When is a GMP inspection from ANMAT necessary?
For drug product manufacturing sites, when they are not located in an Annex I country, and are not already certified by an Annex I country. (for a list of Annex I countries, see this page) The GMP requirement is drug product-specific, meaning that the product of interest must be stated in the certificate for it to be accepted.
Agreement among MERCOSUR countries: when a drug product is manufactured in a country member of the MERCOSUR, other MERCOSUR countries may publish and officially recognize as own GMP certificates issued by the manufacturer country. By experience, I can assert that this happens in many cases between Argentina and Brazil.
MERCOSUR countries: Argentina, Brazil, Paraguay, Uruguay, Venezuela, Bolivia (in process of becoming a full member).
Application for inspection by ANMAT: required documents
- Written request
- Copy of ANMAT authorization to requestor
- Information on manufacturer/s
- Site Master File
- Site authorization from Health Authority in country in which it is located
- List of pharmaceutical forms manufactured in site
- List of drug substances manipulated in site
- List of pharmaceutical forms by drug substances to import
- Information and documents on third parties involved in manufacturing or control
- Fee
Last update: October 2013
Regulatory Affairs in Latin America 