Requirements:

ADMINISTRATIVE - LEGAL INFORMATION: (MODULE I)

• Manufacturing license

• Certificates of good manufacturing practice for raw materials and finished products or equivalent

• Free sales certificate or equivalent

• Authorization or representation letter

• Certificate of raw materials analysis

• ​Pharmacology background in other countries

QUALITY INFORMATION

• Drug formulation

• Quality controls

• Specifications

• Analytical methods and validations

• Analysis certification

• Information on additives

• Description of the manufacturing process (flow, process and controls)

• Cover pages, manufacturing and conditioning orders for stability lots

• ​Stability studies as per the Mexican regulation

BIBLIOGRAPHY (MODULE III)

Recent scientific, medical and technical bibliography to justify safety and efficiency; must be specific in:

​

a) The pharmaceutical form

b) Therapeutic indication

c) Group, ages to which the product is directed

​d) Dose justification or clinical - preclinical studies

PRE-CLINICAL - CLINICAL STUDIES: (MODULE IV & V)