HEALTH AUTHORISATION COMMISSION

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EXECUTIVE DIRECTORATE OF AUTHORIZATION OF PRODUCTS AND
ESTABLISHMENTS

INDEX OF DOCUMENTATION FOR ADMISSION OF APPLICATION FOZR

RECOGNITION OF ORPHAN MEDICINAL PRODUCT

Assigned Color: Orange

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DOCUMENTATION / INFORMATION BE FIND

MODULE I. ADMINISTRATIVE AND LEGAL INFORMATION

1.1 Sanitary License
1.2 Warehouse Site Operation Notice
1.3 Notice of Operation of the Distribution Site
1.4 Notice from health officer
1.5 Labeling projects (label)
1.6 Instructions (if applicable)
1.7 Arts of the country of origin
1.8 Insert of origin country
1.9 Information to prescribe in its broad version
1.10 Information to prescribe in its reduced version
1.11 Certificate of good manufacturing practice of the establishment(s) manufacturer(s) of
the drug(s)
1.12 Certificate of good manufacturing practice of the establishment(s) manufacturer(s) of
the medicinal product
1.13 Certificate of good manufacturing practice of the establishment(s) manufacturer(s) of
the diluent (if applicable)
1.14 For foreign-made medicines, in addition to the above
1.14.1 Certificate of Free Sale or equivalent
1.14.2 Letter of representation
1.15 Distinctive name (commercial)
1.16 Patent information of the drug(s)
MODULE II. QUALITY INFORMATION
2.1 Drug (Integrating the drug and the diluent if applicable)
2.1.1 Manufacturing information
2.1.2 General information
 2.1.3 Drug controls
2.1.3.1 Specifications with their justification
2.1.3.2 Monograph or bibliographic references
2.1.3.3 Analytical methods
2.1.3.4 Validation of analytical methods
2.1.3.5 Analytical certificate
2.1.4 Closing Container System Information
2.1.5 Stability
2.1.5.1 Stability report
2.2 Finished product (medicine and diluent if applicable)
2.2.1 Quali-quantitative formula
2.2.2 Description of the medicinal product
2.2.3 Manufacturing information
2.2.3.1 Process description / flowchart
2.2.3.2 In-process controls
2.2.4 Controls of the finished product
2.2.4.1 Specifications with their justification
2.2.4.2 Analytical methods
2.2.4.3 Analytical certificates
2.2.5 Stability studies
2.2.5.1 Protocol to the stability study
2.2.5.2 Mixture stability study
2.2.6 Container system closure
2.2.6.1 Description and capacity of the primary packaging
2.2.6.2 Description and capacity of the secondary packaging
2.2.6.3 Description and capacity of attached devices
MODULE III. ORPHAN PRODUCT RECOGNITION
3.1 Prevalence of reported cases of the disease in the population
3.2 International database information of the recognition of orphan drugs
3.3 Information of diagnosed cases in Mexico
MODULE IV. PRECLINICAL STUDY INFORMATION
4.1 Preclinical studies
4.2 Pharmacodynamic studies
4.3 Pharmacokinetic studies
4.4 Toxicology
MODULE IV. CLINICAL TRIAL INFORMATION
5.1 Phase I studies
5.2 Phase II studies
5.3 Phase III studies
5.4 Phase IV Studies (if applicable)