A sanitary registration is an inscription that is placed on the label of the product for its commercialization.
It is useful for the identification of the type of product, as well as to guarantee its legal commercialization and that its manufacture complies with all the legal requirements of quality, hygiene, safety, sterility, among others, according to the type of product.
Each sanitary registration must have been granted by the Ministry of Health of Guatemala through the Regulation and Food Control Department. This entity bases the requirements and procedure on the Central American Technical Regulation (RTCA) 67.01.31:07, PROCESSED FOOD. PROCEDURE FOR GRANTING SANITARY REGISTRATION AND INSCRIPTION.
The following are the 5 STEPS TO OBTAIN THE FOODS SANITARY REGISTRATION in Guatemala:
- Fill out the Application Form provided by the Ministry of Health with all the data indicated and attach to the file of the product for its entry, being these the following:
- Information of the Holder and its Legal Representative.
- Information of the Manufacturer, and of its Sanitary License, if applicable.Information of the Warehouse or Distributor in Guatemala, as well as its Legal Representative.
- Details of the Product, including Name, Brand, Description, and Classification.
- Original labels or their drafts.
- Copy of the Sanitary License of the warehouse or distributor in Guatemala, authorized by the Ministry of Health.
- Apostilled Certificate of Free Sale (CLV). In case of products manufactured abroad.
- Samples of the product.
- Cancel the rights of analysis and registration fees, completing the forms provided by the entity. The corresponding payment must be made at an Authorized Bank.
- The interested party must submit to the Ministry of Health the dossier with the complete requirements together with the form so that it can verify compliance with the requirements.
- In case the product requires quality analysis, the file is transferred to the National Health Laboratory so that it can proceed with it, the previous presentation of the required samples.
- When the documentation is approved, the authority will notify the interested party and issue the Sanitary Registration Certificate, which is valid for 5 years, renewable for other equal periods prior to its expiration.
In case there are modifications after the registration has been granted (for example, change of manufacturer, change of distributor, change of product name, change of description, change of brand, change of country, change of label artwork, change of address, or others) it will be necessary to notify the competent authorities and submit the corresponding documentation as appropriate.
