ESTUDIO DELION - Since 1984 Prestige - Experience - Success
REGULATORY AFFAIRS IN PERU - DIGESA
Peruvian Regulatory Affairs - Health registration of food products and industrialized beverages is handled by the General Direction of Environmental Health - DIGESA
Regulatory affairs in Peru are regulated by the Ministry of Health and its two entities: the General Direction of Environmental Health DIGESA and the General Direction of Medicines and Drugs- DIGEMID.
The owner of any food products and industrialized beverages can get the right to manufacture, trade, or import these types of products; they must apply for the Health Registration in Peru for these products before the General Direction of Environmental Health DIGESA.
Estudio Delion includes within its staff professionals specialized in Pharmaceutical Chemistry, who work together with the firm’s lawyers, and provide personalized consultancy using Work meetings and Feasibility Studies that allow us to understand the necessities of each particular case referring to Health Registration. This policy saves time and money because it decreases transaction costs and facilitates the taking of correct decisions in a shorter time.
- Peruvian Regulatory affairs – Health Registration for Foodstuffs.
- Integral Consultancy.
Peruvian Regulatory Affairs Requirements for Food products
- Request in the form of Affidavit directed to the General Director of DIGESA. This request must be duly signed by the Legal Representative and include the components of the product, packaging materials, preserving conditions, lifespan, batch coding system), as well as the Distributor and Manufacturer’s data.
- Physical, chemical and microbiological analysis of the end product, confirming it is fit in accordance with the health regulations in force, granted by a laboratory authorized by INDECOPI or by the Manufacturer’s quality control laboratory.
- Certificate of Free Sale or the like or Health Certificate issued by the competent authority of the country of origin, in original or copy duly legalized by the Peruvian Consulate in case the food or beverage was imported.
- Label of the products labelled.
- The Food and Beverages of special regimens, shall mention their nutritional properties enclosing the respective bromatological analysis performed by a laboratory authorized by INDECOPI.
- Affidavit stating the applicant is a micro or small business (MYPE), if this the case.
- Validation Certificate of natural resource and product, for its use in health, granted by the Intercultural Health Centre-CENSI.