Traditional Medicines and OTC Products
An intro to the legal situation for traditional products and OTC medicines in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
In Chile, Traditional Herbal Medicines shall be understood as those constituted by plants or parts of plants, fresh or dried, whole or crushed, packaged and labeled by hand and labeled with the commonly used name in the field of Chilean cultural traditions, which have been recognized in the respective technical rule approved by Supreme Decree of the Ministry. These medicines must:
- Be in a list contained in a technical rule approved by Supreme Decree of the Ministry, issued in use of their legal technical regulatory powers, which will indicate the denomination, therapeutic properties and uses of each of them, should be used as auxiliaries symptomatic.
- Be hand-packed as isolated plant species, not mixed.
- Include in their labels only those properties recognized in the aforementioned decree.
Resolution N° 548/2009 issued by the Ministry of Health approved the list of Traditional Herbal Medicines allowed in the country and their medical properties.
Our regulation does not include a definition for complementary or alternative medicines/devices; however, any product claiming a therapeutic property shall be considered a pharmaceutical product and therefore, it must be subject to regulation regarding pharmaceutical products.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Traditional herbal medicines are considered pharmaceutical products as per article 7 of S.D. No. 3/2010; therefore, they are subject to regulation regarding pharmaceutical products. See Chapter 3 – question 20.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
For Traditional Herbal Medicines, it is only possible to display those properties and traditional uses as recognized by Resolution N° 548/2009.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The regulatory requirements for the registration of OTC products are the same that apply for prescription products (See Chapter 1 – question 3B), with the following considerations:
- If they are well known products, they can be registered under simplified procedure (no safety and efficacy studies are required);
- The advertising of OTC medicines is allowed but it must be previously approved by the ISP;
- The sale of OTC products can be performed on shelves, dispensers or other similar devices, which can be used solely for the exhibition and sale of OTC products in a pharmacy having a previous approval from ISP to said purpose.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Please refer to Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising, question 18.
6. What health, advertising, and marketing claims may be made for OTC products?
All claims must be in accordance with the approved registration information (indication, mode of use, etc.) and marketing claims and advertising must be previously approved by ISP.
7. Can OTC products be marketed or advertised directly to the public?
Yes. Please refer to Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising, question 20.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
To switch the sale condition of a pharmaceutical product from “under prescription” to “OTC”, the Ministry of Health issued Resolution No. 1133 of July 2001 (and its modification, Resolution No. 779 of November 2005), approving the Technical Rule No. 58, which establishes the criteria for OTC switch.
The criteria to perform this change correspond to safety criteria (wide therapeutic margin, use of at least 10 years in the country, no severe side effects, among others), criteria that allow determining the condition of direct sale (use to prevent symptoms of easy recognition, not to be used parenterally) and criteria for the information of the user (information to the patient must be complete, there may be specific requirements for its labeling, etc.).
9. What are the requirements for the importation of either traditional medicines or OTC products?
Same as for prescription products, that is, they must have a sanitary registration approved by ISP in order to be imported into the national territory.