Legal & Regulatory > Uruguay > Traditional Medicines and OTC Products

The key facts about traditional medicines and OTC products in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Regarding medicines and devices please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview.

Decrees 403/016 and 404/016 state that any company undertaking operations with herbal medicines, vegetable drugs, vegetable raw materials with pharmacological activity, vegetable products, phytotherapic medicines and homeopathic medicines must do so in establishments authorized to such ends and with a valid authorization of the MSP, which shall comply with the “Good Manufacturing and Control Practices” and the “Good Practices on Storage, Distribution and Transport”.

In order to register herbal medicines, vegetable drugs, vegetable raw materials with pharmacological activity, vegetable products and phytotherapic medicines the same requirements detailed for drugs apply (Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview.)

In the case of homeopathies (Decree 404/016), besides what is foreseen for drugs (Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview) the following must also be submitted:

1. analysis of intermediate products;
2. complete analysis of all raw materials;
3. microbiological analysis of the final product;
4. master formula;
5. manufacturing order;
6. stability study (organoleptic, pharmacotechnical and microbiological characteristics).

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Rules related to medicines advertising apply to these types of products (Decrees 403/016 and 404/016). In this context, please refer to Question 17 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Rules related to medicines advertising apply to these types of products (Decrees 403/016 and 404/016). In this context, please refer to Question 19 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Regulatory requirements for over-the-counter (non-prescription) medications are the ones described for general drugs in the Regulatory, Pricing, and Reimbursement Overview. Advertising of over-the-counter products is allowed, as referred to Question 17 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

5. Are there any limitations on locations or channels through which OTC products may be sold?

Please refer to Question 17 and 18 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

6. What health, advertising, and marketing claims may be made for OTC products?

Please refer to Question 19 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

7. Can OTC products be marketed or advertised directly to the public?

Yes. Please refer to Question 17 and 19 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

There is no legal mechanism. Depending on the change of the registered product (e.g. formula, indications, adverse effects, etc.) a new registration or an amendment to the already existing registration must be requested.

9. What are the requirements for the importation of either traditional medicines or OTC products?

Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview.