Snapshot

The Procedure for the recognition of sanitary registration of medicines. pathway has been developed by the Ministerio de Salud Pública y Asistencia Social (MSPAS) of Guatemala.

This pathway can be used where all therapeutic products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Argentina Australia Brazil Canada Chile Colombia Cuba EU-EMA Japan Mexico Switzerland United States

Applicants must submit the files for the Department and for the National Health Laboratory in blue folder, with the requirements and documents established the reference guidance. Once the application and other requirements have been submitted, the documents will be evaluated, for which the Department and the National Health Laboratory will have (20) working days for their evaluation. If observations are found in the professional evaluation process, the interested party will be notified only once, through the Food and Drug Services Window. If the professional evaluation is favorable, the Department of Regulation and Control of Pharmaceutical and Related Products, within thirty (30) working days from the date of receipt of the application and other requirements indicated, will assign the Sanitary Registration number and the respective Certification will be issued.