Table Of Contents (TOC) for MONGOLIA

MONGOLIA

Authority

website

if any

REQUIREMENT FOR PRODUCT REGISTRATION

S.No.

INDEX

1.

Notarized copy of the certificate of company/Bussiness registration Factory premises by the district office.

2.

Document from the manufacture of product owner authorizing the applicant to be the product license holder.

Document from that the product is manufactured under license of the product owner profile of the manufacturer

3.

Document from relevant drug country of authority certifying that the manufacturer is in compliance of the GMP requirements of the country.

Free sale Certificate from country of origin and product registration    
A).certificate from other countries and approved indication(s) for the

product, If any

4.

The pharmaceutical product certificate WHO – type are attached (for countries who are members of WHO certification Scheme)

5.

Product Information A) Product specification B) Certificate of Analysis of the finished product (recent copies of such Certificates should be submitted.) C) Method of analysis of active ingredient (s) D) Method of analysis of Finished product E) Stability study data justifying the shelf life of the medicinal product F) Therapeutic Indication (Summary of main indication) G) Master manufacturing formula (including details of batch size) H) Manufacturing process (including in – process quality Control)

6.

Pharmacological Data

A) Bioavailability Studies

B) Brief summary of the main adverse side effects (including effects on the ability to drive and use machines, effects of the product in pregnancy)

C) Brief summary of the main interaction with other medicaments and other forms of interaction.

7.

Clinical Data:

Brief summary of the  clinical data on the safety, efficacy and toxicity of the product with a brief description of the conclusion (not include essential drugs )( Not relevant to generic drug)

8.

Samples of the finished product and reference substances. (adequate quantity for laboratory testing)

Label, pamphlet, carton (including batch number, expiry date and precautionary label, if any)