Registration needs in Syria
General Information about the Manufacturer

Name of company:
Main address:
Names & addresses of various working branches:

Inside country of origin
Address                                                       Name

Outside country of origin
Address                                                       Name

Name and address of branch supplying the Syrian market

N.B. If the branch supplying the Syrian market is not the Mother Company, please fill separate application for the Mother Company.

Names and addresses of the companies, those cooperate or share in its activities, in the field of Drugs. What sort of relation?

Year of foundation and date of any further modification if there is any.

 Registered annual capital

 Working annual capital (optional)

 Annual sales value (optional)

Commercial from

Total number of employees

Additional requirements for registering the pharmaceutical companies in Syria

Possession of the company if it is private, public or stock company with other needed information about this point.

GMP certificate.

A copy of manufacturing license.

Names, year of foundation, kind of relationship with a copy of the contact available and GMP certificates of all manufacturer partners if there is any.

To which countries you are exporting the product you are going to export to Syria with a copy of documents that approve this exportation and all other necessary information where you are registering for the time being, we need maximum 5 countries if this is available and we have to mention if the opposite is being

Raw materials suppliers for the chosen products and the way of its approval and evaluation.

In case you are producing raw material by your self, to which countries you are exporting.

Registered capital in the local currency and USD together.  

Names and formulas of its pharmaceutical preparations (N.B. may be submitted separately)

Are these preparations totally or partially manufactured by the firm itself?

If partially manufactured what are these products, where manufactured and why?

Research products produced by the firm itself during the last ten years

Other activities besides pharmaceutical manufacturing

Research Division

Do you have research laboratories?

Number of specialized personnel working in these research laboratories (excluding administration)

Physicians: 

Pharmacists:        

Chemists:   

Others:       

What research activities and trials carried by these laboratories?

Do you own or have at your disposal hospitals or medical centers for carrying out tests and experiments on your products.

Do you collaborate with universities or scientific centers in research fields? Give details

What is the annual budget reserved for research and development?

Number of square meters assigned for these laboratories

Production Division

Origin of principal raw material

- Self manufacturing?    

- Under License?           

- Other sources?            

Number and qualification of personnel working in this division:

Pharmacist 

Chemist      

Others        

Number of square meters assigned for production area:

Control Laboratories

Do you have control Laboratories?

- For testing raw materials             

- For in-process control                  

- For testing final products             

What type of Laboratory tests you perform?

- Physico - chemical tests                

- Microbiological tests           

- Pharmacological tests                  

- Other tests

 

Number and qualification of personnel working in these laboratories

Do you resort to the aid of other laboratories for control purpose, name these labs and indicate what sort of assistance?

Number of square meters assigned for these laboratories

Give in details the activities performed by the competent authorities for controlling your establishment and its production

I the undersigned (full name of the person responsible for the establishment) Hereby declare that all the information given above are true, and I assume full responsibility for this Declaration with all consequences, which might arise from false or erroneous information

Date

Name of establishment

Signature and Stamp

Legalization of the Ministry of Health or the official organization in charge of the control and inspection of pharmaceutical manufacturers that the information given is correct

Legalization of the Syrian embassy

N.B.

Please sign and stamp each page of this form

Special questioner about the relation between the company and Israel

(All answers should be no)

1. Do you have now or previously a major or subsidiary company or plant or assembling in Israel.

2. Do you have now or previously a General agencies or office in Israel which take over your business in Middle East or in international level.

3. Did you or any of your subsidiaries grant Israeli persons or in situations the right of utilizing your name or your trade marks or manufacture permissions or inventions….etc

4. Do you have now or previously shares in Israeli institutions or Israeli business inside or out side Israel

5. Do you present now or previously any consolatory service or technical assistance to any Israeli institution or establishment

6. Do you present now or previously any Israeli institutions or establishment inside or outside Israel.

7. What are names & nationalities & nature of companies business in which you have share and what is the percentage of your capital share in each company.

8. What are names & nationalities of those companies which have shares in your company it self or your subsidiaries and what is the percentage of their shares in the capital of each company and what does these shares represent in the total capital of shared company.

Please let us the required affidavit taking into your consideration that this affidavit should be legalized by Syrian Embassy.

This section must be legalized separately

Instructions for the registration of human pharmaceutical products

In virtue of the technical committee’s decision taken in its session on 8/10/85 and its session on 17/12/89 for the introduction on your products into Syrian markets. You are kindly requested to observe the following instruction when submitting an application for the registering of new products:

1. Application for registering should be addressed to General Foreign trade organization

2. An original certificate of origin issued by the health authorities entitled to issue such certificate. Duly legalized by the Ministry of Foreign Affairs of your country and by Syrian or acting embassy in your country, testifying that the pharmaceutical preparation required to be registered is manufactured and sold or used in country or origin. This certificate to be worded according to the enclosed model of the certificate of origin adopted by the world health organization. This certificate should be accompanied by this certified translation into Arabic by a sworn translator legalized by Ministry justice and Ministry of Foreign Affairs.

3. Documents displaying the composition of product in its active ingredients and excipients and its conservation elements. Components along with packing and packaging materials. The technical Manager or the production Manager of the plant should sign this document.

4. A document showing the method of analysis of all components of the preparation and its stability study signed by the Manager of analysis laboratory of the plant.

5. A certificate of analysis for all the samples submitted for consideration.

6. Samples for pharmaceutical active substances and reference standard standing materials for the active ingredients. Primary reference standards for the active ingredients.

7. Some copies of the study made on the preparation. 

8. G.M.P certificate and other support documents providing such a certificate to be duly legalized by Health authorities in country of origin and duly legalized from containing General data on the manufacture.

9. Please send a full additional copy of registration file in favour of the directorate of control laboratories and pharmaceutical research with reference standards or a notified validity for each pharmaceutical preparation to be imported.

1- PRECLINICAL STUDIES    

Chemistry:

Active substance

Pharmacology

Toxicology (animal)

Drug formulation analysis

Formulation for route

Pharmaceutical form

Dosage schedule

Drug interaction

111 Subjects

2- CLINICAL STUDIES:

Protocol

Therapeutic effects

Pharmacodynamic effects

Pharmacokinetics

Drug monitoring

Clinical Pharmacology

Phase1       24-30 months

Phase11     12-24 months

Phase111   12-24 months

Phase 1V   12-24 months

A fifty (V) phase with unlimited period

Metabolism Biotransformation

Toxicology (HUMAN)

Acute chronic isolation of liver

Protein biding

Enzymatic system (liver)

Single dose, repeated dose

Study of metabolic after administration I.V.P. O. (Gold product radiolabelled product)

Excretion of urine and bile

3- TOXICITY:

Hematological (leucopoenia agranulocytosis thrombocytopnic and lemolyticanemia teratogenesis in animal and in the Human normal dose and large doses in pregnancy different period.

Immunological studies

10. A duly legalized document indicating the name of the manufacturer of active ingredients to be attached to studies carried out these active ingredients as required in paragraph 7

11. Price quotation for the submitted product. Preferably on C&F basis

12. A certificate showing the public selling price of the preparation in country of origin duly legalized by the bodies referred to in
paragraph 2 (it is not a must)

13. The application for registration s well as the document act out in item:

A. Should be put in an envelop featuring the statement (registration of new products) and send to General Foreign trade Organization through registered airmail the number and date of the circular should as well be written down on the envelope.

B. A cheque covering US$ 150 awarded to General Foreign Trade Organization, as evolution fees for each preparation and dosage packing accompanied by a letter indicating the name of preparations submitted for evaluation.

C. 30 samples of the preparation destined for sale. And could be more in case tests are carried out thereon.

D. When the preparation is accepted in the M.O.H. a sum of US$ 250 should be paid as registration fees

E. The Certificate of origin will remain for 5 years starting from the registration date of the product in Syria and should be renewed each 5 years with no payment fees.