Legal & Regulatory > Nicaragua > Traditional Medicines and OTC Products

An insight into traditional medicines and OTC products in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

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

Find attach a document with drugs Requirements.
Find attachment document with Device Requirements.

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

Traditional, herbal, complementary, or alternative products can be sold directly to the public or through pharmacies or grocery stores.

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

According to the LAW OF DEFENSE OF CONSUMERS. LAW No. 182, consumers are protected in the following articles:

Article 12.– Consumers have the right to:

1. Protection of their health and safety in the consumption of goods and services;
2. Education for consumption;
3. A truthful, timely, clear and adequate information on the goods and services available in the market;
4. Equitable and non-abusive treatment by the suppliers of goods and services;
5. A comprehensive, timely and adequate compensation for the damages suffered and which are the responsibility of the supplier;
6. Require compliance with promotions and offers when the provider does not comply;
7. Associate and form consumer groups;
8. Access the corresponding administrative or judicial bodies for the protection of their rights and legitimate interests;
9. The preservation of an adequate environment that guarantees the conservation and development of natural resources;
10. Claiming to the institutions of the State about negligence for the public services provided and that have caused direct harm to the consumer;
11. Be protected in relation to their life, safety and property, when they make use of land, water and air transport services, all in charge of the providers of these services, who must compensate them when they are affected.

Chapter IV. Information and Publicity – Article 13.– Every supplier of goods will provide the consumer with clear, truthful and sufficient information at least on the following characteristics:

1. Composition, purpose and additives used;
2. Quantity of products;
3. Date of production and expiration of the product;
4. Instructions and indication for its use;
5. Warning, risks and incompatibilities with other products.

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

Same requirements detailed in the Central American Technical Regulations.

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

No, these can be sold in authorized pharmacies, grocery stores.

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

According to the LAW OF DEFENSE OF CONSUMERS. LAW No. 182, consumers are protected in the following articles:

Article 12.– Consumers have the right to:

1. Protection of their health and safety in the consumption of goods and services;
2. Education for consumption;
3. A truthful, timely, clear and adequate information on the goods and services available in the market;
4. Equitable and non-abusive treatment by the suppliers of goods and services;
5. A comprehensive, timely and adequate compensation for the damages suffered and which are the responsibility of the supplier;
6. Require compliance with promotions and offers when the provider does not comply;
7. Associate and form consumer groups;
8. Access the corresponding administrative or judicial bodies for the protection of their rights and legitimate interests;
9. The preservation of an adequate environment that guarantees the conservation and development of natural resources;
10. Claiming to the institutions of the State about negligence for the public services provided and that have caused direct harm to the consumer;
11. Be protected in relation to their life, safety and property, when they make use of land, water and air transport services, all in charge of the providers of these services, who must compensate them when they are affected.

Chapter IV. Information and Publicity – Article 13.– Every supplier of goods will provide the consumer with clear, truthful and sufficient information at least on the following characteristics:

1. Composition, purpose and additives used;
2. Quantity of products;
3. Date of production and expiration of the product;
4. Instructions and indication for its use;
5. Warning, risks and incompatibilities with other products.

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

OTC products can be sold directly to the public or through pharmacies or grocery stores.

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

Does not exist

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

The product must have the health registration number.