Table Of Contents (TOC) for MEXICO

MEXICO

Authority

Secretaria de salud commission nacional de Investigacion en salud

website

www.salud.gob.mx/, http://201.147.97.103/

if any

DOSSIER REQUIRMENTS

1.

Certificate of Pharmaceutical Product

This document has to be due legalized before Mexican embassy from origin country or with Apostille.

2.

GMP certificate issued by the local authorities.

GMP certificate issued by the origin country.

This document has to be due legalized before Mexican embassy or with Apostille.

3.

Letter of authorization in a letter head paper and signed by the legal representative of the owner of product.

Technical Documents

2.

Qualitative and Quantitative formula with function of each ingredient and Pharmacopoeial references either they are or not in the finished product, signed by the responsible technician.

3.

Justification of Pharmaceutical form, formulation, Manufacturing Process, In-Process controls and Packaging material.

4.

Raw Material Specifications & Standard Test Procedures (Active ingredient) with Bibliographic references

5.

Validation Report of the API methods if the method is non-pharmacopoieal along with the chromatograms for all the parameters of validation i.e. Assay, Related substances and Residual solvents as applicable.

6.

Certificate of Analysis of Active Ingredient with Identification, Assay, related substances and Residual solvents (wherever applicable) chromatograms and Calculation sheets/ spectras.

7.

API Information

8.

Raw Material Specifications & Standard Test Procedures (Excipients including capsules) with Bibliographic references

9.

Certificate of Analysis of Excipients from the manufacturer of Dosage form and Supplier of Excipient.

To include TSE free certificate for excipients derived from human or animal sources containing stearates, capsule shell etc.          

10.

Manufacturing Procedures

Summary of Mfg Process

Flow chart with controls and frequency

11.

Validation Protocol of the manufacturing Process of the drug product, including report + analytical evidence.

12.

Manufacturing Order (Executed FO), In process Tests for 3 stability batches/ 3 commercial batches.

13.

Packaging Material Specifications & Standard Test Procedures.

14.

CoAs of Packaging Material from the manufacturer of Dosage form and Supplier of Packaging Material. To include Water vapour permeation test results for HDPE materials.

15.

Packaging line records including leak tests for 3 stability batches/3 commercial batches with a declaration of performing leak test during packaging process (when applicable).

16.

Finished Product Specification and Standard Test Procedures with Bibliographic references.

FPS and STP has to be done as per the pharmacopoeia (if applicable).

17.

Certificate of Analysis of Finished Product  with Identification, Assay, Dissolution, Related Substances and uniformity of dosage units chromatograms/ spectras for 3 stability batches or any 3 commercial batches.

18.

Analytical validation Report of Assay, Related substances and dissolution method as applicable along with the chromatograms for all the parameters of validation, in case method of Finished product is non-Pharmacopoeial.

19.

Stability Data including Protocol

20.

Scientific Information

Interchangeability test/ BE Study Report against Test and Mexico Innovator, to be conducted locally at CRO approved by MOH.