Traditional Medicines and OTC Products
The ins and outs of the legal requirements for traditional medicines and OTC medicines in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Storage, Commercialization, importation, distribution require, with the exception of alternative medicine, a Sanitary Registration for each product.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
They can be advertised as long as they don’t require a prescription, provided they comply with local regulation which implies including the dosage and main warning of precautions consigned in the Sanitary Authorization.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Health, advertising and marketing claims must match the Sanitary Authorization for the product. Furthermore, the doses, and main warnings and precautions of the products must always be mentioned. In the case of herbal products, the general information of the medicinal herpes included in the composition must be included.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Over the counter medications require a Sanitary Authorization for their Storage, Commercialization, importation and/or distribution.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Over the Counter products may only be sold in establishments with the proper licenses, including Sanitary Authorization for commercialization of pharmaceutical products.
6. What health, advertising, and marketing claims may be made for OTC products?
Health, advertising and marketing claims must match the Sanitary Registration for the product. Furthermore, the doses, and main warnings and precautions of the products must always be mentioned.
7. Can OTC products be marketed or advertised directly to the public?
Over the counter products can be commercialized and advertised directly to the public
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
A prescription medicine can be converted to an Over the Counter product provided that, in addition to meeting the criteria for being sold without a prescription it fulfils the following requirements:
- Show a favorable safety and efficacy index with drug monitoring data.
- Not shown an increase in adverse results in the period of commercialization.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Importation of medicines must comply with the following requirements:
- Resolution that authorizes the Sanitary Registration or the Certificate of Sanitary Registration.
- Shipment Identification per fabrication batch.
- For products derived from human plasma, a Certificate certifying HIV and Hepatitis B, C negativity.
- For biological products derived from bovine, sheep and goat, a Certificate certifying bovine spongiform encephalopathy negativity.