Our Registration Department prepares all the necessary technical documentation and the “Dossiers” to obtain the sanitary registration of each product for any given country.

The required information to apply for the sanitary registration varies for each country.

Some of the documents that could be necessary include:

  1. Free sale certificate: declare quail-quantitative formulation, duly legalized.
  2. GMP or Good Manufacturing Practices: issued by the official sanitary authority, duly legalized in case of imported products.
  3. Dossier:
  • Proposed name.
  • Layout of text of packaging materials.
  • Quali-quantitative formulation, to corroborate and support the use of extra active ingredients added to the formula.
  • Monograph of the product.
  • Packaging material specifications.
  • Manufacturing: procedure description in detail, Master formula, Manufacturing Order (of an industrial batch, with corresponding signatures verifying the quantities weighed), in-process controls.
  • Analytical procedure for the active ingredients and the finished product: specifications, physicochemical characteristics, identification and assay of the active ingredient in the finished product. 
  • Type of package (bulk, for sale).

This is some of the necessary documentation for product registration and it will differ from country to country.