Import-Export-Transit Permit of Controlled Drugs

Any individual or organizations that intend to: - Import for production, distribution, or possession of controlled drugs - Export - Transit Must obtain approval from the Ministry of Health when the import of the controlled drugs.

1. Pharmaceutical factory and Import-Export of Pharmaceutical company which has been duly registered with the conditions that can import-export and distribution
2. Pharmaceutical store class I and II which has been duly registered with the conditions that can retail in accordance with doctor’s prescription
3. State hospital at a central and local level or private hospital with a license in accordance with condition that can distribute or retail by a pharmacist as per doctor’s prescription.

• Law on Drugs and Medical Products (Amended) 07/NA · 21.12.2011
• Order on the Management of Narcotics and Psychotropic Substances 456/MOPH · 19.04.2006
• Decision on the List of Controlled Drugs for Distribution and Sales and Prescription and List of General Drugs for Distribution-Sales and General Use 1498/MOH · 25.11.2002

Means of presentation

At the Authority Offices

Address of authority

Food and Drugs Department, Ministry of Public Health

Processing time

3

Has an expiry date

YES

Renewal process

- This permit is valid from the signing date until 31 December of that year. - It does not need to renew the import authorization. In case there is no importation during the specified period the import authorization will be eliminated.

- Before import-export-transit of the controlled drugs the authorized importer must obtain an import authorization from the Ministry of Health. - The import company must declare the import authorization and relevant documents to the food and drug authority at the checkpoint each time. In case there is any change in the import authorization the import company must return the original of the import authorization to the Food and Drug Department in order to amend such import authorization.