Paraguay Opens Consultation on Draft Regulation for Infant and Follow-Up Formula Registration

The National Direction for Sanitary Surveillance (DINAVISA) has launched a public consultation on a draft regulation for the registration of infant and follow-up formula. The proposal outlines the required documentation for obtaining sanitary registration, including but not limited to:

• GMP Certification of the establishment and the finished product

• Quali-quantitative formula, presentation form, indications of use

• Documentation supporting nutrition and health claims, if applicable

• Label

• Certificate of analysis of the finished product

• Stability studies when the shelf-life is greater than 2 years or if requested by the sanitary authority

• Free sales certificate

DINAVISA aims to complete the evaluation within 60 working days. However, this timeline may be paused if additional technical or documentary information is requested by the authority. 

The draft regulation also provides the labelling requirements and restrictions for the distribution of infant formula. This product category would only be allowed to be marketed in pharmacies, while follow-up formulas would have no restrictions.