Licensing a pharmaceutical factory

Estimated Time:

Two weeks from the date of submitting documents 

Location:

Health Professions and Institutions Licensing Directorate/ Pharmaceutical Institutions Licensing Department  

Estimated Fee:

(50) JD

1
  • Description
  • Procedures
  • Required Documents
  • Persons benefiting from the service
  • Files
  • Related Services

none

Conditions for obtaining service

  1. The technical manager should be a licensed full-time pharmacist.
  2. An area of 2000 square meters available for the factory to be licensed. 

Notes

none

Partner institutions:

none

Procedures

  1. Referring to the Pharmaceutical Institutions Licensing Department and submitting the application on the form of factory licensing and requesting an inspection and attaching the required documents.
  2. Auditing documents and accrediting the application.
  3. Documenting application in the register.
  4. Transferring the application to the director of the Health Professions and Institutions Licensing Directorate to be transferred to the Pharmaceutical Institutions Licensing Department.
  5. Placing the licensing applications on the program of field inspection.
  6. The relevant committee inspects the site to make sure that conditions are met.
  7. In the event of disapproval, the applicant is given an official letter with the reasons of disapproval.
  8. If conditions are met the due fees are paid in finance section.
  9. The applicant is granted an approval signed by the Minister for licensing and work commencement. 

Required Documents

  1. Lease contract in the name of the licensing applicant (valid) or title deed of the premises where the factory is to be licensed.
  2. Area plan from a licensed surveyor with report attached stating the area of the factory.
  3. Approval of the Ministry of Environment of the location of the factory.
  4. valid organizational location plan (issuance date within one year).
  5. Copy of the letter of appointment of the technical manager.
  6. Copy of professions practice certificate for the technical manager.
  7. Copy of the commercial register issued by the Ministry of Industry, Trade and Supply.
  8. Copy of trade name registration certificate. 

Persons benefiting from the service

Individuals wanting to invest in the pharmaceutical industries sector. 

Files

No Found Files

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