By: Laura Portillo
What is a sanitary registration of a product?
Sanitary registration is the process by which a product undergoes documentary evaluation and analysis before the competent health authority of a country, which will allow the product to be marketed in the country of manufacture or a foreign country for human or animal consumption.
The products that require sanitary registration for their commercialization are:
o Food
o Beverages
o Medicines
o Natural products
o Medical devices
o Cosmetics
o Hygienic products
o Animal food and medicines
In El Salvador the entities in charge of registering products for human and animal consumption are:
o National Directorate of Medicines (DNM)
o Ministry of Health (MINSAL)
o Ministry of Agriculture and Livestock
In the case of pharmaceutical products, Chapter II, Art. 13 Concepts and Definitions of the Law of Medicines in El Salvador mentions that a sanitary registration is the technical legal process that ensures that the medicine to be marketed complies with the quality, efficacy and safety requirements, which culminates with the obtaining of a sanitary certification for commercialization, which is issued by the competent authority.
Having a sanitary registration allows the Health Authorities to protect health, control products, protect consumers and comply with the quality standards established by the regulations of each country.