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:

CLINICAL TRIAL DETAILS

  • 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

WAREHOUSING

  • 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

  • Sponsor contact information
    • Name of the sponsor institution/company
    • Name and surname of the contact person
    • Address
    • Phone number
    • Fax number
    • E-mail
  • 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
    • E-mail
  • IMP Code(s) and quantity of the product(s) to be imported

OTHER FILES

  • 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

Omega is the first clinical trial specific depot in Turkey. We offer clinical trial storage services since 2003. Also Omega is the only one clinical trial specific depot that stored and distrubute 340.000 IMPs for Turkish Ministry of Health.