Table Of Contents (TOC) for Ministry of Health Iraq

Ministry of Health, Iraq

Authority

MOH, Technical affairs Directorate Registration Department

website

www.iraqiphrma.com/registration%20req.htm

if any

DOSSIER REQUIRMENTS

S.No

Documents

Page No

1

Registration form to be filled in one copy.(appendix 3)  

2

Free sale certificate issued by the health authority legalized officially (including the number and date of registration and that the product is freely sold in the country of origin). e.g.: according to WHO form.     

3

Product(s) of significant therapeutic and pharmaceutical value that are not marketed in the country of origin but available in other countries can be exempted from the country of origin stipulation through the submission of an approval certificate from one of the following authorities (FDA, HPB, CE, OPSR)     

4

Method of manufacturing in detail.  

5

Specifications of the finished products    

6

Certificate of analysis for the finished products.    

7

Quantities and specifications of both active and non-active ingredients which should be according to the latest edition of either BP, or USP, or Japanese pharmacopoeia unless it is not stated.      

8

Specifications of the packaging materials.    

9

List including countries where the item had been registered including number and date of registration.     

10

In process and finished product Q.C. method with the validation of that method unless the product was a pharmacopeal one.   

11

Bioavailability and/ or bioequivalence study    

12

BSE Certificate.    

13

A certificate stating the safety of blood products from HIV, HAV, HDV, HCV, HBS, submitting control method used for the pool and individual blood.     

14

For herbal products and supplements (any product of plant or animal origin that may improve the welfare of health in human being without a known toxic or adverse effects), all the mentioned above requirements are required except what is mentioned at number 11. 

15

For oral liquid dosage forms in addition to the mentioned above submit a certificate issued by the health authority legalized officially confirm that there is no contamination with diethylene glycol in the raw materials used in the production of these products.     

16

If alcohol is used in the formula, specify its percentage and state the reasons for such percent.      

17

Any scientific studies (pharmacological, clinical, toxicological and antidotes studies). For new entity drugs.    

18

Stability studies derived from tests on the final dosage form in its final and marketed container and packaging.     

Accelerated stability   

Long term stability  

19

In case of manufacturing by contract whether importing the finished and packed, bulk products to be packed or semi finished to be processed and packed, the GMP certificate of the contract manufacturer of the relevant product is required.   

20

In case of under license arrangement the applicant should submit an official letter from the mother company conforming its approval to export this item to Iraq.             

21

Multinational companies can register products of its different manufacturing sites under the mother company’s name, only the GMP certificates of the subsidiary facility is required together with the requirements of registering the product.     

22

Registration and analysis samples required are as stated in (appendix5)     

23

Companies who wish to register their products should submit all the requirements for analysis    

a) International reference standards for the active components and the related substances      

24

Samples of the outer pack and label         

25

Samples of insert leaflets       

26

For national pharmaceutical products, all the mentioned above requirements to be submitted except what is mentioned at no. 2, 3, 9.

27

Registration fee $165 for each product.