Import License
We provide import license submission procedures to MoH. Our depot is also 8 km (5 miles) to MoH. With these location advantage, we speed up the submission procedures.
For import license procedures please provide below information and files, to see details please click on related section.
- Full title of the clinical trial
- Protocol number of the trial (if exists)
- Names of the clinical trial centers/Name and surname of the person to be delivered/Quantity of the trial supplies to be delivered
- Is there a domestic warehouse for the trial supplies?
- Does the warehouse own an authorization certificate? (Please insert Omega’s authorization certificate)
- Is there any person/institution or company responsible of trial supplies warehousing? Address and contact information
- Sponsor contact information
- Name of the sponsor institution/company
- Name and surname of the contact person
- Address
- Phone number
- Fax number
- Legal represent of the sponsor (if different from the sponsor)
- Name of the sponsor institution/company
- Name and surname of the contact person
- Address
- Phone number
- Fax number
- IMP Code(s) and quantity of the product(s) to be imported
- A copy of the first letter of conformity given by the Ministry for the initiation of the trial (if this is a conditioned conformity, a sample of the letter given by the Ministry related to the completion of the condition should be attached to the application file)
- License of authorization -if exists- (Original license of authorization for the first import application, license of authorization photocopy for the other applications)
- Proforma invoice for trial product(s) (Approved and signed in 2 copies by the company which arranged the proforma invoice or the company which applied for the import)
- Original Receipt (and a sample) received in return of the application fee payment according to fee published on General Directorate of Pharmaceuticals and Pharmacy official website.
- A copy of the warehouse authorization certificate (if a warehouse exists)
- In case of use of products obtained from blood in clinical drug trials; an original document apostilled by the productor company which states that the donors neither have Creutzfeldt-Jakob disease nor have a suspicion of Creutzfeldt-Jakob disease.
- In case of restricted substances (narcotic and/or psychotropic substances) use in clinical drug trials; a document indicating application for authorization to General Directorate of Pharmaceuticals and Pharmacy Narcotic and Psychotropic Department