exceptional regimes for non-registered drugs, for example, national health programs carried out by the MoH and the exceptional regime for access to non-registered drugs (“RAEM” after its acronym in Spanish, also known as “compassionate use regime”). The RAEM regime regulates the procedure by which non-registered drugs can be imported by patients, under an individual basis, when an identical, similar or alternative therapeutic product is not available in the country, and by duly justified medical reasons sufficient for ANMAT to approve such import for a limited period of time (e.g., 90-day treatment).